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Cidara Therapeutics, Inc. (CDTX), headquartered in San Diego, California, is a pioneering biotechnology company focused on the discovery, development, and commercialization of novel anti-infectives and immunotherapies. The company's mission is to address diseases inadequately treated by current standard of care therapies. Utilizing its proprietary Cloudbreak® platform, Cidara develops drug-Fc conjugates (DFCs) aimed at saving lives and improving patient outcomes for serious diseases such as cancer, viral infections, and autoimmune diseases.
The company's core portfolio includes:
- Rezafungin (REZZAYO™): An FDA and EC-approved treatment for invasive candidiasis, licensed to multiple partners for commercialization in the U.S. and internationally.
- CD101 IV: A potential once-weekly intravenous therapy for systemic fungal infections.
- CD101 Topical: The first topical application of the echinocandin class of anti-fungals for vulvovaginal candidiasis (VVC).
- CD388: A long-acting antiviral investigational drug for the prevention of all strains of influenza A and B, currently in Phase 2b development.
Recent achievements include significant data presentations at prestigious conferences and strategic realignments to focus on the most promising components of their pipeline. Cidara’s financial stability is reinforced by a $240 million private placement led by RA Capital Management, with participation from top-tier investors like Bain Capital Life Sciences and Biotech Value Fund (BVF).
Noteworthy partnerships include collaborations with Johnson & Johnson for CD388 and Mundipharma for the divestiture of rezafungin, which has led to substantial cost savings and allows Cidara to focus on its Cloudbreak platform. The company is also preparing for a Phase 2b clinical trial of CD388, aiming to deliver universal, season-long protection against influenza.
For more information, visit www.cidara.com.
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.
Cidara Therapeutics (NASDAQ: CDTX) announced an $11 million milestone payment from Mundipharma following the European Medicines Agency's acceptance of the marketing authorization application for rezafungin, aimed at treating candidemia and invasive candidiasis. The company is eligible for up to an additional $108 million in milestones from existing partnerships over the next two years. Cidara retains rights to rezafungin in Japan and has licensed its U.S. rights to Melinta Therapeutics. Rezafungin has received Fast Track and Orphan Drug designations from the FDA.
Cidara Therapeutics (NASDAQ: CDTX) announced that the FDA accepted its NDA for rezafungin, designed to treat candidemia and invasive candidiasis, granting it a Priority Review and setting a PDUFA date of March 22, 2023. This follows promising data from Phase 2 and 3 trials, showing rezafungin's non-inferiority to the current treatment, caspofungin. Rezafungin has QIDP and Orphan Drug Designation, evidencing its potential as a critical treatment for serious fungal infections. The company retains rights in Japan while licensing commercial rights to Melinta and Mundipharma for other regions.
Cidara Therapeutics (Nasdaq: CDTX) has initiated a Phase 2a trial for CD388, a drug-Fc conjugate designed for universal influenza prevention. Conducted in collaboration with Janssen, the trial, started on September 10, 2022, aims to assess the safety, tolerability, and antiviral activity of CD388 in healthy volunteers. With a target of 168 participants, the study will evaluate multiple dose levels prior to inducing an influenza viral challenge. Cidara's Cloudbreak platform underpins this innovative approach to combat seasonal and pandemic influenza, potentially enhancing prevention strategies for vulnerable populations.
Cidara Therapeutics (NASDAQ: CDTX) announced that its President and CEO, Jeffrey Stein, Ph.D., will present at the 24th Annual H.C. Wainwright Global Investment Conference on September 12, 2022, at 7:00 AM ET. The presentation will be available on-demand in the Investors section of the company’s website. Cidara focuses on developing long-acting therapeutics for serious diseases, including its lead Phase 3 antifungal candidate, rezafungin, and drug-Fc conjugates targeting viral and oncology diseases.
Cidara Therapeutics (NASDAQ: CDTX) reported its Q2 2022 financial results, revealing revenues of $6.2 million, down from $32.9 million in Q2 2021. The company achieved a key milestone with the submission of an NDA for rezafungin to treat candidemia and invasive candidiasis. A licensing agreement with Melinta Therapeutics could yield up to $460 million. However, a net loss of $13.1 million was recorded for Q2, contrasting with a net income of $10.7 million in the prior year. Cash reserves dwindled to $25.0 million from $62.3 million since the start of 2022.
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