AbbVie to Showcase Oncology Portfolio and Pipeline During the 2022 ASCO and EHA Annual Congresses | INN

2022-05-14 21:45:06 By : Ms. Yvonne Lau

ABBVie (NYSE: ABBV) will present 46 abstracts across eight types of cancer during the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting ( June 3-7 ) and the European Hematology Association (EHA) Congress ( June 9-17 ).

"AbbVie continues working to transform the standards of care for cancer treatments as a result of our commitment to patients, innovation and partnerships," said Mohamed Zaki , M.D., Ph.D., vice president and global head of oncology development, AbbVie. "The data being presented at ASCO and EHA will provide a look at our continued research advancements in cancer across our expanding oncology portfolio and pipeline."

During both meetings, AbbVie will present nine abstracts evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, including data from multiple arms of the ongoing phase 1b /2 EPCORE™ NHL-2 clinical trial, evaluating the safety and preliminary efficacy of epcoritamab in combination with standard-of-care therapies for the treatment of various types of B-cell non-Hodgkin lymphoma (NHL). Additionally, data will be presented from the Phase 2 REFINE study of investigational compound navitoclax + ruxolitinib in JAK inhibitor-treatment-naïve patients with myelofibrosis.

At this year's ASCO annual meeting AbbVie will be presenting on its solid tumor research with data from telisotuzumab vedotin (Teliso-V) in non-small cell lung cancer.

During the EHA Congress, the five-year update from the CLL14 trial of a combined regimen of venetoclax + obinutuzumab versus obinutuzumab + chlorambucil comparing the efficacy and safety in participants with untreated chronic lymphocytic leukemia (CLL) will be presented.

Details about presentations are as follows:

Primary Results From the Double-Blind, Placebo-Controlled, Phase III SHINE Study of Ibrutinib in Combination With Bendamustine- Rituximab (BR) and R Maintenance as a First-Line Treatment for Older Patients (Pts) with Mantle Cell Lymphoma (MCL)

Session: Hematologic Malignancies— Lymphoma and Chronic Lymphocytic Leukemia

Fixed-Duration (FD) Ibrutinib (I) Plus Venetoclax (V) for First-Line (1L) Treatment (tx) of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) 3-year Follow-up From the FD Cohort of the Phase 2 CAPTIVATE Study

Session: Hematologic Malignancies— Lymphoma and Chronic Lymphocytic Leukemia

Phase 1/2 Study of Zilovertamab and Ibrutinib in Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL)

Session: Hematologic Malignancies— Lymphoma and Chronic Lymphocytic Leukemia

Prognostic Testing and Treatment Patterns in Black Patients (Pts) With Chronic Lymphocytic Leukemia (CLL) From the Inform CLL Prospective Observational Registry

Upper Gastrointestinal (GI) Morbidity, Peptic Ulcer Risk, and Proton Pump Inhibitor (PPI)/H2 Blocker (H2B) Use in Patients (Pts) Treated With Bruton's Tyrosine Kinase Inhibitors (BTKis) During Routine Care

Characteristics and Clinical Outcomes Among Patients Receiving Either Ibrutinib or Anti-CD20 Monotherapy as First-Line (1L) Treatment for Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) A Retrospective Analysis in Community Oncology Practice

Real-World Clinical Outcomes in Patients Receiving Either Ibrutinib or Chemo- Immunotherapy (CIT) as First-Line (1L) Treatment for Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) A Retrospective Analysis

Efficacy and Safety of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients with Untreated Acute Myeloid Leukemia

Session: Hematologic Malignancies— Leukemia, Myelodysplastic Syndromes, and Allotransplant

First-Line Treatment (Tx) With Subcutaneous (SC) Epcoritamab (Epco) + R-CHOP in Patients (Pts) With High-Risk Diffuse Large B-Cell Lymphoma (DLBCL): Phase 1/2 Data Update

Session: Hematologic Malignancies— Lymphoma and Chronic Lymphocytic Leukemia

Subcutaneous Epcoritamab With Rituximab + Lenalidomide (R 2 ) in Patients (Pts) with Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Update from Phase 1/2 Trial

Session: Hematologic Malignancies— Lymphoma and Chronic Lymphocytic Leukemia

Subcutaneous Epcoritamab + R-DHAX/C in Patients (Pts) With Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Who Are Eligible for Autologous Stem Cell Transplant (ASCT): Preliminary Phase 1/2 Results

Session: Hematologic Malignancies— Lymphoma and Chronic Lymphocytic Leukemia

Epcoritamab (Epco) with Gemcitabine + Oxaliplatin (GemOx) in Patients (Pts) With Relapsed or Refractory (R/R) Diffuse Large B‑Cell Lymphoma (DLBCL) Ineligible for Autologous Stem Cell Transplant (ASCT) Induces High Response Rate Even in Pts Failing CAR T Therapy

