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MeiraGTx Holdings plc, a clinical stage gene therapy company, focusing on developing treatments for patients with serious diseases. The company develops various therapies for ocular diseases, including inherited blindness, as well as Xerostomia following radiation treatment for head and neck cancers; degenerative diseases; neurodegenerative diseases, such as amyotrophic lateral sclerosis; and Parkinson's diseases. Its programs in clinical development include Phase 1/2 clinical stage programs in Achromatopsia, X-Linked Retinitis Pigmentosa, RPE65-deficiency, and radiation-induced Xerostomia, as well as Parkinson's program. The company also focuses on initiating a clinical program in xerostomia related to Sjogren's syndrome and have preclinical programs in neurodegenerative diseases. It has a research collaboration agreement with Janssen Pharmaceuticals, Inc. to develop regulatable gene therapy treatment using the company's proprietary riboswitch technology. MeiraGTx Holdings plc was incorporated in 2015 and is based in New York, New York.

MeiraGTx Holdings plc

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-GAINED ALIGNMENT WITH U.S. FOOD AND DRUG ADMINISTRATION (FDA) ON THE ONGOING PHASE 2 AQUAX2 RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED PIVOTAL STUDY IN GRADE 2/3 RADIATION-INDUCED XEROSTOMIA (RIX) TO SUPPORT A POTENTIAL BIOLOGICS LICENSE APPLICATION (BLA) FILING; ON TRACK FOR POTENTIAL DATA READOUT LATE 2026 -FDA GRANTED REGENERATIVE MEDICINE ADVANCED THERAPY (RMAT) DESIGNATION FOR AAV-GAD FOR THE TREATMENT OF PARKINSON'S DISEASE -IN COLLABORATION WITH HOLOGEN, FDG-PET DATA FROM POSITIVE PHASE 2 DOUBLE-BLIND, SHAM-SURGERY CONTROLLED CLINICAL TRIALS OF AAV-GAD SHOWS SIGNIFICANT DISEASE-MODIFYING EFFECTS IN PATHOLOGICAL BASAL GANGLIA CIRCUITRY, INCLUDING THE SUBSTANTIA NIGRA  THE SITE OF DOPAMINE-PRODUCING NEURONS AFFECTED IN PARKINSON'S DISEASE -ON TRACK TO FILE FOR MARKETING AUTHORIZATION APPROVAL (MAA) UNDER EXCEPTIONAL CIRCUMSTANCES WITH THE U.K. MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) FOR THE TREATMENT OF LCA4, AND BLA IN THE US WITH THE FDA VIA A SIMILAR PATHWAY TO APPROVAL IN THE FOURTH QUARTER OF 2025 LONDONANDNEW YORK, AUG. 14, 2025 (GLOBE NEWSWIRE) -- MEIRAGTX HOLDINGS PLC(NASDAQ: MGTX), A VERTICALLY INTEGRATED, CLINICAL-STAGE GENETIC MEDICINES COMPANY, TODAY ANNOUNCED FINANCIAL AND OPERATIONAL RESULTS FOR THE SECOND QUARTER ENDED JUNE 30, 2025, AND PROVIDED A CORPORATE UPDATE. DURING THE SECOND QUARTER, WE CONTINUED TO HAVE VERY PRODUCTIVE REGULATORY INTERACTIONS WITH THE MHRA AND FDA AROUND MULTIPLE LATER STAGE CLINICAL PROGRAMS AS WELL AS MANUFACTURING, SAID ALEXANDRIA FORBES, PH.D.

