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Cidara Therapeutics, Inc. - CDTX STOCK NEWS

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

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.

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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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Cidara Therapeutics, Inc. (Nasdaq: CDTX) will present new preclinical data on its dual-acting CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO Immuno-Oncology (IO) Annual Congress. The company will also present new preclinical data on CBO421, its first-in-class CD73 targeting DFC. The conference is scheduled for December 6-8, 2023, virtually and in-person in Geneva, Switzerland.
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) has been named a Top Workplace by The San Diego Union-Tribune, reflecting the company's commitment to fostering a supportive work environment. The recognition is based on employee feedback gathered through a third-party survey, measuring critical culture drivers. Cidara's president, Jeffrey Stein, expressed pride in the company's dedication to bringing novel therapies to patients.
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FAQ

What is Cidara Therapeutics' primary focus?

Cidara Therapeutics focuses on discovering, developing, and commercializing novel anti-infectives and immunotherapies for diseases inadequately treated by current therapies.

What is the Cloudbreak® platform?

The Cloudbreak® platform is Cidara's proprietary technology used to develop drug-Fc conjugates (DFCs) that target serious diseases by combining small molecules and peptides with human antibody fragments.

What are some of Cidara's key products?

Key products include REZZAYO™ (rezafungin) for invasive candidiasis, CD101 IV for systemic fungal infections, CD101 Topical for vulvovaginal candidiasis, and CD388 for the prevention of influenza A and B.

Has Cidara received any approvals for its products?

Yes, Cidara has received FDA and EC approval for REZZAYO™ (rezafungin) for the treatment of invasive candidiasis.

What recent strategic decisions has Cidara made?

Cidara recently divested rezafungin to Mundipharma, resulting in significant cost savings, and reacquired the global rights to CD388 from Johnson & Johnson to focus on their Cloudbreak platform.

How is Cidara funded?

Cidara is funded through investments, including a $240 million private placement led by RA Capital Management, and milestone payments from collaborations with partners like Mundipharma and Johnson & Johnson.

What upcoming clinical trials does Cidara have?

Cidara is planning to initiate a Phase 2b clinical trial to evaluate the efficacy and safety of CD388 as a universal preventative for influenza.

Where is Cidara Therapeutics headquartered?

Cidara Therapeutics is headquartered in San Diego, California.

Who are Cidara's major partners?

Major partners include Johnson & Johnson for CD388 and Mundipharma for rezafungin.

How can I get more information about Cidara?

For more information, you can visit Cidara's official website at www.cidara.com.

Cidara Therapeutics, Inc.

Nasdaq:CDTX

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Biological Product (except Diagnostic) Manufacturing
Manufacturing
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United States of America
SAN DIEGO