Psyence Biomedical (PBM) FDA Approvals $5.27 +0.11 (+2.15%) As of 10:18 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsNews and TrendsOwnershipSEC Filings Psyence Biomedical's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Psyence Biomedical (PBM). Over the past two years, Psyence Biomedical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as NPX-5. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. NPX-5 FDA Regulatory Events NPX-5 is a drug developed by Psyence Biomedical for the following indication: for Adjustment Disorder. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Dosing Update - April 23,2026Dosing Update Phase 2bDrug: NPX-5Announced Date: April 23, 2026Indication: for Adjustment DisorderAnnouncementPsyence Biomedical Ltd. announced that the first patient has been dosed in its Phase IIb clinical trial evaluating NPX-5 (25mg of nature-derived psilocybin) for the treatment of Adjustment Disorder in patients with cancer in a palliative care setting.AI SummaryPsyence Biomedical Ltd. announced the first patient has been dosed in its Phase IIb clinical trial of NPX-5 (25 mg nature-derived psilocybin) for Adjustment Disorder in patients with cancer receiving palliative care. This marks the company’s first large-scale human evaluation of NPX-5 and the start of systematic data generation across five Australian clinical sites, including centers in Perth and Melbourne. NPX-5 is described as a GMP-compliant, nature-derived psilocybin developed through PsyLabs as part of Psyence’s vertically integrated platform. The randomized, double-blind, three-arm trial will assess safety, tolerability, clinical response, and treatment durability when psilocybin is given alongside structured therapeutic support. The study’s results are intended to inform future development and potential regulatory pathways. Dr. Neil Maresky said the team is focused on disciplined execution, consistent patient recruitment, and producing high-quality data to evaluate the therapeutic potential of a 25 mg dose.Read Announcement Psyence Biomedical FDA Events - Frequently Asked Questions Has Psyence Biomedical received FDA approval? As of now, Psyence Biomedical (PBM) has not received any FDA approvals for its therapy in the last two years. What drugs has Psyence Biomedical submitted to the FDA? In the past two years, Psyence Biomedical (PBM) has reported FDA regulatory activity for NPX-5. What is the most recent FDA event for Psyence Biomedical? The most recent FDA-related event for Psyence Biomedical occurred on April 23, 2026, involving NPX-5. The update was categorized as "Dosing Update," with the company reporting: "Psyence Biomedical Ltd. announced that the first patient has been dosed in its Phase IIb clinical trial evaluating NPX-5 (25mg of nature-derived psilocybin) for the treatment of Adjustment Disorder in patients with cancer in a palliative care setting." What conditions do Psyence Biomedical's current drugs treat? Currently, Psyence Biomedical has one therapy (NPX-5) targeting the following condition: for Adjustment Disorder. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Alterity Therapeutics FDA EventsBridgeBio Pharma FDA EventsBenitec Biopharma FDA EventsCrescent Biopharma FDA EventsEstablishment Labs FDA EventsNatera FDA EventsVaxcyte FDA EventsRadiopharm Theranostics FDA EventsRani Therapeutics FDA EventsRezolute FDA EventsvTv Therapeutics FDA EventsEli Lilly and Company FDA EventsGenmab A/S FDA EventsAgenus FDA EventsInflaRx FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Dogwood Therapeutics FDA Events Cassava Sciences FDA Events SCYNEXIS FDA Events Veru FDA Events Karyopharm Therapeutics FDA Events Incannex Healthcare FDA Events MIRA Pharmaceuticals FDA Events Optimi Health FDA Events Polyrizon FDA Events Quantum Biopharma FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:PBM last updated on 4/23/2026 by MarketBeat.com Staff. 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Dosing Update - April 23,2026Dosing Update Phase 2bDrug: NPX-5Announced Date: April 23, 2026Indication: for Adjustment DisorderAnnouncementPsyence Biomedical Ltd. announced that the first patient has been dosed in its Phase IIb clinical trial evaluating NPX-5 (25mg of nature-derived psilocybin) for the treatment of Adjustment Disorder in patients with cancer in a palliative care setting.AI SummaryPsyence Biomedical Ltd. announced the first patient has been dosed in its Phase IIb clinical trial of NPX-5 (25 mg nature-derived psilocybin) for Adjustment Disorder in patients with cancer receiving palliative care. This marks the company’s first large-scale human evaluation of NPX-5 and the start of systematic data generation across five Australian clinical sites, including centers in Perth and Melbourne. NPX-5 is described as a GMP-compliant, nature-derived psilocybin developed through PsyLabs as part of Psyence’s vertically integrated platform. The randomized, double-blind, three-arm trial will assess safety, tolerability, clinical response, and treatment durability when psilocybin is given alongside structured therapeutic support. The study’s results are intended to inform future development and potential regulatory pathways. Dr. Neil Maresky said the team is focused on disciplined execution, consistent patient recruitment, and producing high-quality data to evaluate the therapeutic potential of a 25 mg dose.Read Announcement
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