REMEDY PHARMACEUTICALS

Looking ahead, Remedy is planning a pivotal Phase 3 trial that will confirm CIRARA's effect in LHI patients with lesion volumes below 125 mL who undergo EVT. This carefully designed study will recruit 300 patients at 50 top-tier sites, in the U.S., Europe, Australia, Canada, and Israel. With an estimated cost of $50-$70 million and a target completion date in 2027, the trial seeks to build on the robust data already gathered, propelling CIRARA towards FDA and EMA approval... The market potential for CIRARA is substantial, with an estimated annual value of over $3 billion. In the U.S. alone, the addressable market comprises approximately 75,000 LHI patients. Between the patent portfolio developed by Remedy (both before the Biogen deal and after the asset's return) and a new formulation patent developed by Biogen that is now owned by Remedy, the company has built a thicket of patent claims from multiple patent families, providing exclusivity by way of treatment method, dosing regimen,..

Also known as: Remedy, Remedy Pharmaceuticals Inc.