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 has successfully completed recruitment for its pivotal Phase 3 ReSTORE trial, evaluating rezafungin as a potential first-line treatment for candidemia and invasive candidiasis. The trial involved 184 patients, addressing a significant unmet medical need with mortality rates as high as 40%. Top-line data is expected by the end of 2021, with an NDA filing anticipated in mid-2022. Rezafungin aims to offer a once-weekly treatment option for critically ill patients, with Mundipharma responsible for international distribution.
Cidara Therapeutics, Inc. (NASDAQ: CDTX) reported strong Q2 2021 financial results, with revenue of $32.9 million, up from $3.4 million in Q2 2020, largely attributed to a collaboration with Janssen. The company ended Q2 with $53.1 million in cash. Notably, Cidara achieved a net income of $10.7 million in Q2 2021, a significant turnaround from a net loss of $18.3 million the previous year. They anticipate filing an IND for lead candidate CD388 by year-end and report ongoing Phase 3 trials for rezafungin, expecting top-line data availability by year's end.
Cidara Therapeutics (NASDAQ: CDTX) announced that its President and CEO, Jeffrey Stein, Ph.D., will participate in a panel discussion at the 2021 Wedbush PacGrow Healthcare Conference on August 11, 2021, at 4:40 PM ET. The event will feature a live audio webcast available on the company's website. Cidara focuses on developing long-acting therapeutics for serious fungal and viral infections, highlighting its lead antifungal candidate, rezafungin, and its antiviral platform, Cloudbreak®.
Cidara Therapeutics (NASDAQ: CDTX) announced presentations of clinical data on rezafungin at the ISHAM Asia Congress from August 6-8, 2021. Rezafungin, a novel once-weekly echinocandin, aims to treat and prevent serious fungal infections. The presentations will include updated findings from the Phase 2 STRIVE study and activity analysis against Candida and Aspergillus spp. isolates from Asia-Pacific. The Chief Medical Officer, Taylor Sandison, will lead these discussions, showcasing the progress of the ongoing Phase 3 trials.
Cidara Therapeutics (NASDAQ: CDTX) presented new clinical data on rezafungin at the ECCMID 2021, showcasing its effectiveness in treating candidemia. The oral presentation highlighted that a single dose of rezafungin significantly improved infection clearance compared to standard treatments like caspofungin. Critical findings from the STRIVE Phase 2 trial indicated higher rates of negative blood cultures within 24 and 48 hours for patients treated with rezafungin. The ongoing Phase 3 ReSTORE trial aims to validate these results, with top-line data expected by the end of 2021.
Cidara Therapeutics (Nasdaq: CDTX) announced the grant of 172,000 stock options and restricted stock units to eight new employees under its 2020 Inducement Incentive Plan. The options have an exercise price of $2.02 per share, equivalent to the stock's closing price on June 30, 2021. Vesting occurs over four years, with 25% vesting after one year and the remainder in equal monthly installments. These awards are a strategic inducement to attract new talent in line with Nasdaq rules.
Cidara Therapeutics, Inc. (NASDAQ: CDTX) announced the resignation of CFO James Levine, effective July 9, 2021, to pursue new opportunities. Levine will continue to provide consulting support for at least six months. CEO Jeffrey Stein praised Levine for his leadership and contributions to partnerships with Mundipharma and Janssen Pharmaceuticals. In light of this change, Stein will also take on the role of principal financial officer, while Brady Johnson has been promoted to vice president of finance and principal accounting officer, enhancing the company's financial management.
Cidara Therapeutics (NASDAQ: CDTX) is set to present new analyses, including an oral presentation on rezafungin, at the 31st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) virtually from July 9-12, 2021. Rezafungin, a once-weekly echinocandin, is currently in Phase 3 trials for treating serious fungal infections in critically ill patients. Highlights include a session on the STRIVE Phase 2 trial's efficacy and safety analysis. The presentations will be accessible via Cidara's website and ECCMID's platform.
Cidara Therapeutics (Nasdaq: CDTX) announced that CEO Jeffrey Stein and CFO James Levine will participate in investor meetings at the Raymond James Human Health Innovation Conference from June 21-23, 2021. The company focuses on developing long-acting therapeutics to address serious fungal and viral infections, with notable products including the antifungal candidate rezafungin and antiviral candidates from its Cloudbreak platform. Cidara is headquartered in San Diego, California.
Cidara Therapeutics (NASDAQ: CDTX) announced its participation in the Mycology 2021 Conference, showcasing results from pre-clinical to Phase 2 trials of rezafungin, a novel, once-weekly echinocandin for invasive fungal disease treatment and prevention. The spotlight presentation will occur on June 12, 2021, featuring Dr. Varun Mehra from Kings College Hospital. Rezafungin aims to enhance safety and efficacy in treating serious fungal infections, currently in Phase 3 trials: ReSTORE for candidemia and ReSPECT for prevention in allogeneic transplant patients.
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