Articles from Melinta Therapeutics, LLC

Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announces that it has entered into a definitive agreement to be acquired by CorMedix Inc. (“CorMedix”) (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions. The acquisition is a testament to the exceptional value Melinta has created through its strong portfolio, culture, capabilities, and experienced team within the hospital ecosystem for acute care.

The National Home Infusion Association (NHIA) and Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, are pleased to announce the addition of Melinta to NHIA’s Future of Infusion Advisory Council (FIAC). FIAC is a strategic advisory group comprised of manufacturing and service companies that are intensely invested in the home and alternate site infusion industry. The group consistently works with the association staff and Board of Directors to address critical issues, challenges, and opportunities facing this growing segment of healthcare.

Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today, ten scientific presentations with data focused on Melinta’s portfolio of commercial and investigational stage products to be shared at Infectious Disease Week (IDWeek) 2024, Oct. 16-19, 2024, in Los Angeles, California.

Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announces the appointment of Sunitha Lakshminarayanan, as Chief Technology Officer, effective today.

Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announces the appointment of Dr. Fabrizio Tondolo as Vice President of Medical Affairs, effective today.

Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults. The data analyses in the article, “Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species. Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups.

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, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today, the presentation of nine scientific presentations with data from its current anti-infective portfolio at Infectious Disease Week (IDWeek) 2023, taking place October 11-15, 2023, in Boston, MA.

Melinta Therapeutics, LLC today announced the availability of REZZAYO™ (rezafungin for injection), for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade. Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review.

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, 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.

Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) approved REZZAYO™ (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.

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.

Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative patient care therapies for acute and life-threatening illnesses, is partnering with OptimizeRx Corp. (OptimizeRx) in an Innovate4Outcomes event - a healthcare design thinking-inspired event.

Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today, the presentation of nine scientific presentations with data from its current antibiotic portfolio at Infectious Disease Week (IDWeek) 2022, taking place October 19– 22, 2022, in Washington, D.C. Additionally, new rezafungin clinical and preclinical data will be presented in six poster presentations. As previously announced, Melinta has licensed the U.S. commercial rights to rezafungin, an investigational candidate currently under FDA review, from Cidara Therapeutics.

Melinta Therapeutics, LLC (“Melinta”) and Cidara Therapeutics (“Cidara”) today announced that they have entered into a License Agreement (the “Agreement”) to facilitate a strategic partnership to commercialize rezafungin, a novel, once-weekly echinocandin antifungal in the United States (U.S.). Cidara is developing rezafungin for the treatment of candidemia and invasive candidiasis in adults, as well as for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation.

Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today that it has acquired the U.S. rights to TOPROL-XL® (metoprolol succinate) and its Authorized Generic (AG) through an agreement between Melinta and New American Therapeutics Inc.

Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announces the appointment of Dr. Peter Piliero as Vice President of Medical Affairs, effective today.

Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today that President and Chief Executive Officer Christine Ann Miller has been elected to the Board of Directors of IVERIC bio, Inc. (Nasdaq: ISEE), effective immediately.

Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announces the appointment of Dr. Doug Girgenti as Vice President of Drug Development, effective today.

Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announces the appointment of Jisoo Park as Head of Business Development, M&A and Strategy, effective today.

Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announces the appointment of Susan Blum as Chief Financial Officer, effective July 1, 2021.