News Focus
News Focus
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DewDiligence

03/26/20 12:42 PM

#229859 RE: DewDiligence #229853

BMY/Zeposia addendum—The US commercial launch of Zeposia is on hold due to the COVID-19 crisis, but this doesn’t affect BMY-R, the CELG $9/sh, which depends on the dates of FDA approvals, not on the dates of commercial launches.
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DewDiligence

03/27/20 12:43 PM

#229927 RE: DewDiligence #229853

CHMP approves BMY’s Zeposia for RMS—one day after FDA approval:

https://www.businesswire.com/news/home/20200327005326/en

In the EU (as well as the US), the actual product launch will be delayed due to the COVID-19 pandemic.
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DewDiligence

03/31/20 11:37 AM

#230203 RE: DewDiligence #229853

BMY/BLUE submit BLA for bb2121 (anti-BCMA CAR-T):

https://finance.yahoo.com/news/bristol-myers-squibb-bluebird-bio-105900728.html

bb2121 is one of the three drugs that comprise the $9/sh BMY-R CVR (#msg-145844551); it has an FDA-approval deadline of 3/31/21, which is doable if there is no hitch in the FDA review.

The Zeposia (ozanimod) FDA approval has already occurred (#msg-154586608), which leaves liso-cel/JCAR017 as the only other requirement; liso-cel has a PDUFA date of 8/17/20 and a CVR deadline of 12/31/20.