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 (CDTX) delivers innovative solutions for serious infectious diseases through its Cloudbreak® platform, which engineers targeted immunotherapies and anti-infectives. This page provides investors and healthcare professionals with essential updates on clinical developments, regulatory milestones, and strategic initiatives.
Access real-time announcements about CDTX's pipeline candidates, antiviral DFC advancements, and partnership agreements. Our curated collection includes press releases on trial results, FDA interactions, and research collaborations – all critical for evaluating the company's progress in addressing unmet medical needs.
Key updates cover three focus areas: clinical trial phases for antifungal/antiviral therapies, technology licensing deals involving the Cloudbreak® platform, and financial developments impacting R&D priorities. Bookmark this resource to monitor how CDTX's dual approach of direct pathogen targeting and immune system engagement evolves across influenza, oncology, and fungal infection programs.
On January 25, 2023, Cidara Therapeutics (CDTX) announced a positive recommendation from the FDA Antimicrobial Drugs Advisory Committee for its New Drug Application for rezafungin, aimed at treating candidemia and invasive candidiasis. The vote, which was 14 to 1, noted sufficient evidence supporting its benefit-risk assessment for adult patients with limited treatment options. If approved, rezafungin would be the first new treatment in over a decade for these conditions. The FDA's decision is expected by the PDUFA target date of March 22, 2023. Rezafungin’s efficacy was supported by clinical trials showing it was statistically non-inferior to the current standard of care.
Cidara Therapeutics (NASDAQ: CDTX) announced the selection of CBO-212, a first-in-class CD73 inhibitor, as its initial oncology drug-Fc conjugate (DFC) candidate from the Cloudbreak® platform. This milestone marks a significant advancement in Cidara's oncology program aimed at developing innovative immunotherapies. CBO-212 targets CD73, which plays a role in immune evasion in cancer, and is designed to overcome limitations seen with current therapies. The company plans to advance CBO-212 through IND enabling studies and will share updates at upcoming conferences.
Cidara Therapeutics announced the issuance of U.S. Patent No. 11,510,992 for CD388, a long-acting drug-Fc conjugate aimed at preventing influenza. This patent, projected to expire in 2039, marks a significant milestone for CD388, Cidara's lead product in clinical trials. The company anticipates initial clinical data from ongoing Phase 1 and Phase 2a trials in the first half of 2023. CD388 is designed to target viral proliferation, potentially offering universal protection against seasonal and pandemic influenza with a single seasonal dose.
Cidara Therapeutics, Inc. (NASDAQ: CDTX) and Melinta Therapeutics announced the peer-reviewed publication of pivotal Phase 3 trial data for rezafungin, a novel once-weekly antifungal. The study, published in The Lancet, shows that rezafungin is statistically noninferior to the daily caspofungin for treating candidemia and invasive candidiasis. The FDA has granted Priority Review for rezafungin's NDA, with a target action date set for March 22, 2023. The data highlight rezafungin's potential to transform treatment for serious fungal infections, following positive topline results reported in December 2021.
Cidara Therapeutics (NASDAQ: CDTX) announced that its President and CEO, Jeff Stein, Ph.D., will join a panel at the World Antiviral Congress in San Diego, California, from November 28 to December 1, 2022.
The discussion will focus on pandemic preparedness and developing broad-spectrum therapeutics. The panel session titled 'Therapeutic Approaches to Pandemic Preparedness' is scheduled for December 1, 2022, from 8:20 to 9:30 a.m. PST at Loews Coronado Bay Resort. Cidara is innovating long-acting therapeutics, targeting serious diseases, including its lead Phase 3 antifungal candidate, rezafungin.
Cidara Therapeutics (NASDAQ: CDTX) has announced that Jeffrey Stein, Ph.D., President and CEO, will present at the Stifel Healthcare Conference on November 15, 2022, at 4:45 PM ET. The presentation will showcase Cidara's developments in long-acting therapeutics aimed at improving patient care. The event will be available for on-demand viewing on the company’s website following the presentation. Cidara focuses on innovative treatments including the Phase 3 antifungal candidate, rezafungin, and drug-Fc conjugates from its proprietary Cloudbreak platform.
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.
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