{"success":true,"data":{"pressRelease":{"id":"154658","rtpr_id":"nACSdk3Rba-20260928","ticker":"MPH","exchange":"","all_tickers":["MPH"],"title":"Medicure Announces Completion of Enrollment in Its MEND-PNPO Phase 3 Clinical Trial","author":"ACCESSWIRE","published_at":"2026-09-28T22:00:01.200Z","article_body":"WINNIPEG, MB / ACCESS Newswire (https://www.accessnewswire.com/) / September\n28, 2026 / Medicure Inc. (\"Medicure\" or the \"Company\") (TSXV:MPH)(OTC\nPINK:MCUJF), a company focused on the development and commercialization of\npharmaceuticals and healthcare products for patients and prescribers in the\nUnited States market, today announced the completion of patient enrollment in\nthe MEND-PNPO Phase 3 study (ClinicalTrials.gov NCT04706013\n(https://pr.report/quu8)), a pivotal trial evaluating MC-1 for the treatment\nof Pyridox(am)ine 5'-Phosphate Oxidase (PNPO) deficiency.\n\nThe MEND-PNPO study has successfully enrolled 10 patients, meeting the\nCompany's enrollment objective. Patients enrolled in the study continue to\nprogress through their respective treatment and follow-up periods, with\nseveral patients having already completed key study milestones.\n\nPNPO deficiency (https://pr.report/quu9) is an ultra-rare inherited\nneurometabolic disorder caused by mutations in the PNPO gene, resulting in an\ninability to produce adequate levels of pyridoxal 5'-phosphate (P5P), the\nactive form of vitamin B6. The condition commonly presents in newborns and\ninfants with severe, difficult-to-control seizures and can lead to significant\ndevelopmental impairment, neurological dysfunction, and death if untreated.\nPlease note, MC-1 is not FDA-approved. The safety and effectiveness of MC-1\nhas not been established.\n\nThe U.S. Food and Drug Administration (\"FDA\") has granted both Rare Pediatric\nDisease Designation and Orphan Drug Designation to MC-1 for the treatment of\nseizures associated with PNPO deficiency. In addition, the European Medicines\nAgency (\"EMA\") has granted Orphan Drug Designation to MC-1 for the treatment\nof PNPO deficiency. Medicure has also received Fast Track Designation\n(https://pr.report/quua) for MC-1 in PNPO deficiency, which is intended to\nfacilitate the development and review of a future New Drug Application (\"NDA\")\nby the FDA.\n\nUpon approval of an NDA for MC-1 in PNPO deficiency, Medicure is eligible to\nreceive a Priority Review Voucher from the FDA, which may be redeemed or sold.\n\nThe Company presented the design and baseline data from the MEND-PNPO study at\nthe European Epilepsy Congress (EEC) in Athens, Greece, earlier this year. The\npresentation was delivered by lead investigator Phillip Pearl, MD, Director of\nEpilepsy and Clinical Neurophysiology at Boston Children's Hospital and\nWilliam G. Lennox Chair and Professor of Neurology at Harvard Medical School.\nIt outlined the study design, primary and secondary endpoints, and MC-1 dosing\nregimen, along with baseline pyridoxal 5'-phosphate (P5P) levels in enrolled\npatients. The same data will be presented later this year at the Child\nNeurology Society (CNS) Annual Meeting in Montreal, Canada, and the American\nEpilepsy Society (AES) Annual Meeting in Denver, Colorado.\n\n\"The completion of enrollment in the MEND-PNPO study marks a major milestone\nfor Medicure and for the PNPO deficiency community,\" said Albert D. Friesen,\nPresident, Chief Executive Officer of Medicure and Chair of its Board of\nDirectors. \"We are grateful to the patients, families, investigators, and\nstudy coordinators whose commitment made this achievement possible. Our focus\nnow turns to completing patient follow-up and advancing MC-1 toward a\npotential NDA submission as we work to bring the first approved therapy for\nPNPO deficiency to patients in need.\"\n\nAbout Medicure Inc.\nMedicure is a company focused on the development and commercialization of\npharmaceuticals and healthcare products for patients and prescribers in the\nUnited States market. The present focus of the Company is the marketing and\ndistribution of AGGRASTAT(®) (tirofiban hydrochloride) injection and\nZYPITAMAG(®) (pitavastatin) tablets in the United States, where they are sold\nthrough the Company's U.S. subsidiary, Medicure Pharma Inc. Medicure also\noperates Marley Drug Inc. (\"Marley Drug\"), a pharmacy subsidiary servicing all\n50 states, Washington D.C. and Puerto Rico. Marley Drug(®) is committed to\nimproving access to medications for all Americans together with exceptional\ncustomer service and free home delivery. Medicure also operates Gateway\nMedical Pharmacy (\"Gateway\"), located in Portland, Oregon in a medical office\nbuilding near major transportation lines and multiple healthcare clinics and\ncenters. In addition to regular customers, the pharmacy services multiple\nlong-term care facilities and provides non-sterile compounding services.