MGTX · MeiraGTx Holdings plc

MeiraGTx Holdings plc has executed a strategic reversal of its prior transaction with Janssen, repurchasing the global rights to botaretigene sparoparvovec (bota-vec), a gene therapy for X-linked retinitis pigmentosa (XLRP). The company paid an upfront cash consideration of $25 million, with additional contingent consideration of $50 million payable upon achieving specific regulatory and commercial milestones in the United States. The agreement also stipulates royalty payments in the mid-teens percentage on global net sales, commencing on or after July 1, 2029. This transaction effectively unwinds the Original Asset Purchase Agreement dated December 20, 2023, under which MeiraGTx had originally sold these assets to Janssen. Concurrently, the companies terminated the related supply and transition service agreements.

The reacquisition provides MeiraGTx with full control over the bota-vec program, which has completed Phase 3 trials. Although the novel primary endpoint (Visual Mobility Assessment) did not meet statistical significance, the company reported strong statistically significant improvements across multiple secondary endpoints measuring retinal function and visual acuity. MeiraGTx intends to immediately pursue global regulatory filings, targeting a potential launch in 2027. The company highlighted its existing commercial manufacturing capabilities and available product inventory as facilitators for a rapid regulatory submission.

Additionally, the filing discloses amendments to the Hologen joint venture framework. Hologen agreed to issue 250,000 Class A shares to MeiraGTx and modified the completion conditions for the Neuro and Manufacturing framework agreements. These amendments adjust the structure of the upfront payments and equity ownership distribution upon completion. Johnson & Johnson Innovation – JJDC, Inc., the investment arm of Johnson & Johnson and owner of Seller, currently owns more than 5% of MeiraGTx's outstanding shares and has agreed to a 12-month lock-up period, providing stability to the shareholder base following the transaction.