MeiraGTx Holdings plc (NASDAQ: MGTX) shares paled Thursday, as the vertically integrated, clinical stage gene therapy company announced financial and operational results for the fourth quarter and full-year ended December 31, 2023, and provided a corporate update
The London-based company aligned with FDA on requirements for ongoing Phase 2 AQUAx2 clinical trial for Grade 2/3 radiation-induced xerostomia to be considered pivotal supporting potential BLA filing.
The firm also entered into an asset purchase agreement with Janssen Pharmaceuticals, Inc. (Janssen) related to botaretigene sparoparvovec (bota-vec, formerly AAV-RPGR) for the treatment of X-linked retinitis pigmentosa (XLRP) for up to $415 million, as well as a commercial supply agreement pursuant to which the Company will manufacture and supply bota-vec to Janssen
It also received $30 million strategic investment from Sanofi and entered into a right of first negotiation (ROFN) agreement for the use of MeiraGTx’s riboswitch gene regulation technology for certain Central Nervous System (CNS) and Immunology and Inflammation (I&I) targets, as well as for GLP-1 and other gut peptides for metabolic disease, and for MeiraGTx’s Phase 2 xerostomia program.
The Company will deliver an oral presentation of the Phase 1 AQUAx study at the American Academy of Oral Medicine 2024 annual meeting (AAOM) taking place from April 17-20
MGTX shares dropped 13 cents, or 2.1%, to $6.22.
