1 AdCom Meeting This Week! 🗓️
Last week, the FDA approved two therapies: PTC Therapeutics' KEBILIDI™ (eladocagene exuparvovec) and Syndax's Revuforj® (revumenib). Notably, Revuforj's approval came ahead of its PDUFA target date. This week, an AdCom meeting is scheduled for AstraZeneca's sBLA for Andexxa.
See summary for more details on recent FDA decisions & upcoming PDUFA/Adcom events this month. 👇
📌 This Week’s AdCom:
AZN:
⇨ Andexxa (coagulation factor Xa)
‣ Life-threatening or uncontrolled bleeding
‣ Adcom: 11/21/24 (sBLA)
🗓 Last Week’s PDUFA decisions:
SNDX: Approved 11/15
⇨ Revuforj® (revumenib)
‣ Adult and Pediatric R/r Acute Leukemia
‣ PDUFA: 12/26/24 (NDA)
PTCT: Approved 11/13
⇨ KEBILIDI™ (eladocagene exuparvovec)
‣ AADC deficiency
‣ PDUFA: 11/13/24 (BLA)
📣 PDUFAs & AdCom in Upcoming Weeks:
Check out also the November PDUFA calendar below. 👇
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 11/19/24 AV & EJV
#AZN #SNDX #PTCT #APLT #BBIO #JAZZ #ZYME