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Biotech Stocks Facing FDA Decision In June 2022

Bristol Myers Squibb
Bristol Myers Squibb

The FDA is expected on decide on two of Bristol-Myers Squibb Co.’s (BMY) regulatory filings in June - Breyanzi and Reblozyl.

The company is seeking FDA approval to expand Breyanzi’s current indication to include earlier use of this drug for the treatment of adults with relapsed or refractory large B-cell lymphoma after failure of first-line therapy and a decision is expected on June 24, 2022.

Breyanzi was approved in the U.S. last February for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

As for Reblozyl, it is being considered for the expanded use in treating anemia in adults with non-transfusion-dependent beta thalassemia, with a decision anticipated on June 27, 2022.

Reblozyl is already approved by the FDA for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions and to treat anemia in adults with lower-risk Myelodysplastic Syndromes.

Reblozyl is being co-developed and co-commercialized by Bristol Myers Squibb and Merck & Co. (MRK).

In 2021, Breyanzi generated annual sales of $87 million while Reblozyl recorded sales of $551 million.

BMY closed Thursday’s (May 26, 2022) trading at $77.59.