Cidara Therapeutics

Cidara Therapeutics, Inc. is a biotechnology company, which engages in the discovery, development, and commercialization of novel anti-infectives. Its product pipeline includes Rezafungin and Cloudbreak. The company was founded by Kevin M. Forrest, Kevin J. Judice, and H. Shaw Warren in December 2012 and is headquartered in San Diego, CA.

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Cidara Therapeutics, Inc. is a biotechnology company, which engages in the discovery, development, and commercialization of therapeutics for patients facing serious diseases, specifically oncology and infectious diseases. Its product pipeline includes Rezafungin Acetate and Cloudbreak. The company was founded by Kevin M. Forrest, Kevin J. Judice, and H. Shaw Warren in December 2012 and is headquartered in San Diego, CA.

SAN DIEGO, April 22, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the Company effected a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-20. The effective time of the reverse stock split will be 5 p.m. ET on April 23, 2024. The Company's common stock will begin trading on a split-adjusted basis commencing upon market open on April 24, 2024.

Cidara Therapeutics Announces Reverse Stock Split

- Multispecific CD73/PD-1 DFC demonstrates improved tumor reduction compared to PD-1 monotherapy in nonclinical study - CCR5-targeting DFC demonstrates potent efficacy in colorectal cancer mouse model - Late-breaking CBO421 data demonstrates improved efficacy compared to oleclumab in human triple-negative breast cancer cell lines SAN DIEGO, April 05, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, announced the company will deliver four poster presentations, including one late-breaking poster presentation, at this year's American Association for Cancer Research (AACR) Annual Meeting being held April 5-10, 2024 at the San Diego Convention Center in San Diego, California. The presentations highlight data on the company's multispecific CD73/PD-1 drug Fc-conjugate (DFC), its CCR5-targeting DFC, and CBO421, its lead oncology DFC candidate targeting CD73.

Cidara Therapeutics Presents Promising New Data on Novel Drug-Fc Conjugate Candidates at the American Association for Cancer Research (AACR) Annual Meeting 2024

Abstracts to include preclinical data on several drug-Fc conjugate (DFC) candidates including multispecific CD73/PD-1 DFC, CCR5 targeting DFC and CBO421 (CD73 targeting DFC) Abstracts to include preclinical data on several drug-Fc conjugate (DFC) candidates including multispecific CD73/PD-1 DFC, CCR5 targeting DFC and CBO421 (CD73 targeting DFC)

Cidara Therapeutics to Present Preclincal Data on Multiple Novel Drug-Fc Conjugate Candidates at American Association dor Cancer Research (AACR) Annual Meeting 2024

SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults.

Cidara Therapeutics Receives $11.14 Million Milestone Payment Following European Approval of REZZAYO

SAN DIEGO, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced 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.

Cidara Therapeutics Announces Approval of REZZAYO by the MHRA for the Treatment of Invasive Candidiasis in Adults

Cidara's (CDTX) Rezzayo (rezafungin acetate) gets approval from the European Commission for the treatment of invasive candidiasis in adults. The stock rises 11.1%.

Cidara (CDTX) Up on EC Nod for Rezzayo in Invasive Candidiasis

SAN DIEGO, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) today announced REZZAYO (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.

Cidara Therapeutics Announces European Approval of REZZAYO® (rezafungin) for the Treatment of Invasive Candidiasis in Adults

First in class, multi-specific CD73/PD-1 inhibitor DFC, exhibited robust anti-tumor activity in humanized mouse models of colorectal cancer at low doses

Cidara Therapeutics Presents New Promising Preclincal Data on Novel Dual-Acting Drug-Fc Conjugates at ESMO Immuno-Oncology Annual Congress

SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the company, along with Mundipharma, 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.

Cidara Therapeutics Announces Completion of Enrollment in Phase 3 Restore Trial of Rezafungin in China

PARSIPPANY, N.J. & SAN DIEGO--(BUSINESS WIRE)--Melinta Therapeutics, LLC and Cidara Therapeutics, Inc. (NASDAQ: CDTX) today announced the peer-reviewed publication of pooled data from two completed global clinical trials evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis. The article, “Efficacy and safety of rezafungin and caspofungin in candidemia and invasive candidiasis: pooled data from two prospective randomised controlled trials,” publi.

Melinta Therapeutics & Cidara Therapeutics Announce Publication of Pooled Data from Phase 3 Pivotal ReSTORE Trial & Phase 2 STRIVE Trial of REZZAYO® (rezafungin for injection) for the Treatment of Candidemia & Invasive Candidiasis in The Lancet ID

Preclinical data on dual CD73/PD-1 targeting DFC to be presented for the first time Preclinical data on dual CD73/PD-1 targeting DFC to be presented for the first time

Cidara Therapeutics to Present New Preclinical Data on Novel Dual-Acting Drug-Fc Conjugates at ESMO Immuno-Oncology Annual Congress

SAN DIEGO, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that it has been named a Top Workplace by The San Diego Union-Tribune. Cidara was among the top 100 companies and organizations included in the 2023 Top Workplace list.

