🚨 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.
