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NEWS & INSIGHTS

Dive into the Biopharma Space

Stay up-to-date on major biopharma news, deeper dives into specific companies and biopharma themes, and how it all relates to biopharma partners.

6 companies with FDA approval decisions expected before the end of November

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.


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Article History:

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


Not legal, investing, or tax advice.

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