🚨 PDUFA Alert: 2 PDUFAs this Week! 🗓

We’re always excited to find bio/pharma companies nearing their therapeutic product launch! Following Biogen's Leqembi IV maintenance dosing approval last week, this week brings two key FDA decisions: Vertex's Suzetrigine (VX-548) for moderate-to-severe acute pain and Axsome's AXS-07 for migraine. See summary for more details.

 📌 This Week’s PDUFA:

• VRTX: 🤔

➯ Suzetrigine (VX-548)

» Non-opioid pain signal inhibitor

» Indication: Moderate-to-severe acute pain

» PDUFA date: 1/30/25 (NDA)

• AXSM: 🤔

➯ AXS-07 (MoSEIC™ meloxicam and rizatriptan)

» NSAID & 5-HT1B/1D agonist combination

» Indication: Migraine

» PDUFA date: 1/31/25 (Resubmitted NDA)

 🗓️ Last Week’s PDUFA:

• BIIB: Approved 🎉

➯ Leqembi (Lecanemab) IV Maintenance Dosing

» Amyloid beta-directed antibody

» Indication: Early Alzheimer’s Disease

» PDUFA date: 1/25/25 (sBLA)

Check out the January PDUFA calendar below  👇

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Article History:

MV/AV/DG (1/30/25)

This article is not investment, tax, or legal advice. Please do your own diligence and seek advice from professional advisors representing your interests.