We used our biopharmIQ online platform to identify upcoming FDA approval (PDUFA) dates for small and mid-sized biopharma companies through the end of November 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 6 companies have FDA final approval decision (PDUFA) dates before the end of November:

Iterum Therapeutics

• 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

• Drug/Therapy: DFD-29 (Minocycline Hydrochloride)

  • low-dose minocycline (tetracycline antibiotics)

• Indication: Rosacea

• PDUFA date: November 4, 2024

• NDA

Autolus Therapeutics

• 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

• 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

• Drug/Therapy: Acoramidis

  • TTR stabilizer, small molecule

• Indication: ATTR-CM (transthyretin amyloid cardiomyopathy)

• PDUFA date: November 29, 2024

• NDA

Zymeworks

• Drug/Therapy: Zanidatamab

  • HER2-targeted bispecific antibody

• Indication: BTC (Biliary tract cancer)

• PDUFA date: November 29, 2024

• BLA

• Granted Priority Review

See table below 📸👇

FIG 1. PDUFA Approvals expected before the end of November.

Have questions or want to schedule a demo of our online platform?

Contact marketing@biopharmiq.com

***

Article History:

MV/AV/DG (10/24/24)

Not legal, investing, or tax advice.