Fungemia

Approval triggered by positive results from ReSTORE Phase III clinical trial Payment will advance Cidara’s Cloudbreak platform for the development of drug-Fc conjugates (DFCs) SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults. This approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the standard of care, caspofungin, dosed once daily. The drug was previously approved by the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in patients with limited or no treatment options. “The European approval of REZZAYO marks a significant milestone for patients who are in need of new treatment options for invasive candidiasis, and we look forward to seeing Mundipharma bring it to the EU market,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With the payment we’ve received from this milestone, we remain committed to advancing our Cloudbreak platform to develop targeted immunotherapies for cancer patients.” Cidara is currently advancing its Cloudbreak drug-Fc conjugate (DFC) platform to design targeted immunotherapies that inhibit specific diseases while simultaneously engaging the immune system. Its lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells. An IND is anticipated this year. About Cidara Therapeutics Cidara is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit 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. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at . Forward-Looking Statements This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin, and the likelihood that rezafungin will be prescribed by physicians in the EU or approved for reimbursement by member state authorities. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. INVESTOR CONTACT: Brian Ritchie LifeSci Advisors 212-915-2578 britchie@lifesciadvisors.com MEDIA CONTACT: Veronica Eames LifeSci Communications 646-970-4682 veames@lifescicomms.com

The UK MHRA approval follows approvals by the U.S. FDA and the European Commission Cidara is entitled to receive a milestone payment of approximately $2.8 million from Mundipharma Jan. 29, 2024 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults. “Today’s announcement by the MHRA expands treatment options to even more patients suffering from life-threatening invasive candidiasis infections globally,” said Taylor Sandison, M.D. M.P.H., Chief Medical Officer at Cidara. “Our team, in partnership with Mundipharma, is proud to help bring the first new treatment option in 15 years to patients with this disease.” This approval comes after positive results from the ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care, daily-dosed caspofungin. Rezafungin’s safety and efficacy are further supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. Rezafungin is already approved by the United States Food and Drug Administration (FDA) and European Commission (EC). Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan. The company is entitled to receive a $2.8 million milestone payment from Mundipharma for the MHRA approval. Cidara is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA and EC approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com. Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%. IC is characterized as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis. 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. The content above comes from the network. if any infringement, please contact us to modify.

THURSDAY, Jan. 25, 2024 -- Eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult cough syrups have been recalled due to possible contamination. The products, which are made by Haleon, may be contaminated with a microbe, and "in immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal infection," the recall notice said. In people with healthy immune systems, infection is unlikely to lead to severe illness. "However, the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out," the company said. Haleon says that no illnesses in customers using the product have yet been reported. The recall only pertains to eight specific lots, which are listed in the full company announcement posted by the U.S. Food and Drug Administration. Customers who know they have purchased one of the recalled products should not use them, and they should reach out to Haleon at 1-800-245-1040 (Monday through Friday 8 a.m. to 6 p.m. Eastern Time) or via email to mystory.us@haleon.com. More Information Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.