By Colin Kellaher


Shares of 2seventy bio fell sharply Wednesday amid concerns about a Food and Drug Administration advisory committee meeting on Abecma, the gene therapy it sells with partner Bristol Myers Squibb.

Shares of 2seventy were recently down 16% to $3.97, while Bristol Myers shares slipped 0.9% to $53.90.

In briefing documents released ahead of Friday's meeting, the FDA raised concerns about a higher rate of early deaths in patients receiving Abecma in a Phase 3 study aimed at winning approval for earlier use of the gene therapy in the treatment course for people with the blood cancer multiple myeloma.

Abecma is currently approved by the FDA for adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy.

Bristol Myers and 2seventy have said the study showed that Abecma significantly reduced the risk of disease progression or death versus standard regimens in adults with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.

The FDA had been slated to act on an application by the companies for the earlier use of Abecma in December but instead opted to hold the advisory committee meeting, where it will ask panelists whether the benefits of Abecma outweigh its risks.

The FDA often turns to advisory committees to obtain advice from experts who work outside of the government when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective. The agency usually follows the advice of its advisory committees, but it isn't bound by the recommendations.

2seventy, based in Cambridge, Mass., in January said it would sell its research and development pipeline to Regeneron Pharmaceuticals as part of a pivot by the biotechnology company to focus exclusively on the commercialization and development of Abecma.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

03-13-24 1416ET