Session: Hematologic Malignancies— Lymphoma and Chronic Lymphocytic Leukemia

Navitoclax Plus Ruxolitinib in JAK inhibitor- Naïve Patients (Pts) With Myelofibrosis: Preliminary Safety and Efficacy in a Multicenter, Open-Label Phase 2 Study

Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Lemzoparlimab (Lemzo) with Venetoclax (Ven) and/or Azacitidine (Aza) in Patients (Pts) With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) A Phase 1b Dose Escalation Study

Session: Hematologic Malignancies— Leukemia, Myelodysplastic Syndromes, and Allotransplant

Phase 1/1B study of Telisotuzumab Vedotin (Teliso-V) + Osimertinib (Osi), After Failure on Prior Osi, in Patients (Pts) With Advanced, c-Met Overexpressing, EGFR-Mutated Non- Small Cell Lung Cancer (NSCLC).

Session: Lung Cancer – Non-Small Cell Metastatic

Telisotuzumab Vedotin (Teliso-V) Monotherapy in Patients (Pts) With Previously Treated c-Met-Overexpressing (OE) Advanced Non-Small Cell Lung Cancer (NSCLC)

Session: Lung Cancer – Non-Small Cell Metastatic

The ASCO 2022 Annual Meeting abstracts are available here .

Immune Restoration and Synergistic Activity with First-Line (1L) Ibrutinib (IBR) Plus Venetoclax (VEN): Translational Analyses of CAPTIVATE Trial Patients with CLL

Primary Results From the Phase 3 Shine Study of Ibrutinub in Combination With Bendamustine-Rituximab (BR) and R Maintenance as a First-Line Treatment for Older Patients With Mantle-Cell Lymphoma

Session: Indolent and Mantle Cell Lymphoma

Absence of BTK, BCL2, and PLCG2 Mutations in Relapsing Chronic Lymphocytic Leukemia (CLL) After First-Line Treatment with Fixed- Duration Ibrutinib (I) Plus Venetoclax (V)

Session: Chronic lymphocytic leukemia and related disorders - Clinical Friday, June 10, 2022

Fixed-Duration (FD) Ibrutinib + Venetoclax for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymophocytic Lymphoma (SLL): 3-Year Follow-up From the Phase 2 CAPTIVATE Study FD Cohort

Cross-Trial Analysis of Fixed-Duration Ibrutinib (I) Plus Venetoclax (V) Vs Fludarabine (F), Cyclophosphamide (C), And Rituximab (R) As First-Line Treatment for Chronic Lymphocytic Leukemia (CLL)

Session: Chronic lymphocytic leukemia and related disorders - Clinical Abstract Publication Only

Venetoclax-Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia: 5- Year Results of the Randomized CLL14 Study

VIALE-M: A Randomized, Double-Blind, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Intensive Chemotherapy

Session: Acute myeloid leukemia - Clinical Friday, June 10, 2022

VIALE-T: A Randomized, Open-Label, Phase 3 Study of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia

Session: Acute myeloid leukemia - Clinical Friday, June 10, 2022

The Impact of Post-Remission Granulocyte Colony-Stimulating Factor Use in the Phase 3 Studies of Venetoclax Combination Treatments in Patients With Newly Diagnosed Acute Myeloid Leukemia

Session: Acute myeloid leukemia - Clinical Friday, June 10, 2022

Transfusion Independence Among Newly Diagnosed Acute Myeloid Leukemia Patients Receiving Venetoclax-Based Combinations Vs Other Therapies: Results from the AML Real World Evidence (ARC) Initiative

Session: Acute myeloid leukemia - Clinical Friday, June 10, 2022

Clinical Outcomes in Patients With Higher-Risk Myelodysplastic Syndromes Receiving Hypomethylating Agents: a Large Population-Based Analysis

Session: Myelodysplastic syndromes - Clinical Friday, June 10, 2022

Venetoclax in Patients With Chronic Lymphocytic Leukemia With 17p Deletion: 6- Year Follow-Up and Genomic Analyses in a Pivotal Phase 2 Trial

Treatment Sequences and Outcomes of Patients (Pts) with CLL Treated With Targeted Agents in Real-World Settings

Session: Chronic lymphocytic leukemia and related disorders - Clinical Friday, June 10, 2022

Healthcare Resource Utilization and Costs Of Therapy With Fixed-Duration Venetoclax Among CLL Patients (Pts)

Transcriptomic Characterization of MRD Response and Non-Response in Patients (Pts)

