Welcome to our dedicated page for Cidara Theraptcs news (Ticker: CDTX), a resource for investors and traders seeking the latest updates and insights on Cidara Theraptcs stock.
Cidara Therapeutics, Inc. (CDTX) generates news primarily as a clinical-stage biotechnology company developing drug-Fc conjugate (DFC) therapeutics through its proprietary Cloudbreak platform. Most recent coverage focuses on CD388, a long-acting antiviral DFC designed as a non-vaccine preventative for seasonal and pandemic influenza, as well as on corporate transactions and government collaborations.
News about Cidara frequently highlights clinical trial milestones for CD388. This includes updates on the Phase 2b NAVIGATE trial in healthy unvaccinated adults and the Phase 3 ANCHOR trial in adults and adolescents at higher risk of influenza complications, including individuals with immune-compromised conditions, certain comorbidities, and adults over 65 years of age. Articles often describe trial design, enrollment progress, interim analysis plans, and safety and efficacy results reported by the company.
Investors following CDTX news will also see disclosures on regulatory interactions and designations, such as Fast Track and Breakthrough Therapy designations granted by the U.S. Food and Drug Administration (FDA) for CD388, and company commentary on plans to seek biologics license application (BLA) approval based on a single Phase 3 study. Additional coverage includes Cidara’s BARDA agreement to support expanded manufacturing and clinical development of CD388, detailing federal funding for onshoring manufacturing and additional clinical and non-clinical work.
Another major theme in Cidara’s news flow is its acquisition by Merck. Releases describe Merck’s definitive agreement to acquire Cidara through a cash tender offer and subsequent merger, the tender offer terms, and Merck’s statements about integrating CD388 into its respiratory portfolio. Updates from Merck note the successful completion of the tender offer, the planned merger to make Cidara a wholly owned subsidiary, and the expected delisting of Cidara’s common stock from the Nasdaq Global Market.
On this CDTX news page, readers can review historical and transaction-related announcements, clinical data presentations at scientific conferences, investor conference participation, and quarterly corporate updates. For those researching Cidara’s development of CD388, its Cloudbreak platform, and the transition of Cidara into Merck’s portfolio, this news feed provides a centralized view of key public communications over time.
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.
Tentarix Biotherapeutics has established a new Scientific Advisory Board (SAB) to enhance its development of targeted, conditional antibody-based therapies. The SAB includes immunology and cancer biology experts Thomas Bumol, Brian Kuhlman, and John Teijaro. Tentarix also appointed Donald Santel and Bumol to its Board of Directors, with Santel as chairperson, and hired Brady Johnson as Senior VP of Finance and Operations. These strategic appointments aim to bolster Tentarix’s leadership and advance its innovative pipeline of biologics for patient care.
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