About four months after starting its search for strategic alternatives, Sesen Bio Inc. disclosed an all-stock merger with privately held cell-therapy specialist Carisma Therapeutics Inc., a move that sent shares (NASDAQ:SESN) down 22 cents, or 32.7%, to close at 45 cents. Sesen stockholders are expected to own about 41.7% of the combined firm, and Carisma the remainder.
An unexpected complete response letter (CRL) from the FDA has thrown a wrench into Sesen Bio Inc.’s commercial launch plans for Vicineum (oportuzumab monatox) in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The company, which has spent the past few months completing its commercial build phase and hiring sales reps ahead of the Aug. 18 PDUFA date, instead must now address outstanding clinical and statistical data and analyses, in addition to CMC issues, cited in the CRL.
