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.
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.
MeiraGTx (NASDAQ: MGTX) will present 3-year data from the open-label Phase 1 AQUAx study of AAV-hAQP1 for treatment of persistent grade 2/3 radiation-induced xerostomia on April 16, 2026 at 8:00 a.m. ET.
The presentation includes cohort-level and individual patient data for PRO Xerostomia Questionnaire (XQ) and objective Unstimulated Whole Saliva Flow Rate (UWSFR) out to three years for bilateral and unilateral cohorts, an investigator discussion of disease burden and treatment administration, commercial opportunity commentary, and a Q&A. A live webcast and replay will be available on the company investor website.
MeiraGTx (Nasdaq: MGTX) announced FDA Breakthrough Therapy Designation for AAV2-hAQP1 to treat Grade 2–3 radiation-induced xerostomia, aligned Phase 2 AQUAx2 endpoints to support a potential BLA in H1 2027 and targeted US launch in early 2028. The company reported year-end cash of $68.2M, license revenue of $75M from Lilly, and a 2025 net loss of $114.2M (−$1.42/share).
Strategic deals include a $200M upfront Hologen joint venture payment, a $75M Lilly upfront, plus potential milestones and manufacturing agreements with J&J for bota-vec.
ZipBio and MeiraGTx (Nasdaq: MGTX) signed an exclusive license agreement to advance ZipBio's first-in-class AAV gene therapy programs for Geographic Atrophy targeting the complement pathway. The deal grants MeiraGTx exclusive rights and includes upfront plus potential milestone and royalty payments; financial terms were not disclosed. The collaboration pairs ZipBio's COMPACT™ AI-designed protein therapeutics with MeiraGTx's vector design, clinical development, and in-house manufacturing capabilities, while ZipBio focuses its internal efforts on immunology and cardiovascular programs.
Graviton Bioscience (NASDAQ:MGTX) will present selective ROCK2 obesity data at the 8th Annual Evercore HealthCONx Conference on December 2, 2025 at 8:45 AM ET. CEO Samuel Waksal will lead a fireside chat covering Graviton's obesity program and its selective ROCK2 inhibitor, GV101.
Key points to be discussed include:
- Target biology: ROCK2 roles in fibrosis, inflammation, cytoskeletal mechanics, and adipose tissue.
- Preclinical efficacy: GV101 reduced lipid droplets in mouse and human adipocytes and produced weight loss in rodent models with lean mass preservation.
- Clinical significance: GV101 appears to sustain fat loss while preserving muscle.
The presentation will be webcast and open to media, investors, and the public.
MeiraGTx (Nasdaq: MGTX) reported Q3 2025 results and operational updates on Nov 13, 2025. Key corporate actions include a broad ophthalmology collaboration with Eli Lilly (upfront $75.0M; >$400M in potential milestones; tiered royalties) and progress on a joint venture with Hologen (received $50.0M of $200.0M; MeiraGTx to hold 30% of JV).
Clinical/regulatory highlights: RMAT designations for AAV2-hAQP1 and AAV-GAD, AQUAx2 pivotal enrollment on track to finish end-2025 with potential BLA pathway in early 2027, and Specials program dosing for BBS10 (RPDD).
Cash: $17.1M at Sept 30, 2025; service revenue fell to $0.4M for Q3 2025 from $10.9M year-ago.