Biotech General Discussion

Last week, the FDA approved two new treatments: Checkpoint Therapeutics' UNLOXCYT for advanced cSCC and Neurocrine Biosciences' CRENESSITY for Congenital Adrenal Hyperplasia. This week, Ionis Pharmaceuticals' Olezarsen is up for FDA decision for Familial Chylomicronemia syndrome.

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

 This Week’s PDUFA:

• IONS: 🤔

⇨ IONIS-APOCIII-LRx (Olezarsen)

‣ FCS (Familial chylomicronemia syndrome)

‣ PDUFA: 12/19/24 (NDA)

 Last Week’s PDUFA Decisions:

• CKPT: Approved 12/13/24 ✅

 ⇨ UNLOXCYT (cosibelimab-ipdl)

‣ Advanced cSCC (cutaneous squamous cell carcinoma)

‣ PDUFA: 12/28/24 (resubmitted BLA)

• NBIX: Approved 12/13/24 ✅

⇨ CRENESSITY™ (crinecerfont) capsule

‣ Congenital Adrenal Hyperplasia (Adult & Pediatric)

‣ PDUFA: 12/29/24 (NDA)

• NBIX: Approved 12/13/24 ✅

⇨ CRENESSITY™ (crinecerfont) oral solution

‣ Congenital Adrenal Hyperplasia (Adult & Pediatric)

‣ PDUFA: 12/30/24 (NDA)

 Remaining PDUFAs in December: 

• ZLDPF ⇨ Glepaglutide

• RYTM ⇨ IMCIVREE™ (Setmelanotide)

• MIRM ⇨ Chenodal® (chenodiol)

• BMY ⇨ Opdivo® Subcutaneous (nivolumab + hyaluronidase)

• BGNE ⇨ Tislelizumab + chemo

Check out also the December 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 12/18/24 AV & EJV