FTC clearance, just obtained, was the last remaining regulatory hurdle. The merger will close Nov 20 (rather than immediately) because that’s the expiration date of BMY’s tender offer for CELG bonds.
Based on results from TRANSCEND NHL 001, Bristol-Myers Squibb expects to complete the submission of a Biologics License Application to the U.S. FDA by the end of the year.
Liso-cel and bb2121 (#msg-152665844) are two of the three drugs that comprise the CVR from the CELG acquisition (#msg-145844551); they have approval deadlines of 12/31/20 and 3/31/21, respectively.
With BMY guiding to a BLA submission for Liso-cel by 12/31/19, FDA approval by the 12/31/20 deadline would seem to be doable.
Zeposia is one of the three FDA approvals by a specified deadline required for BMY-R, the $9/sh CELG CVR, to pay out. The other two are: liso-cel/JCAR017 (PDUFA date 8/17/20) by 12/31/20 (PDUFA date: ; and bb2121 by 3/31/21. (Some people think BMY will deliberately try to slow these approvals to avert having to pay the CVR, but I highly doubt that BMY will want to subject itself to the inevitable litigation that would ensue if there were even a hint of sabotage.)
Yesterday was the ozanimod PDUFA date, so there was no delay to the NDA review time on account of COVID-19.
Liso-cell is one of the three drugs that comprises the $9/sh CVR for prior CELG shareholders (#msg-145844551); liso-cel has an FDA-approval of 12/31/20 (6 weeks after the PDUFA date) for the CVR to pay out, so there’s now only 6 weeks of slack in the liso-cel schedule. The CVR (BMY-RI) is currently trading for about $4, -9%.