Cybin (HELP) FDA Approvals $12.59 0.00 (0.00%) As of 08/21/2026 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsNews and TrendsOwnershipSEC FilingsShort Interest Cybin's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Cybin (HELP). Over the past two years, Cybin has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as HLP003. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. HLP003 FDA Regulatory Events HLP003 is a drug developed by Cybin for the following indication: adjunctive treatment of major depressive disorder ("MDD"). 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. Enrollment Update - July 21,2026Enrollment Update Phase 3Drug: HLP003Announced Date: July 21, 2026Indication: adjunctive treatment of major depressive disorder ("MDD")AnnouncementHelus Pharma announced that it has completed enrollment in its APPROACH Phase 3 pivotal study of HLP003 in patients living with Major Depressive Disorder ("MDD").AI SummaryHelus Pharma said it has finished enrolling patients in APPROACH, the first pivotal Phase 3 study in its PARADIGM program for HLP003 in adults with major depressive disorder. The study includes people with moderate to severe MDD who still have symptoms despite taking a stable antidepressant. Reaching full enrollment is an important step toward the company’s planned topline data readout in the fourth quarter of 2026. The broader PARADIGM program is also moving forward. Enrollment is still ongoing in EMBRACE, the second pivotal Phase 3 study. Some participants from APPROACH and EMBRACE may later move into EXTEND, a long-term study designed to gather more safety, durability, and possible redosing data. Helus Pharma said the program is built to support clear and reliable results, with placebo control, safety monitoring, and longer-term follow-up.Read AnnouncementEnrollment Update - June 24,2026Enrollment Update Phase 3Drug: HLP003Announced Date: June 24, 2026Indication: adjunctive treatment of major depressive disorder ("MDD")AnnouncementHelus Pharma™ nnounced that enrollment in the APPROACH Phase 3 clinical trial of HLP003 for the adjunctive treatment of major depressive disorder ("MDD") is progressing as planned and has surpassed 86% enrollment.AI SummaryHelus Pharma said enrollment in its APPROACH Phase 3 trial of HLP003 for adjunctive treatment of major depressive disorder is moving ahead as planned and is now more than 86% complete. The company said this study is testing both the safety and effectiveness of HLP003 as an add-on treatment for patients with MDD, and it is part of a larger Phase 3 program. Helus also pointed to earlier Phase 2 results that showed strong and lasting benefits. In those data, patients had about a 23-point drop in MADRS scores after 12 months, following two 16 mg doses given three weeks apart. Response and remission rates were 75% at week 18, then improved to 100% and 71% by 12 months. The company said it remains on track to report topline Phase 3 data in Q4 2026.Read Announcement Cybin FDA Events - Frequently Asked Questions Has Cybin received FDA approval? As of now, Cybin (HELP) has not received any FDA approvals for its therapy in the last two years. What drugs has Cybin submitted to the FDA? In the past two years, Cybin (HELP) has reported FDA regulatory activity for HLP003. What is the most recent FDA event for Cybin? The most recent FDA-related event for Cybin occurred on July 21, 2026, involving HLP003. The update was categorized as "Enrollment Update," with the company reporting: "Helus Pharma announced that it has completed enrollment in its APPROACH Phase 3 pivotal study of HLP003 in patients living with Major Depressive Disorder ("MDD")." What conditions do Cybin's current drugs treat? Currently, Cybin has one therapy (HLP003) targeting the following condition: adjunctive treatment of major depressive disorder ("MDD"). More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events ACADIA Pharmaceuticals FDA EventsPrecision BioSciences FDA EventsGilead Sciences FDA EventsTakeda Pharmaceutical FDA EventsScholar Rock FDA EventsAC Immune FDA EventsAlector FDA EventsAlzamend Neuro FDA EventsArcutis Biotherapeutics FDA EventsBioNTech FDA EventsHarrow FDA EventsIonis Pharmaceuticals FDA EventsMilestone Pharmaceuticals FDA EventsRadiopharm Theranostics FDA EventsRein Therapeutics 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 Arcutis Biotherapeutics FDA Events MBX Biosciences FDA Events Tarsus Pharmaceuticals FDA Events Supernus Pharmaceuticals FDA Events Atai Beckley FDA Events Trevi Therapeutics FDA Events Urogen Pharma FDA Events Rapport Therapeutics FDA Events Harmony Biosciences FDA Events Ocular Therapeutix FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:HELP last updated on 7/21/2026 by MarketBeat.com Staff. 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Enrollment Update - July 21,2026Enrollment Update Phase 3Drug: HLP003Announced Date: July 21, 2026Indication: adjunctive treatment of major depressive disorder ("MDD")AnnouncementHelus Pharma announced that it has completed enrollment in its APPROACH Phase 3 pivotal study of HLP003 in patients living with Major Depressive Disorder ("MDD").AI SummaryHelus Pharma said it has finished enrolling patients in APPROACH, the first pivotal Phase 3 study in its PARADIGM program for HLP003 in adults with major depressive disorder. The study includes people with moderate to severe MDD who still have symptoms despite taking a stable antidepressant. Reaching full enrollment is an important step toward the company’s planned topline data readout in the fourth quarter of 2026. The broader PARADIGM program is also moving forward. Enrollment is still ongoing in EMBRACE, the second pivotal Phase 3 study. Some participants from APPROACH and EMBRACE may later move into EXTEND, a long-term study designed to gather more safety, durability, and possible redosing data. Helus Pharma said the program is built to support clear and reliable results, with placebo control, safety monitoring, and longer-term follow-up.Read Announcement
Enrollment Update - June 24,2026Enrollment Update Phase 3Drug: HLP003Announced Date: June 24, 2026Indication: adjunctive treatment of major depressive disorder ("MDD")AnnouncementHelus Pharma™ nnounced that enrollment in the APPROACH Phase 3 clinical trial of HLP003 for the adjunctive treatment of major depressive disorder ("MDD") is progressing as planned and has surpassed 86% enrollment.AI SummaryHelus Pharma said enrollment in its APPROACH Phase 3 trial of HLP003 for adjunctive treatment of major depressive disorder is moving ahead as planned and is now more than 86% complete. The company said this study is testing both the safety and effectiveness of HLP003 as an add-on treatment for patients with MDD, and it is part of a larger Phase 3 program. Helus also pointed to earlier Phase 2 results that showed strong and lasting benefits. In those data, patients had about a 23-point drop in MADRS scores after 12 months, following two 16 mg doses given three weeks apart. Response and remission rates were 75% at week 18, then improved to 100% and 71% by 12 months. The company said it remains on track to report topline Phase 3 data in Q4 2026.Read Announcement
