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BIIB & SAGE: Zuranolone

Big PDUFA from a big collaboration:


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


Details re: CRL for zuranolone for MDD

Per FDA:

Not enough evidence of effectiveness

Additional studies needed

SAGE and BIIB reviewing next steps


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)



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