Press Release

F2G Receives Complete Response Letter from FDA for New Drug Application for Olorofim for The Treatment of Invasive Fungal Infections; Plans Resubmission With Additional Data and Analyses

MANCHESTER, United Kingdom, June 15, 2023 – 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.  According to the CRL, FDA […]

F2G Receives Complete Response Letter from FDA for New Drug Application for Olorofim for The Treatment of Invasive Fungal Infections; Plans Resubmission With Additional Data and Analyses Read More »

F2G Wins Investment Deal of the Year Bionow 2022 Award

MANCHESTER, United Kingdom, March 17, 2023 – F2G Ltd. today announced the company has been awarded a prestigious Bionow award in recognition of its contributions to the North England biotech industry and progress towards developing a new class of antifungals for treatment of rare fungal infections. F2G was awarded Investment Deal of the Year at the Bionow

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F2G to Present at Biotech Showcase™ 2023

MANCHESTER, United Kingdom, January 5, 2023 – F2G Ltd. today announced that the Company’s chief executive officer, Francesco Lavino will provide a corporate overview at Biotech Showcase™ 2023 taking place in San Francisco, California, from January 9-11, 2023. Francesco Maria Lavino will discuss the Company’s lead antifungal drug candidate, olorofim, a first-in-class, oral small molecule with a

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F2G Announces FDA Filing Acceptance of New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections

Application submitted under priority review with PDUFA target action date set for June 17, 2023 NDA submission is based on positive data from ongoing Phase 2b open-label study of oral olorofim in 100 patients with invasive fungal infections with limited or no treatment options F2G is continuing preparations for a possible U.S. commercial launch of

F2G Announces FDA Filing Acceptance of New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections Read More »

F2G Announces Data from Phase 2b Study at ID Week 2022 Showing Positive Therapeutic Response in Patients with Invasive Fungal Infections Treated with Olorofim

Data are based on analysis of the first 100 patients from an ongoing Phase 2b study of patients who have limited or no treatment options for invasive fungal infections Overall, a 44% response rate, defined as complete or partial response, was seen across fungi at day 42, the primary endpoint All-cause mortality (ACM) at day

F2G Announces Data from Phase 2b Study at ID Week 2022 Showing Positive Therapeutic Response in Patients with Invasive Fungal Infections Treated with Olorofim Read More »

F2G to Present Interim Results from Phase 2B Open Label Study of Olorofim in Invasive Fungal Infections at IDWeek 2022

MANCHESTER, United Kingdom, Oct. 13, 2022 — 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

F2G to Present Interim Results from Phase 2B Open Label Study of Olorofim in Invasive Fungal Infections at IDWeek 2022 Read More »

F2G Announces $70 Million Financing to Advance Development and Commercialization of New Antifungal Agent Olorofim

New Investment from Forbion and Sofinnova Partners MANCHESTER, UK, 4 August 2022 – 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 announces a $70 million financing. The financing was co-led by new investors Forbion and Sofinnova

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Shionogi Co., Ltd. and F2G Enter Strategic Collaboration to Develop and Commercialize the New Antifungal Agent Olorofim in Europe and Asia

Shionogi to conduct clinical trials, subsequent registration, and commercialization of olorofim for invasive aspergillosis (IA) in Europe and Asia F2G to receive upfront payment of $100m and share development costs F2G will also be eligible for additional regulatory and commercial milestones of up to $380m, as well as double-digit royalties on net sales OSAKA, Japan,

Shionogi Co., Ltd. and F2G Enter Strategic Collaboration to Develop and Commercialize the New Antifungal Agent Olorofim in Europe and Asia Read More »

Clinical Stage Rare Disease Biotech F2G Appoints New Non-Executive Director And Two Senior Executives Ahead Of Pivotal Year

26 January 2022 – F2G, the clinical stage rare disease biotech developing the first and only anti-fungal treatment to be granted Breakthrough Therapy status by the US Food and Drug Administration (FDA), has announced a trio of senior appointments to its board and executive team. The new hires bring a significant amount of combined experience

Clinical Stage Rare Disease Biotech F2G Appoints New Non-Executive Director And Two Senior Executives Ahead Of Pivotal Year Read More »

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