FDA Events for Contineum Therapeutics (CTNM)
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 Timeline and 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:
- 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 January 8, 2025, involving PIPE-307. The update was categorized as "Enrollment Update," with the company reporting: "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)."
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 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
This page (NASDAQ:CTNM) was last updated on 7/14/2025 by MarketBeat.com Staff
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