4 - MeiraGTx Holdings plc (0001735438) (Issuer)

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Chardan Capital Markets resumed coverage of MeiraGTx with a rating of Buy and set a new price target of $36.00

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LONDON and NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage genetic medicines company, today announced the Company will exhibit four poster presentations at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting, which is being held from May 13-17, 2025, in New Orleans, LA. The posters will be available on the Posters and Publications page of the Company's website. The details of the poster presentations are below: Poster 507: An Ultra-Low Dose of a Localized CNS Gene Therapy for Severe Pediatric ObesityPoster Session: Tuesday, May 13, 6:00-7:30 pm CDTAbstract:Brain-derived neurotrophic factor (BDN

-  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 BL

-  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 LONDON and NEW 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 t

-  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 demonst

- 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 LONDON and NEW YORK, March 13,

As disclosed in the paper, 4 out of 4 young children with the AIPL1-related retinal dystrophy, LCA4, benefited substantially from unilateral subretinal administration of rAAV8.hRKp.AIPL1 with improved visual acuity, functional vision, and protection against progressive retinal degenerationFollowing the strong safety and substantial efficacy demonstrated in this first cohort of 4 children treated unilaterally, a further 7 children have now been treated bilaterally and all showed substantial benefit from treatment with rAAV8.hRKp.AIPL1Meaningful responses have been observed in 11 out of 11 LCA4 children treated to date with rAAV8.hRKp.AIPL1All 11 children treated with rAAV8.hRKp.AIPL1 between

LONDON and NEW YORK, Jan. 22, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings Plc (NASDAQ:MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced the U.S. Food and Drug Administration (FDA) has granted the Company Rare Pediatric Disease Designation to its AAV8-RK-RetGC program for the treatment of patients with Leber congenital amaurosis due to GUCY2D mutations (LCA1). This is the fourth Rare Pediatric Disease Designation the Company has received in the last three months, including AAV8-RK-AIPL1 for the treatment of LCA4 retinal dystrophy, AAV8-RK-BBS10 for the treatment of Bardet-Biedl syndrome (BBS) due to BBS10 mutations and AAV5-RDH12 for the treatment of R

-  RMAT designation recognizes the preliminary clinical evidence of the potential benefit of AAV2-hAQP1 as a one-time treatment for this debilitating condition -  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 LONDON and NEW YORK, Dec. 09, 2024 (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 AAV2-hAQP1 for the tr

ROCKVILLE, Md. and SUZHOU, China, Nov. 24, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily for malignancies, today announced that it has appointed Ms. Marina S. Bozilenko and Dr. Debra Yu as additional independent non-executive directors of the company with effect from November 25, 2024. "I would like to extend a warm welcome to Ms. Marina S. Bozilenko and Dr. Debra Yu, who are joining Ascentage Pharma as independent non-executive

Received 3 Rare Pediatric Disease Designations (RPDD) from FDA for each of 3 potential therapies for 3 different rare inherited retinopathies including AAV-AIPL1 Agreed on pathway with MHRA for Marketing Authorization Application (MAA) under exceptional circumstances for AAV-AIPL1 for the treatment of Leber congenital amaurosis (LCA4) retinal dystrophy without further clinical studies Announced positive data from randomized, sham-controlled clinical bridging study of AAV-GAD for the treatment of Parkinson's disease LONDON and NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage genetic medicines company, today announced

ROCKVILLE, Md. and SUZHOU, China, Nov. 24, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily for malignancies, today announced that it has appointed Ms. Marina S. Bozilenko and Dr. Debra Yu as additional independent non-executive directors of the company with effect from November 25, 2024. "I would like to extend a warm welcome to Ms. Marina S. Bozilenko and Dr. Debra Yu, who are joining Ascentage Pharma as independent non-executive

Company cofounder and CTO to lead button battery safety tech company toward commercialization The Directors of Landsdowne Labs, LLC, are pleased to announce the appointment of Bryan Laulicht to Chief Executive Officer. Laulicht, a company cofounder, has served as Lansdowne's Chief Technology Officer since the company's formation in 2017. He has also co-founded and served in leadership positions at two other companies focused on applying biophysics and bioengineering approaches to fulfilling unmet medical and safety needs. Both of those companies have been acquired for a combined total greater than $500M. Lansdowne's technology, applied to small, coin-like "button" batteries, is design

LONDON and NEW YORK, April 27, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced the appointment of Dr. Debra Yu to its Board of Directors. Dr. Yu currently serves as President and Chief Strategy Officer of LianBio, and previously served as LianBio's President and Chief Business Officer. Dr. Yu has more than 30 years of healthcare industry experience in business development, alliance management, investment banking and capital markets. She has held senior positions at Pfizer in its Worldwide Business Development organization and Labrador Advisors, LLC, where she advised numerous partnerships and licen

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Clinically meaningful improvements in xerostomia symptoms measured by two different xerostomia PROs demonstrated across both unilaterally and bilaterally treated cohorts at 12 monthsIncreases in whole saliva flow rates observed post-treatment, providing objective evidence of biological activity, reaching the normal range in bilaterally treated participants by 2 months and persisting through the Month 12 assessmentAcross assessments, greater improvements observed in bilaterally treated participants compared to those treated unilaterally Early long-term follow-up data suggest durability of improvement to at least 3 years post-treatmentAAV2-hAQP1 appears safe and well tolerated at each dose te

LONDON and NEW YORK, June 22, 2023 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced it will host a conference call and webcast to present an update on the Company's AAV-hAQP1 clinical program for the treatment of grade 2/3 radiation-induced xerostomia (RIX) on Tuesday, June 27, 2023, at 8:00 a.m. ET. The presentation will include: 1) Data from the completed Phase 1 AQUAx clinical study for the 24 patients treated with AAV-hAQP1 in the unilateral and bilateral cohorts: Safety and tolerability12-month data for PRO assessments of xerostomia symptoms in the unilateral cohorts (n=12)12-month data for

Clinically meaningful improvements in xerostomia symptoms and disease burden reported in patient reported outcome (PRO) measures in both unilateral and bilateral cohortsIncreases in whole saliva flow rates were seen in both unilateral and bilateral cohorts Overall degree of improvement was greater in bilateral compared to unilateral cohorts AAV2-hAQP1 appears safe and well tolerated at each dose tested Webcast and conference call to be held today, December 13, 2022, at 8:00 a.m. ET LONDON and NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced positive clinical data from the ongoin

LONDON and NEW YORK, Dec. 08, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced it will host a conference call and webcast to present clinical data from the Company's AAV-hAQP1 Phase 1 AQUAx clinical trial for the treatment of radiation-induced xerostomia (RIX) on Tuesday, December 13, 2022, at 8:00 a.m. ET. The Phase 1 AQUAx conference call will also include a clinical program update for product candidate AAV-hAQP1, a potential treatment for RIX, from MeiraGTx's senior management and lead investigator Michael Brennan, DDS, Chairman of the Department of Oral Medicine and Director of the Sjögren's Syn

• The primary outcome of the MGT009 study is safety, and botaretigene sparoparvovec treatment was found to be generally safe and well-tolerated • Significant improvements were demonstrated in multiple different endpoints in botaretigene sparoparvovec-treated patients across each of the three domains of vision: retinal function, visual function and functional vision • MeiraGTx to host a conference call on Tuesday, June 28, 2022, at 8am ET LONDON and NEW YORK, June 28, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced top-line data from the Phase 1/2 clinical study MGT009 (NCT03252847) of

LONDON and NEW YORK, Dec. 14, 2021 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, will host a virtual R&D Day via webcast and conference call on Wednesday, December 15, 2021, from 10:00 a.m. to 12:00 p.m. ET highlighting the Company's gene regulation platforms. MeiraGTx's R&D Day webcast will feature a presentation by Alexandria Forbes, Ph.D., President and Chief Executive Officer. The event will provide a detailed overview of the Company's gene regulation platforms including promoter engineering and MeiraGTx's proprietary platform driven by novel synthetic riboswitches controlled by oral small molecules. The presenta

Clinically meaningful improvements in xerostomia symptoms and disease burden reported in two validated Patient Reported Outcome (PRO) measures6 of the 7 participants through 90-day assessments following treatment achieved clinically meaningful improvement in symptoms using both the McMaster Global Rate of Change PRO and the Xerostomia QuestionnaireOne participant with the maximum response evaluable at 12 months has now reached 24 months and the same level of response/xerostomia symptom improvement was maintainedAAV-hAQP1 appears safe and well-tolerated at each dose testedWebcast and conference call to be held today, December 7, 2021 at 8:00 a.m. ET LONDON and NEW YORK, Dec. 07, 2021 (GLOB

LONDON and NEW YORK, Nov. 29, 2021 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced it will host a conference call and webcast to provide an update on the Company's AAV-hAQP1 Phase 1 AQUAx clinical trial for the treatment of radiation-induced xerostomia (RIX) on Tuesday, December 7, 2021, at 8:00 a.m. ET. MeiraGTx will also host a virtual R&D Day via webcast and conference call that will be held on Wednesday, December 15, 2021, from 10:00 a.m. to 12:00 p.m. ET to focus on the Company's gene regulation platforms. The Phase 1 AQUAx conference call will include a clinical program update for product candida