5 Companies with FDA Approval Decisions Expected Before the End of December
We’re always excited to find bio/pharma companies nearing their therapeutic product launch!
These 5 companies have FDA final approval decision (PDUFA) dates before the end of December:
Ionis Pharmaceuticals (NASDAQ: IONS)
Drug/Therapy: Olezarsen
LIgand Conjugated Antisense (LICA) medicine
Indication: FCS (Familial chylomicronemia syndrome)
PDUFA date: December 19, 2024
NDA, granted Priority Review
Zealand Pharma (OTCMKTS:ZLDPF)
Drug/Therapy: Glepaglutide
GLP-2 analog
Indication: Short bowel syndrome
PDUFA date: December 22, 2024
NDA
Rhythm Pharmaceuticals (NASDAQ: RYTM)
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 (NASDAQ: MIRM)
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 (NASDAQ: CKPT)
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
See table 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 12/5/24 AV & EJV
#IONS #ZLDPF #RYTM #MIRM #CKPT