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Cidara Theraptcs - CDTX STOCK NEWS

Welcome to our dedicated page for Cidara Theraptcs news (Ticker: CDTX), a resource for investors and traders seeking the latest updates and insights on Cidara Theraptcs stock.

Company Overview

Cidara Therapeutics (CDTX) is an innovative biotechnology company focused on transforming the treatment paradigms for infectious diseases that have long been underserved by standard therapies. Through a multifaceted approach, the company develops novel immunotherapies and anti-infectives, leveraging its proprietary Cloudbreak® platform to engineer drug-Fc conjugates (DFCs) that uniquely combine targeted small molecules or peptides with a human antibody fragment. This integrated strategy allows Cidara to address complex infectious challenges including systemic fungal infections, vulvovaginal candidiasis, and seasonal as well as pandemic influenza among others.

Core Technologies and Business Model

At the heart of Cidara Therapeutics is its breakthrough Cloudbreak® platform, a versatile and cutting-edge technology designed to create single molecule cocktails with dual functionality. The platform enables the generation of DFCs that not only inhibit specific disease targets directly, but also engage the immune system, thereby potentially enhancing the overall efficacy of the treatment. The company’s approach spans several therapeutic areas, including anti-fungal and antiviral applications as well as oncologic and autoimmune indications, setting it apart in the competitive biotechnology landscape.

Pipeline and Product Candidates

Cidara’s product pipeline is strategically diversified to mitigate risk and maximize the clinical impact. The company is advancing multiple product candidates:

  • CD101 IV and CD101 Topical: These candidates target systemic fungal infections and vulvovaginal candidiasis, respectively, representing the first steps in introducing novel anti-fungal therapies with potential once-weekly or topical administration regimes.
  • CD388: As a long-acting antiviral DFC, CD388 is designed to provide universal prevention against influenza A and B by directly inhibiting viral proliferation. This candidate is engineered to function independently of the host immune response, offering potential advantages over traditional vaccines.
  • Cloudbreak-Facilitated Immunotherapies: In addition to its anti-infective portfolio, Cidara leverages its Cloudbreak platform to develop immunotherapeutic agents aimed at targeting oncologic, viral, and autoimmune diseases, broadening the company’s application footprint and research potential.

Market Position and Competitive Landscape

Cidara Therapeutics operates in a highly specialized niche within the biotechnology sector. By focusing on areas where current standard of care therapies fall short, the company positions itself as a catalyst for change in treatment protocols. Its use of innovative immunotherapeutic strategies, particularly the creation of DFCs via the Cloudbreak® platform, equips it with a unique competitive advantage. While facing challenges common to the biotechnology arena such as rigorous clinical validation and regulatory hurdles, CDTX differentiates itself through its precise and targeted approach, underpinned by robust partnerships and strategic asset optimization.

Operations and Clinical Development

The company’s operations are characterized by a dedicated focus on clinical research and development. Cidara’s scientific methodology emphasizes the identification and validation of molecular targets related to severe infectious diseases, followed by the development of therapies that harness the body’s own immune system. The approach includes detailed clinical investigations to assess safety, pharmacokinetics, and overall efficacy of its product candidates, ensuring that each development milestone reinforces the company’s technical credibility and commitment to patient safety.

Strategic Initiatives and Industry Impact

Cidara Therapeutics continuously refines its strategic focus through targeted asset divestitures and reacquisitions, ensuring that resources are effectively directed towards high-impact projects. The company’s ability to secure substantial investment through non-dilutive financing and private placements highlights its robust pipeline and commitment to clinical excellence. By concentrating on a subset of transformative treatment areas, Cidara is not only paving the way for new therapeutic options but also setting benchmarks in drug development methodologies that can serve as a model for the broader biotechnology community.

Research and Development Excellence

In a field that demands both precision and innovation, the expertise at Cidara Theraputics is demonstrated by its rigorous research protocols and validated data from early clinical studies. The company’s scientific leadership, supported by collaborative partnerships with industry leaders, has enabled the generation of compelling preclinical and clinical data. This multi-disciplinary approach ensures that all aspects of the product development process are optimized to maximize the potential for clinical success and long-term sustainability in the competitive healthcare market.

Conclusion

In summary, Cidara Therapeutics is a biotechnology innovator focused on delivering next-generation immunotherapies and anti-infectives that address critical unmet needs in infectious disease treatment. By combining state-of-the-art technologies with an integrated clinical development strategy, the company provides a comprehensive and nuanced approach to modern therapeutic challenges. Its ongoing commitment to scientific rigor, operational excellence, and strategic asset management underscores Cidara’s significant role in shaping the future landscape of modern medicine, while ensuring that the content remains informative and relevant for years to come.

