Companies seeking green light for earlier use of multiple myeloma therapy
Shares of Bristol Myers Squibb Co. (BMY) and 2seventy bio Inc. (TSVT) fell premarket on Monday after the companies said the U.S. Food and Drug Administration would miss its target date for potential approval of earlier use of a cancer therapy.
Bristol Myers Squibb and 2seventy bio are jointly developing the cell therapy, Abecma, which is already approved for treatment of relapsed or refractory multiple myeloma. The FDA will not make a decision on the drug’s approval for earlier use in multiple myeloma patients before its target regulatory action date of Dec. 16, the companies said in a release.
An FDA advisory committee will meet to review clinical trial data on Abecma, the companies said, but the agency has not yet confirmed the date of that meeting.
Bristol Myers shares fell more than 4% premarket on Monday, while 2seventy bio stock dropped more than 11%.
For 2seventy bio, approval of Abecma for earlier treatment of multiple myeloma could drive a return to growth in the first quarter of next year, Leerink Partners analysts wrote in a report last week. The analysts in late October downgraded 2seventy bio shares to market perform from outperform and slashed their price target on the stock to $7 from $29, saying any upside in the shares from an earlier-line label expansion would likely be short-lived.
Analysts at BMO Capital Markets also downgraded Bristol Myers Squibb in late October, saying Abecma is facing increasing competition, including from Johnson & Johnson (JNJ) and Legend Biotech Corp.’s (LEGN) Carvykti.
Bristol Myers stock is down 29% in the year to date, while 2seventy bio shares have dropped 77% and the S&P 500 SPX has gained 17%.