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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 (CDTX) has completed enrollment of 5,000 subjects in its Phase 2b NAVIGATE trial, evaluating CD388 for pre-exposure prophylaxis of seasonal influenza. The study, conducted across US and UK clinical sites, is designed to assess the efficacy and safety of CD388 as a long-acting, universal influenza preventative.
The randomized, double-blind, controlled trial involves healthy, unvaccinated adult subjects not at risk of influenza complications. Participants receive single doses of CD388 (150mg, 300mg, or 450mg) or placebo at the start of flu season and are monitored for breakthrough cases throughout the season. The trial will evaluate safety, pharmacokinetics, and rates of laboratory and clinically confirmed influenza.
Cidara Therapeutics (CDTX) has announced a $105 million private placement led by new investor Venrock Healthcare Capital Partners, with participation from both new and existing life sciences-focused investors. The company will issue approximately 3.89 million shares of common stock at $14.912 per share and pre-funded warrants for 3.15 million shares at $14.9119 per warrant. The placement is expected to close around November 25, 2024. The proceeds will be used to fund research and development of product candidates, working capital, and general corporate purposes. RBC Capital Markets acted as sole placement agent, while Guggenheim Securities served as financial advisor.
Cidara Therapeutics (CDTX) has announced its participation in the Evercore 7th Annual HealthCONx Conference. The company's President and CEO, Jeffrey Stein, Ph.D., will engage in a fireside chat on Tuesday, December 3, 2024, at 7:55 AM ET. The presentation will be available via webcast, with a 90-day replay accessible in the Investors section of Cidara's website. The company, which develops drug-Fc conjugate immunotherapies through its proprietary Cloudbreak® platform, will also conduct one-on-one investor meetings during the event.
Cidara Therapeutics (CDTX) reported Q3 2024 financial results and corporate updates. Key highlights include the initiation of Phase 2b NAVIGATE trial for CD388, their influenza prevention drug candidate. The company reported cash and equivalents of $127.4 million as of September 30, 2024. Revenue was zero for Q3 2024, compared to $9.2 million in Q3 2023. Net loss increased to $16.0 million for Q3 2024. The company implemented a 30% workforce reduction to focus on CD388 development. The company presented positive Phase 2a and Phase 1 trial data for CD388 at multiple conferences, demonstrating its potential for single-dose seasonal flu protection.
Cidara Therapeutics (Nasdaq: CDTX) has announced its participation in two major investor conferences in November 2024. CEO Jeffrey Stein will present at the Guggenheim Securities Healthcare Innovation Conference on November 11 at 1:30 PM ET in a fireside chat format, which will be available via webcast. The company will also attend the Jefferies London Healthcare Conference from November 19-21.
The Guggenheim presentation will be accessible through a webcast link and remain available for replay on Cidara's website for 90 days. The company, which develops drug-Fc conjugate immunotherapies through its Cloudbreak® platform, will conduct one-on-one investor meetings at both events.
Cidara Therapeutics announced two presentations on its drug-Fc conjugate, CD388, at IDWeek 2024. The presentations will highlight clinical data on safety, pharmacokinetics, and prophylactic activity of CD388 for influenza prevention. An oral presentation will discuss CD388's prophylactic activity in a Phase 2a human challenge study, where a single dose prevented symptomatic disease in subjects who seroconverted after influenza challenge. A poster presentation will cover a study evaluating CD388's safety, tolerability, and pharmacokinetics in healthy subjects. Results showed rapid absorption, slow elimination, and potential for seasonal influenza prevention with one dose. No safety concerns or anti-drug antibody formation were observed, supporting annual use.
Cidara Therapeutics (CDTX), a biotechnology company, announced the granting of a non-qualified stock option award and restricted stock units (RSUs) to Dipesh Bhatt, a new employee, under its 2020 Inducement Incentive Plan. The award includes 1,110 shares of common stock with an exercise price of $10.75 per share, matching the stock's closing price on September 30, 2024. The stock options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the next three years. RSUs vest annually over four years. The award is given under Nasdaq Listing Rule 5635(c)(4) as an inducement for Bhatt's employment. Additionally, Cidara corrected an earlier press release, clarifying that 81,000 shares, not 71,000, were granted to Jim Beitel in a previous inducement award.
Cidara Therapeutics (Nasdaq: CDTX) announced two presentations on its influenza drug-Fc conjugate (DFC) candidate, CD388, at the OPTIONS XII conference in Brisbane, Australia. The presentations will highlight safety and pharmacokinetic data from clinical studies.
The oral presentation will summarize safety data from three CD388 clinical trials involving 108 subjects followed for 5-14 months. No dose-, route- or repeat-dose-related treatment-emergent adverse events were observed, supporting CD388's safety profile for single-dose seasonal influenza prevention.
The poster presentation will focus on pharmacokinetics and safety data from 27 healthy Japanese volunteers dosed subcutaneously with CD388. Results showed low-to-moderate variability across doses and were similar to previous studies in Western participants. No clinically significant treatment-emergent adverse events were reported.
Cidara Therapeutics (Nasdaq: CDTX) has announced the initiation of its Phase 2b NAVIGATE trial, evaluating CD388 for the prevention of seasonal influenza. The study has begun dosing the first subjects and aims to enroll 5,000 healthy unvaccinated adults across clinical sites in the US and UK.
The trial is designed as a randomized, double-blind, controlled study with three CD388 dose groups and a placebo group. Subjects will receive a single dose at the start of the flu season and be monitored for breakthrough cases. The study will compare rates of laboratory and clinically confirmed influenza between the CD388 and placebo groups.
CD388, developed using Cidara's proprietary Cloudbreak® platform, is a drug-Fc conjugate (DFC) immunotherapy. Unlike vaccines, it does not rely on an immune response, potentially offering protection regardless of immune status. The therapy has shown promise in preventing infection by both seasonal and pandemic strains of influenza A and B.
Cidara Therapeutics (Nasdaq: CDTX) has announced the appointment of four renowned infectious disease experts to its Scientific Advisory Board (SAB). The new members are Rick Bright, Ph.D., Philip Krause, M.D., Mario Barro, Ph.D., and Frederick G. Hayden, M.D., FACP. These appointments aim to strengthen Cidara's expertise in pandemic preparedness, clinical and regulatory strategy, and infectious disease research.
The new SAB members will provide guidance on the development of CD388, Cidara's drug candidate currently entering a Phase 2b trial to test a single dose for season-long protection against influenza A & B. Each expert brings extensive experience in various aspects of infectious diseases, vaccine development, and regulatory affairs, which aligns with Cidara's focus on developing drug-Fc conjugate (DFC) immunotherapies using its proprietary Cloudbreak® platform.
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