Celgene rights down on potential delay in key approval

The Contingent Value Right (CVR) (NYSE:BMY.RT) associated with Bristol Myers Squibb’s (BMY -2.2%) $74B takeover of Celgene is down ~24% today in apparent reaction to management comments at a Citigroup conference revealing that the manufacturing plant for CAR T therapies has not yet been inspected by the FDA.

The disclosure has unnerved investors considering the agency’s November 16 action date for its review of the company’s marketing application for CAR T lisocabtagene maraleucal (liso-cel) for relapsed/refractory large B-cell lymphoma patients who have received at least two prior lines of treatment.

The FDA nod is one of two qualifying milestones for a $9 payout. The other is U.S. approval of CAR T idecabtagene vicleucel (ide-cel) (bb2121) for multiple myeloma (MM) patients who have received at least three prior lines of treatment by March 31, 2021.

In May, BMY received a Refusal to File letter from the agency in response to its ide-cel marketing application citing the need for additional information in the Chemistry, Manufacturing and Control (CMC) module.

Celgene and licensor bluebird bio (BLUE +3.9%) have been collaborating on CAR T therapies since March 2013. Per a March 2018 contract, the companies agreed to co-develop and co-promote bb2121 for MM in the U.S.

https://seekingalpha.com/news/3612232-celgene-cvr-down-24-on-potential-delay-in-key-approval