Cidara Theraptcs Stock Price, News & Analysis

Cidara Therapeutics, Inc. (Nasdaq: CDTX) is a biotechnology company in the biological product manufacturing sector that focuses on developing drug-Fc conjugate (DFC) therapeutics. The company is using its proprietary Cloudbreak® platform to create novel DFCs that comprise targeted small molecules or peptides coupled to a proprietary human antibody fragment. According to company disclosures, these agents are designed to directly inhibit disease targets while also directing immune-mediated clearance of disease. Cidara is headquartered in San Diego, California.

Cidara’s lead DFC candidate is CD388, a long-acting antiviral being developed as a non-vaccine preventative for seasonal and pandemic influenza. Company materials describe CD388 as a drug-Fc conjugate that uses a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. CD388 is designed to function as a long-acting small molecule inhibitor, with the goal of preventing influenza A and B infections in individuals at higher risk of influenza complications.

The company reports that CD388 is intended to provide season-long prevention of influenza illness with a single subcutaneous dose by directly inhibiting viral proliferation. Unlike vaccines, CD388 is not designed to rely on an immune response, and Cidara states that it is expected to be efficacious regardless of immune status. CD388 has been evaluated in the Phase 2b NAVIGATE trial in healthy unvaccinated adults and is being studied in the Phase 3 ANCHOR trial in adults and adolescents at high risk of complications from influenza, including those who are immune compromised, have certain comorbidities, or are over 65 years of age.

According to Cidara’s public updates, the NAVIGATE trial was a randomized, double-blind, placebo-controlled Phase 2b study that met its primary and secondary endpoints for prevention of seasonal influenza in healthy unvaccinated adults aged 18 to 64. The company reports that CD388 was well tolerated at all doses tested in this study and that prevention efficacy was observed across multiple dose levels. Based on these data, CD388 received Fast Track designation in June 2023 and Breakthrough Therapy designation in October 2025 from the U.S. Food and Drug Administration (FDA.

The ongoing ANCHOR trial is described by Cidara as a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. It is designed to evaluate the safety and efficacy of a single 450-milligram subcutaneous dose of CD388 administered at the beginning of the flu season. The company has stated that the study population includes adults and adolescents with high-risk comorbidities or immune-compromised status, as well as generally healthy adults over the age of 65. Cidara has indicated a target enrollment of 6,000 participants across sites in the United States and the United Kingdom, with an interim analysis planned after the Northern Hemisphere flu season.

Cidara’s disclosures also highlight a significant collaboration with the U.S. government. The company entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, to support expanded manufacturing and clinical development of CD388. Under this agreement, BARDA is providing base-period funding to support onshoring of CD388 manufacturing to the United States as an addition to the initial commercial supply chain, as well as clinical and non-clinical work related to higher-concentration formulations, different presentations, and activity against pandemic influenza strains.

In addition to government support, Cidara has pursued capital markets financing to advance its programs. The company has reported entering into an underwriting agreement for an underwritten public offering of its common stock, with gross proceeds expected from the sale of newly issued shares. Cidara has also used shelf registration and at-the-market (ATM) facilities, and later suspended an ATM prospectus in connection with a larger underwritten offering, as described in its SEC filings.

Corporate governance and capital structure developments are reflected in Cidara’s reports of stockholder actions. At its annual meeting of stockholders, the company’s investors approved an increase in the authorized number of shares of common stock and an amendment to its equity incentive plan to increase the number of shares available for issuance. These actions support Cidara’s ability to finance its operations and provide equity-based compensation as it advances CD388 and other potential DFC candidates.

Cidara’s regulatory filings and press releases emphasize that the company is focused on seeking biologics license application (BLA) approval for CD388 based on a single Phase 3 study, subject to FDA review. The company has described an expanded and accelerated development plan following an End-of-Phase 2 meeting with the FDA, including broadening the ANCHOR trial population to substantially increase the number of patients potentially eligible to receive CD388 in the United States.

