Biotech General Discussion

Applied Therapeutics' NDA for Govorestat was rejected by the FDA last week due to clinical application deficiencies. As the year draws to a close, get ready for an exciting December with 12 upcoming PDUFA decisions!

See summary for more details on recent FDA decisions & upcoming PDUFA events this month. 

 Last Week’s PDUFA decision:

• APLT: CRL 11/27/24

 ⚠️ FDA cited deficiencies in clinical application

⇨ Govorestat

‣ Classic Galactosemia

‣ PDUFA: 11/28/24 (NDA)

 📌 Upcoming PDUFAs in December:

• IONS ⇨ IONIS-APOCIII-LRx (Olezarsen)

• ZLDPF ⇨ Glepaglutide

• RYTM ⇨ IMCIVREE™ (Setmelanotide)

• MIRM ⇨ Chenodal® (chenodiol)

• CKPT ⇨ Cosibelimab (CK-301) 

• NBIX ⇨ Crinecerfont capsule

• BMY ⇨ Opdivo® Subcutaneous (nivolumab + hyaluronidase)

• NBIX ⇨ Crinecerfont oral solution

• ROIV ⇨ VTAMA (Tapinarof)

• BGNE ⇨ Tislelizumab + chemo

• AZN ⇨ Imfinzi (durvalumab)

• AZN ⇨ Dato-DXd (Datopotamab deruxtecan)

Check out also the November & December PDUFA calendars 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 12/3/24 AV & EJV

#APLT #IONS #ZLDPF #RYTM #MIRM #CKPT #NBIX #BMY #BGNE #AZN