Biotech

New analysis of EXPLORER-HCM trial assessing impact of mavacamten on patient's health status to be presented as late-breaking oral presentation

Interim results of EXPLORER long-term extension study of mavacamten safety and efficacy data in patients with obstructive hypertrophic cardiomyopathy (oHCM) also to be presented

Bristol Myers Squibb (NYSE: BMY) today announced that data from multiple studies across the company's clinical program investigating mavacamten in patients with obstructive hypertrophic cardiomyopathy (oHCM) will be presented at the upcoming American College of Cardiology's 70 th Annual Scientific Session (ACC.21), being held virtually May 15 to May 17, 2021.

Key presentations include:

  • A late-breaking oral presentation reporting results from a new analysis of data from the EXPLORER-HCM Phase 3 trial of mavacamten in patients with oHCM, which tested the impact of mavacamten on patients' health status (symptoms, function and quality of life) as measured by the Kansas City Cardiomyopathy Questionnaire. These data will be presented as part of the Featured Clinical Research I Session in the Hot Topics Channel on Saturday, May 15 from 12:15 – 1:30 p.m. EDT.
  • A moderated poster session highlighting interim results from MAVA-LTE, an ongoing, dose-blinded 5-year extension study of the EXPLORER-HCM Phase 3 trial. Findings from the interim analysis demonstrated that in patients with oHCM, mavacamten was well tolerated and showed durable improvement in left ventricular outflow tract (LVOT) gradients, diastolic function, N-terminal-pro hormone B-type natriuretic peptide (NT-proBNP) and symptoms.
  • A poster presentation of results from a real-world data analysis measuring the clinical and economic burden of oHCM in the United States, which found the condition is associated with substantial healthcare resource utilization and costs.

"These data add to the growing body of evidence that further supports the goal of addressing a high unmet medical need in patients with oHCM with mavacamten as a first-in-class medicine," said Jay Edelberg, M.D., Ph.D., head, Heart Failure and Cardiomyopathy Development at Bristol Myers Squibb. "We look forward to potentially bringing this therapy to oHCM patients early next year."

Mavacamten Presentations

  • Health Status Benefits of Mavacamten in Patients with Symptomatic Obstructive Cardiomyopathy: Results From the EXPLORER-HCM Randomized Clinical Trial
    • Author: John A. Spertus
    • Session 403-09 – Featured Clinical Research I
    • Session Type: Late-Breaking Clinical Trials, Hot Topics Channel
    • Saturday, May 15: 12:15 – 12:25 p.m. EDT
  • Long-Term Safety of Mavacamten in Patients with Obstructive Hypertrophic Cardiomyopathy: Interim Results of the MAVA-Long Term Extension (LTE) Story
    • Author: Florian Rader
    • Session 1033-03 – Advances in Hypertrophic Cardiomyopathy
    • Session Type: Moderated Poster Contributions, eAbstract Site
    • Saturday, May 15: 12:30 – 12:40 p.m. EDT
  • Clinical and Economic Burden of Obstructive Hypertrophic Cardiomyopathy in the United States
    • Author: Sneha S. Jain
    • Session 2192 – Heart Failure and Cardiomyopathies: Population Science 1
    • Session Type: Poster Contributions, eAbstract Site
    • Saturday, May 15: 2:45 – 3:30 p.m. EDT

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy, or HCM, is a chronic, progressive disease in which excessive contraction of the heart muscle and reduced ability of the left ventricle to fill can lead to the development of debilitating symptoms and cardiac dysfunction. HCM is estimated to affect one in every 500 people.

The most frequent cause of HCM is mutations in the heart muscle proteins of the sarcomere. In either obstructive or non-obstructive HCM patients, exertion can result in fatigue or shortness of breath, interfering with a patient's ability to participate in activities of daily living. HCM has also been associated with increased risks of atrial fibrillation, stroke, heart failure and sudden cardiac death, with mortality among HCM patients shown to be approximately three-fold higher than the U.S. general population at similar ages.

There are currently approximately 160,000 to 200,000 people diagnosed with symptomatic obstructive HCM across the U.S. and EU, with no existing effective drug treatment options beyond limited symptomatic relief.