MEIRAGTX REPORTS SECOND QUARTER 2025 FINANCIAL AND OPERATIONAL RESULTS

MULTIPLE POSTER PRESENTATIONS HIGHLIGHT THE DEPTH AND NOVELTY OF MEIRAGTX'S TECHNOLOGY PLATFORMS FOR GENE AND CELL THERAPY MULTIPLE POSTER PRESENTATIONS HIGHLIGHT THE DEPTH AND NOVELTY OF MEIRAGTX'S TECHNOLOGY PLATFORMS FOR GENE AND CELL THERAPY

MEIRAGTX ANNOUNCES THE PRESENTATION OF FOUR POSTERS AT THE AMERICAN SOCIETY OF GENE AND CELL THERAPY (ASGCT) 2025 ANNUAL MEETING

- ANNOUNCED STRATEGIC COLLABORATION WITH HOLOGEN AI, INCLUDING A $200 MILLION CASH UPFRONT PAYMENT TO MEIRAGTX AND THE FORMATION OF A JOINT VENTURE, HOLOGEN NEURO AI LTD, WITH A FURTHER $230 MILLION IN CAPITAL COMMITTED TO INITIALLY FOCUS ON EXPEDITING PHASE 3 CLINICAL DEVELOPMENT OF AAV-GAD FOR PARKINSON'S DISEASE - U.S. FOOD AND DRUG ADMINISTRATION (FDA) GRANTED REGENERATIVE MEDICINE ADVANCED THERAPY (RMAT) DESIGNATION FOR AAV-GAD FOR THE TREATMENT OF PARKINSON'S DISEASE - GAINED ALIGNMENT WITH FDA ON THE ONGOING PHASE 2 AQUAX2 RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED PIVOTAL STUDY IN GRADE 2/3 RADIATION-INDUCED XEROSTOMIA (RIX) TO SUPPORT A POTENTIAL BLA FILING - EFFICACY DATA OF RAAV8.HRKP.AIPL1 FOR THE TREATMENT OF AIPL1-RELATED RETINAL DYSTROPHY, OR LCA4, PUBLISHED IN THE LANCET, DEMONSTRATING MEANINGFUL RESPONSES IN 11 OUT OF 11 LCA4 CHILDREN TREATED. FILING FOR MARKETING AUTHORIZATION APPROVAL (MAA) UNDER EXCEPTIONAL CIRCUMSTANCES WITH THE U.K. MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) AND IN DISCUSSIONS WITH THE FDA AROUND A POTENTIALLY SIMILAR PATHWAY TO APPROVAL IN THE US LONDONANDNEW YORK, MAY 13, 2025 (GLOBE NEWSWIRE) -- MEIRAGTX HOLDINGS PLC(NASDAQ: MGTX), A VERTICALLY INTEGRATED, CLINICAL-STAGE GENETIC MEDICINES COMPANY, TODAY ANNOUNCED FINANCIAL AND OPERATIONAL RESULTS FOR THE FIRST QUARTER ENDED MARCH 31, 2025, AND PROVIDED A CORPORATE UPDATE.

MEIRAGTX REPORTS FIRST QUARTER 2025 FINANCIAL AND OPERATIONAL RESULTS

- THIS RMAT DESIGNATION IS BASED ON DATA FROM 3 CLINICAL STUDIES DEMONSTRATING THE POTENTIAL BENEFIT OF AAV-GAD AS A ONE-TIME TREATMENT FOR PARKINSON'S DISEASE - RMAT DESIGNATION INCLUDES THE BENEFITS OF THE FAST TRACK AND BREAKTHROUGH THERAPY DESIGNATIONS, ALLOWS FREQUENT REGULATORY INTERACTIONS WITH THE FDA, AND POTENTIAL ROUTES TO ACCELERATED APPROVAL AND PRIORITY REVIEW LONDONANDNEW YORK, MAY 09, 2025 (GLOBE NEWSWIRE) -- MEIRAGTX HOLDINGS PLC(NASDAQ: MGTX), A VERTICALLY INTEGRATED, CLINICAL-STAGE GENETIC MEDICINES COMPANY, TODAY ANNOUNCED THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS GRANTED REGENERATIVE MEDICINE ADVANCED THERAPY (RMAT) DESIGNATION TO AAV-GAD FOR THE TREATMENT OF PARKINSON'S DISEASE NOT ADEQUATELY CONTROLLED WITH ANTI-PARKINSONIAN MEDICATIONS. THIS RMAT WAS AWARDED FOLLOWING THE PRESENTATION TO THE FDA OF POSITIVE DATA FROM 3 CLINICAL STUDIES DEMONSTRATING THE BENEFIT OF AAV-GAD WHEN ADMINISTERED IN A ONE-TIME STEREOTACTIC INFUSION TO THE SUBTHALAMIC NUCLEUS IN THE BRAIN.

