6 Companies with FDA Approval Decisions Expected Before the End of November
We’re always excited to find bio/pharma companies nearing their therapeutic product launch!
These 6 companies have FDA final approval decision (PDUFA) dates before the end of November:
Iterum Therapeutics (NASDAQ: ITRM)
Drug/Therapy: Oral Sulopenem
broad-spectrum penem β-lactam antibiotic
Indication: uUTI (Uncomplicated Urinary Tract Infection)
PDUFA date: October 25, 2024
AdCom discussion held Sep 29, 2024
resubmitted NDA
Journey Medical (NASDAQ: DERM)
Drug/Therapy: DFD-29 (Minocycline Hydrochloride)
low-dose minocycline (tetracycline antibiotics)
Indication: Rosacea
PDUFA date: November 4, 2024
NDA
Autolus Therapeutics (NASDAQ: AUTL)
Drug/Therapy: Obe-cel
CD19 autologous CAR T
Indication: Adult ALL (Acute Lymphoblastic Leukemia)
PDUFA date: November 16, 2024
BLA
Granted Orphan Drug & RMAT designations
Applied Therapeutics (NASDAQ: APLT)
Drug/Therapy: Govorestat (AT-007)
CNS penetrant aldose reductase inhibitor
Indication: Galactosemia
PDUFA date: November 28, 2024
NDA
Granted Orphan Drug, Pediatric Rare Disease, & Fast Track designations
BridgeBio Pharma (NASDAQ: BBIO)
Drug/Therapy: Acoramidis
TTR stabilizer, small molecule
Indication: ATTR-CM (transthyretin amyloid cardiomyopathy)
PDUFA date: November 29, 2024
NDA
Zymeworks (NASDAQ: ZYME)
Drug/Therapy: Zanidatamab
HER2-targeted bispecific antibody
Indication: BTC (Biliary tract cancer)
PDUFA date: November 29, 2024
BLA
Granted Priority Review
See the 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 10/23/24 AV & EJV