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FDA clears Pasithea's IND for PAS-004 to treat NF1-associated cutaneous neurofibromas in Phase 2 trial

Company Fundamentals
03 Nov 2026, 14:00 WIB
GlobeNewsWire
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Bullish
FDA clears Pasithea's IND for PAS-004 to treat NF1-associated cutaneous neurofibromas in Phase 2 trial

Pasithea Therapeutics announced FDA clearance of its Investigational New Drug (IND) application for PAS-004, a next-gen oral MEK inhibitor, to treat cutaneous neurofibromas (cNF) associated with neurofibromatosis type 1 (NF1). This clearance allows Pasithea to start a randomized, placebo-controlled Phase 2 clinical trial in the U.S. cNF affects over 95% of NF1 patients and currently has no FDA-approved systemic treatments. PAS-004 aims to address this unmet need, potentially becoming the first FDA-approved systemic therapy for cNF, impacting an estimated 80,000 U.S. patients with moderate to severe disease.

Pasithea Therapeutics' FDA clearance for PAS-004 in treating neurofibromatosis type 1 offers context for health sector performance. For readers following health stocks, here is Pluang's market snapshot as of Nov 03, 2026 19:02 WIB: Among 150 priced US health stocks, 74 rose and 69 fell. BioNTech SE (BNTX) stood out with a 2.94% gain and 100% buy order activity, contrasting with Travere Therapeutics (TVTX) which declined by 3.98%. Aurora Cannabis (ACB) also gained 4.27%, with a typical hold time of 26 days on Pluang.

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