🗓️ PDUFA Pulse: 1 PDUFA this week
Last week, the FDA approved two therapies: BridgeBio's Attruby™ and Jazz Pharmaceutical's Ziihera®. An AdCom was also held for AstraZeneca's Andexxa®, where the committee discussed the drug's safety and clinical benefit. This week, a PDUFA date is scheduled for Applied Therapeutics' Govorestat.
See summary for more details on recent FDA decisions & upcoming PDUFA/Adcom events this month.
This Week’s PDUFA:
APLT:
⇨ Govorestat
‣ Classic Galactosemia
‣ PDUFA: 11/28/24 (NDA)
Last Week’s Adcom & PDUFA decisions:
BBIO: Approved 11/22
⇨ Attruby (Acoramidis)
‣ ATTR-CM (transthyretin amyloid cardiomyopathy)
‣ PDUFA: 11/29/24 (NDA)
AZN: Discussion, no vote
⇨ Andexxa (coagulation factor Xa)
‣ Life-threatening or uncontrolled bleeding
‣ Adcom: 11/21/24 (sBLA)
⇨ Ziihera (zanidatamab)
‣ HER2-positive biliary tract cancer
‣ PDUFA: 12/29/24 (BLA)
Check out also the November PDUFA calendar below.
Our Thanksgiving sale is here! 🦃
Get a free 7-day trial of BPIQ Elite with our 50% off sale!
Become a BPIQ Elite member & get:
All catalyst & PDUFA dates!
Big/Suspected Movers
Hedge fund analysis & M&A data!
Stock ideas from our model portfolios, which are beating XBI by a lot!
This article is not investment, tax, or legal advice. Please do your own diligence and seek advice from professional advisors representing your interests.
Article history:
First published 11/26/24 AV & EJV
#APLT #BBIO #AZN #JAZZ #ZYME