Biotech General Discussion

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: 

• APLT ‣ Govorestat

• BBIO ‣ Acoramidis

• JAZZ & ZYME ‣ Zanidatamab

Check out also the November PDUFA calendar below.  👇

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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