Treated With Fixed-Duration Venetoclax- Obinutuzumab

Fixed-Duration (FD) Ibrutinib (I) Plus Venetoclax (V) for First-Line (1L) Treatment (Tx) of Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL): 3-Year Follow-Up From the FD Cohort of the Phase 2 CAPTIVATE Study

PedAL/EuPAL International Collaboration to Improve the Outcome of Children With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Session: Acute myeloid leukemia - Clinical Friday, June 10, 2022

Cross-Trial Analysis of Fixed-Duration Ibrutinib (I) Plus Venetoclax (V) Versus Fludarabine (F), Cyclophosphamide (C), and Rituximab (R) as First-Line Treatment for Chromic Lymphoma Leukemia (CLL)

Session: Chronic lymphocytic leukemia and related disorders - Clinical Abstract Publication Only

Safety and Effectiveness of Venetoclax Monotherapy in Relapsed/Refractory CLL Patients (Pts) With or Without Risk-Associated Genetic Markers – Data from the Observational VeRVe Study

Session: Chronic lymphocytic leukemia and related disorders - Clinical Friday, June 10, 2022

Effectiveness and Safety of Venetoclax in Combination with Rituximab (VenR) in Relapsed/Refractory CLL Patients With or Without Risk-Associated Genetic Markers – Data from the Observational VeRVe Study

Session: Chronic lymphocytic leukemia and related disorders - Clinical Friday, June 10, 2022

Real-Life Efficacy and Safety of Venetoclax Monotherapy in Relapsed/Refractory Chronic Lymphocytic Leukemia – Interim Analysis of Multicentric Study VERONE

Session: Chronic lymphocytic leukemia and related disorders - Clinical Friday, June 10, 2022

Venetoclax in Combination With Obinutuzumab in First Line Chromic Leukemia in Argentina: A Cost-Effectiveness Analysis

Session: Quality of life, palliative care, ethics and health economics Friday, June 10, 2022

Lemzoparlimab (Lemzo) With Venetoclax (Ven) And/Or Azacitidine (Aza) in Patients (Pts) With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS): A Phase 1b Dose Escalation Study

Session: Acute myeloid leukemia - Clinical Friday, June 10, 2022

Assessing Safety, Tolerability, and Efficacy of Subcutaneous Epcoritamab in Novel Combinations With Anti-Neoplastic Agents in Patients (Pts) With Non-Hodgkin Lymphoma in an Open-Label Phase 1B/2 Study

Session: Aggressive Non-Hodgkin lymphoma - Clinical Abstract Publication Only

Subcutaneous (SC) Epcoritamab + R-CHOP in Previously Untreated Patients (Pts) With High- Risk Diffuse Large B-Cell Lymphoma (DLBCL): Phase 1/2 Data Update

Subcutaneous (SC) Epcoritamab With Rituximab + Lenalidomide (R2) in Patients (Pts) With Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Update From Phase 1/2 Trial

Subcutaneous (SC) Epcoritamab + R-DHAX/C in Patients (Pts) With Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Who Are Eligible For Autologous Stem Cell Transplant (ASCT): Preliminary Phase 1/2 Data

Epcoritamab With Gemcitabine + Oxaliplatin (GemOx) in Patients (Pts) With Relapsed or Refractory (R/R) Diffuse Large B Cell Lymphoma (DLBCL) Who Are Ineligible for Autologous Stem Cell Transplant (ASCT): Phase 1/2 Data

Navitoclax Monotherapy in Patients (Pts) With MF Previously Treated With JAK-2 Inhibitors: Safety and Tolerability

Session: Myeloproliferative neoplasms - Clinical Friday, June 10, 2022

Navitoclax plus ruxolitinib in JAK Inhibitor-naïve Patients with Myelofibrosis: Preliminary Safety and Efficacy in a Multicenter, Open-label Phase 2 Study

Session: Treatments and complications in MPN Friday, June 11, 2022

The EHA 2022 Congress abstracts are available here .

* Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' broad oncology collaboration.

**Lemzoparlimab is investigational and being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumor in collaboration with AbbVie and I-Mab.

***Use of venetoclax in myelodysplastic syndromes (MDS) is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About Ibrutinib (IMBRUVICA ® ) IMBRUVICA ® (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc. IMBRUVICA ® blocks the Bruton's tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, to multiply and spread. 1,2 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs. 3

IMBRUVICA ® is approved in more than 100 countries and has been used to treat more than 250,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 ongoing or completed Phase 3 studies, over 11 years evaluating the efficacy and safety of IMBRUVICA ® .

