Cidara Therapeutics

Rezafungin Awarded Promising Innovation Medicine (PIM) Designation by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the Treatment of Invasive Candidiasis

Retrieved on: 
Thursday, March 3, 2022
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Invasive Candidiasis, Rezafungin, Cidara Therapeutics, Mundipharma, INVASIVE CANDIDIASIS, REZAFUNGIN, CIDARA THERAPEUTICS, MUNDIPHARMA

Mundipharma and Cidara Therapeutics, Inc. (NASDAQ: CDTX) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has granted rezafungin Promising Innovative Medicine (PIM) designation for the treatment of invasive candidiasis.

Key Points: 
  • Mundipharma and Cidara Therapeutics, Inc. (NASDAQ: CDTX) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has granted rezafungin Promising Innovative Medicine (PIM) designation for the treatment of invasive candidiasis.
  • A PIM designation is a pre-requisite for application to the UKs Early Access to Medicines Scheme (EAMS).
  • This scheme aims to give patients with life threatening or seriously debilitating conditions such as invasive candidiasis, access to medicines that do not yet have a marketing authorisation.
  • Rezafungin, as a next generation echinocandin, has the potential to help critically ill, vulnerable patients battling invasive Candida infections.

Orphan Drug Designation Granted to Rezafungin in EU for the Treatment of Invasive Candidiasis

Retrieved on: 
Tuesday, January 26, 2021
Infectious diseases, Biotechnology, Pharmaceutical, Health, Fungal diseases, Antifungals, Branches of biology, Echinocandins, Infectious diseases, Sepsis, Invasive candidiasis, Caspofungin, Candidiasis, Fungemia, Esophageal candidiasis, Rezafungin, Mundipharma, Cidara Therapeutics

We are proud that patients affected with invasive candidiasis may have an additional treatment option to treat this potentially life-threatening condition.

Key Points: 
  • We are proud that patients affected with invasive candidiasis may have an additional treatment option to treat this potentially life-threatening condition.
  • We look forward to continuing to work closely with our colleagues at Mundipharma to advance rezafungin through late-stage clinical development.
  • Activity of a long-acting echinocandin, rezafungin, and comparator antifungal agents tested against contemporary invasive fungal isolates (SENTRY Program, 2016 to 2018).
  • Rezafungin versus Caspofungin in a Phase 2, Randomized, Double-Blind Study for the Treatment of Candidemia and Invasive Candidiasis- The STRIVE Trial.

Cidara Therapeutics and Mundipharma Form Strategic Partnership to Develop and Commercialize Rezafungin

Retrieved on: 
Tuesday, September 3, 2019
Health, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, Invasive Fungal Infections, Rezafungin, Cidara Therapeutics, Mundipharma

Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Mundipharma announced today that they have entered into a strategic partnership to develop and commercialize rezafungin for the treatment and prevention of invasive fungal infections.

Key Points: 
  • Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Mundipharma announced today that they have entered into a strategic partnership to develop and commercialize rezafungin for the treatment and prevention of invasive fungal infections.
  • Cidara will continue to lead the ongoing global Phase 3 development programs for rezafungin with the support of Mundipharma.
  • Mundipharma is particularly well positioned globally with established hospital and hematology/oncology business units to fully leverage the commercial potential of rezafungin.
  • By partnering with Cidara on rezafungin, we continue to serve our purpose - to move medicine forward, said Alberto Martinez, Ph.D., M.B.A., President and Chief Executive Officer of Mundipharma.

Cidara Therapeutics to Present Data from its Cloudbreak Antiviral Program at the Options X for the Control of Influenza Conference

Retrieved on: 
Wednesday, August 21, 2019
Research, Infectious diseases, Clinical trials, Biotechnology, Pharmaceutical, Health, Science, Infectious diseases, Articles, Viruses, RTT, Animal virology, Influenza, Antiviral drug, Flu season, Pandemic, Cloudbreak AVCs, Influenza, Cidara Therapeutics

Options X is the largest international conference exclusively dedicated to influenza prevention, control and treatment, including seasonal flu and pandemic preparedness, and the premier event of the International Society of Influenza and other Respiratory Virus Diseases (ISIRV).

Key Points: 
  • Options X is the largest international conference exclusively dedicated to influenza prevention, control and treatment, including seasonal flu and pandemic preparedness, and the premier event of the International Society of Influenza and other Respiratory Virus Diseases (ISIRV).
  • Cidaras presentations will feature data from preclinical studies evaluating the antiviral activity of CB-012, the first AVC candidate generated by its Cloudbreak anti-infective immunotherapy platform, against seasonal and pandemic influenza A and influenza B strains.
  • Cidaras Cloudbreak AVCs are potent, small-molecule antivirals conjugated to the Fc domain of a human antibody (IgG1).
  • In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases.