4 Companies with FDA Approval Decisions Expected Before the End of January 🗓️

We’re always excited to find bio/pharma companies nearing their therapeutic product launch!

These 4 companies have FDA final approval decision (PDUFA) dates before the end of January:

Atara Biotherapeutics (NASDAQ: ATRA)

• Drug/Therapy: Tab-cel (tabelecleucel)

  • Allogeneic T-cell immunotherapy

• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

• PDUFA date: January 15, 2025

• BLA with priority review

Biogen (NASDAQ: BIIB)

• Drug/Therapy: Leqembi (Lecanemab) IV Maintenance Dosing

  • Amyloid beta-directed antibody

• Indication: Early Alzheimer’s Disease

• PDUFA date: January 25, 2025

• sBLA

Vertex Pharmaceuticals (NASDAQ: VRTX)

• Drug/Therapy: Suzetrigine (VX-548)

  • Non-opioid pain signal inhibitor

• Indication: Moderate-to-severe acute pain

• PDUFA date: January 30, 2025

• NDA with priority review

Axsome Therapeutics (NASDAQ: AXSM)

• Drug/Therapy: AXS-07 (MoSEIC™ meloxicam and rizatriptan)

  • NSAID & 5-HT1B/1D agonist combination

• Indication: Migraine

• PDUFA date: January 31, 2025

• Resubmitted NDA

See January PDUFA calendar 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 1/6/25 AV, DG & EJV

#ATRA #BIIB #VRTX #AXSM