IMBRUVICA ® was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated for adult patients in six disease areas, including five hematologic cancers. These include adults with CLL/small lymphocytic lymphoma (SLL) with or without 17p deletion (del17p) and adults with Waldenström's macroglobulinemia (WM), as well as adult patients with previously treated mantle cell lymphoma (MCL)*, adult patients with previously treated marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy*, as well as adult patients with previously treated chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy. 4

*Accelerated approval was granted for MCL and MZL based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

Since 2019, the National Comprehensive Cancer Network ® (NCCN ® ), recommends ibrutinib (IMBRUVICA ® ) as a preferred regimen for first-line treatment of CLL/SLL, with Category 1 status for previously untreated patients without del17p. Additionally, IMBRUVICA ® is a preferred treatment regimen for previously untreated patients with del17p. Since January 2020, the NCCN Guidelines recommend IMBRUVICA ® as a category 2A preferred regimen for the treatment of relapsed/refractory MCL. Since September 2020, the NCCN Guidelines recommend IMBRUVICA ® with or without rituximab as a Category 1 preferred regimen for both untreated and previously treated WM patients.

For more information, visit www.IMBRUVICA.com .

*Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Side Effect Information 5 Before taking IMBRUVICA ® , tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA ® with certain other medicines may affect how IMBRUVICA ® works and can cause side effects.

How should I take IMBRUVICA ® ?

What should I avoid while taking IMBRUVICA ® ?

What are the possible side effects of IMBRUVICA ® ? IMBRUVICA ® may cause serious side effects, including:

The most common side effects of IMBRUVICA ® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

The most common side effects of IMBRUVICA ® in adults with cGVHD include:

Diarrhea is a common side effect in people who take IMBRUVICA ® . Drink plenty of fluids during treatment with IMBRUVICA ® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

These are not all the possible side effects of IMBRUVICA ® . Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of IMBRUVICA ® Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA ® for a condition for which it was not prescribed. Do not give IMBRUVICA ® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA ® that is written for health professionals.

Please click here for full Prescribing Information. 5

About VENCLEXTA®/VENCLYXTO® (venetoclax) 6

VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood cancers. Venetoclax is approved in more than 80 countries, including the U.S.

What is the most important information I should know about VENCLEXTA? VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA? Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

What should I avoid while taking VENCLEXTA? You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA? VENCLEXTA can cause serious side effects, including:

Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance .

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA ® can be found here .

Indications and Important Venclyxto (venetoclax) EU Safety Information 8

VENCLYXTO in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

VENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

VENCLYXTO monotherapy is indicated for the treatment of CLL:

Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

Hypersensitivity to the active substance or to any of the excipients is contraindicated.  Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumour lysis syndrome (TLS). Concomitant use of preparations containing St. John's wort as Venclyxto efficacy may be reduced.

Special Warnings & Precautions for Use

Tumour Lysis syndrome, including fatal events, has occurred in patients when treated with Venclyxto. For CLL and AML, please refer to the indication-specific recommendations for prevention of TLS in the Venclyxto summary of product characteristic (SmPC).

Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS.  The risk of TLS is a continuum based on multiple factors, including comorbidities. Venclyxto poses a risk for TLS at initiation and during the dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venclyxto and at each dose increase. During postmarketing surveillance, TLS, including fatal events, has been reported after a single 20 mg dose of venetoclax.

Neutropenia (grade 3 or 4) has been reported.  Complete blood counts should be monitored throughout the treatment period.

In patients with AML, neutropenia (grade 3 or 4) is common before starting treatment. The neutrophil counts can worsen with Venetoclax in combination with a hypomethylating agent. Neutropenia can recur with subsequent cycles of therapy. Dose modification and interruptions for cytopenias are dependent on remission status.

For CLL and AML, please refer to the indication-specific recommendations for dose modifications for toxicities in the Venclyxto SmPC.

Serious infections including sepsis with fatal outcome have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections should receive prompt treatment, including antimicrobials and dose interruption or reduction as appropriate.

Live vaccines should not be administered during treatment or thereafter until B-cell recovery.

In CLL and AML CYP3A inhibitors may increase Venclyxto plasma concentrations.

In CLL, at initiation and dose-titration phase, Strong CYP3A inhibitors are contraindicated due to increased risk for TLS and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, please refer to the recommendations for dose modifications in the Venclyxto SmPC.

In AML, please refer to the AML-specific recommendation for dose modifications for potential interactions with CYP3A inhibitors, in the VENCLYXTO SmPC.

Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.

CYP3A4 inducers may decrease Venclyxto plasma concentrations.  Avoid coadministration with strong or moderate CYP3A inducers. These agents may decrease venetoclax plasma concentrations.

Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.

The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab or rituximab were neutropenia, diarrhoea, and upper respiratory tract infection.  In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.

