F2G

EQS-News: Abivax reports 2023 financial results and operational update

Retrieved on: 
Wednesday, April 10, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

Abivax reports 2023 financial results and operational update

Retrieved on: 
Tuesday, April 2, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

F2G and Shionogi Present Full Data Set from Pivotal Phase 2b Study at Trends in Medical Mycology (TIMM) 2023 Demonstrating Positive Therapeutic Responses in Patients with Invasive Fungal Infections Treated with Oral Olorofim

Retrieved on: 
Saturday, October 21, 2023
Standard of care, TIMM, Immunodeficiency, Congress, MD, EORTC, Doctor of Philosophy, Fungus, Research, Coccidioidomycosis, DRC, Shionogi, UZ Leuven, Hematology, OASIS, Scopulariopsis, World Health Organization, Risk, Antifungal, Medical Mycology, ACM, Fungal infection, Goodyear F2G Corsair, Patient, Infection, Birth control, Pharmaceutical industry, Coccidioides, F2G

These findings were submitted as a late breaking abstract and exceptionally accepted for an oral presentation during the 11th Congress on Trends in Medical Mycology (TIMM) 2023 held in Athens, Greece, from 20-23 October 2023.

Key Points: 
  • These findings were submitted as a late breaking abstract and exceptionally accepted for an oral presentation during the 11th Congress on Trends in Medical Mycology (TIMM) 2023 held in Athens, Greece, from 20-23 October 2023.
  • F2G and Shionogi & Co., Ltd. are collaborating to develop and commercialise olorofim, bringing the novel antifungal therapy to patients with invasive fungal infections.
  • F2G has commercial responsibility for olorofim in North America, and Shionogi has commercial responsibility for olorofim in Europe and Asia Pacific.
  • F2G and Shionogi are currently enrolling patients with invasive aspergillosis in a global Phase 3 study (OASIS) to compare treatment with olorofim versus AmBisome® followed by standard of care ( NCT05101187 ).

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

Retrieved on: 
Monday, June 19, 2023
Shionogi, Symantec Endpoint Protection, New Drug Application, NDA, Patient, Standard of care, PDUFA, CRL, Fungal infection, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Medical device, F2G

Complete Response Letter is related to the request for additional data and analyses.

Key Points: 
  • Complete Response Letter is related to the request for additional data and analyses.
  • F2G along with its partner Shionogi & Co., Ltd. is enrolling patients with invasive aspergillosis in a global Phase 3 study to compare treatment with olorofim versus AmBisome® followed by standard of care.
  • According to the CRL, FDA was not able to approve olorofim at this time, requesting additional data and analyses.
  • F2G has commercial responsibility for olorofim in North America, and Shionogi has commercial responsibility for olorofim in Europe and Asia Pacific.

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

Retrieved on: 
Monday, December 19, 2022
Fungus, Disease, PDUFA, Scopulariopsis, Food, Mycosis, MD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Antibiotic, File, NDA, DHODH, Patient, Mortality, Aspergillosis, Prescription Drug User Fee Act, FDA, Breakthrough therapy, Coccidioides, New Drug Application, Pharmaceutical industry, F2G

F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited, well-defined population with invasive fungal infections and limited or no treatment options.

Key Points: 
  • F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited, well-defined population with invasive fungal infections and limited or no treatment options.
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 17, 2023.
  • “Invasive fungal infections cause substantial morbidity and mortality, particularly among immunosuppressed patients, and can prove to be lethal in also healthy individuals when they get into deeper tissues.
  • If approved, olorofim will be the first of a new class of antifungal drugs.”
    Olorofim is the only antifungal medication to be awarded Breakthrough Therapy Designation by the FDA.

Novo Holdings Portfolio Company F2G enters strategic collaboration with Shionogi to commercialise its new antifungal agent Olorofim in Europe and Asia

Retrieved on: 
Monday, May 16, 2022
Fungus, Novo Nordisk Foundation, Company, US Foods, Infection, Asthma, BTD, Patient, Investment, COPD, Novo Holdings A/S, Initial public offering, Bronchiectasis, FDA, Mycosis, Antifungal, Shionogi, Partnership, Board, Cancer, Growth, Novo Nordisk, Fine chemical, Pharmaceutical industry, Financial services, F2G

Novo Ventures, the venture capital team at Novo Holdings, has led and participated in a series of financings since 2016.

Key Points: 
  • Novo Ventures, the venture capital team at Novo Holdings, has led and participated in a series of financings since 2016.
  • Naveed Siddiqi, Senior Partner at Novo Holdings, serves as a Board Member of F2G and Eric Snyder, Partner at Novo Holdings, as Board Observer.
  • Olorofim is a novel oral antifungal therapy developed by F2G to treat invasive aspergillosis (IA) and other rare mold infections.
  • Novo Holdings A/S is a private limited liability company wholly owned by the Novo Nordisk Foundation.