About Mavacamten

Mavacamten is a potential first-in-class, oral, allosteric modulator of cardiac myosin, under investigation for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Mavacamten reduces cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation that results in hypercontractility, left ventricular hypertrophy and reduced compliance. In clinical and preclinical studies, mavacamten has consistently reduced biomarkers of cardiac wall stress, lessened excessive cardiac contractility and increased diastolic compliance.

About Bristol Myers Squibb

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 .

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. 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 historical performance and 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 possibility that future study results will be consistent with the results to date, that mavacamten may not receive regulatory approval for the indication(s) described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication(s) described in this release will be commercially successful. 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, 2020, 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.

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Bristol Myers Squibb

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IBM, ABBV, & TWTR Class Actions: Bronstein, Gewirtz & Grossman, LLC, A Leading Class Action Firm Reminds Shareholders to Actively Participate

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

Bronstein, Gewirtz and Grossman, LLC, Monday, May 16, 2022, Press release picture

International Business Machines Corporation (NYSE:IBM)
Class Period: April 4, 2017 - October 20, 2021
Deadline: June 6, 2022
For more info: www.bgandg.com/ibm.

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SHAREHOLDER ALERT: CELH AUPH MULN: The Law Offices of Vincent Wong Reminds Investors of Important Class Action Deadlines

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

Celsius Holdings, Inc. (NASDAQ:CELH)

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/celsius-holdings-inc-loss-submission-form?prid=27287&wire=1
Lead Plaintiff Deadline: May 16, 2022
Class Period: August 12, 2021 - March 1, 2022

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Kessler Topaz Meltzer & Check, LLP Reminds Investors of Securities Fraud Class Action Lawsuit against AbbVie, Inc. and Encourages Investors with Substantial Losses to Contact the Firm

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

CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE

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'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?

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.

CONTACT:

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/123953

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AbbVie to Showcase Depth of Gastroenterology Portfolio and Pipeline at Digestive Disease Week®

  • A total of 27 abstracts reinforce AbbVie leadership in advancing research and the standards of care across multiple gastroenterological conditions, including inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS)
  • Presentations include further analyses of Phase 3 clinical study programs for RINVOQ ® (upadacitinib) in moderately to severely active ulcerative colitis and investigational use of risankizumab in moderately to severely active Crohn's disease

ABBVie (NYSE: ABBV) today announced that 27 abstracts across its gastroenterology portfolio will be presented at the Digestive Disease Week (DDW) Annual Meeting, May 21-24, 2022 in San Diego and virtually.

AbbVie's research to be presented at DDW 2022 addresses digestive and inflammatory bowel diseases, including ulcerative colitis (UC), Crohn's disease (CD), and irritable bowel syndrome with constipation (IBS-C) / chronic idiopathic constipation (CIC).

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AbbVie and Cugene Announce Collaboration in Autoimmune Diseases

- AbbVie receives the option to license worldwide rights to CUG252 from Cugene, a clinical-stage and potential best-in-class Treg-selective IL-2 mutein, building on AbbVie's commitment to developing novel therapies in immunology

- Cugene to complete a Phase 1a study in healthy volunteers and to conduct a Phase 1b study in patients with autoimmune/inflammatory disease during the option period

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Aurinia Pharmaceuticals Announces Presentations at the 2022 ERA Congress and the 2022 EULAR Congress

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, today announced that data from multiple studies of LUPKYNIS™ (voclosporin) will be presented at the 59th European Renal Association (ERA) Congress and at the European Congress of Rheumatology, European Alliance of Associations for Rheumatology (EULAR) 2022. The 2022 ERA Congress will take place virtually and in Paris on May 19-22 and the EULAR 2022 Congress will take place virtually and in Denmark on June 1-4.

"Aurinia continues to expand its clinical evidence supporting LUPKYNIS as a reliable treatment option for people and HCPs working to protect their patients' kidneys from the devastating impact of lupus nephritis," said Neil Solomons, M.D., Chief Medical Officer at Aurinia. "We look forward to presenting new data for LUPKYNIS at the ERA and EULAR Congresses, including our results from the two-year AURORA 2 continuation study evaluating the long-term safety and tolerability of LUPKYNIS for the treatment of lupus nephritis."

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