The most frequently occurring serious adverse reactions (≥2%) in patients receiving venetoclax in combination with obinutuzumab or rituximab were pneumonia, sepsis, febrile neutropenia, and TLS.  In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.

Discontinuations due to adverse reactions occurred in 16% of patients in both combination studies (CLL14 and MURANO). In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.

Dosage reductions due to adverse reactions occurred in 21% of patients treated with the combination of venetoclax and obinutuzumab in the CLL14 study, in 15% of patients treated with the combination of venetoclax and rituximab in the Murano study, and in 14% of patients treated with venetoclax in the monotherapy studies. The most common adverse reaction that led to dose interruptions was neutropenia.

The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in combination with azacitidine or decitabine in the VIALE-A and M14-358, respectively, were thrombocytopenia, neutropenia, febrile neutropenia, nausea, diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia, and decreased appetite, haemorrhage, dizziness/syncope, hypotension, headache, abdominal pain, and anaemia.

The most frequently reported serious adverse reactions (≥5%) in patients receiving venetoclax in combination with azacitidine were febrile neutropenia, pneumonia, sepsis and haemorrhage. In M14-358, the most frequently reported serious adverse reactions (≥5%) were febrile neutropenia, pneumonia, bacteraemia and sepsis.

Discontinuations due to adverse reactions occurred in 24 % of patients treated with venetoclax in combination with azacitidine in the VIALE-A study, and 26% of patients treated with venetoclax in combination with decitabine in the M14-358 study, respectively.

Dosage reductions due to adverse reactions occurred in 2% of patients in VIALE-A, and in 6% of patients in M14-358. Venetoclax dose interruptions due to adverse reactions occurred in 72% and 65 % of patients, respectively. The most common adverse reaction that led to dose interruption (>10%) of Venetoclax in VIALE-A, were febrile neutropenia, neutropenia, pneumonia, and thrombocytopenia.  The most common adverse reactions that led to dose interruption (≥5%) of venetoclax in M14-358 were febrile neutropenia, neutropenia/neutrophil count decreased, pneumonia, platelet count decreased, and white blood cell count decreased.

Patients with reduced renal function (CrCl

For patients with severe (Child-Pugh C) hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended.

Venclyxto may cause embryo-fetal harm when administered to a pregnant woman. Advise nursing women to discontinue breastfeeding during treatment.

This is not a complete summary of all safety information. See Venclyxto (venetoclax) SmPC at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About Epcoritamab Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells. 9 Epcoritamab was developed with selective, silencing mutations that may limit, systemic non-specific activity. 10 CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia. 11 ,12 Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' broad oncology collaboration.

About Lemzoparlimab Lemzoparlimab is investigational and being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumor in collaboration with AbbVie and I-Mab.

About Navitoclax Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. The BCL-2 family of proteins are known regulators of the apoptosis pathway. 13 Navitoclax is not approved by any regulatory authority. Its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.

AbbVie is currently recruiting for two Phase 3 trials of navitoclax (TRANSFORM-1 and TRANSFORM-2) in combination with ruxolitinib for the treatment of myelofibrosis that will enroll more than 500 patients. The company anticipates pivotal trial readouts and regulatory submission for navitoclax in 2023.

About Telisotuzumab Vedotin Teliso-V is an investigational antibody-drug conjugate (ADC) targeting c-Met, a receptor tyrosine kinase that is overexpressed in tumors including NSCLC. Teliso-V is not approved by any regulatory authority and its safety and efficacy are under evaluation.

About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology .

About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency . Accessed November 2020 . 2 Turetsky, et al. Single cell imaging of Bruton's Tyrosine Kinase using an irreversible inhibitor. Scientific Reports. volume 4, Article number: 4782 (2014) 3 de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012;119(11):2590-2594. 4 IMBRUVICA U.S. Prescribing Information, April 2020 . 5 IMBRUVICA U.S. Prescribing Information, April 2020 . 6 Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. 7 ISI verified against ISI listed on venclexta.com 24Oct2021 8 Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. 9 "Diffuse Large B-Cell Lymphoma." Lymphoma Research Foundation, https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/ ; date accessed: 11 February 2022 . 10 van der Horst, H.J., de Jonge, A.V., Hiemstra, I.H. et al. Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment. Blood Cancer J. 11, 38 (2021). https://doi.org/10.1038/s41408-021-00430-6 11 Rafiq, Sarwish, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties." J. Immunol. ( Baltimore , Md. 1950), U.S. National Library of Medicine, 15 Mar. 2013, www.ncbi.nlm.nih.gov/pmc/articles/PMC3631574/ . 12 Singh, Vijay, et al. "Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response." J Cancer Sci Ther., U.S. National Library of Medicine, Nov. 2015, www.ncbi.nlm.nih.gov/pmc/articles/PMC4939752/ . 13 Tsujimoto Y. (1998). Role of Bcl-2 family proteins in apoptosis: apoptosomes or mitochondria?. Genes to cells: devoted to molecular & cellular mechanisms, 3(11), 697–707. https://doi.org/10.1046/j.1365-2443.1998.00223.x

