Upcoming PDUFAs in February 🗓️

Following approvals of JOURNAVX (Vertex) and SYMBRAVO (Axsome) last week, the FDA approved ONAPGO (Supernus) today! Three more PDUFAs are expected this February. See the summary below for details.

 🗓️ Last Week’s PDUFAs:

• VRTX: Approved ✅

➯ JOURNAVX (suzetrigine)

» Non-opioid pain signal inhibitor

» Indication: Moderate-to-severe acute pain

» PDUFA date: 1/30/25 (NDA)

• AXSM: Approved ✅

➯ SYMBRAVO (meloxicam & rizatriptan) (AXS-07)

» NSAID & 5-HT1B/1D agonist combination

» Indication: Migraine

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

• SUPN: Approved ✅

➯ ONAPGO™ (apomorphine hydrochloride)

» subcutaneous apomorphine infusion device

» Indication: Parkinson’s Disease

» PDUFA date: 2/1/25 (NDA)

 📌 Upcoming PDUFAs in February:

• GSK » Meningococcal ABCWY vaccine

• ETON » ET-400 (Hydrocortisone Oral Solution)

• SWTX » Mirdametinib

Check out the January & February PDUFA calendar below.  👇

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Article History:

MV/AV/DG (2/4/25)

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