In November 2025, Cidara announced that it had entered into an Agreement and Plan of Merger with Merck Sharp & Dohme LLC and a Merck subsidiary. Under this agreement, Merck, through its subsidiary, commenced a cash tender offer to acquire all outstanding shares of Cidara’s common stock and Series A preferred stock for cash consideration. The merger agreement contemplates that, following completion of the tender offer and subject to customary conditions, the Merck subsidiary will merge with and into Cidara, with Cidara surviving as a wholly owned subsidiary of Merck.

Subsequently, Merck announced the successful completion of the cash tender offer for all outstanding shares of Cidara common stock and indicated its intention to complete the acquisition through a merger. Merck stated that, after completion of the merger, Cidara will become a wholly owned subsidiary of Merck and that Cidara’s common stock will no longer be listed or traded on the Nasdaq Global Market. According to Merck’s announcement, the acquisition is expected to be accounted for as an asset acquisition and is intended to strengthen and complement Merck’s respiratory portfolio by adding CD388 as a late-phase antiviral candidate.

Historically, Cidara also worked on antifungal candidates and immunotherapy approaches, as reflected in earlier descriptions of its pipeline. Prior materials described the company as focused on discovery, development, and commercialization of anti-infectives for diseases inadequately addressed by current standard-of-care therapies, including systemic fungal infections and vulvovaginal candidiasis, and referenced its Cloudbreak platform as a way to direct a patient’s immune cells to attack and eliminate pathogens. More recent disclosures, however, center on CD388 and its development for influenza prevention using the Cloudbreak platform.

Business focus and development model

Cidara’s business model, as described in its public statements, centers on research and development of DFC therapeutics, advancement of lead candidates through clinical trials, and collaboration with larger pharmaceutical partners and government agencies. The company’s financial disclosures highlight research and development expenses associated with clinical trials such as NAVIGATE and ANCHOR, manufacturing-related costs for CD388, and milestone obligations under licensing and collaboration agreements.

In addition to its direct development activities, Cidara has entered into licensing and technology transfer arrangements. The company reports that it re-acquired rights to CD388 from a prior collaborator through a license and technology transfer agreement, and that dosing of the first subjects in the ANCHOR study triggered a milestone payment under that agreement. Cidara has also reported the sale of certain assets, such as its former rezafungin assets and related contracts, which are now reported as discontinued operations in its financial statements.

Regulatory and clinical context

Because Cidara operates in the biotechnology and biological product manufacturing sector, regulatory interactions play a central role in its activities. The company’s disclosures reference Fast Track and Breakthrough Therapy designations for CD388, an End-of-Phase 2 meeting with the FDA, and plans for a BLA submission based on Phase 3 data. Cidara’s SEC filings and press releases also describe the design of its clinical trials, including randomization, double-blind, placebo-controlled structures, and specific primary endpoints based on laboratory-confirmed influenza, body temperature thresholds, and symptom criteria.

Through its Cloudbreak platform and DFC approach, Cidara positions itself within the broader field of anti-infective drug development, focusing on agents that combine direct antiviral or anti-pathogen activity with immune engagement. While historical descriptions mention applications in systemic fungal infections and other infectious diseases, the company’s most recent communications concentrate on influenza prevention and the potential for CD388 to address unmet needs in high-risk populations and individuals seeking alternatives to traditional influenza vaccines.

Corporate status and listing

As disclosed in SEC filings and Merck’s public announcements, Cidara agreed to be acquired by Merck through a tender offer and subsequent merger. Merck has reported the successful completion of the tender offer for Cidara’s common stock and has stated that, following the merger, Cidara will become a wholly owned subsidiary and its common stock will cease to trade on the Nasdaq Global Market. For investors researching the CDTX ticker, this means that CDTX historically represented Cidara Therapeutics as an independent Nasdaq-listed biotechnology company, and that, following completion of the merger, Cidara’s equity will be held by Merck rather than public shareholders.