An overall success rate of 28.7% was seen at day 42, the primary endpoint, and 27.2% at day 84, as determined by a data review committee (DRC) using the EORTC-MSG criteriaThe success rate rose to...
MANCHESTER, United Kingdom, June 19, 2023 (GLOBE NEWSWIRE) -- F2G Ltd. today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for olorofim, an investigational antifungal, for the treatment of invasive fungal infections in patients who have limited or no treatment options.
Complete Response Letter is related to the request for additional data and analyses.F2G remains committed to bringing olorofim to patients and intends to meet with FDA in the coming months to align on...
F2G Announces FDA Filing Acceptance of New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections
MANCHESTER, United Kingdom, Oct. 21, 2022 (GLOBE NEWSWIRE) -- F2G Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections with a high unmet medical need, today announced at IDWeek 2022 positive data from the first 100 patients who completed study treatment in its ongoing Phase 2b open-label study (Study 32, NCT03583164) of oral olorofim as a treatment for invasive fungal infections.
MANCHESTER, United Kingdom, Oct. 13, 2022 (GLOBE NEWSWIRE) -- F2G Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections with a high unmet medical need, today announced that it will present new clinical data in three oral presentations and two poster presentations at IDWeek 2022, to be held in Washington, D.C. from October 19-23, 2022.
F2G Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal ...
F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its lead first-in-class candidate, olorofim (formerly F901318) for the indication of 'Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species'. Olorofim is the first antifungal agent to be granted Breakthrough Therapy designation.