Bristol Myers Squibb and 2seventy Bio to Present Abecma Label Expansion to FDA Advisory Committee

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BRISTOL-MYERS ($NYSE:BMY): Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines to patients and healthcare providers. With a wide range of products, the company works to extend and improve the lives of people around the world. Recently, Bristol Myers Squibb and 2seventy Bio have announced that they will be appearing before the FDA Advisory Committee (AdCom) to seek an expansion of the label for Abecma. Abecma is a B-cell maturation antigenside-effect receptor agonist therapy that has been approved for the treatment of certain patients with multiple myeloma who have received at least one prior therapy.

The companies are seeking to expand the label to include additional doses and settings for the drug. If approved, this would give more options to patients in need of therapy. The companies are hopeful that their presentation before the FDA AdCom will lead to a favorable decision that will ultimately expand the label for Abecma.

Stock Price

On Monday, BMS stock opened at $48.8 and closed at $48.9, down 3.8% from the prior closing price of 50.8. The two companies are hoping to receive approval to expand the label of Abecma, a chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adult patients with relapsed or refractory multiple myeloma. If approved, Abecma would become the first approved CAR-T therapy for this condition. The Abecma label expansion would provide a much needed treatment option for adult patients with relapsed or refractory multiple myeloma who have not responded to prior therapies.

BMS is confident that the data supporting the Abecma label expansion is strong enough for approval and they are hopeful that the Advisory Committee will recognize the clinical benefit of the therapy and approve its use in this population. BMS and 2seventy Bio are committed to bringing new and innovative treatments to those living with multiple myeloma and other cancers, and their efforts to secure an Abecma label expansion reflect this commitment. Live Quote…

About the Company

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Analysis

At GoodWhale, we recently conducted an analysis of BRISTOL-MYERS SQUIBB‘s wellbeing. According to our Star Chart, BRISTOL-MYERS SQUIBB is classified as ‘rhino’, indicating that the company has achieved moderate revenue or earnings growth. Investors who may be interested in this company include those who seek stable returns from a dividend component, as well as those looking for a moderate growth portfolio. BRISTOL-MYERS SQUIBB is strong in both dividend and growth and has moderate profitability, but is weak in asset. Nevertheless, the company has a high health score of 8/10, indicating that it is likely to be able to sustain operations in future times of crisis. This may make it a good choice for investors looking for a long-term investment with some dividend component. More…

Peers

The company was founded in 1887 and is headquartered in New York City. The company’s products are sold in over 100 countries. Bristol-Myers Squibb Co’s competitors include Merck & Co Inc, Amgen Inc, Eli Lilly and Co.

– Merck & Co Inc ($NYSE:MRK)

Merck & Co Inc is a global health care company that offers a wide range of products and services to customers in more than 140 countries. The company has a market cap of 236.25B as of 2022 and a Return on Equity of 28.84%. Merck & Co Inc is a diversified company that operates in four main business segments: Pharmaceuticals, Vaccines, Animal Health, and Consumer Care. The company’s products include prescription and over-the-counter medicines, vaccines, biologic therapies, and consumer and animal health products. Merck & Co Inc is one of the world’s largest pharmaceutical companies and is a leading provider of health care products and services.

– Amgen Inc ($NASDAQ:AMGN)

Amgen Inc is a large biotechnology company with a market cap of 132.76B as of 2022. The company has a strong return on equity of 460.37%. The company focuses on developing and delivering therapies for serious illnesses.

– Eli Lilly and Co ($NYSE:LLY)

Eli Lilly and Co is a pharmaceutical company with a market cap of 312.88B as of 2022. Its return on equity is 45.88%. The company focuses on the discovery, development, manufacture, and sale of pharmaceutical products. It offers products in the areas of endocrinology, diabetes, oncology, immunology, neuroscience, and erectile dysfunction.

Summary

Bristol-Myers Squibb (BMS) is facing an upcoming FDA AdCom for label expansion of Abecma, its B-cell maturation antigen (BCMA)-targeting antibody-drug conjugate. This FDA AdCom is expected to be a key catalyst for the stock in the coming months. The stock price has recently decreased, but there may still be opportunity for investors to capitalize on Abecma’s potential.

This is due to Abecma’s potential to address multiple myeloma, a cancer type with a high unmet need and a large market size. Investors should carefully consider the risks associated with Abecma approval, including the competitive landscape and regulatory hurdles.