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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 has submitted a New Drug Application (NDA) for rezafungin to the U.S. FDA for treating candidemia and invasive candidiasis, with an expected action date in early 2023. The company signed an agreement with Melinta Therapeutics, granting them exclusive rights to commercialize rezafungin in the U.S., potentially earning Cidara up to $460 million, including an upfront payment of $30 million and milestone payments. Rezafungin, a novel once-weekly antifungal, has shown positive results in clinical trials, making it a significant treatment option for patients with serious fungal infections.
Cidara Therapeutics will host a virtual R&D day on July 7, 2022, at 10 AM ET to showcase its Cloudbreak platform in oncology. Key opinion leaders, including Ezra Cohen and Perry Nisen, will discuss the advantages of Drug-Fc Conjugates (DFCs) over traditional therapies. Cidara's collaboration with Janssen Pharmaceuticals on CD388, currently in Phase 1 studies, will also be highlighted. Attendees can submit questions during the session. For more details and registration, click here.
Tentarix Biotherapeutics has established a new Scientific Advisory Board (SAB) to enhance its development of targeted, conditional antibody-based therapies. The SAB includes immunology and cancer biology experts Thomas Bumol, Brian Kuhlman, and John Teijaro. Tentarix also appointed Donald Santel and Bumol to its Board of Directors, with Santel as chairperson, and hired Brady Johnson as Senior VP of Finance and Operations. These strategic appointments aim to bolster Tentarix’s leadership and advance its innovative pipeline of biologics for patient care.
Cidara Therapeutics (NASDAQ: CDTX) reported a strong Q1 2022, achieving $7.1 million in revenue, up from $2.4 million in Q1 2021, primarily due to a collaboration with Janssen Pharmaceuticals. The company advanced its product pipeline, notably initiating a Phase 1 trial of CD388, an influenza drug, and preparing to submit a New Drug Application for rezafungin in mid-2022. However, cash reserves decreased to $38 million from $62 million.
The Phase 3 ReSTORE trial of rezafungin by Cidara Therapeutics (NASDAQ: CDTX) met its primary endpoints, demonstrating non-inferiority to caspofungin for treating candidemia and invasive candidiasis. Results showed 23.7% all-cause mortality at day 30 for rezafungin against 21.3% for caspofungin. Early mycological efficacy was high, with 53.7% negative blood cultures at 24 hours for rezafungin. Tolerability profiles were similar, with no concerning treatment emergent adverse events reported. NDA submission to the FDA is anticipated in mid-2022.
Cidara Therapeutics (NASDAQ: CDTX) and Mundipharma are set to present new clinical data on rezafungin, a novel echinocandin for treating candidemia and invasive candidiasis, at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) from April 23-26, 2022. The data includes results from the global Phase 3 ReSTORE trial and analyses from STRIVE Phase 2 trials. Notably, there will be two late-breaking presentations, highlighting the significant advancements in this promising treatment.
Cidara Therapeutics (Nasdaq: CDTX) has initiated a Phase 1 trial for CD388, a long-acting antiviral immunotherapy aimed at universal prevention of seasonal and pandemic influenza. The trial, conducted in collaboration with Janssen Pharmaceuticals, is a randomized, double-blind study assessing the safety and pharmacokinetics of CD388 in healthy volunteers. Initial safety and pharmacokinetics data are expected in the second half of 2022. CD388 targets a conserved region on the influenza virus, presenting a novel approach to improve flu prevention, especially for high-risk patients.
Cidara Therapeutics (CDTX) reported financial results for Q4 and full year 2021, showcasing substantial progress in its development pipeline. Q4 revenue reached $7.2 million, with full-year revenue of $49.6 million, up from $12.1 million in 2020. The company plans to file a New Drug Application for rezafungin in mid-2022, following positive Phase 3 trial results. Cidara also announced FDA acceptance of an IND for its lead influenza drug, CD388. Cash reserves stood at $62.3 million as of December 31, 2021, while net loss improved to $42.5 million for the year, down from $72.1 million in 2020.
Cidara Therapeutics (NASDAQ: CDTX) and Mundipharma have announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted rezafungin Promising Innovative Medicine (PIM) designation for treating invasive candidiasis, a life-threatening systemic fungal infection. This designation indicates a high unmet medical need, as the mortality rate for invasive candidiasis can reach 40%. Both companies plan to submit an application for the Early Access to Medicines Scheme in Q3 2022, aimed at providing early access to this potential advance in treatment.
Cidara Therapeutics (NASDAQ: CDTX) has received FDA approval for its Investigational New Drug application for CD388, a long-acting antiviral immunotherapy targeting influenza. The company plans to begin a Phase 1 trial in Q1 2022, focusing on universal prevention and treatment of seasonal and pandemic flu. Cidara collaborates with Janssen Pharmaceuticals for development and commercialization, with Janssen covering Phase 1 trial costs. The DFC platform aims to improve flu vaccine efficacy. This milestone supports Cidara's efforts to address unmet needs in flu prevention, particularly for high-risk patients.
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