MEIRAGTX GRANTED FDA REGENERATIVE MEDICINE ADVANCED THERAPY (RMAT) DESIGNATION FOR AAV-GAD FOR THE TREATMENT OF PARKINSON'S DISEASE

THE GLOBAL CONE ROD DYSTROPHY MARKET, VALUED AT US$131.29 MILLION IN 2024, IS PROJECTED TO REACH US$177.59 MILLION BY 2030, GROWING AT A CAGR OF 5.33%. KEY DRIVERS INCLUDE ADVANCEMENTS IN GENE THERAPIES, PERSONALIZED MEDICINE, AND GOVERNMENT PROGRAMS. NORTH AMERICA REMAINS THE LARGEST MARKET, WHILE ASIA PACIFIC LEADS GROWTH. MAJOR PLAYERS LIKE SPARINGVISION AND BEACON THERAPEUTICS PROPEL INNOVATION THROUGH ONGOING CLINICAL TRIALS. THE GLOBAL CONE ROD DYSTROPHY MARKET, VALUED AT US$131.29 MILLION IN 2024, IS PROJECTED TO REACH US$177.59 MILLION BY 2030, GROWING AT A CAGR OF 5.33%. KEY DRIVERS INCLUDE ADVANCEMENTS IN GENE THERAPIES, PERSONALIZED MEDICINE, AND GOVERNMENT PROGRAMS. NORTH AMERICA REMAINS THE LARGEST MARKET, WHILE ASIA PACIFIC LEADS GROWTH. MAJOR PLAYERS LIKE SPARINGVISION AND BEACON THERAPEUTICS PROPEL INNOVATION THROUGH ONGOING CLINICAL TRIALS.

CONE ROD DYSTROPHY MARKET REPORT 2025-2030, WITH PROFILES OF SPARINGVISION, BEACON THERAPEUTICS, NANOSCOPE THERAPEUTICS, MEIRAGTX, ASCIDIAN THERAPEUTICS, JCYTE, BLUEROCK THERAPEUTICS AND MORE