\nMedicure also operates West Olympia Pharmacy (\"West Olympia\"), located in\nOlympia, Washington in a medical office complex near multiple clinics. For\nmore information visit www.marleydrug.com. For more information about Medicure\nplease visit www.medicure.com. For additional information about AGGRASTAT(®),\nplease visit www.aggrastat.com or refer to the full Prescribing Information\n(https://pr.report/quue). For additional information about ZYPITAMAG(®),\nplease visit www.zypitamag.com or refer to the full Prescribing Information.\n(https://pr.report/quug)\n\nTo be added to Medicure's e-mail list, please visit:\nhttp://medicure.mediaroom.com/alerts\n\nNeither the TSX Venture Exchange nor its Regulation Services Provider (as that\nterm is defined in policies of the TSX Venture Exchange) accepts\nresponsibility for the adequacy or accuracy of this release.\n\nForward Looking Information: Statements contained in this press release that\nare not statements of historical fact, including, without limitation,\nstatements containing the words \"believes\", \"may\", \"plans\", \"will\",\n\"estimates\", \"continues\", \"anticipates\", \"intends\", \"expects\" and similar\nexpressions, may constitute \"forward-looking information\" within the meaning\nof applicable Canadian and U.S. federal securities laws (such forward-looking\ninformation and forward-looking statements are hereinafter collectively\nreferred to as \"forward-looking statements\"). Forward-looking statements,\ninclude estimates, analysis and opinions of management of the Company made in\nlight of its experience and its perception of trends, current conditions and\nexpected developments, as well as other factors which the Company believes to\nbe relevant and reasonable in the circumstances. Inherent in forward-looking\nstatements are known and unknown risks, uncertainties and other factors beyond\nthe Company's ability to predict or control that may cause the actual results,\nevents or developments to be materially different from any future results,\nevents or developments expressed or implied by such forward-looking\nstatements, and as such, readers are cautioned not to place undue reliance on\nforward-looking statements. Such risk factors include, among others, the\nCompany's future product revenues, expected results, including future revenue\nfrom P5P, the filing of an NDA submission, the likelihood of approval of an\nNDA, the likelihood of receiving a priority review voucher from the United\nState Food and Drug Administration, expected future growth in revenues, stage\nof development, additional capital requirements, risks associated with the\ncompletion and timing of clinical trials and obtaining regulatory approval to\nmarket the Company's products, the ability to protect its intellectual\nproperty, dependence upon collaborative partners, changes in government\nregulation or regulatory approval processes, and rapid technological change in\nthe industry. Such statements are based on a number of assumptions which may\nprove to be incorrect, including, but not limited to, assumptions about:\ngeneral business and economic conditions; the impact of changes in Canadian-US\ndollar and other foreign exchange rates on the Company's revenues, costs and\nresults; the timing of the receipt of regulatory and governmental approvals\nfor the Company's research and development projects; the availability of\nfinancing for the Company's commercial operations and/or research and\ndevelopment projects, or the availability of financing on reasonable terms;\nresults of current and future clinical trials; the uncertainties associated\nwith the acceptance and demand for new products and market competition. The\nforegoing list of important factors and assumptions is not exhaustive. The\nCompany undertakes no obligation to update publicly or otherwise revise any\nforward-looking statements or the foregoing list of factors, other than as may\nbe required by applicable legislation. Additional discussion regarding the\nrisks and uncertainties relating to the Company and its business can be found\nin the Company's other filings with the applicable Canadian securities\nregulatory authorities or the US Securities and Exchange Commission, and in\nthe \"Risk Factors\" section of its current Form 20F.\n\nAGGRASTAT(®) (tirofiban hydrochloride) injection, ZYPITAMAG(®)\n(pitavastatin) tablets, and Marley Drug(®) are registered trademarks.\n\nFor more information, please contact:\nDr. Albert D. Friesen\nChief Executive Officer\nTel. 888-435-2220\nFax 204-488-9823\nE-mail: info@medicure.com\nwww.medicure.com\n\nSOURCE: Medicure, Inc.