Incannex Healthcare PSX-001 Program Aligns with White House Executive Order Accelerating Access to Psychedelic Treatments for Serious Mental Illness

About this update from Incannex Healthcare Inc.

Company’s oral synthetic psilocybin program advances within significantly improved regulatory environment MELBOURNE, Australia and NEW YORK, April 22, 2026 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, today supports the White House Executive Order signed by President Donald J. Trump on April 18, 2026, titled, “Accelerating Medical Treatments for Serious Mental Illness.” The Company believes its PSX-001 development program aligns with the goals outlined in the Executive Order and believes the data demonstrated to date, along with a more amenable regulatory environment, may provide significant hope for those suffering from anxiety disorders. “We agree with the Administration’s recognition that the mental health crisis in America demands a new level of regulatory urgency and scientific ambition,” commented Incannex CEO Joel Latham. ”For years, patients suffering from debilitating anxiety disorders have had limited options, particularly for those who fail first-line treatments. PSX-001, our oral synthetic psilocybin therapeutic for Generalized Anxiety Disorder, is designed for exactly these patients and this Executive Order represents a meaningful step toward ensuring that novel, evidence-based therapies like ours can reach them without unnecessary delay.” PSX-001: Rigorous Science, Compelling Data, a Clear Path Forward PSX-001 is an oral, fixed-dose synthetic psilocybin formulation in development for Generalized Anxiety Disorder (GAD), a condition affecting an estimated 280 million people globally and approximately 6.8 million in the United States. In Incannex’s completed Phase 2 clinical trial, PSX-001 demonstrated statistically significant and clinically meaningful improvements across all primary and secondary endpoints: The Executive Order’s direction to the FDA to prioritize review of psychedelic compounds with Breakthrough Therapy designations create Right to Try pathways for investigational psychedelics, and initiate DEA rescheduling upon successful Phase 3 completion. The move also addresses systemic barriers that have historically constrained the development and commercialization of this entire therapeutic category. Incannex views these measures as meaningfully reducing regulatory and commercial risk for the psilocybin class broadly. “This Executiv...

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