Biogen Inc. hardly blinked at the competition faced by Apellis Pharmaceuticals Inc. as the two companies sealed a deal whereby the former has agreed to acquire all outstanding shares of the latter for $41 each, or about $5.6 billion.
Gelmedix Inc. has completed a $13 million seed financing to support progression of the company’s lead program, GMX-101, a retinal pigment epithelial (RPE) cell therapy to treat late-stage geographic atrophy.
Zipbio has signed an exclusive license agreement with Meiragtx Holdings plc to advance an AAV gene therapy for geographic atrophy. Under the agreement, Meiragtx will receive exclusive rights to Zipbio’s first-in-class therapies targeting the complement pathway for geographic atrophy.
Pulsesight Therapeutics SAS has submitted a clinical trial authorization (CTA) to the French authority ANSM seeking to conduct a first-in-human phase I trial of PST-611 for dry age-related macular degeneration (AMD)/geographic atrophy (GA).
The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
Astellas Pharma Inc. has withdrawn its marketing authorization application from the EMA for its avacincaptad pegol intravitreal solution for the treatment of geographic atrophy secondary to age-related macular degeneration. “The company's decision to withdraw its application followed interactions” with the EMA’s Committee for Medicinal Products for Human Use, an Astellas spokesperson told BioWorld.
For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.
France’s Théa Open Innovation, a subsidiary of Laboratoires Théa SAS, terminated its licensing agreement with South Korea’s Olix Pharmaceuticals Inc., and returned global rights of Olix’s ocular small interfering RNA (siRNA) biologic agents, OLX-301D and OLX-301A.
4D Molecular Therapeutics Inc. has obtained IND clearance by the FDA for 4D-175, an R100 vector-based intravitreal genetic medicine, for the treatment of patients with geographic atrophy.