\nView the original press release\n(https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/medicure-announces-completion-of-enrollment-in-its-mend-pnpo-phase-3-1228105)\non ACCESS Newswire\n\n\nCopyright 2026 ACCESS Newswire. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nACSdk3Rba-20260928","title":"Medicure Announces Completion of Enrollment in Its MEND-PNPO Phase 3 Clinical Trial","author":"ACCESSWIRE","ticker":"MPH","created":"2026-09-28T22:00:01.200Z","tickers":["MPH"],"exchange":"","article_body":"WINNIPEG, MB / ACCESS Newswire (https://www.accessnewswire.com/) / September\n28, 2026 / Medicure Inc. (\"Medicure\" or the \"Company\") (TSXV:MPH)(OTC\nPINK:MCUJF), a company focused on the development and commercialization of\npharmaceuticals and healthcare products for patients and prescribers in the\nUnited States market, today announced the completion of patient enrollment in\nthe MEND-PNPO Phase 3 study (ClinicalTrials.gov NCT04706013\n(https://pr.report/quu8)), a pivotal trial evaluating MC-1 for the treatment\nof Pyridox(am)ine 5'-Phosphate Oxidase (PNPO) deficiency.\n\nThe MEND-PNPO study has successfully enrolled 10 patients, meeting the\nCompany's enrollment objective. Patients enrolled in the study continue to\nprogress through their respective treatment and follow-up periods, with\nseveral patients having already completed key study milestones.\n\nPNPO deficiency (https://pr.report/quu9) is an ultra-rare inherited\nneurometabolic disorder caused by mutations in the PNPO gene, resulting in an\ninability to produce adequate levels of pyridoxal 5'-phosphate (P5P), the\nactive form of vitamin B6. The condition commonly presents in newborns and\ninfants with severe, difficult-to-control seizures and can lead to significant\ndevelopmental impairment, neurological dysfunction, and death if untreated.\nPlease note, MC-1 is not FDA-approved. The safety and effectiveness of MC-1\nhas not been established.\n\nThe U.S. Food and Drug Administration (\"FDA\") has granted both Rare Pediatric\nDisease Designation and Orphan Drug Designation to MC-1 for the treatment of\nseizures associated with PNPO deficiency. In addition, the European Medicines\nAgency (\"EMA\") has granted Orphan Drug Designation to MC-1 for the treatment\nof PNPO deficiency. Medicure has also received Fast Track Designation\n(https://pr.report/quua) for MC-1 in PNPO deficiency, which is intended to\nfacilitate the development and review of a future New Drug Application (\"NDA\")\nby the FDA.\n\nUpon approval of an NDA for MC-1 in PNPO deficiency, Medicure is eligible to\nreceive a Priority Review Voucher from the FDA, which may be redeemed or sold.\n\nThe Company presented the design and baseline data from the MEND-PNPO study at\nthe European Epilepsy Congress (EEC) in Athens, Greece, earlier this year. The\npresentation was delivered by lead investigator Phillip Pearl, MD, Director of\nEpilepsy and Clinical Neurophysiology at Boston Children's Hospital and\nWilliam G. Lennox Chair and Professor of Neurology at Harvard Medical School.\nIt outlined the study design, primary and secondary endpoints, and MC-1 dosing\nregimen, along with baseline pyridoxal 5'-phosphate (P5P) levels in enrolled\npatients. The same data will be presented later this year at the Child\nNeurology Society (CNS) Annual Meeting in Montreal, Canada, and the American\nEpilepsy Society (AES) Annual Meeting in Denver, Colorado.\n\n\"The completion of enrollment in the MEND-PNPO study marks a major milestone\nfor Medicure and for the PNPO deficiency community,\" said Albert D. Friesen,\nPresident, Chief Executive Officer of Medicure and Chair of its Board of\nDirectors. \"We are grateful to the patients, families, investigators, and\nstudy coordinators whose commitment made this achievement possible. Our focus\nnow turns to completing patient follow-up and advancing MC-1 toward a\npotential NDA submission as we work to bring the first approved therapy for\nPNPO deficiency to patients in need.\"\n\nAbout Medicure Inc.\nMedicure is a company focused on the development and commercialization of\npharmaceuticals and healthcare products for patients and prescribers in the\nUnited States market. The present focus of the Company is the marketing and\ndistribution of AGGRASTAT(®) (tirofiban hydrochloride) injection and\nZYPITAMAG(®) (pitavastatin) tablets in the United States, where they are sold\nthrough the Company's U.S. subsidiary, Medicure Pharma Inc. Medicure also\noperates Marley Drug Inc. (\"Marley Drug\"), a pharmacy subsidiary servicing all\n50 states, Washington D.C. and Puerto Rico. Marley Drug(®) is committed to\nimproving access to medications for all Americans together with exceptional\ncustomer service and free home delivery. Medicure also operates Gateway\nMedical Pharmacy (\"Gateway\"), located in Portland, Oregon in a medical office\nbuilding near major transportation lines and multiple healthcare clinics and\ncenters. In addition to regular customers, the pharmacy services multiple\nlong-term care facilities and provides non-sterile compounding services.