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CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for ZINBRYTA™ (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. ZINBRYTA is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. ZINBRYTA is also currently under regulatory review in the United States, Switzerland, Canada and Australia. “For people with relapsing forms of MS (RMS) and active disease, ZINBRYTA has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “ZINBRYTA may offer another option for people with multiple sclerosis (MS) with its targeted mechanism of action (MOA) which did not cause broad and prolonged immune cell depletion.” The CHMP positive opinion is now referred to the European Commission (EC), which grants marketing authorizations for centrally authorized medicines in the European Union. A decision from the EC is expected within the coming months. “Together with Biogen, AbbVie is committed to meeting the needs of patients with MS, and the positive opinion issued by the CHMP is a critical step that moves us closer to bringing ZINBRYTA to patients in Europe,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. According to the CHMP opinion, the benefits of ZINBRYTA are its ability to reduce the annualized relapse rate (ARR), as well as the risk of 24-week confirmed disability progression. The opinion is based on results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA 150 mg, administered subcutaneously every four weeks improved results on key measures of MS disease activity in patients with RMS compared to AVONEX 30 mcg intramuscular injection administered weekly and placebo, respectively. In the DECIDE study, the overall incidence of adverse events was similar in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA compared to AVONEX, there was an increased incidence of serious infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper limit of normal (6% versus 3%), gastrointestinal disorders (31% versus 24%), and depression (8% versus 6%). About ZINBRYTA™ (daclizumab) ZINBRYTA (daclizumab) is an investigational compound being developed for the treatment of relapsing forms of MS. ZINBRYTA is a new form of a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become activated in people with MS. ZINBRYTA modulates IL-2 signaling without general immune cell depletion. Biogen and AbbVie are jointly developing ZINBRYTA. About Biogen Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter. Biogen Safe Harbor This press release contains forward-looking statements, including statements about the anticipated timing of the EC’s decision on the marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA, if approved. These statements may be identified by words such as “believe,” “expect,” “may,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. You should not place undue reliance on these statements. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that the EC may fail to approve or may delay approval of ZINBRYTA or may not follow the recommendation of the CHMP, uncertainty of success in commercialization of ZINBRYTA For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities and risks relating to our collaborations with third parties, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page. Forward-Looking Statements Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel. According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung. Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars. The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion. Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

Click here to read the full article on Fierce Biotech.

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of ABBVie Inc. (NYSE: ABBV) between April 30, 2021 and August 31, 2021, inclusive (the "Class Period"), of the important June 6, 2022 lead plaintiff deadline.

SO WHAT: If you purchased AbbVie securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the AbbVie class action, go to https://rosenlegal.com/submit-form/?case_id=5119 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than June 6, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) safety concerns about Xeljanz and Xeljanz XR extended to Rinvoq and other Janus kinase (JAK) inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, defendants' statements about AbbVie's business, operations, and prospects lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the AbbVie class action, go to https://rosenlegal.com/submit-form/?case_id=5119 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Laurence Rosen, Esq. Phillip Kim, Esq. The Rosen Law Firm, P.A. 275 Madison Avenue, 40th Floor New York, NY 10016 Tel: (212) 686-1060 Toll Free: (866) 767-3653 Fax: (212) 202-3827 lrosen@rosenlegal.com pkim@rosenlegal.com cases@rosenlegal.com www.rosenlegal.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/124029

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Bronstein, Gewirtz & Grossman, LLC reminds investors that a class action lawsuit has been filed against the following publicly-traded companies. You can review a copy of the Complaints by visiting the links below or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss, you can request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. A lead plaintiff acts on behalf of all other class members in directing the litigation. The lead plaintiff can select a law firm of its choice. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff

Stronghold Digital Mining, Inc. (NASDAQ:SDIG)

Class Period: Class A common stock pursuant and/or traceable to the registration statement and prospectus (collectively, the "Registration Statement") issued in connection with Stronghold Digital Mining's October 2021 initial public offering ("IPO").

Deadline: June 13, 2022 For more info:www.bgandg.com/sdig.

