Vaborbactam

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. 'The FDA approval of REZZAYO represents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis' “The FDA approval of REZZAYO represents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “I am extremely proud of all of the Cidara employees who collectively advanced REZZAYO from preclinical development to NDA approval and am grateful to the many patients and healthcare teams who have participated in the clinical studies.” George Thompson, M.D., principal investigator in the ReSTORE trial and professor of clinical medicine at the University of California, Davis, School of Medicine, added, “The FDA approval of REZZAYO is tremendous news for those of us who have been hoping for a new option to treat our patients with these deadly fungal infections. Based on the totality of clinical data generated, REZZAYO has the potential to simplify the management of invasive candidiasis and enhance the continuity of echinocandin care.” The FDA approval of once-weekly REZZAYO was based on clinical data from Cidara’s global ReSTORE Phase 3 trial and supported by the STRIVE Phase 2 clinical trial and extensive non-clinical development program. In clinical studies, REZZAYO, dosed once-weekly, met the FDA and EMA primary endpoints, demonstrating statistical non-inferiority versus caspofungin, a current once-daily standard of care. In addition, overall rates of adverse events and serious adverse events were comparable in patients receiving REZZAYO and caspofungin, while rates of adverse events leading to study drug discontinuation were also similar for REZZAYO and caspofungin. Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review. Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, added, “We are thrilled that the FDA has approved REZZAYO, and are firmly committed to offering this innovative therapy to address unmet medical needs and simplify the treatment for patients suffering from invasive Candida infections. We intend to leverage our expansive commercial infrastructure and experience launching anti-infective drugs into acute care settings. We are working closely with Cidara and anticipate bringing REZZAYO, a differentiated once-weekly treatment to patients, this summer.” Last year, Melinta announced that it had acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies. The European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for rezafungin in August 2022 and it is currently under review. About REZZAYO™ (rezafungin for injection) REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism. About Cidara Therapeutics Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms leveraging drug-Fc conjugates (DFCs) targeting viral and oncological diseases from Cidara’s proprietary Cloudbreak® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com. About Melinta Therapeutics Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our commercial portfolio currently includes the newly approved REZZAYO (rezafungin for injection), in addition to six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam). With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. For additional information, including product and respective important safety information, please visit our website.

FDA decision expected by PDUFA target action date of March 22, 2023 If approved, rezafungin will be the first new drug for the treatment of candidemia and invasive candidiasis in over a decade SAN DIEGO, CA & PARSIPPANY, NJ, USA I January 25, 2023 I 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. “We are extremely pleased that the FDA’s advisory committee has recommended that the FDA approve rezafungin for difficult-to-treat and often deadly candidemia and invasive candidiasis,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “This positive recommendation is a significant step towards our goal of providing a once-weekly treatment option for patients with invasive Candida infections, for which no new drugs have been approved in over a decade. We believe rezafungin, if approved, could provide an effective new alternative for patients battling these potentially deadly diseases. We want to thank the many patients and healthcare teams who have participated in the clinical studies of these deadly infections, and we look forward to working with the FDA as it completes its review of our application.” The Committee’s positive vote was based on clinical data from the Cidara’s global ReSTORE Phase 3 and supported by the STRIVE Phase 2 clinical trials and extensive non-clinical development program. Rezafungin dosed once-weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once-daily, meeting the primary endpoints for both the FDA and the European Medicines Agency (EMA). “The Committee’s robust discussion was an important step in the FDA’s review of rezafungin. We are pleased that the committee recognized the unmet need that rezafungin will address in the treatment of candidemia and invasive candidiasis. We remain committed to working closely with our partner Cidara in securing FDA approval of rezafungin,” Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, added. “We also look forward to leveraging our established commercial infrastructure and experience in marketing infectious disease products, especially within the hospital and acute care settings, to make rezafungin available to healthcare providers and their patients, if approved.” The FDA is not bound by the Advisory Committee’s recommendations, but generally takes the recommendation into consideration when making its decision. Cidara’s NDA for rezafungin was accepted for filing and granted Priority Review by the FDA on September 20, 2022. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 22, 2023, enabled by rezafungin’s designation as a Qualified Infectious Disease Product (QIDP). Last year, Melinta announced that it had acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies. The European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for rezafungin in August 2022 and it is currently under review. About Cidara Therapeutics Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncological diseases from Cidara’s proprietary Cloudbreak ® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com . About Melinta Therapeutics Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes six commercial-stage products: Baxdela ® (delafloxacin), Kimyrsa ® (oritavancin), Minocin ® (minocycline) for Injection, Orbactiv ® (oritavancin), TOPROL-XL ® (metoprolol succinate) and Vabomere ® (meropenem and vaborbactam). Melinta also has a licensing agreement in place with Cidara Therapeutics securing the rights to market and distribute the development candidate, rezafungin in the United States. With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. For additional information, including product and respective important safety information, please visit our website . SOURCE: Cidara Therapeutics