\nMedicure also operates West Olympia Pharmacy (\"West Olympia\"), located in\nOlympia, Washington in a medical office complex near multiple clinics. For\nmore information visit www.marleydrug.com. For more information about Medicure\nplease visit www.medicure.com. For additional information about AGGRASTAT(®),\nplease visit www.aggrastat.com or refer to the full Prescribing Information\n(https://pr.report/quue). For additional information about ZYPITAMAG(®),\nplease visit www.zypitamag.com or refer to the full Prescribing Information.\n(https://pr.report/quug)\n\nTo be added to Medicure's e-mail list, please visit:\nhttp://medicure.mediaroom.com/alerts\n\nNeither the TSX Venture Exchange nor its Regulation Services Provider (as that\nterm is defined in policies of the TSX Venture Exchange) accepts\nresponsibility for the adequacy or accuracy of this release.\n\nForward Looking Information: Statements contained in this press release that\nare not statements of historical fact, including, without limitation,\nstatements containing the words \"believes\", \"may\", \"plans\", \"will\",\n\"estimates\", \"continues\", \"anticipates\", \"intends\", \"expects\" and similar\nexpressions, may constitute \"forward-looking information\" within the meaning\nof applicable Canadian and U.S. federal securities laws (such forward-looking\ninformation and forward-looking statements are hereinafter collectively\nreferred to as \"forward-looking statements\"). Forward-looking statements,\ninclude estimates, analysis and opinions of management of the Company made in\nlight of its experience and its perception of trends, current conditions and\nexpected developments, as well as other factors which the Company believes to\nbe relevant and reasonable in the circumstances. Inherent in forward-looking\nstatements are known and unknown risks, uncertainties and other factors beyond\nthe Company's ability to predict or control that may cause the actual results,\nevents or developments to be materially different from any future results,\nevents or developments expressed or implied by such forward-looking\nstatements, and as such, readers are cautioned not to place undue reliance on\nforward-looking statements. Such risk factors include, among others, the\nCompany's future product revenues, expected results, including future revenue\nfrom P5P, the filing of an NDA submission, the likelihood of approval of an\nNDA, the likelihood of receiving a priority review voucher from the United\nState Food and Drug Administration, expected future growth in revenues, stage\nof development, additional capital requirements, risks associated with the\ncompletion and timing of clinical trials and obtaining regulatory approval to\nmarket the Company's products, the ability to protect its intellectual\nproperty, dependence upon collaborative partners, changes in government\nregulation or regulatory approval processes, and rapid technological change in\nthe industry. Such statements are based on a number of assumptions which may\nprove to be incorrect, including, but not limited to, assumptions about:\ngeneral business and economic conditions; the impact of changes in Canadian-US\ndollar and other foreign exchange rates on the Company's revenues, costs and\nresults; the timing of the receipt of regulatory and governmental approvals\nfor the Company's research and development projects; the availability of\nfinancing for the Company's commercial operations and/or research and\ndevelopment projects, or the availability of financing on reasonable terms;\nresults of current and future clinical trials; the uncertainties associated\nwith the acceptance and demand for new products and market competition. The\nforegoing list of important factors and assumptions is not exhaustive. The\nCompany undertakes no obligation to update publicly or otherwise revise any\nforward-looking statements or the foregoing list of factors, other than as may\nbe required by applicable legislation. Additional discussion regarding the\nrisks and uncertainties relating to the Company and its business can be found\nin the Company's other filings with the applicable Canadian securities\nregulatory authorities or the US Securities and Exchange Commission, and in\nthe \"Risk Factors\" section of its current Form 20F.\n\nAGGRASTAT(®) (tirofiban hydrochloride) injection, ZYPITAMAG(®)\n(pitavastatin) tablets, and Marley Drug(®) are registered trademarks.