Melinta Therapeutics Announces Publication of the Outcomes by Candida Species from the ReSTORE Phase 3 trial and Recently Approved Rezafungin CLSI Breakpoints for Candida glabrata and Candida auris
Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam
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 and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.
Melinta Therapeutics Announces Presentations of New Data on Infectious Disease Portfolio at IDWeek 2023
Melinta Therapeutics Announces Expanded Reimbursement and Access for REZZAYO™ (rezafungin for injection)
Melinta Therapeutics Announces Commercial Availability of REZZAYO™ (rezafungin for injection)
PARSIPPANY, N.J.--(BUSINESS WIRE)--Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics currently FDA-approved for adults, BAXDELA® (delafloxacin) and VABOMERE® (meropenem and vaborbactam), for use in pediatrics. In addition, Melinta and BARDA will partner on the development of BAXDELA® against biothreat pathogens. Under this contract, BARDA has awarded $20.5M for the base period, with the potential of additional funding of $121.4M, amounting to total funding up to $141.9M if all options are exercised. With this BARDA funding, Melinta aims to submit four supplemental New Drug Applications (sNDAs) for these new indications.
Melinta Therapeutics secured a BARDA deal worth nearly $142 million to make two currently approved antibiotics available for children.
PARSIPPANY, N.J. & OAKVILLE, Ontario--(BUSINESS WIRE)--Melinta Therapeutics, LLC (Melinta) and Xediton Pharmaceuticals Inc (Xediton) today announced they have entered into an exclusive commercialization and licensing agreement for BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), ORBACTIV® (oritavancin) and VABOMERE® (meropenem and vaborbactam), four novel anti-infective products. Under the terms of the agreement, Xediton is responsible for the registration and commercialization of these products in Canada.