- TODAY ANNOUNCED STRATEGIC COLLABORATION WITH HOLOGEN AI, INCLUDING A $200 MILLION UPFRONT PAYMENT TO MEIRAGTX AND THE FORMATION OF A JOINT VENTURE, HOLOGEN NEURO AI LTD, WITH A FURTHER $230 MILLION IN CAPITAL COMMITTED TO INITIALLY FOCUS ON EXPEDITING PHASE 3 CLINICAL DEVELOPMENT OF AAV-GAD FOR PARKINSON'S DISEASE - MEIRAGTX AND HOLOGEN HAVE CREATED THE FIRST NEURO-AI CLINICAL DRUG DEVELOPMENT COMPANY TO TRANSFORM THE DISCOVERY AND DEVELOPMENT OF THERAPIES TARGETING CNS CIRCUITRY IN NEURODEGENERATIVE AND NEUROPSYCHIATRIC DISORDERS - ANNOUNCED POSITIVE DATA FROM RANDOMIZED, DOUBLE BLIND, SHAM-CONTROLLED CLINICAL BRIDGING STUDY OF AAV-GAD FOR THE TREATMENT OF PARKINSON'S DISEASE DEMONSTRATING SIGNIFICANT BENEFITS IN UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) PART 3 AND PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39) - GRANTED FDA REGENERATIVE MEDICINE ADVANCED THERAPY (RMAT) DESIGNATION FOR AAV2-HAQP1 FOR THE TREATMENT OF GRADE 2/3 RADIATION-INDUCED XEROSTOMIA (RIX) - EFFICACY DATA OF RAAV8.HRKP.AIPL1 FOR THE TREATMENT OF LCA4 PUBLISHED IN THE LANCET ; UNPRECEDENTED RESPONSES OBSERVED IN 100% OF LCA4 CHILDREN AND MEIRAGTX INTENDS TO SUBMIT A MARKETING AUTHORIZATION APPLICATION (MAA) UNDER EXCEPTIONAL CIRCUMSTANCES WITH MHRA, AND FOLLOW A PARALLEL PATHWAY TO BLA WITH THE FDA THIS YEAR - RECEIVED FDA RARE PEDIATRIC DISEASE DESIGNATIONS (RPDD) FOR FOUR POTENTIAL THERAPIES FOR RARE INHERITED RETINAL DISEASES (IRDS) INCLUDING RAAV8.HRKP.AIPL1 FOR LCA4 - RECEIVED FROM HPRA AND MHRA ADDITIONAL CLINICAL AND COMMERCIAL LICENSURES IN IRELAND AND UK FOR SHANNON AND LONDON GMP VIRAL VECTOR MANUFACTURING FACILITIES AS WELL AS QC FACILITIES LONDONANDNEW YORK, MARCH 13, 2025 (GLOBE NEWSWIRE) -- MEIRAGTX HOLDINGS PLC(NASDAQ: MGTX), A VERTICALLY INTEGRATED, CLINICAL STAGE GENETIC MEDICINES COMPANY, TODAY ANNOUNCED FINANCIAL AND OPERATIONAL RESULTS FOR THE FOURTH QUARTER AND FULL-YEAR ENDED DECEMBER 31, 2024, AND PROVIDED A CORPORATE UPDATE. MEIRAGTX DEMONSTRATED EXCELLENT EXECUTION

MEIRAGTX REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL AND OPERATIONAL RESULTS AND RECENT BUSINESS UPDATES

- MEIRAGTX TO RECEIVE $200 MILLION IN UPFRONT CASH CONSIDERATION - MEIRAGTX AND HOLOGEN WILL FORM A JOINT VENTURE, HOLOGEN NEURO AI LTD, WITH AN ADDITIONAL $230 MILLION COMMITTED CAPITAL FROM HOLOGEN TO FUND 100% OF THE DEVELOPMENT OF AAV-GAD FOR PARKINSON'S DISEASE THROUGH TO COMMERCIALIZATION, AS WELL AS OTHER POTENTIAL PIPELINE PRODUCTS - MEIRAGTX WILL ENTER INTO CLINICAL AND COMMERCIAL SUPPLY AGREEMENTS WITH HOLOGEN NEURO AI LTD TO MANUFACTURE AAV-GAD AND OTHER LOCALLY DELIVERED CNS GENETIC MEDICINES - HOLOGEN WILL ALSO FUND A PORTION OF MEIRAGTX'S MANUFACTURING OPERATIONS AND WILL OWN A MINORITY STAKE IN MEIRAGTX'S MANUFACTURING SUBSIDIARY LONDONANDNEW YORK, MARCH 13, 2025 (GLOBE NEWSWIRE) -- MEIRAGTX HOLDINGS PLC(NASDAQ: MGTX), A VERTICALLY INTEGRATED, CLINICAL STAGE GENETIC MEDICINES COMPANY, TODAY ANNOUNCED A BROAD STRATEGIC COLLABORATION WITH HOLOGEN LIMITED, A WORLD-LEADING DEVELOPER OF MULTI-MODAL GENERATIVE AI FOUNDATION MODELS OF REAL-WORLD CLINICAL DATA FOR CLINICAL MEDICINE AND PHARMACEUTICAL DRUG DEVELOPMENT. MEIRAGTX WILL RECEIVE $200 MILLION IN UPFRONT CASH AT CLOSING AND MEIRAGTX AND HOLOGEN ARE FORMING A JOINT VENTURE, CALLED HOLOGEN NEURO AI LTD.

