MeiraGTx Reports Third Quarter 2026 Financial and Operational Results
Key Highlights
- ➤Bota-vec EMA MAA submission targeted for December 2026
- ➤Bota-vec full FDA BLA submission expected in the first quarter of 2027
- ➤AAV2-hAQP1 AQUAx2 12-month pivotal data readout remains on track for mid-2027
- ➤Lilly deal provides $75 million upfront, over $400 million milestones, plus tiered royalties
- ➤Cash runway expected into the second half of 2028, including $95.0 million due from Hologen
Expert Statements
Alexandria Forbes, Ph.D., President and chief executive officer of MeiraGTx
“We are pleased to report that we have now completed much of the work towards submission of full global regulatory filings with the EMA and FDA for bota-vec for the treatment of XLRP. The MAA dossier is complete and awaiting submission and the BLA is expected to follow early next year”
Alexandria Forbes, Ph.D., President and chief executive officer of MeiraGTx
“In parallel with these filings, we have been preparing our market access and commercial teams ahead of the anticipated launch of our first commercial product, bota-vec, in late 2027.”
Alexandria Forbes, Ph.D., President and chief executive officer of MeiraGTx
“We are actively preparing for our pivotal Phase 2 AQUAx2 12-month data readout for the treatment of radiation-induced xerostomia in mid-2027. As we progress these two lead programs through filing for potential approval and commercialization, we are also advancing several programs towards IND. Two of these programs use our transformative riboswitch platform: Ribo-Leptin for metabolic disease, and a novel target with riboswitch to treat neuropathic pain.”
Alexandria Forbes, Ph.D., President and chief executive officer of MeiraGTx
“Other programs to highlight in the coming quarters, which we have spent years optimizing, are our dry AMD and Geographic Atrophy programs where we are advancing two novel targets”
Alexandria Forbes, Ph.D., President and chief executive officer of MeiraGTx
“Using our internal and partnered AI technology, we have developed proprietary intravitreal capsids and strong cell specific promoters which can deliver a highly potent combination addressing both upstream and downstream pathways involved in the pathogenesis of dry AMD.”
* Submission of Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa (XLRP) expected in December 2026 * Submission of full Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bota-vec expected in the first quarter of 2027 * 12-month data readout in pivotal Phase 2 AQUAx2 study of AAV2-hAQP1 for the treatment of radiation-induced xerostomia (RIX) mid-2027 * Upcoming oral presentation at ObesityWeek highlights AAV-BDNF program for the treatment of MC4R/BDNF genetic obesity (severe early-onset syndromic obesity) * Strengthened leadership with the appointment of John Knighton as Executive Vice President of Global Manufacturing and Supply Chain and Alan M. Sebulsky to the Board of Directors LONDON and NEW YORK, Nov. 12, 2026 (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, 2026, and provided a corporate update.
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