Cidara Theraptcs Stock Price, News & Analysis

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.

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.