MEIRAGTX ENTERS INTO A STRATEGIC COLLABORATION WITH HOLOGEN AI TO EXPEDITE PHASE 3 DEVELOPMENT OF AAV-GAD FOR PARKINSON'S DISEASE AND INDUSTRIALIZE MEIRAGTX'S PROPRIETARY MANUFACTURING PROCESS

LONDONANDNEW YORK, FEB. 21, 2025 (GLOBE NEWSWIRE) -- MEIRAGTX HOLDINGS PLC(NASDAQ: MGTX), A VERTICALLY INTEGRATED, CLINICAL STAGE GENETIC MEDICINES COMPANY, TODAY ANNOUNCED THE PUBLICATION OF RESULTS FROM THE FIRST-IN-HUMAN INTERVENTIONAL STUDY TO TREAT CHILDREN WITH AIPL1-ASSOCIATED SEVERE RETINAL DYSTROPHY. THE DATA WERE PUBLISHED IN THE LANCET IN A PAPER TITLED, "GENE THERAPY IN CHILDREN WITH AIPL1-ASSOCIATED SEVERE RETINAL DYSTROPHY: AN OPEN-LABEL, FIRST-IN-HUMAN INTERVENTIONAL STUDY". THIS PAPER PRESENTS DATA FROM THE FIRST 4 CHILDREN TREATED UNILATERALLY WITH RAAV8.HRKP.AIPL1. A FURTHER 7 CHILDREN WITH LCA4 WERE TREATED BILATERALLY WITH RAAV8.HRKP.AIPL1 DEMONSTRATING SIMILARLY REMARKABLE EFFECTS ON VISION, WITH ALL 11 OF THE 11 CHILDREN TREATED WHO WERE BLIND AT BIRTH NOW HAVING VISUAL ACUITY IN THE TREATED EYES.

MEIRAGTX ANNOUNCES THE LANCET PUBLICATION OF DATA DEMONSTRATING THE EFFICACY OF RAAV8.HRKP.AIPL1 FOR THE TREATMENT OF LEBER CONGENITAL AMAUROSIS 4 (LCA4) RETINAL DYSTROPHY

MEIRAGTX HAS RECENTLY RECEIVED RARE PEDIATRIC DISEASE DESIGNATION (RPDD) FOR FOUR INHERITED RETINAL DISEASES (IRDS) REFLECTING THE TRANSFORMATIVE THERAPEUTIC POTENTIAL OF THE COMPANY'S PROPRIETARY TECHNOLOGY PLATFORMS MEIRAGTX HAS RECENTLY RECEIVED RARE PEDIATRIC DISEASE DESIGNATION (RPDD) FOR FOUR INHERITED RETINAL DISEASES (IRDS) REFLECTING THE TRANSFORMATIVE THERAPEUTIC POTENTIAL OF THE COMPANY'S PROPRIETARY TECHNOLOGY PLATFORMS

MEIRAGTX RECEIVES RARE PEDIATRIC DISEASE DESIGNATION FROM FDA FOR AAV8-RK-RETGC FOR THE TREATMENT OF PATIENTS WITH LEBER CONGENITAL AMAUROSIS DUE TO GUCY2D MUTATIONS

RESULTS INDICATE A POTENT AND EFFECTIVE LOCALLY DELIVERED AAV-BDNF GENE THERAPY FOR THE TREATMENT OF OBESITY CAUSED BY MC4R DEFICIENCY RESULTS INDICATE A POTENT AND EFFECTIVE LOCALLY DELIVERED AAV-BDNF GENE THERAPY FOR THE TREATMENT OF OBESITY CAUSED BY MC4R DEFICIENCY

MeiraGTx Holdings plc

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