The complaint alleges that the IPO's Registration Statement was materially false and misleading and omitted to state that: (1) contracted suppliers, including Minerva Semiconductor Corp., were reasonably likely to miss anticipated delivery quantities and deadlines; (2) due to strong demand and pre-sold supply of mining equipment in the industry, Stronghold Digital Mining would experience difficulties obtaining miners outside of confirmed purchase orders; (3) as a result, there was a significant risk that Stronghold Digital Mining could not expand its mining capacity as expected; (4) thus, Stronghold Digital Mining would likely experience significant losses; and (5) consequently, defendants' positive statements about Stronghold Digital Mining's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Aurinia Pharmaceuticals Inc.(NASDAQ:AUPH)

Class Period: May 7, 2021 - February 25, 2022

Deadline: June 14, 2022 For more info:www.bgandg.com/auph.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (1) Aurinia was experiencing declining revenues; (2) Aurinia's 2022 sales outlook for LUPKYNIS would fall well short of expectations; (3) accordingly, the Company had significantly overstated LUPKYNIS's commercial prospects; (4) as a result, the Company had overstated its financial position and/or prospects for 2022; and (5) as a result, the Company's public statements were materially false and misleading at all relevant times.

Lilium N.V. f/k/a Qell Acquisition Corp. (NASDAQ:LILM, LILMW, QELL, QELLU, QELLW)

Class Period: March 30, 2021 - March 14, 2022

Deadline: June 17, 2022 For more info:www.bgandg.com/lilm.

The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements and/or failed to disclose that: (1) Lilium materially overstates the Lilium Jet's design and capabilities; (2) Lilium materially overstates the likelihood for the Lilium Jet's timely certification; (3) Lilium misrepresents its ability to obtain or create the necessary batteries for the Lilium Jet; (4) the SPAC-merger would not and did not generate enough cash to commercially launch the Lilium Jet; (5) Qell Acquisition Corp. did not engage in proper due diligence regarding the Merger; and (6) as a result, defendants' public statements were materially false and/or misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

Bronstein, Gewirtz & Grossman, LLC Peretz Bronstein or Yael Nathanson

212-697-6484 | info@bgandg.com

SOURCE: Bronstein, Gewirtz and Grossman, LLC

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The Law Offices of Vincent Wong announce that class actions have commenced on behalf of certain shareholders in the following companies. If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. There will be no obligation or cost to you

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/volta-inc-loss-submission-form?prid=27234&wire=1 Lead Plaintiff Deadline: May 31, 2022 Class Period: August 2, 2021 - March 28, 2022

Allegations against VLTA include that: (1) Volta had improperly accounted for restricted stock units issued in connection with the business combination of Volta Industries, Inc. ("Legacy Volta") and Tortoise Acquisition Corp. II; (2) as a result, the Company had understated its net loss for third quarter 2021; (3) there were material weaknesses in the Company's internal control over financial reporting that resulted in a material error; (4) as a result of the foregoing, the Company would restate its financial statements; (5) as a result of the foregoing, Legacy Volta's founders would imminently exit the Company; (6) as a result, the Company's financial results would be adversely impacted; and (7) as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/abbvie-inc-loss-submission-form-2?prid=27234&wire=1 Lead Plaintiff Deadline: June 6, 2022 Class Period: April 30, 2021 - August 31, 2021

Allegations against ABBV include that: (1) safety concerns about Pfizer Inc.'s drug Xeljanz extended to Abbvie's drug Rinvoq and to other Janus kinase enzyme inhibitor drugs; (2) as a result, it was likely that the U.S. Food and Drug Administration would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, defendants' statements about the Company's business, operations, and prospects lacked a reasonable basis.

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/aurinia-pharmaceuticals-inc-loss-submission-form?prid=27234&wire=1 Lead Plaintiff Deadline: June 14, 2022 Class Period: May 7, 2021 - February 25, 2022

Allegations against AUPH include that: (i) Aurinia was experiencing declining revenues; (ii) Aurinia's 2022 sales outlook for the Company's only product which it offers for the treatment of adult patients with active lupus nephritis, LUPKYNIS, would fall well short of expectations; (iii) accordingly, the Company had significantly overstated LUPKYNIS's commercial prospects; (iv) as a result, the Company had overstated its financial position and/or prospects for 2022; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times.

To learn more contact Vincent Wong, Esq. either via email vw@wongesq.com or by telephone at 212.425.1140.

Vincent Wong, Esq. is an experienced attorney who has represented investors in securities litigations involving financial fraud and violations of shareholder rights. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT: Vincent Wong, Esq. 39 East Broadway Suite 304 New York, NY 10002 Tel. 212.425.1140 Fax. 866.699.3880 E-Mail: vw@wongesq.com

SOURCE: The Law Offices of Vincent Wong

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The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE: ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period").

