Welcome to our dedicated page for Meiragtx Holdings news (Ticker: MGTX), a resource for investors and traders seeking the latest updates and insights on Meiragtx Holdings stock.
MeiraGTx Holdings plc develops clinical-stage genetic medicines for diseases with high unmet need, with recurring updates centered on AAV gene therapy programs, ocular disease, radiation-induced xerostomia, and regulated gene-expression technology. Company news includes clinical disclosures for AAV-hAQP1 and AAV2-hAQP1 in grade 2/3 radiation-induced xerostomia, ophthalmology programs such as AAV-AIPL1 for Leber congenital amaurosis 4, and the acquired bota-vec program for X-linked retinitis pigmentosa.
Updates also cover strategic collaborations and license agreements, in-house manufacturing capabilities for genetic medicines, riboswitch platform development, operating results, financing arrangements, shareholder voting matters, and capital-structure disclosures tied to MGTX ordinary shares.
Graviton BioScience reported peer-reviewed Phase Ib/II data for GV101, a selective ROCK2 inhibitor, in 60 patients with moderate to severe chronic graft versus host disease (cGvHD) who had failed one to five prior systemic therapies. At 24 weeks, best overall response rate was 86.2% at 400 mg and 67.9% at 200 mg, with failure‑free survival of 89.4% and 78.6%, respectively; overall survival was 96.6% (400 mg) and 100% (200 mg). Median time to first response was 30.0 days at 400 mg and 44.5 days at 200 mg, and complete responses occurred in all organ systems except lower GI. Safety findings showed mainly transient bilirubin elevations and headache, with no grade ≥3 leukopenia, thrombocytopenia, or anemia, one grade 3 neutropenia, and no CMV infections. Graviton is planning a Phase III randomized controlled trial in cGvHD and intends to advance the higher dose.
MeiraGTx (Nasdaq: MGTX) reported second quarter 2026 results and significant strategic progress, including FDA Breakthrough Therapy Designation for AAV2-hAQP1 in radiation‑induced xerostomia, positive three‑year Phase 1 AQUAx data, and completion of enrollment in the pivotal Phase 2 AQUAx2 study with a 12‑month readout expected in Q2 2027.
The company acquired all rights to bota‑vec for X‑linked retinitis pigmentosa from Johnson & Johnson for $25 million and is preparing global filings in 2026. MeiraGTx secured up to $400 million from Oberland Capital, including $135 million initially, raised $100 million in equity, and signed a collaboration with Lilly that delivered $75 million upfront and potential milestones over $400 million. Cash, cash equivalents and restricted cash rose to $145.4 million from $34.4 million a year earlier, while Q2 2026 revenue included $11.9 million service revenue, $104.9 million related‑party service revenue, and $204.6 million related‑party license revenue.
Graviton BioScience received FDA Investigational New Drug (IND) clearance on August 7, 2026 for a novel capsule formulation of GV101, a selective ROCK2 inhibitor being developed as an oral treatment for Friedreich's ataxia (FA). The clearance allows initiation of a randomized, placebo-controlled, 12-week Phase 2 trial, enrolling up to 48 participants at multiple U.S. and international sites starting in the first quarter of 2027. According to Graviton BioScience, GV101 has shown favorable safety in over 500 clinical participants and has increased frataxin mRNA and protein levels in preclinical and clinical studies, supporting its potential as a disease-modifying therapy targeting the underlying frataxin deficiency in FA.
MeiraGTx (Nasdaq: MGTX) announced that the Compensation Committee of its Board approved equity awards under the 2026 Employment Inducement Award Plan for a new employee, in accordance with Nasdaq Listing Rule 5635(c)(4). The grant includes 75,000 non-qualified stock options and 75,000 time-based RSUs.
The stock options have an exercise price equal to the closing price of MeiraGTx ordinary shares on the employee’s start date. Twenty‑five percent of the options vest on the first anniversary, with the remainder vesting in 36 substantially equal monthly installments, subject to continued employment. For the RSUs, 50% vest on the second anniversary, and 25% on each of the third and fourth anniversaries, also contingent on continued employment.
MeiraGTx (Nasdaq:MGTX) announced a strategic investment of up to $400 million from Oberland Capital to support development and commercialization of AAV2-hAQP1, botaretigene sparoparvovec (bota-vec) and AAV-AIPL1.
The deal combines up to $375 million non-dilutive royalty funding with up to $25 million in equity, features low single-digit capped royalties, milestone-based optional tranches through 2028, and an option for MeiraGTx to buy back the funded royalty note.
MeiraGTx (Nasdaq:MGTX) approved an inducement equity grant for new Chief Development Officer Penny Fleck under Nasdaq Listing Rule 5635(c)(4).
The award includes options to purchase 100,000 shares at $9.97 and 100,000 time-based RSUs, with multi-year, employment-based vesting schedules.
MeiraGTx (Nasdaq:MGTX) reported Q1 2026 results and major pipeline, deal and financing updates. The company reacquired full rights to late-stage XLRP gene therapy bota-vec from Johnson & Johnson for $25 million upfront plus milestones and royalties, and received FDA Breakthrough Therapy designation for AAV2-hAQP1 in radiation-induced xerostomia supported by 3-year Phase 1 data. MeiraGTx raised about $100 million via an equity offering of 11.1 million shares at $9, projecting funding into 2H 2028. Q1 cash was $73.8 million; service revenue was $0.3 million and net loss was $46.3 million, or $0.57 per share.
MeiraGTx (Nasdaq: MGTX) priced an underwritten offering of 11,111,111 ordinary shares at $9.00 per share for gross proceeds of approximately $100 million. All shares are being sold by the company; the offering is expected to close on or about April 17, 2026.
The company said net proceeds, together with existing cash, are expected to fund operations and potential commercial launches of bota-vec and AAV-hAQP1 into the second half of 2028. BofA Securities and Goldman Sachs are joint bookrunners; Raymond James is co-manager.
MeiraGTx (Nasdaq: MGTX) agreed to acquire botaretigene sparoparvovec (bota-vec) from Johnson & Johnson for X-linked retinitis pigmentosa (XLRP), paying a $25 million upfront cash payment plus a one-time U.S. regulatory/commercial milestone and a high double-digit global royalty starting mid-2029.
The company completed CMC PPQ, holds commercial manufacturing licenses, has several hundred vials ready, and intends to file BLA/MAA in the U.S., EU and Japan aiming for a potential 2027 launch. Phase 3 LUMEOS showed strong secondary endpoints and functional vision gains despite the primary maze endpoint not meeting significance.
MeiraGTx (NASDAQ: MGTX) reported positive three-year data from the completed Phase 1 AQUAx study of AAV-hAQP1 for grade 2/3 late radiation-induced xerostomia on April 16, 2026. The full 36-month dataset shows PRO XQ symptom improvements and unstimulated whole saliva flow increases maintained through three years, with AAV-hAQP1 described as safe and well tolerated across doses. Management highlighted one-time in-office dosing, durability of responses, and plans for a data presentation webcast on April 16, 2026.