Contineum Therapeutics' Drug in the FDA Approval Process
This 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.
- Drug:
- PIPE-307
- Announced Date:
- November 20, 2025
- Indication:
- For the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)
Announcement
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).
AI Summary
Contineum 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- Drug:
- PIPE-307
- Announced Date:
- January 8, 2025
- Indication:
- For the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)
Announcement
Contineum 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 Summary
Contineum 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
As of now, Contineum Therapeutics (CTNM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Contineum Therapeutics (CTNM) has reported FDA regulatory activity for PIPE-307.
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)."
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
Companies With Recent 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
FDA progress for NASDAQ:CTNM last updated on 11/21/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
Free CTNM Stock Alerts