We used our biopharmIQ online platform to identify upcoming FDA approval (PDUFA) dates for small and mid-sized biopharma companies through the end of December 2024. See the below for more info on these upcoming PDUFA dates.

Check out our free PDUFA calendar for info re: all upcoming PDUFAs next month.

These 5 companies have FDA final approval decision (PDUFA) dates before the end of December (Table 1):

Ionis Pharmaceuticals

• Drug/Therapy: Olezarsen

  • LIgand Conjugated Antisense (LICA) medicine

• Indication: FCS (Familial chylomicronemia syndrome)

• PDUFA date: December 19, 2024

• NDA, granted Priority Review

Zealand Pharma

• Drug/Therapy: Glepaglutide

  • GLP-2 analog

• Indication: Short bowel syndrome

• PDUFA date: December 22, 2024

• NDA

Rhythm Pharmaceuticals

• Drug/Therapy: IMCIVREE™ (Setmelanotide)

  • Melanocortin-4 receptor (MC4R) agonist

• Indication: Obesity (POMC or LEPR deficiency or BBS) in children 

• PDUFA date: December 26, 2024

• sNDA, granted Priority Review

Mirum Pharmaceuticals

• Drug/Therapy: Chenodal® (chenodiol) tablets

  • Naturally occurring bile acid

• Indication: CTX (Cerebrotendinous xanthomatosis)

• PDUFA date: December 28, 2024

• NDA, granted orphan drug designation

Checkpoint Therapeutics

• Drug/Therapy: Cosibelimab (CK-301)

  • anti-programmed death ligand-1 (PD-L1) antibody

• Indication: mCSCC (metastatic Cutaneous squamous cell carcinoma)

• PDUFA date: December 28, 2024

• resubmitted BLA

Table 1. PDUFA approvals expected before the end of December.

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Contact marketing@biopharmiq.com

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Article History:

MV/AV/DG (12/5/24)

Not legal, investing, or tax advice.