Cidara Therapeutics Named as a San Diego Metro Area Top Workplace

SAN DIEGO, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced new preclinical data on its drug-Fc conjugate (DFC) candidate, CBO421, at the Society for Immunotherapy of Cancer (SITC)'s 38th Annual Meeting. The conference is taking place November 1-5, 2023, both virtually and in-person in San Diego, CA.

Cidara Therapeutics Presents Preclinical Data on Novel Drug-Fc Conjugate CBO421 at SITC's 38ᵗʰ Annual Meeting

SAN DIEGO, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company focused on developing targeted therapies designed to save lives and improve the standard of care for patients facing serious diseases, today reported financial results for the third quarter ended September 30, 2023 and provided an update on its corporate activities and product pipeline.

Cidara Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results

SAN DIEGO and CAMBRIDGE, England, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, and Mundipharma today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.1

Cidara Therapeutics and Mundipharma receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults(1)

CAMBRIDGE, England & SAN DIEGO--(BUSINESS WIRE)--Mundipharma and Cidara Therapeutics (Nasdaq: CDTX) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.1 The CHMP based its positive opinion on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority* for rezafungin, dos.

Mundipharma and Cidara Therapeutics receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults1

SAN DIEGO, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced new data on its drug-Fc conjugate (DFC) candidate, CD388, at IDWeek 2023. The conference is taking place both in-person at the Boston Convention and Exhibition Center in Boston, MA and virtually from October 11 – 15, 2023.

Cidara Therapeutics Presents New Preclinical and Clinical Data on Novel Drug-Fc Conjugate CD388 at IDWeek 2023

SAN DIEGO, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that it will present new data on its drug-Fc conjugate (DFC) candidate, CD388, in an oral presentation and two poster presentations at IDWeek 2023. The conference will take place both in-person at the Boston Convention and Exhibition Center in Boston, MA and virtually from October 11 – 15, 2023.

Cidara Therapeutics to Present New Data on Novel drug-Fc conjugate CD388 at IDWeek 2023

Janssen's decision to proceed with CD388 further de-risks Cidara Therapeutics (CDTX) and validates the potential of the Cloudbreak platform. Combined with impressive preclinical data by oncology candidates presented in the Virtual Research & Development Day I upgrade my recommendation to "Strong buy". CDTX's cash runway is limited, but they are eligible for additional non-dilutive capital and I expect more partnerships will be formed to support Cloudbreak development.

Cidara Therapeutics: Reduced Risk Due To Janssen's Decision And Progress In The Oncology Pipeline

• Update on Phase 2a data for JNJ-0953 (CD388) for universal prevention of seasonal influenza from Janssen Pharmaceuticals, Inc. leadership following Election to Proceed notification

Cidara Therapeutics to Host Virtual Research & Development Day on its Cloudbreak® Development Pipeline on September 21, 2023

SAN DIEGO, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will present at the 25th Annual H.C. Wainwright Global Investment Conference.

Cidara to Present at the 25th Annual H.C. Wainwright Global Investment Conference

Johnson & Johnson

Shares of Cidara Therapeutics soared 18.5% in early New York trading, buoyed by news that Janssen Pharmaceuticals, a subsidiary of healthcare giant Johnson & Johnson (NYSE:JNJ) Inc, is set to champion the development of Cidara's promising flu prevention drug, CD388. Preliminary tests have already highlighted the treatment's potential: a single dose notably reduced flu symptoms and was found to be safe for users.

Cidara shares surge 18.5% as J&J unit Janssen takes lead on flu drug

Decision follows promising interim efficacy and safety data from ongoing Phase 1 and 2a trials Cidara to receive a $7 million milestone payment and is eligible to receive an additional $685 million in milestones, plus royalties SAN DIEGO, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has announced that Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has delivered to Cidara its Election to Proceed Notice for CD388 (JNJ-0953) which is being developed for the universal prevention of influenza A and B.

Cidara Therapeutics Announces Janssen's Election to Proceed Under its License Agreement Relating to Novel Drug-Fc Conjugates Targeting Influenza

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Cidara Therapeutics has recently gained FDA approval for rezafungin and is now focused on advancing its Cloudbreak platform in oncology and infectious disease indications, which has great potential. Potential revenue from rezafungin, CDTX's partnership-based business model and track record, and the major advantages of Cloudbreak platform all point to major upside potential for CDTX. My recommendation is "Buy" rather than "Strong Buy" because the Cloudbreak platform is still at a very early stage; setbacks are more likely than not and dilution risk is high.

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