Stock Monitor: BioTime Post Earnings Reporting
LONDON, UK / ACCESSWIRE / March 21, 2018 / Active-Investors.com has just released a free research report on Cidara Therapeutics, Inc. (NASDAQ: CDTX). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=CDTX as the Company's latest news hit the wire. On March 19, 2018, the Company announced positive top-line results from the global, randomized Phase-2 STRIVE clinical trial, evaluating the Company's lead antifungal candidate rezafungin acetate, in patients with candidemia and/or invasive candidiasis. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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STRIVE Met All of its Primary Objectives
STRIVE met all of its primary objectives. The once-weekly intravenous dosing of rezafungin was observed to be generally well tolerated and safe in patients with candidemia and/or invasive candidiasis. The efficacy of rezafungin was demonstrated with the clearance of Candida from the blood or other normally sterile sites, resolution of signs related to the infection, investigator assessment of clinical response, and overall survival. The rezafungin 400mg/200mg regimen (Group 2) had the highest efficacy rate in all assessments. There were no concerning trends in adverse events observed.
Cidara to Initiate Two Phase-3 Clinical Trials of Treatment and Prophylaxis in Mid-2018
Based on the STRIVE trial results, Cidara plans to initiate two Phase-3 clinical trials in mid-2018:
- Phase-3 ReSTORE Treatment Trial: A single, global, randomized, double-blind, controlled Phase-3 pivotal clinical trial in approximately 150 mITT patients with candidemia and/or invasive candidiasis. This global Phase-3 trial is expected to generate topline data in 2020.
- Phase-3 ReSPECT Prophylaxis (Prevention) Trial: A single, global, randomized, double-blind, controlled Phase-3 pivotal clinical trial in patients undergoing allogeneic bone marrow transplant to enable use of rezafungin in a 90-day prophylaxis regimen to prevent infections due to Candida, Aspergillus, and Pneumocystis. This trial is expected to produce an interim futility read-out in 2019 and provide top-line results in 2020.
FDA Approved Drug for Treatment of Invasive Fungal Infections
In March 2015, the US Food and Drug Administration (FDA) approved Japanese drugmaker Astellas Pharma Inc's anti-fungal drug, Cresemba, for the treatment of two rare, often fatal invasive fungal infections that target patients with blood cancers. Cresemba was approved for use against invasive aspergillosis and invasive mucormycosis. In clinical trials, the drug, also known as isavuconazonium, proved at least as safe and effective in reducing mortality as voriconazole, which Pfizer sells under the brand name Vfend, the standard of care for aspergillosis.
About Invasive Fungal Infections
Invasive fungal infections (IFIs) are a significant health problem in immunocompromised patients. It continues to be a global health issue, especially for critically ill patients in hospitals and patients with compromised immune systems, including cancer and transplant patients. Approximately 90% of IFI-related deaths are associated with Candida, Aspergillus, and Pneumocystis.
Rezafungin is a novel antifungal echinocandin being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious invasive fungal infections. Rezafungin is being studied to address unmet needs in treatment of candidemia and invasive candidiasis, and prevention of invasive fungal infections, including Candida, Aspergillus and Pneumocystis. The FDA has designated rezafungin as a Qualified Infectious Disease Product (QIDP) with Fast Track status and orphan drug designation.
The STRIVE Trial
STRIVE is an international, multicenter, double-blind trial evaluating the safety, tolerability and efficacy of once-weekly dosing of rezafungin acetate compared to once-daily dosing of caspofungin in patients with candidemia and/or invasive candidiasis. 92 patients were randomized to one of two rezafungin arms or the comparator arm, in which patients received caspofungin. In the two rezafungin arms of the trial, patients received either 400 mg of rezafungin administered intravenously once weekly for two to four weeks, or 400 mg for the first week followed by 200 mg once weekly for up to four weeks in total. In the comparator arm, patients received daily caspofungin administered intravenously.
About Cidara Therapeutics, Inc.
Founded in 2013 and headquartered in San Diego, California, Cidara Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of novel anti-infectives for the treatment of various diseases.
Stock Performance Snapshot
March 20, 2018 - At Tuesday's closing bell, Cidara Therapeutics' stock fell 8.33%, ending the trading session at $5.50.
Volume traded for the day: 919.97 thousand shares, which was above the 3-month average volume of 152.44 thousand shares.
After yesterday's close, Cidara Therapeutics' market cap was at $114.79 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.1% at the end of the session.
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