Every 8-K that Meiragtx Holdings Plc (MGTX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow MGTX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full MGTX filings page.
MeiraGTx Holdings plc reported a sharp improvement in results for the quarter ended June 30, 2026, driven by large collaboration and licensing revenues. Total revenue was $321.4 million, up from $3.7 million a year earlier, including $204.6 million of license revenue and $104.9 million of related-party service revenue largely tied to J&J/Reogen transactions and Lilly manufacturing services.
Operating expenses rose to $77.0 million, mainly from higher research and development spending of $57.8 million related to reacquiring bota-vec from J&J and advancing the AAV2-hAQP1 program. Despite non-operating charges, including a $71.9 million loss on an equity method investee and a $5.2 million loss on a derivative liability linked to Oberland Capital, net income attributable to shareholders reached $160.7 million, versus a $38.8 million loss in the prior-year quarter.
As of June 30, 2026, MeiraGTx held $143.2 million in cash and cash equivalents and reported total assets of $396.4 million and shareholders’ equity of $215.8 million. The company expects its current cash plus proceeds and payments from Oberland Capital and Hologen to fund operations into the second half of 2028, excluding potential milestone receipts from Lilly.
MeiraGTx Holdings plc entered into a strategic financing with Oberland Capital for up to $400 million to fund late-stage gene therapy programs. The structure includes up to $375 million of senior secured royalty notes tied to capped low single-digit royalties on global net sales of AAV-AIPL1, AAV2-hAQP1 and bota-vec, plus up to $25 million of equity.
The first equity tranche covers 950,570 ordinary shares at $10.52 per share for about $10 million, with an additional $15 million purchase right. Royalty payments start quarterly after marketing approval and adjust after a December 31, 2031 test date based on how much of the funded amount has been repaid. MeiraGTx can voluntarily repurchase the notes and Oberland can require repurchase upon certain events of default.
The company used this transaction to redeem in full its outstanding Perceptive notes and related interest and fees, terminating that agreement without early termination penalties. MeiraGTx granted Oberland security interests over cash, equity interests, receivables, property, plant and equipment and specified assets related to the included products, and granted registration rights for resale of the new equity.
MeiraGTx Holdings plc reported results of its annual general meeting held on June 11, 2026. Shareholders representing 75,326,022 ordinary shares, about 81.4% of shares outstanding as of the April 21, 2026 record date, were present or represented by proxy.
Three Class II directors — Ellen Hukkelhoven, Ph.D., Nicole Seligman and Debra Yu, M.D. — were elected to serve until the 2029 annual meeting and until their successors are elected and qualified. Shareholders also approved the ratification of Ernst & Young LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2026, with 73,933,288 votes for, 1,029,075 against, and 363,659 abstaining.
MeiraGTx Holdings plc reported first quarter 2026 results and highlighted major regulatory, pipeline and financing milestones. Service revenue was $0.3 million for the quarter, while net loss widened to $46.3 million, or $0.57 per share. Cash, cash equivalents and restricted cash totaled $73.8 million as of March 31, 2026.
The company received FDA Breakthrough Therapy Designation for AAV2-hAQP1 in radiation-induced xerostomia and reported positive three-year Phase 1 data. It also entered an asset purchase agreement with Johnson & Johnson to reacquire botaretigene sparoparvovec (bota-vec) for X-linked retinitis pigmentosa, which already has Fast Track, Orphan Drug and EU PRIME designations.
MeiraGTx strengthened its balance sheet with a $100 million public equity financing and expects, together with a $14.7 million tax incentive receivable and a remaining $95 million upfront payment from Hologen, to fund operations into the second half of 2028, while covering a $25 million upfront payment to J&J and scheduled debt repayments of $25 million in June 2026 and $50 million in July 2027.
MeiraGTx Holdings plc entered into a strategic collaboration and license agreement with Hologen focused on AAV-GAD and AAV-BDNF gene therapies and a proprietary CNS delivery device. The collaboration includes an upfront cash payment commitment of $200 million under existing framework agreements.
Of this amount, Hologen has previously paid $105 million, which was partly used to fund MeiraGTx Neuro US and to subscribe for shares in Hologen Neuro AI Limited (HNAI) and MeiraGTx Manufacturing Limited. After completion, Hologen is expected to own 70% of HNAI, with MeiraGTx Neuro UK owning 30%. Hologen will also hold a minority stake in MeiraGTx Manufacturing, with an option to increase its ownership up to 40% within twelve months of an additional share purchase, while MeiraGTx retains a later option to buy back Hologen’s MeiraGTx Manufacturing shares.
MeiraGTx Holdings plc entered an underwriting agreement for a public offering of 11,111,111 ordinary shares at $9.00 per share under its effective shelf registration. All shares are being sold by the company.
The company expects net proceeds of about $93.3 million, to be used for general corporate purposes, including working capital and capital expenditures. Management states that, together with existing cash and cash equivalents, this funding should cover operating and capital needs, including potential commercial launches of bota-vec for X‑linked retinitis pigmentosa and AAV‑hAQP1 for radiation-induced xerostomia, in each case if approved, into the second half of 2028.
