Pasithea's PAS-004 Gains Momentum with FDA Fast Track for NF1 Plexiform Neurofibromas
June 15, 2026
The release includes standard forward-looking statements and risk disclosures regarding regulatory uncertainties and clinical development timelines.
PAS-004 remains Pasithea’s lead NF1 candidate, a next-generation macrocyclic MEK inhibitor in Phase 1/1b for NF1-associated plexiform neurofibromas and Phase 1 for other cancers, with regulatory milestones shaping its development timeline.
FDA Fast Track and Rare Pediatric Disease designations for PAS-004 underscore potential for accelerated development and earlier access, complemented by an FDA Orphan Drug designation in ALS and a new Chief Medical Officer to steer clinical efforts.
Conference outreach is active, with invitations for attendees to schedule meetings with Pasithea representatives in advance to discuss PAS-004.
The NF Conference is highlighted as a premier event for NF research and clinical collaboration across NF1, schwannomatosis, and NF2-related schwannomatosis.
The conference participation is part of a broader strategy to build awareness, support trial recruitment, and strengthen PAS-004’s long-term positioning amid ongoing regulatory progress and financing updates.
Pasithea will exhibit at the Children’s Tumor Foundation 2026 NF Conference in Denver, June 26–30, to engage with the NF1 clinical and academic community about PAS-004.
CEO focus remains on directly engaging the NF1 community to pursue safer, longer-term therapies and foster collaborations with CTF and NF1 researchers.
Investor relations contact for Pasithea is Patrick Gaynes, available via the provided email.
Stock context shows KTTA reacting to positive regulatory milestones with company-specific momentum rather than broad biotech sector movement.
Plexiform neurofibromas are discussed as NF1-related tumors with potential morbidity and risk of malignant transformation, setting the clinical context for PAS-004.
Summary based on 3 sources
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Sources

Yahoo! Finance • Jun 15, 2026
Pasithea Therapeutics Announces Exhibit at Children’s Tumor Foundation 2026 NF Conference
The Manila Times • Jun 15, 2026
Pasithea Therapeutics Announces Exhibit at Children’s Tumor Foundation 2026 NF Conference
Stock Titan • Jun 15, 2026
Pasithea Therapeutics Announces Exhibit at Children’s Tumor Foundation 2026 NF Conference