Cidara Therapeutics, Inc. - CDTX STOCK NEWS

Cidara Therapeutics (NASDAQ: CDTX) reported its Q3 2022 financial results, revealing revenues of $40.7 million, significantly up from $7.1 million year-over-year. This growth was attributed to a key $25.9 million intellectual property license to Melinta. The FDA has accepted the NDA for rezafungin for priority review, with a target action date set for March 22, 2023. The company also secured an $11.1 million milestone payment from Mundipharma. Cidara's cash reserves stand at $53.1 million as of September 30, 2022, and they continue to advance clinical trials for their antiviral program.

On October 17, 2022, Cidara Therapeutics (NASDAQ: CDTX) announced its participation in IDWeek 2022, presenting new clinical data for rezafungin, a novel antifungal therapy, via six poster presentations. Rezafungin is aimed at treating candidemia and invasive candidiasis, with a target action date from the FDA set for March 22, 2023. The drug has received QIDP designation and Orphan Drug Designation in the U.S. and EU. Cidara retains rights in Japan and has licensed U.S. rights to Melinta Therapeutics. The company is focused on improving treatment options for serious diseases.

Cidara Therapeutics (NASDAQ: CDTX) announced an $11 million milestone payment from Mundipharma following the European Medicines Agency's acceptance of the marketing authorization application for rezafungin, aimed at treating candidemia and invasive candidiasis. The company is eligible for up to an additional $108 million in milestones from existing partnerships over the next two years. Cidara retains rights to rezafungin in Japan and has licensed its U.S. rights to Melinta Therapeutics. Rezafungin has received Fast Track and Orphan Drug designations from the FDA.

Cidara Therapeutics (NASDAQ: CDTX) announced that the FDA accepted its NDA for rezafungin, designed to treat candidemia and invasive candidiasis, granting it a Priority Review and setting a PDUFA date of March 22, 2023. This follows promising data from Phase 2 and 3 trials, showing rezafungin's non-inferiority to the current treatment, caspofungin. Rezafungin has QIDP and Orphan Drug Designation, evidencing its potential as a critical treatment for serious fungal infections. The company retains rights in Japan while licensing commercial rights to Melinta and Mundipharma for other regions.

Cidara Therapeutics (Nasdaq: CDTX) has initiated a Phase 2a trial for CD388, a drug-Fc conjugate designed for universal influenza prevention. Conducted in collaboration with Janssen, the trial, started on September 10, 2022, aims to assess the safety, tolerability, and antiviral activity of CD388 in healthy volunteers. With a target of 168 participants, the study will evaluate multiple dose levels prior to inducing an influenza viral challenge. Cidara's Cloudbreak platform underpins this innovative approach to combat seasonal and pandemic influenza, potentially enhancing prevention strategies for vulnerable populations.

Cidara Therapeutics (NASDAQ: CDTX) announced that its President and CEO, Jeffrey Stein, Ph.D., will present at the 24th Annual H.C. Wainwright Global Investment Conference on September 12, 2022, at 7:00 AM ET. The presentation will be available on-demand in the Investors section of the company’s website. Cidara focuses on developing long-acting therapeutics for serious diseases, including its lead Phase 3 antifungal candidate, rezafungin, and drug-Fc conjugates targeting viral and oncology diseases.

Cidara Therapeutics (NASDAQ: CDTX) reported its Q2 2022 financial results, revealing revenues of $6.2 million, down from $32.9 million in Q2 2021. The company achieved a key milestone with the submission of an NDA for rezafungin to treat candidemia and invasive candidiasis. A licensing agreement with Melinta Therapeutics could yield up to $460 million. However, a net loss of $13.1 million was recorded for Q2, contrasting with a net income of $10.7 million in the prior year. Cash reserves dwindled to $25.0 million from $62.3 million since the start of 2022.

Cidara Therapeutics has submitted a New Drug Application (NDA) for rezafungin to the U.S. FDA for treating candidemia and invasive candidiasis, with an expected action date in early 2023. The company signed an agreement with Melinta Therapeutics, granting them exclusive rights to commercialize rezafungin in the U.S., potentially earning Cidara up to $460 million, including an upfront payment of $30 million and milestone payments. Rezafungin, a novel once-weekly antifungal, has shown positive results in clinical trials, making it a significant treatment option for patients with serious fungal infections.

Cidara Therapeutics will host a virtual R&D day on July 7, 2022, at 10 AM ET to showcase its Cloudbreak platform in oncology. Key opinion leaders, including Ezra Cohen and Perry Nisen, will discuss the advantages of Drug-Fc Conjugates (DFCs) over traditional therapies. Cidara's collaboration with Janssen Pharmaceuticals on CD388, currently in Phase 1 studies, will also be highlighted. Attendees can submit questions during the session. For more details and registration, click here.