Approval triggered by positive results from ReSTORE Phase III clinical trialPayment will advance Cidara™s Cloudbreak platform for the development of drug-Fc conjugates (DFCs) SAN DIEGO, Feb. ...
Napp announces authorisation of REZZAYO® (rezafungin) in Great Britain
SAN DIEGO, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) today announced REZZAYO (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.
CAMBRIDGE, England--(BUSINESS WIRE)--Mundipharma today announced rezafungin (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.
Top-line data expected in Q2 2024 SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology developing therapies designed to save lives and improve...
PARSIPPANY, N.J. & SAN DIEGO--(BUSINESS WIRE)--Melinta Therapeutics, LLC and Cidara Therapeutics, Inc. (NASDAQ: CDTX) today announced the peer-reviewed publication of pooled data from two completed global clinical trials evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis. The article, “Efficacy and safety of rezafungin and caspofungin in candidemia and invasive candidiasis: pooled data from two prospective randomised controlled trials,” published in The Lancet Infectious Diseases, reports on pooled data analyses of the pivotal ReSTORE Phase 3 randomized controlled clinical trial, which demonstrated the non-inferiority of REZZAYO as compared to caspofungin for all-cause mortality, and the STRIVE Phase 2 randomized controlled trial, which provided safety and supportive efficacy data for REZZAYO. The pooled analyses in the article further support the non-inferiority of rezafungin versus caspofungin for all-cause mortality and with similar safety profiles and provide additional evidence for potential early treatment benefits.
Melinta Therapeutics Announces Expanded Reimbursement and Access for REZZAYO™ (rezafungin for injection)
Melinta Therapeutics Announces Commercial Availability of REZZAYO™ (rezafungin for injection)
SAN DIEGO & PARSIPPANY, N.J.--(BUSINESS WIRE)--Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee voted favorably 14 to 1 that Cidara, as part of its New Drug Application (NDA), provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options.
CAMBRIDGE, England--(BUSINESS WIRE)--Napp today announces that the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients. The marketing authorisation application is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority of rezafungin dosed once-weekly when compared to the current standard of care, caspofungin, dosed once daily. This trial provides evidence of efficacy and the safety profile of rezafungin as a potential treatment for candidemia and invasive candidiasis with a once-weekly dosing schedule.1