MeiraGTx Holdings plc Stock News

GV101, a novel, highly selective ROCK2 inhibitor, yielded an 86.2% best overall response rate (bORR) at 400 mg and a 67.9% bORR at 200 mg at 24 weeks in chronic Graft versus Host Disease (cGvHD) patients who had failed at least two prior lines of therapy. GV101's 24-week bORR exceeds published 6-month bORRs for all existing, approved steroid-refractory cGvHD therapies.

Received FDA Breakthrough Therapy Designation for AAV2-hAQP1 and reported positive three-year data from Phase 1 AQUAx clinical trial evaluating AAV2-hAQP1 for the treatment of moderate to severe grade 2/3 radiation-induced xerostomia   Completed the acquisition of all interests and rights to botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa (XLRP) from Joh...

Graviton received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a novel capsule formulation of GV101 on August 7, 2026. FDA clearance marks a critical regulatory milestone in advancing this formulation of GV101, a capsule with improved PK and oral availability, into human trials for Friedreich's ataxia (FA).

LONDON and NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced that the Compensation Committee of the Company's Board of Directors approved equity awards under the Company's 2026 Employment Inducement Award Plan to a new employee. The equity awards were granted as an inducement mater...

LONDON and NEW YORK, July 07, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced that it has entered into an agreement with Oberland Capital Management LLC (Oberland Capital) for an investment of up to $400 million in the Company, including up to $375 million in non-dilutive capital for capped royalty...

LONDON and NEW YORK, May 14, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced that the Compensation Committee of the Company's Board of Directors approved equity awards to Penny Fleck in connection with her employment with the Company as Chief Development Officer. The equity awards were granted as a...

Received FDA Breakthrough Therapy Designation for AAV2-hAQP1 Reported positive three-year data from the Phase 1 AQUAx study of AAV2-hAQP1 for the treatment of grade 2/3 late radiation-induced xerostomia Entered into an asset purchase agreement with Johnson & Johnson* (J&J) to acquire all interests in botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa (XLRP)...

LONDON and NEW YORK, April 16, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced the pricing of an underwritten offering of 11,111,111 of its ordinary shares at an offering price of $9.00 per share. Gross proceeds to MeiraGTx from the offering are expected to be approximately $100 million, before ded...