FDA Rejects Astellas' Izervay Update; Cytokinetics and Bayer Announce Aficamten Licensing Deal
核心洞察
The FDA rejected Astellas' request to update Izervay's prescribing information for bi-monthly injections due to a statistical matter, maintaining Apellis' dosing advantage.
Cytokinetics (搜索) granted Bayer exclusive rights to develop and commercialize aficamten in Japan, with potential milestone payments for Cytokinetics.
Jupiter Bioventures (搜索), founded by Norman Sharpless and Nathaniel David, launched with $70 million to create startups focused on cancer (搜索) and other diseases.
The FDA has declined Astellas Pharma's application to revise the prescribing information for Izervay, its geographic atrophy (搜索) drug. This decision prevents patients from receiving injections every other month, maintaining the current monthly dosing schedule. According to Astellas, the rejection was due to a "statistical matter related to labeling language" and not the drug's safety or efficacy. This ruling preserves Apellis Pharmaceuticals’ Syfovre's advantage, which can be administered every 25 to 60 days.
Cytokinetics and Bayer Collaborate on Aficamten
Cytokinetics (搜索) and Bayer have entered into an exclusive licensing agreement for aficamten in Japan. Bayer will pay Cytokinetics 50 million euros ($53 million) upfront. Under the agreement, Bayer will conduct a Phase 3 trial of aficamten in Japanese patients with obstructive hypertrophic cardiomyopathy (搜索). Cytokinetics will expand its ongoing trial in patients with non-obstructive disease to Japan. These studies aim to support potential authorization in Japan, where Bayer will hold exclusive commercialization rights. Cytokinetics is eligible to receive up to 90 million euros more upon achieving specific milestones through the market launch of aficamten.
Jupiter Bioventures Launches with $70 Million Funding
Former National Cancer (搜索) Institute director Norman Sharpless and biotech entrepreneur Nathaniel David have launched Jupiter Bioventures (搜索), a startup creator, with $70 million in funding. The firm will use seed funds to acquire intellectual property, vet it through in-house experiments, and build companies around promising concepts. These companies will focus on cancer and other diseases. Funding from the Mayo Clinic, Mission BioCapital, and others will help Jupiter form eight to 10 startups.