Big PDUFA from a big collaboration:
BIIB & SAGE
PDUFA - 8/5/23
- Zuranolone in MDD & PPD
Collaboration since 2020…
BIIB invested $1.5B in SAGE
• $875M upfront pmt
• $650M equity
⇨ BIIB bought 6.2 million shares of SAGE
• Jointly develop Zuran
⇨ (MDD &PPD) & SAGE-324 (essential tremor & more neuro)
• Commercialization
⇨ U.S. = 50/50
• Outside U.S. = Biogen (except JP, TW & SK)
• Possible $1.6B in milestones
Mixed congrats for SAGE & BIIB
FDA Approval for Postpartum depression
But not MDD*
Boxed warning re: no driving
Other warning re: fetal toxicity
Next PDUFA up this month
GRTX
Details re: CRL for zuranolone for MDD
Per FDA:
Not enough evidence of effectiveness
Additional studies needed
SAGE and BIIB reviewing next steps
So...
SAGE / BIIB get PPD but not MDD
Is this net a win or loss for BIIB & SAGE?
SAGE did not run up into PDUFA
MDD miss already in stock price?
We will find out Monday
SAGE hosting Q2 investor call 8/7
Q&A should be interesting
Re: Zuranolone (ZURZAUVAE)
Durability of response not long enough for FDA?
Ph3 Coral 1' endpoint changed from day 15 to day 3
Even if approved there were questions about commercial value with such short duration.
But, wouldn't it be helpful if you were the MDD patient to get a jump start on feeling better with zuroanolone?
Will be interesting to see if SAGE/BIIB are done with Zuro and MDD
This article is NOT legal, investment or tax advice. Please do your own diligence before making any investment decisions.
Article History: Originally posted 8/7/23 (RB)