Connectm Technology Solutions (CNTM) FDA Approvals $6.09 +0.20 (+3.32%) As of 11:09 AM Eastern Add Compare Share Share FDA Events Stock AnalysisChartEarningsFDA EventsHeadlinesInsider TradesSEC FilingsBuy This Stock Connectm Technology Solutions' Drug in the FDA Approval ProcessThis 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. Positive Data - September 18,2025Positive Data Phase 1bDrug: PIPE-791Announced Date: September 18, 2025Indication: For Chronic PainAnnouncementContineum Therapeutics, Inc announced positive topline data from its PIPE-791 Phase 1b positron emission tomography (PET) trial.AI SummaryContineum Therapeutics announced positive topline data from its PIPE-791 Phase 1b PET trial. PIPE-791 is a novel oral small molecule that blocks the lysophosphatidic acid 1 (LPA1) receptor and crosses the blood–brain barrier. The study showed PIPE-791 achieved high brain receptor occupancy in both healthy volunteers and progressive multiple sclerosis patients. Researchers also found a clear link between drug levels in the blood and receptor engagement in the brain over time. The trial reported a safety and tolerability profile consistent with earlier clinical studies. No new safety concerns emerged, supporting the potential for once-daily dosing with sustained target coverage. Based on these findings, Contineum plans to use similar doses in upcoming Phase 2 proof-of-concept trials for idiopathic pulmonary fibrosis and progressive multiple sclerosis, aiming for more than 90% receptor coverage at trough levels with daily dosing.Read AnnouncementProvided Update - June 25,2025Provided Update Phase 1bDrug: PIPE-791Announced Date: June 25, 2025Indication: For Chronic PainAnnouncementContineum 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 SummaryContineum 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 AnnouncementProvided Update - March 6,2025Provided Update Drug: PIPE-791Announced Date: March 6, 2025Indication: For Chronic PainAnnouncementContineum Therapeutics, Inc affirmed its key clinical development milestones.AI SummaryContineum 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 AnnouncementData readout - March 4,2025Data Readout Drug: PIPE-791Announced Date: March 4, 2025Indication: For Chronic PainAnnouncementContineum Therapeutics, Inc announced that Topline data readout planned for early 2026AI SummaryContineum 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 AnnouncementDosing Update - March 4,2025Dosing Update Phase 1bDrug: PIPE-791Announced Date: March 4, 2025Indication: For Chronic PainAnnouncementContineum Therapeutics, Inc today initiated patient dosing in its exploratory PIPE-791 Phase 1b, randomized, double-blind, placebo-controlled, crossover, chronic pain trial.AI SummaryContineum 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 AnnouncementDose Update - December 16,2024Dose Update Phase 1bDrug: PIPE-791Announced Date: December 16, 2024Indication: For Chronic PainAnnouncementContineum 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 SummaryContineum 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 AnnouncementFDA Authorization - November 18,2024Fda Authorization NDADrug: PIPE-791Announced Date: November 18, 2024Indication: For Chronic PainAnnouncementContineum 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 SummaryContineum 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 Has Connectm Technology Solutions received FDA approval? As of now, Connectm Technology Solutions (CNTM) has not received any FDA approvals for its therapy in the last two years. What drugs has Connectm Technology Solutions submitted to the FDA? In the past two years, Connectm Technology Solutions (CNTM) has reported FDA regulatory activity for PIPE-791. What is the most recent FDA event for Connectm Technology Solutions? The most recent FDA-related event for Connectm Technology Solutions occurred on September 18, 2025, involving PIPE-791. The update was categorized as "Positive Data," with the company reporting: "Contineum Therapeutics, Inc announced positive topline data from its PIPE-791 Phase 1b positron emission tomography (PET) trial." What conditions do Connectm Technology Solutions' current drugs treat? Currently, Connectm Technology Solutions has one therapy (PIPE-791) targeting the following condition: For Chronic Pain. 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 EventsCAMP4 Therapeutics FDA EventsEikon Therapeutics FDA EventsIDEAYA Biosciences FDA EventsKura Oncology FDA EventsMedicus Pharma FDA EventsMaplight Therapeutics FDA EventsPacira BioSciences FDA EventsVeru FDA EventsEstrella Immunopharma FDA EventsGilead Sciences FDA EventsPrima BioMed FDA EventsMannKind FDA EventsNewAmsterdam Pharma FDA EventsOncobiologics 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 Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for OTCMKTS:CNTM last updated on 9/18/2025 by MarketBeat.com Staff. 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Positive Data - September 18,2025Positive Data Phase 1bDrug: PIPE-791Announced Date: September 18, 2025Indication: For Chronic PainAnnouncementContineum Therapeutics, Inc announced positive topline data from its PIPE-791 Phase 1b positron emission tomography (PET) trial.AI SummaryContineum Therapeutics announced positive topline data from its PIPE-791 Phase 1b PET trial. PIPE-791 is a novel oral small molecule that blocks the lysophosphatidic acid 1 (LPA1) receptor and crosses the blood–brain barrier. The study showed PIPE-791 achieved high brain receptor occupancy in both healthy volunteers and progressive multiple sclerosis patients. Researchers also found a clear link between drug levels in the blood and receptor engagement in the brain over time. The trial reported a safety and tolerability profile consistent with earlier clinical studies. No new safety concerns emerged, supporting the potential for once-daily dosing with sustained target coverage. Based on these findings, Contineum plans to use similar doses in upcoming Phase 2 proof-of-concept trials for idiopathic pulmonary fibrosis and progressive multiple sclerosis, aiming for more than 90% receptor coverage at trough levels with daily dosing.Read Announcement
Provided Update - June 25,2025Provided Update Phase 1bDrug: PIPE-791Announced Date: June 25, 2025Indication: For Chronic PainAnnouncementContineum 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 SummaryContineum 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
Provided Update - March 6,2025Provided Update Drug: PIPE-791Announced Date: March 6, 2025Indication: For Chronic PainAnnouncementContineum Therapeutics, Inc affirmed its key clinical development milestones.AI SummaryContineum 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
Data readout - March 4,2025Data Readout Drug: PIPE-791Announced Date: March 4, 2025Indication: For Chronic PainAnnouncementContineum Therapeutics, Inc announced that Topline data readout planned for early 2026AI SummaryContineum 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
Dosing Update - March 4,2025Dosing Update Phase 1bDrug: PIPE-791Announced Date: March 4, 2025Indication: For Chronic PainAnnouncementContineum Therapeutics, Inc today initiated patient dosing in its exploratory PIPE-791 Phase 1b, randomized, double-blind, placebo-controlled, crossover, chronic pain trial.AI SummaryContineum 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
Dose Update - December 16,2024Dose Update Phase 1bDrug: PIPE-791Announced Date: December 16, 2024Indication: For Chronic PainAnnouncementContineum 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 SummaryContineum 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
FDA Authorization - November 18,2024Fda Authorization NDADrug: PIPE-791Announced Date: November 18, 2024Indication: For Chronic PainAnnouncementContineum 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 SummaryContineum 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
