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Cidara Therapeutics (CDTX) delivers innovative solutions for serious infectious diseases through its Cloudbreak® platform, which engineers targeted immunotherapies and anti-infectives. This page provides investors and healthcare professionals with essential updates on clinical developments, regulatory milestones, and strategic initiatives.
Access real-time announcements about CDTX's pipeline candidates, antiviral DFC advancements, and partnership agreements. Our curated collection includes press releases on trial results, FDA interactions, and research collaborations – all critical for evaluating the company's progress in addressing unmet medical needs.
Key updates cover three focus areas: clinical trial phases for antifungal/antiviral therapies, technology licensing deals involving the Cloudbreak® platform, and financial developments impacting R&D priorities. Bookmark this resource to monitor how CDTX's dual approach of direct pathogen targeting and immune system engagement evolves across influenza, oncology, and fungal infection programs.
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.
Cidara Therapeutics (Nasdaq: CDTX) has announced a strategic restructuring, reducing its workforce by approximately 30%. This decision aims to focus resources on the clinical development of CD388, their novel drug-Fc conjugate (DFC) candidate for influenza A and B prevention. The company plans to proceed with Phase 2b trials and potential subsequent studies for CD388 as a single-dose, universal preventative.
Cidara continues business development discussions for its oncology DFC programs, including CBO421, a CD73 inhibitor that recently received IND-clearance for a Phase 1 study. The restructuring is expected to substantially reduce capital needs and streamline operations, positioning Cidara for long-term success in its mission to develop innovative immunotherapies for serious diseases.
Cidara Therapeutics (Nasdaq: CDTX), a biotechnology company specializing in drug-Fc conjugate (DFC) immunotherapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's President and CEO, Jeffrey Stein, Ph.D., will present on Monday, September 9, 2024, at 7:00 am ET.
The presentation will be available via webcast and can be accessed through a provided link. Additionally, an on-demand replay will be accessible in the investors section of Cidara's website for 90 days following the event. This conference appearance provides an opportunity for Cidara to showcase its Cloudbreak® platform and its efforts in developing innovative therapies for serious diseases.
Cidara Therapeutics (Nasdaq: CDTX) has appointed Jim Beitel as its new Chief Business Officer (CBO). This strategic move comes as Cidara focuses on advancing its Cloudbreak DFC pipeline, which offers numerous partnering and licensing opportunities. Beitel brings over 20 years of experience in life science corporate development, including strategy, business development, and commercialization.
Beitel's appointment is expected to enhance Cidara's business development efforts, particularly as the company prepares for the Phase 2b trial of CD388, its universal influenza preventative, set to begin this fall. His track record includes successful partnering activities that have generated over $4 billion in upfront payments and collaboration revenues, and contributed to raising over $1 billion in equity financings.