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES. YOU CAN ALSO CLICK ON THEFOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

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LEAD PLAINTIFF DEADLINE:JUNE 6, 2022 CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS: James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

Kessler Topaz Meltzer & Check, LLP James Maro, Jr., Esq. 280 King of Prussia Road Radnor, PA 19087 (484) 270-1453 info@ktmc.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/123612

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-- East Syracuse Site to Serve as the LOTTE Center for North America Operations for LOTTE's biologics contract development and manufacturing organization (CDMO) business --

Bristol Myers Squibb (NYSE: BMY) and LOTTE Corporation today announced that LOTTE has agreed to purchase Bristol Myers Squibb's manufacturing facility in East Syracuse, New York. The East Syracuse site will serve as the LOTTE Center for North America Operations for LOTTE's new biologics contract development and manufacturing organization (CDMO) business in the United States.

The companies anticipate completing the transaction by 2H 2022, subject to receipt of regulatory approvals and the satisfaction of other closing conditions. Upon closing, LOTTE will acquire the East Syracuse site's operations and assets, which include the property, plant and equipment, as well as a workforce with technical capabilities and expertise. Following the closing of the transaction, LOTTE, under a newly-established CDMO relationship, will manufacture product for Bristol Myers Squibb from the East Syracuse facility. Over time, LOTTE is expected to use the facility to expand its CDMO offerings for the biopharma industry.

"The East Syracuse site has been an important part of our company's history and our manufacturing network for many decades, and we are confident that LOTTE will fully leverage the facility, its capabilities and its experienced workforce as it continues to play a vital role for patients around the world," said Karin Shanahan, executive vice president, Global Product Development and Supply, Bristol Myers Squibb. "We have taken a thoughtful approach to this decision and are confident this will best support the continued evolution of our manufacturing network and our mission to deliver innovative medicines that help patients prevail over serious diseases."

"We are pleased to add this state-of-the-art facility to our global pharma operations, which will enable us to rapidly scale and expand our biologics CDMO business in North America," said Hunki Lee, Executive Vice President of LOTTE Corporation. "We look forward to welcoming the talented team in East Syracuse to LOTTE, and we intend to make significant investments to further enhance the facility and its capabilities to support our strategic growth objectives moving forward."

The East Syracuse site will continue to operate as part of Bristol Myers Squibb's manufacturing network until the closing of the transaction.

William Blair is serving as financial advisor to Bristol Myers Squibb, and Baker McKenzie is serving as legal counsel to Bristol Myers Squibb in the transaction.

About the East Syracuse Facility

The East Syracuse site is a state-of-the-art manufacturing facility with commercial-scale production capacity for biologics. The site was originally established in 1943 to answer the U.S. government's call for large scale production of penicillin.

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook , and Instagram .

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

LOTTE Corporation is a holding company of LOTTE Group, based in Seoul, Korea. LOTTE Group was formally established in 1967 and has since grown to become Korea's fifth-biggest conglomerate encompassing four key business areas including Food & Beverage, Retail, Chemical, Hotel & Service with more than 90 affiliates. Most of LOTTE Group's businesses have taken leading position in domestic market. LOTTE Group is in over 30 countries around the world. LOTTE is also well-known for its skyscraper 'LOTTE World Tower' which is the tallest building in South Korea and the 5th tallest in the world.

For more information, visit www.lotte.co.kr .

Bristol Myers Squibb Cautionary Statement Regarding Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the proposed transaction. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the completion of the information and consultation processes with employees or relevant employee representative bodies, if any, in connection with the proposed transaction, the parties' ability to satisfy certain closing conditions, any delay or inability of Bristol Myers Squibb to realize the expected benefits of the proposed transaction and that the proposed transaction will close on the terms or within the time frame described in this document. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220512006132/en/

Bristol Myers Squibb: Media: media@bms.com

Investors: Investor.relations@bms.com

LOTTE Media: Kyeongsu Lee, kyeongsu.lee@lotte.net Jiwoong Park, jiwoong.park@lotte.net

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The law firm of Kessler Topaz Meltzer & Check, LLP ( www.ktmc.com ) informs investors that the firm has filed a securities class action lawsuit in the United States District Court for the Northern District of Illinois against ABBVie, Inc. (ABBVie) ( NYSE: ABBV ) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period").

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES . YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

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TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS : James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

ABBVIE'S ALLEGED MISCONDUCT AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq—an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes—was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

WHAT CAN I DO? AbbVie investors may, no later than June 6, 2022 , seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF? A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com .

CONTACT: Kessler Topaz Meltzer & Check, LLP James Maro, Jr., Esq. 280 King of Prussia Road Radnor, PA 19087 (484) 270-1453 info@ktmc.com

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f3c5b025-daca-4cf6-a322-70224b3efd94

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