MeiraGTx Holdings plc has reacquired full rights to botaretigene sparoparvovec (bota-vec), its gene therapy for X-linked retinitis pigmentosa (XLRP), through an asset purchase from Janssen Pharmaceuticals. The company will pay an upfront $25 million in cash, a $50 million contingent milestone tied to U.S. approval and U.S. net sales first exceeding $250 million, and mid-teens royalties on global net sales commencing on or after July 1, 2029.
The deal transfers Janssen’s UCL license and related RPGR program assets and includes a perpetual, worldwide license to key know-how and patents. Johnson & Johnson’s investment arm, a holder of more than 5% of MeiraGTx shares, agreed to a 12-month lockup on its holdings plus advance notice before any later sales. MeiraGTx plans rapid U.S., EU and Japan filings for bota-vec, aiming for a potential launch in 2027, and ultimately expects to become a commercial-stage company with two products, including AAV-hAQP1 for radiation-induced xerostomia, over the next two years.
MeiraGTx Holdings plc reports positive three-year follow-up data from its Phase 1 AQUAx study of AAV‑hAQP1, a one-time gene therapy for grade 2/3 late radiation‑induced xerostomia. The treatment was observed to be safe and well tolerated across doses, with no dose‑limiting toxicity or treatment‑related serious adverse events.
Clinically meaningful symptom improvements on the Xerostomia Questionnaire and increases in Unstimulated Whole Saliva Flow Rate were maintained out to 36 months, suggesting durable benefit. The company highlights RIX as a severe, lifelong condition with no effective treatments, affecting an estimated 165,000 patients in the U.S. and about 435,000 globally.
Market research cited by MeiraGTx shows strong physician enthusiasm, with approximately 78% clinician‑stated preference translating to around 52% projected usage after adjustment and roughly 90% estimated U.S. market access coverage. Based on commissioned research, the company estimates peak global annual revenue potential of about $3.7 billion, with a steady‑state of $3.2 billion globally and $2.0 billion peak and $1.8 billion steady‑state in the U.S. in the late 2030s, though these figures are forward‑looking and subject to significant development and regulatory risks outlined in its risk disclosures.
MeiraGTx Holdings plc amended its credit facility with Perceptive, extending the notes’ maturity from August 2, 2026 to May 2, 2027 and committing to redeem $25.0 million of principal on or before June 30, 2026. Related warrants for 700,000 ordinary shares were repriced to $8.00 per share. The company reported 2025 revenue of $81.4 million, driven by a $75.0 million upfront license payment from Eli Lilly, and a net loss of $114.2 million versus $147.8 million in 2024. Cash and cash equivalents were $65.9 million as of December 31, 2025. Management believes existing cash, receivables and collaboration funding can support operations into the second half of 2027 and cover scheduled debt repayments of $25.0 million due June 2026 and $50.0 million due May 2027. The FDA granted Breakthrough Therapy Designation to AAV2-hAQP1 for Grade 2/3 radiation-induced xerostomia, and the company highlighted strategic collaborations with Eli Lilly and Hologen and progress in its riboswitch gene regulation platform.
MeiraGTx Holdings plc has provided an update on its business by releasing financial results for the quarter ended September 30, 2025. The company issued a press release describing these quarterly results, and that release is being made available as an exhibit to a current report for investors and the market to review.
The press release is furnished as Exhibit 99.1 and, along with the related information, is specifically described as furnished rather than filed, which means it is not automatically subject to certain liability provisions under U.S. securities laws or incorporated into other securities filings unless later specifically referenced. The report is signed on behalf of MeiraGTx by Richard Giroux, the company’s Chief Financial Officer and Chief Operating Officer.
MeiraGTx (MGTX) announced a strategic collaboration and license with Eli Lilly focused on ophthalmology genetic medicines. MeiraGTx will receive an upfront payment of $75 million and is eligible for up to over $400 million in total milestone payments, including up to $135 million tied to development and regulatory milestones. Lilly receives exclusive, worldwide rights to develop and commercialize the AAV-AIPL1 program for LCA4 and two additional preclinical retinal candidates.
Lilly also receives exclusive licenses to proprietary intravitreal capsids and pan‑retinal/rod‑specific promoters for up to five ophthalmology targets each, plus a right of first designation on certain target-specific transactions and a right of first negotiation for MeiraGTx’s riboswitch technology in ophthalmological gene editing. Lilly will fund research, development and commercialization, and MeiraGTx Ocular will receive tiered royalties. The agreement includes standard IP ownership provisions and is terminable for uncured material breach; Lilly may also terminate in whole, by product, or by country with notice.
MeiraGTx Holdings plc furnished an 8-K after releasing its financial results for the quarter ended June 30, 2025. The company reported these quarterly results in a press release dated August 14, 2025, which is attached as Exhibit 99.1 and incorporated by reference. The press release and related materials are designated as furnished rather than filed, meaning they are not subject to certain Exchange Act liability provisions unless specifically incorporated into other filings.
MeiraGTx (NASDAQ:MGTX) filed an 8-K Regulation FD disclosure announcing it has obtained all required UK foreign-direct-investment clearances for its previously announced transactions with Hologen Ltd., signed March 9 2025.
The clearance removes the final regulatory hurdle, allowing the deal—which management expects to close in July 2025—to proceed to funding and execution.