Rhea-AI Summary
Cidara Therapeutics, a biotechnology company, received a delinquency notice from Nasdaq for failing to file its Annual Report on Form 10-K. The company plans to submit its compliance plan and has implemented a 1-for-20 reverse stock split to maintain its listing.
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Cidara Therapeutics, a biotechnology company, announced a 1-for-20 reverse stock split of its common stock. The reverse split will be effective on April 23, 2024, with trading on a split-adjusted basis starting on April 24, 2024. This decision was made following a stockholder vote and board approval to enhance the stock's value and reduce the number of outstanding shares.
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Cidara Therapeutics, Inc. (CDTX) announced promising preclinical data on its drug-Fc conjugate (DFC) immunotherapies at the AACR Annual Meeting. The multispecific CD73/PD-1 DFC showed improved tumor reduction over PD-1 monotherapy, CCR5-targeting DFC demonstrated efficacy in colorectal cancer, and CBO421 outperformed oleclumab in triple-negative breast cancer cell lines.
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Cidara Therapeutics, Inc. to present preclinical data on drug-Fc conjugate candidates at AACR Annual Meeting, including CD73/PD-1, CCR5, and CBO421 DFCs.
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Cidara Therapeutics, Inc. (CDTX) receives an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ for the treatment of invasive candidiasis. The approval was based on positive results from the ReSTORE Phase III clinical trial, demonstrating statistical non-inferiority to the standard of care. Cidara plans to advance its Cloudbreak platform for the development of targeted immunotherapies, with a focus on cancer patients.
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) announces that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults, expanding treatment options for patients globally. The approval follows positive results from the ReSTORE Phase III clinical trial, demonstrating statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care. Cidara has partnered with Mundipharma, entitled to receive a $2.8 million milestone payment for the MHRA approval.
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) announced the approval of REZZAYO (rezafungin acetate) in the European Union (EU) for the treatment of invasive candidiasis in adults. The approval is based on the positive results from the pivotal ReSTORE Phase III clinical trial, supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Medicines Agency (EMA) approval.
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) announced promising preclinical data on its novel, multi-specific CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO Immuno-Oncology (IO) Annual Congress, showcasing significant tumor growth reduction and superior anti-tumor activity to monotherapies.
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) has completed enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis. The trial included 52 patients and is expected to provide top-line data in Q2 2024. Rezafungin has received FDA approval in the U.S. and a positive CHMP opinion in the EU, with a final decision expected soon. Melinta Therapeutics has exclusive commercialization rights to REZZAYOTM in the U.S., and Mundipharma has rights in all other geographies except the U.S. and Japan.
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Melinta Therapeutics, LLC and Cidara Therapeutics, Inc. (NASDAQ: CDTX) have announced the publication of pooled data from two completed global clinical trials evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis. The publication in The Lancet Infectious Diseases demonstrates the non-inferiority of REZZAYO as compared to caspofungin for all-cause mortality and provides additional evidence for potential early treatment benefits.
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FAQ

What is the current stock price of Cidara Theraptcs (CDTX)?

The current stock price of Cidara Theraptcs (CDTX) is $16.52 as of April 7, 2025.

What is the market cap of Cidara Theraptcs (CDTX)?

The market cap of Cidara Theraptcs (CDTX) is approximately 184.1M.

What is the core focus of Cidara Therapeutics?

Cidara Therapeutics is focused on developing novel immunotherapies and anti-infectives using its proprietary Cloudbreak platform, which enables the creation of innovative drug-Fc conjugates for serious infectious diseases.

How does the Cloudbreak platform work?

The Cloudbreak platform is a proprietary technology that couples targeted small molecules or peptides with a human antibody fragment, creating drug-Fc conjugates that not only inhibit disease targets but also engage the immune system to enhance therapeutic effects.

What therapeutic areas does Cidara address?

Cidara Therapeutics addresses multiple areas including anti-fungal treatments, antiviral therapies for influenza, oncology, and autoimmune diseases, focusing on conditions that are underserved by existing standard of care therapies.

What are some of the key product candidates in Cidara's pipeline?

Key candidates include CD101 IV and CD101 Topical for fungal infections, as well as CD388, a long-acting antiviral designed to provide universal prevention against influenza, along with additional DFC immunotherapies under development.

How does Cidara differentiate itself in the competitive biotech landscape?

Cidara differentiates itself through its innovative approach utilizing the Cloudbreak platform to develop drug-Fc conjugates, strategic asset management including divestitures and reacquisitions, and a focus on unmet medical needs across multiple therapeutic areas.

What is the significance of CD388?

CD388 is a long-acting antiviral candidate developed as part of the Cloudbreak platform, designed to offer universal protection against influenza strains through a single-dose administration, independent of the patient’s immune response.

How does Cidara ensure the safety and efficacy of its product candidates?

Cidara employs rigorous clinical research protocols that include extensive safety, pharmacokinetic, and efficacy assessments. This systematic approach, combined with validated preclinical and clinical data, supports its commitment to patient safety and therapeutic excellence.

Who are the typical partners and investors involved with Cidara Therapeutics?

Cidara works with a range of strategic partners, including major pharmaceutical companies and leading investors from the life sciences sector, which aids in advancing its clinical development programs and broadening its market impact.
Cidara Theraptcs

Nasdaq:CDTX

CDTX Rankings

CDTX Stock Data

184.13M
10.78M
1.38%
69.43%
2.17%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States
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