Contineum Therapeutics (CTNM) FDA Approvals $8.26 -0.16 (-1.92%) As of 11:48 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 FilingsShort Interest Contineum Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Contineum Therapeutics (CTNM). Over the past two years, Contineum Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as PIPE-307. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. PIPE-307 FDA Regulatory Events PIPE-307 is a drug developed by Contineum Therapeutics for the following indication: For the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). 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. Top-line data - November 20,2025Top-Line Data Phase 2Drug: PIPE-307Announced Date: November 20, 2025Indication: For the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)AnnouncementContineum Therapeutics, Inc. today reported topline data from its Phase 2 VISTA trial of PIPE-307, an M1 receptor antagonist, in development for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).AI SummaryContineum Therapeutics reported topline results from the Phase 2 VISTA trial of PIPE-307, a selective M1 receptor antagonist being developed for relapsing-remitting multiple sclerosis (RRMS). The trial showed that PIPE-307 had an acceptable safety and tolerability profile at both doses tested. However, the study did not meet its prespecified primary or secondary efficacy endpoints. In particular, there was no significant change in binocular 2.5% low contrast letter acuity (LCLA) across treatment arms, a key clinical measure used in the trial. The randomized, double-blind, placebo-controlled, multi-center proof-of-concept trial included clinical and imaging endpoints. Contineum said it will continue to analyze exploratory endpoint data and plans to present the complete dataset at a future medical meeting and publish full results in a peer-reviewed journal. The company remains committed to learning from these data as it advances its neuroscience and immunology programs.Read AnnouncementEnrollment Update - January 8,2025Enrollment Update Phase 2Drug: PIPE-307Announced Date: January 8, 2025Indication: For the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)AnnouncementContineum Therapeutics, Inc announced that it has completed the targeted enrollment of 168 patients in its Phase 2 PIPE-307 VISTA trial. PIPE-307 is a potentially first-in-class M1 receptor antagonist in development for patients with relapsing-remitting multiple sclerosis (RRMS).AI SummaryContineum Therapeutics announced a major milestone in its Phase 2 PIPE-307 VISTA trial, achieving the targeted enrollment of 168 patients with relapsing-remitting multiple sclerosis (RRMS). The trial is studying a potentially first-in-class M1 receptor antagonist designed to promote remyelination and offer a new treatment approach for RRMS patients. This is a randomized, double-blind, placebo-controlled, multi-center proof-of-concept study that will assess both safety and effectiveness by measuring several clinical and imaging endpoints sensitive to changes in remyelination. The company expects the last patient to complete the trial in the third quarter of 2025. Contineum Therapeutics believes that the success of the PIPE-307 trial could lead to a breakthrough in the treatment of RRMS, potentially ushering in the next evolution in therapy for these patients.Read Announcement Contineum Therapeutics FDA Events - Frequently Asked Questions Has Contineum Therapeutics received FDA approval? As of now, Contineum Therapeutics (CTNM) has not received any FDA approvals for its therapy in the last two years. What drugs has Contineum Therapeutics submitted to the FDA? In the past two years, Contineum Therapeutics (CTNM) has reported FDA regulatory activity for PIPE-307. What is the most recent FDA event for Contineum Therapeutics? The most recent FDA-related event for Contineum Therapeutics occurred on November 20, 2025, involving PIPE-307. The update was categorized as "Top-line data," with the company reporting: "Contineum Therapeutics, Inc. today reported topline data from its Phase 2 VISTA trial of PIPE-307, an M1 receptor antagonist, in development for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS)." What conditions do Contineum Therapeutics' current drugs treat? Currently, Contineum Therapeutics has one therapy (PIPE-307) targeting the following condition: For the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Arrowhead Pharmaceuticals FDA EventsAtara Biotherapeutics FDA EventsBioVie FDA EventsOcugen FDA EventsOncolytics Biotech FDA EventsParabilis Medicines FDA EventsPharming Group FDA EventsQuoin Pharmaceuticals FDA EventsSarepta Therapeutics FDA EventsEntrada Therapeutics FDA EventsZai Lab FDA EventsAgomAb Therapeutics FDA EventsAlkermes FDA EventsBeam Therapeutics FDA EventsBiomea Fusion 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 Trevi Therapeutics FDA Events ANI Pharmaceuticals FDA Events Ocular Therapeutix FDA Events Compass Pathways FDA Events Eton Pharmaceuticals FDA Events Innoviva FDA Events Rapport Therapeutics FDA Events GH Research FDA Events Avalyn Pharma FDA Events Harrow FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:CTNM last updated on 11/21/2025 by MarketBeat.com Staff. 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Top-line data - November 20,2025Top-Line Data Phase 2Drug: PIPE-307Announced Date: November 20, 2025Indication: For the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)AnnouncementContineum Therapeutics, Inc. today reported topline data from its Phase 2 VISTA trial of PIPE-307, an M1 receptor antagonist, in development for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).AI SummaryContineum Therapeutics reported topline results from the Phase 2 VISTA trial of PIPE-307, a selective M1 receptor antagonist being developed for relapsing-remitting multiple sclerosis (RRMS). The trial showed that PIPE-307 had an acceptable safety and tolerability profile at both doses tested. However, the study did not meet its prespecified primary or secondary efficacy endpoints. In particular, there was no significant change in binocular 2.5% low contrast letter acuity (LCLA) across treatment arms, a key clinical measure used in the trial. The randomized, double-blind, placebo-controlled, multi-center proof-of-concept trial included clinical and imaging endpoints. Contineum said it will continue to analyze exploratory endpoint data and plans to present the complete dataset at a future medical meeting and publish full results in a peer-reviewed journal. The company remains committed to learning from these data as it advances its neuroscience and immunology programs.Read Announcement
Enrollment Update - January 8,2025Enrollment Update Phase 2Drug: PIPE-307Announced Date: January 8, 2025Indication: For the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)AnnouncementContineum Therapeutics, Inc announced that it has completed the targeted enrollment of 168 patients in its Phase 2 PIPE-307 VISTA trial. PIPE-307 is a potentially first-in-class M1 receptor antagonist in development for patients with relapsing-remitting multiple sclerosis (RRMS).AI SummaryContineum Therapeutics announced a major milestone in its Phase 2 PIPE-307 VISTA trial, achieving the targeted enrollment of 168 patients with relapsing-remitting multiple sclerosis (RRMS). The trial is studying a potentially first-in-class M1 receptor antagonist designed to promote remyelination and offer a new treatment approach for RRMS patients. This is a randomized, double-blind, placebo-controlled, multi-center proof-of-concept study that will assess both safety and effectiveness by measuring several clinical and imaging endpoints sensitive to changes in remyelination. The company expects the last patient to complete the trial in the third quarter of 2025. Contineum Therapeutics believes that the success of the PIPE-307 trial could lead to a breakthrough in the treatment of RRMS, potentially ushering in the next evolution in therapy for these patients.Read Announcement
