Cidara Therapeutics, Inc. - CDTX STOCK NEWS

Cidara Therapeutics (NASDAQ: CDTX) reported favorable interim data from its Phase 2a trial of CD388, a potential long-acting antiviral for influenza. As of February 13, 2023, results show that a single 150 mg dose of CD388 significantly reduced influenza viral replication and infection rates compared to placebo, with 21.4% of CD388 recipients infected versus 50% in the placebo group. The drug was well tolerated, with no adverse events linked to it. The study is being conducted in collaboration with Janssen Pharmaceuticals, aiming for universal prevention of seasonal and pandemic influenza strains.

Cidara Therapeutics (NASDAQ: CDTX) announced it will present pharmacokinetic study highlights of its CD73-targeting drug-Fc conjugate (DFC) oncology candidate at the ESMO TAT Congress in Paris from March 6-8, 2023. The studies showcase the drug's ability to inhibit CD73, a component of the adenosine pathway involved in immune evasion in solid tumors. The lead candidate, CBO-212, addresses the limitations of traditional small molecule and monoclonal antibody therapies. The abstract presentation is scheduled for March 6, 2023, at 5:35 p.m. CET in Hall Bordeaux, Palais des Congrès de Paris.

Cidara Therapeutics (Nasdaq: CDTX) announced it has regained compliance with Nasdaq's minimum bid price requirement, after previously being informed of non-compliance on February 28, 2022. After receiving a 180-day extension and a hearing on October 6, 2022, Cidara implemented a plan to regain compliance. The requirement was met as the stock maintained a closing bid price above $1.00 for 10 consecutive trading days from January 25 to February 7, 2023. The Nasdaq Panel confirmed compliance on February 9, 2023, and the matter is now closed, with a monitoring period until November 9, 2023.

Cidara Therapeutics (NASDAQ: CDTX) has expanded its partnership with WuXi XDC to include the development of its CD73 oncology drug-Fc conjugate (DFC), building on their existing collaboration for the CD388 influenza program. This agreement focuses on IND-enabling chemistry, manufacturing, and controls for the oncology program. The CD73 DFC targets the adenosine pathway to address immune evasion in solid cancers. Cidara aims to improve the effectiveness and safety of therapies while leveraging WuXi XDC’s bioconjugate manufacturing expertise. Financial terms of the agreement were not disclosed.

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.