Shares of 2seventy bio fell more than 10% Monday after the biotechnology company’s efforts to win expanded U.S. approval for its Abecma gene therapy with Bristol Myers Squibb hit a delay.
Bristol Myers and 2seventy said the U.S. Food and Drug Administration won’t meet its Dec. 16 target action date on the companies’ application seeking approval of Abecma for earlier lines of triple-class exposed relapsed or refractory multiple myeloma after the agency opted to hold an advisory committee meeting.
Abecma is currently approved for adults after four or more prior lines of therapy.
2seventy and Bristol share equally in all profit and losses related to U.S. development, manufacture and commercialization of Abecma, which generated $302 million in U.S. commercial revenue in the first nine months of 2023.
Analysts at Citi last month initiated coverage of 2seventy bio with a buy rating and a $13 price target, saying they expected an FDA green light for using Abecma in earlier lines would create a capacity-constrained environment that will benefit the therapy.
2seventy shares, which closed Friday at $2.13, were recently down more than 10% at $1.91 in premarket trading.