\n\nFor more information, please contact:\nDr. Albert D. Friesen\nChief Executive Officer\nTel. 888-435-2220\nFax 204-488-9823\nE-mail: info@medicure.com\nwww.medicure.com\n\nSOURCE: Medicure, Inc.\nView the original press release\n(https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/medicure-announces-completion-of-enrollment-in-its-mend-pnpo-phase-3-1228105)\non ACCESS Newswire\n\n\nCopyright 2026 ACCESS Newswire. All Rights Reserved."},"type":"article","timestamp":"2026-09-28T22:00:01.299139003Z","server_sent_at_ms":1790632801299},"received_at":"2026-09-28T22:00:01.535Z","source_url":"https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/medicure-announces-completion-of-enrollment-in-its-mend-pnpo-phase-3-1228105"},"analysis":{"id":"143413","press_release_id":"154658","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":["MC-1 is not FDA-approved; safety and effectiveness not established","only 10 patients enrolled in the pivotal trial, reflecting the ultra-rare indication"],"eventType":"clinical_trial","narrative":"Medicure completed patient enrollment in its MEND-PNPO Phase 3 trial of MC-1 for PNPO deficiency, enrolling 10 patients and meeting its enrollment objective.\n\nMC-1 holds FDA Rare Pediatric Disease, Orphan Drug, and Fast Track designations plus EMA Orphan Drug designation; NDA approval would also make Medicure eligible for a redeemable or sellable Priority Review Voucher.\n\nPatients are progressing through treatment and follow-up, with several already completing key milestones; the next step is completing follow-up and advancing toward a potential NDA submission.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Small-cap rare-disease pipeline milestone -- enrollment done, NDA path and Priority Review Voucher potential ahead."},"keyFigures":{"drugName":"MC-1","phaseOfTrial":"Phase 3","customDimensions":{"indication":"PNPO deficiency","trial_name":"MEND-PNPO","clinicaltrials_id":"NCT04706013","patients_enrolled":10}},"quotedText":"The completion of enrollment in the MEND-PNPO study marks a major milestone for Medicure and for the PNPO deficiency community","namedEntities":{"people":[{"name":"Albert D. Friesen","role":"President and CEO, Chair of the Board"},{"name":"Phillip Pearl, MD","role":"lead investigator, Director of Epilepsy and Clinical Neurophysiology at Boston Children's Hospital"}],"products":["MC-1","AGGRASTAT","ZYPITAMAG","Marley Drug"],"companies":[{"name":"Medicure Inc.","ticker":"MPH"},{"name":"Medicure Pharma Inc.","relationship":"subsidiary"},{"name":"Marley Drug Inc.","relationship":"subsidiary"},{"name":"Boston Children's Hospital","relationship":"investigator institution"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Completion of enrollment in a 10-patient ultra-rare-disease Phase 3 trial is a positive pipeline milestone but not a binary readout or approval. Next catalysts are follow-up completion and a potential NDA submission."},"tickerRelevance":{"others":[{"ticker":"MCUJF","relevance":"OTC ticker of same issuer"}],"primary":"MPH"},"globalImportance":20,"audienceRelevance":12,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"enrollment milestone, not readout","rareDiseaseNiche":true}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Medicure completed patient enrollment in its MEND-PNPO Phase 3 trial of MC-1 for PNPO deficiency, enrolling 10 patients and meeting its enrollment objective.\n\nMC-1 holds FDA Rare Pediatric Disease, Orphan Drug, and Fast Track designations plus EMA Orphan Drug designation; NDA approval would also make Medicure eligible for a redeemable or sellable Priority Review Voucher.\n\nPatients are progressing through treatment and follow-up, with several already completing key milestones; the next step is completing follow-up and advancing toward a potential NDA submission.","key_figures":{"drugName":"MC-1","phaseOfTrial":"Phase 3","customDimensions":{"indication":"PNPO deficiency","trial_name":"MEND-PNPO","clinicaltrials_id":"NCT04706013","patients_enrolled":10}},"named_entities":{"people":[{"name":"Albert D. Friesen","role":"President and CEO, Chair of the Board"},{"name":"Phillip Pearl, MD","role":"lead investigator, Director of Epilepsy and Clinical Neurophysiology at Boston Children's Hospital"}],"products":["MC-1","AGGRASTAT","ZYPITAMAG","Marley Drug"],"companies":[{"name":"Medicure Inc.","ticker":"MPH"},{"name":"Medicure Pharma Inc.","relationship":"subsidiary"},{"name":"Marley Drug Inc.","relationship":"subsidiary"},{"name":"Boston Children's Hospital","relationship":"investigator institution"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-28T22:00:07.032Z","global_importance":20,"audience_relevance":12,"importance_components":{"tickerTier":"micro-cap","eventGravity":"enrollment milestone, not readout","rareDiseaseNiche":true}},"durationMs":5345,"modelName":"glm-5.3-flashx"}}