FDA Events for Connectm Technology Solutions (CNTM)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Connectm Technology Solutions (CNTM).
Over the past two years, Connectm Technology Solutions has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PIPE-791. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PIPE-791 - FDA Regulatory Timeline and Events
PIPE-791 is a drug developed by Connectm Technology Solutions for the following indication: For Chronic Pain.
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-791
- Announced Date:
- June 25, 2025
- Indication:
- For Chronic Pain
Announcement
Contineum Therapeutics, Inc. announced an update on its Phase 1b positron emission tomography (PET) trial of PIPE-791, a selective antagonist of the lysophosphatidic acid 1 (LPA1) receptor.
AI Summary
Contineum Therapeutics, Inc. announced an update on its Phase 1b positron emission tomography (PET) trial for PIPE-791, a selective antagonist of the lysophosphatidic acid 1 (LPA1) receptor. The trial, which evaluates how the drug interacts with the brain, has now fully enrolled both the healthy volunteer and progressive multiple sclerosis (PrMS) cohorts. Enrollment for participants with idiopathic pulmonary fibrosis (IPF) is still in progress.
Dr. Timothy Watkins, Chief Medical Officer, noted that while adding two extra PrMS patients has slightly delayed the reporting of topline data, it has enhanced the clinical understanding of PIPE-791. This improved insight into receptor occupancy in both healthy individuals and patients will help guide dose selection in future studies. The company expects to share topline data from these cohorts in the third quarter of 2025.
Read Announcement- Drug:
- PIPE-791
- Announced Date:
- March 6, 2025
- Indication:
- For Chronic Pain
Announcement
Contineum Therapeutics, Inc affirmed its key clinical development milestones.
AI Summary
Contineum Therapeutics, Inc. affirmed its key clinical development milestones during its Q4 2024 report. The company highlighted that 2025 is set to be a pivotal year with multiple important clinical data readouts and trial initiations. Notably, topline data from the PIPE-791 Phase 1b PET trial is expected in the second quarter of 2025, and results from the PIPE-307 Phase 2 VISTA trial for relapsing-remitting multiple sclerosis are anticipated in the latter half of 2025.
CEO Carmine Stengone emphasized that the company plans to sponsor up to six clinical trials throughout the year. The clinical programs, which include potentially best-in-class LPA1 and M1 receptor antagonists, are designed to address high unmet medical needs in neuroscience, inflammation, and immunology. With a strong cash runway extending through 2027, Contineum remains committed to advancing its innovative therapy pipeline.
Read Announcement- Drug:
- PIPE-791
- Announced Date:
- March 4, 2025
- Indication:
- For Chronic Pain
Announcement
Contineum Therapeutics, Inc announced that Topline data readout planned for early 2026
AI Summary
Contineum Therapeutics, Inc. announced that it has begun dosing patients in its exploratory Phase 1b PIPE-791 trial, which is designed to assess the safety, tolerability, and impact on pain intensity of a new chronic pain treatment. PIPE-791 is a small molecule antagonist targeting the lysophosphatidic acid 1 receptor (LPA1R), which is thought to play a role in chronic pain by affecting nerve fiber function. The trial will involve around 40 patients at up to five sites in the U.S. with a treatment duration of 28 days.
Importantly, the company has set plans to present a topline data readout for this trial in early 2026. This critical milestone will provide insights into whether PIPE-791 could offer a promising and differentiated non-opioid treatment option for patients with osteoarthritis and low back pain.
Read Announcement- Drug:
- PIPE-791
- Announced Date:
- March 4, 2025
- Indication:
- For Chronic Pain
Announcement
Contineum Therapeutics, Inc today initiated patient dosing in its exploratory PIPE-791 Phase 1b, randomized, double-blind, placebo-controlled, crossover, chronic pain trial.
AI Summary
Contineum Therapeutics has begun dosing patients in its exploratory PIPE-791 Phase 1b trial for chronic pain. This study is randomized, double-blind, placebo-controlled, and uses a crossover design to test the safety, tolerability, and impact on pain intensity of PIPE-791. PIPE-791 is a novel, brain penetrant, small-molecule blocker of the LPA1 receptor, which may help tackle the maladaptive changes in the central nervous system that keep pain persistent. The trial will focus on patients with chronic pain from osteoarthritis and low back pain. Around 40 patients will be enrolled across up to five U.S. sites, and the treatment lasts for 28 days. Topline results of the study are expected in early 2026, providing key insights into whether this non-opioid treatment option could offer relief for individuals suffering from chronic pain.
Read Announcement- Drug:
- PIPE-791
- Announced Date:
- December 16, 2024
- Indication:
- For Chronic Pain
Announcement
Contineum Therapeutics, Inc. announced dosing of the first cohort of patients in the PIPE-791 Phase 1b positron emission tomography (PET) trial. PIPE-791 is a novel, brain penetrant, small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1R).
AI Summary
Contineum Therapeutics, Inc. has begun dosing the first group of patients in its PIPE-791 Phase 1b PET trial. PIPE-791 is a novel, brain penetrant small molecule designed to block the lysophosphatidic acid 1 receptor (LPA1R). This trial will use a PET tracer to study how well PIPE-791 binds to receptors in both the brain and lungs.
The open label, single-center study is testing the drug in healthy volunteers as well as patients with idiopathic pulmonary fibrosis and progressive multiple sclerosis. Researchers hope to establish a clear link between the drug’s pharmacokinetics and receptor occupancy, which will help inform dose selection for future trials. Topline data from the trial are expected in the second quarter of 2025.
Read Announcement- Drug:
- PIPE-791
- Announced Date:
- November 18, 2024
- Indication:
- For Chronic Pain
Announcement
Contineum Therapeutics, Inc. announced authorization of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for PIPE-791 for the treatment of chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP). PIPE-791 is a novel, brain penetrant, small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1R).
AI Summary
Contineum Therapeutics announced that the FDA has authorized its Investigational New Drug (IND) application for PIPE-791. The drug is aimed at treating chronic pain associated with osteoarthritis (OA) and low back pain (LBP). PIPE-791 is a novel, brain-penetrant small molecule that blocks the lysophosphatidic acid 1 receptor (LPA1R), which is linked to neuropathic pain mechanisms.
The company plans an exploratory Phase 1b study using a randomized, double-blind design. This study, which will enroll about 40 patients across up to five sites, is expected to begin in the first quarter of 2025 and last 28 days, with initial data anticipated in early 2026. Researchers believe that blocking LPA1R could offer a non-opioid treatment option by reducing pain and counteracting the abnormal nerve signaling seen in both OA and LBP patients.
Read Announcement
Connectm Technology Solutions FDA Events - Frequently Asked Questions
As of now, Connectm Technology Solutions (CNTM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Connectm Technology Solutions (CNTM) has reported FDA regulatory activity for PIPE-791.
The most recent FDA-related event for Connectm Technology Solutions occurred on June 25, 2025, involving PIPE-791. The update was categorized as "Provided Update," with the company reporting: "Contineum Therapeutics, Inc. announced an update on its Phase 1b positron emission tomography (PET) trial of PIPE-791, a selective antagonist of the lysophosphatidic acid 1 (LPA1) receptor."
Currently, Connectm Technology Solutions has one therapy (PIPE-791) targeting the following condition: For Chronic Pain.
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:CNTM) was last updated on 7/12/2025 by MarketBeat.com Staff
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