Novo Holdings Portfolio Company F2G enters strategic collaboration with Shionogi to commercialise its new antifungal agent Olorofim in Europe and Asia

Retrieved on: 
Monday, May 16, 2022
Fungus, Novo Nordisk Foundation, Company, US Foods, Infection, Asthma, BTD, Patient, Investment, COPD, Novo Holdings A/S, Initial public offering, Bronchiectasis, FDA, Mycosis, Antifungal, Shionogi, Partnership, Board, Cancer, Growth, Novo Nordisk, Fine chemical, Pharmaceutical industry, Financial services, F2G

Novo Ventures, the venture capital team at Novo Holdings, has led and participated in a series of financings since 2016.

Key Points: 
  • Novo Ventures, the venture capital team at Novo Holdings, has led and participated in a series of financings since 2016.
  • Naveed Siddiqi, Senior Partner at Novo Holdings, serves as a Board Member of F2G and Eric Snyder, Partner at Novo Holdings, as Board Observer.
  • Olorofim is a novel oral antifungal therapy developed by F2G to treat invasive aspergillosis (IA) and other rare mold infections.
  • Novo Holdings A/S is a private limited liability company wholly owned by the Novo Nordisk Foundation.

Francesco Maria Lavino appointed Chief Executive Officer of F2G Ltd

Retrieved on: 
Monday, April 12, 2021
F2G, Merck & Co., Companies, Pharmaceutical companies, Economy of the United States

b'MANCHESTER, England and VIENNA, April 12, 2021 /PRNewswire/ --F2G Limited ("F2G"), a clinical-stage biopharmaceutical company focused on life threatening fungal diseases, announces that Francesco Maria Lavino has been appointed Chief Executive Officer (CEO) and member of the Board of F2G.

Key Points: 
  • b'MANCHESTER, England and VIENNA, April 12, 2021 /PRNewswire/ --F2G Limited ("F2G"), a clinical-stage biopharmaceutical company focused on life threatening fungal diseases, announces that Francesco Maria Lavino has been appointed Chief Executive Officer (CEO) and member of the Board of F2G.
  • Mr. Lavino brings substantial specialty pharmaceutical leadership and expertise in the antifungal arena, including most notably, serving as AVP, Global Brand Leader, Anti-infectives portfolio at Merck & Co. and as Chief Commercial Officer of Nabriva Therapeutics, Inc.(NASDAQ: NBRV).
  • He is a highly experienced leader with a proven track record of working to create significant value for shareholders.
  • We believe we have a strong team in place to lead F2G into its next phase of growth.

Francesco Maria Lavino appointed Chief Executive Officer of F2G Ltd

Retrieved on: 
Monday, April 12, 2021
F2G, Merck & Co., Companies, Pharmaceutical companies, Economy of the United States

b'MANCHESTER, England and VIENNA, April 12, 2021 /PRNewswire/ --F2G Limited ("F2G"), a clinical-stage biopharmaceutical company focused on life threatening fungal diseases, announces that Francesco Maria Lavino has been appointed Chief Executive Officer (CEO) and member of the Board of F2G.

Key Points: 
  • b'MANCHESTER, England and VIENNA, April 12, 2021 /PRNewswire/ --F2G Limited ("F2G"), a clinical-stage biopharmaceutical company focused on life threatening fungal diseases, announces that Francesco Maria Lavino has been appointed Chief Executive Officer (CEO) and member of the Board of F2G.
  • Mr. Lavino brings substantial specialty pharmaceutical leadership and expertise in the antifungal arena, including most notably, serving as AVP, Global Brand Leader, Anti-infectives portfolio at Merck & Co. and as Chief Commercial Officer of Nabriva Therapeutics, Inc.(NASDAQ: NBRV).
  • He is a highly experienced leader with a proven track record of working to create significant value for shareholders.
  • We believe we have a strong team in place to lead F2G into its next phase of growth.

F2G Appoints Dr. Patrick Vink as Chairman

Retrieved on: 
Monday, April 8, 2019
Vink, F2G

MANCHESTER, England, April 8, 2019 /PRNewswire/ -- F2G Ltd, the European biotech company developing novel therapies for life-threatening fungal infections, today announces the appointment of Dr. Patrick Vink as Chairman of the Board of Directors with immediate effect.

Key Points: 
  • MANCHESTER, England, April 8, 2019 /PRNewswire/ -- F2G Ltd, the European biotech company developing novel therapies for life-threatening fungal infections, today announces the appointment of Dr. Patrick Vink as Chairman of the Board of Directors with immediate effect.
  • Dr. Vink has an MD from the University of Leiden and an MBA from University of Rochester.
  • Ian Nicholson, CEO of F2G Ltd, said: "We are delighted to welcome Patrick to the Board.
  • Dr. Patrick Vink, Chairman of F2G, added:"I am very pleased to join as Chairman and look forward to working closely with the team.