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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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NEW YORK , NOV. 20, 2025 /PRNEWSWIRE/ --GRAVITON BIOSCIENCE CORPORATION, A CLINICAL-STAGE BIOTECHNOLOGY COMPANY DEVELOPING SELECTIVE ROCK2 INHIBITORS FOR METABOLIC, INFLAMMATORY, FIBROTIC, AND CENTRAL NERVOUS SYSTEM DISORDERS, AMONG OTHER THERAPEUTIC INDICATIONS, TODAY ANNOUNCED THAT SAMUEL WAKSAL, PH.D., CHIEF EXECUTIVE OFFICER, WILL PARTICIPATE IN AFIRESIDE CHATAT THE8TH ANNUAL EVERCORE HEALTHCONX CONFERENCE.

GRAVITON BIOSCIENCE TO PRESENT SELECTIVE ROCK2 OBESITY DATA AT 8TH ANNUAL EVERCORE HEALTHCONX CONFERENCE

LONDONANDNEW YORK, NOV. 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 THIRD QUARTER ENDED SEPTEMBER 30, 2025, AND PROVIDED A CORPORATE UPDATE.

MEIRAGTX REPORTS THIRD QUARTER 2025 FINANCIAL AND OPERATIONAL RESULTS

LONDONANDNEW YORK, NOV. 10, 2025 (GLOBE NEWSWIRE) -- MEIRAGTX HOLDINGS PLC (NASDAQ: MGTX), A VERTICALLY INTEGRATED, CLINICAL STAGE GENETIC MEDICINES COMPANY, TODAY ANNOUNCED A BROAD STRATEGIC COLLABORATION IN THE AREA OF OPHTHALMOLOGY WITH ELI LILLY AND COMPANY (LILLY).

MEIRAGTX ENTERS INTO STRATEGIC COLLABORATION WITH ELI LILLY AND COMPANY TO DEVELOP AND COMMERCIALIZE GENETIC MEDICINES IN OPHTHALMOLOGY

LONDONANDNEW YORK, OCT. 07, 2025 (GLOBE NEWSWIRE) -- MEIRAGTX HOLDINGS PLC (NASDAQ: MGTX), A VERTICALLY INTEGRATED, CLINICAL-STAGE GENETIC MEDICINES COMPANY, TODAY ANNOUNCED THE COMPANY WILL EXHIBIT TWO POSTERS AT THE EUROPEAN SOCIETY OF GENE AND CELL THERAPY (ESGCT) 2025 ANNUAL CONGRESS, WHICH IS BEING HELD FROM OCTOBER 7-10, 2025, IN SEVILLE, SPAIN. THE POSTERS ARE AVAILABLE ON THE POSTERS AND PUBLICATIONS PAGE OF THE COMPANY'S WEBSITE.

MEIRAGTX ANNOUNCES TWO POSTERS AT THE EUROPEAN SOCIETY OF GENE AND CELL THERAPY (ESGCT) 2025 ANNUAL CONGRESS

-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

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