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Cidara Therapeutics to Present Late-Breaking Clinical Phase 2 Data on CD388 at ID Week 2025
Globenewswire· 2025-10-13 12:00
Core Insights - Cidara Therapeutics is set to present late-breaking Phase 2 clinical data on its antiviral influenza candidate, CD388, at ID Week 2025 in Atlanta, GA from October 19-22, 2025 [1] Presentation Details - The presentation will focus on a randomized, placebo-controlled trial evaluating the safety and efficacy of CD388 for the prevention of illness due to Influenza A and B in healthy unvaccinated participants [2] - The session is titled "Extra, Extra! New Info on Treating and Preventing RSV and Influenza" and will take place on October 20, 2025, from 3:15 PM to 4:30 PM ET [2] Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugates (DFCs) that combine targeted small molecules or peptides with a human antibody fragment [3] - CD388 is designed as a long-acting antiviral for universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation [3] - The FDA granted Fast Track Designation to CD388 in June 2023, and positive top-line results from its Phase 2b NAVIGATE trial were announced in June 2025, with the Phase 3 ANCHOR trial initiated in September 2025 [3]
Cidara Therapeutics, Inc. (CDTX) Accelerates Phase 3 Trial for Single-Dose Flu Antiviral CD388
Yahoo Finance· 2025-09-30 16:46
Core Insights - Cidara Therapeutics, Inc. is recognized as one of the 12 best performing healthcare stocks, focusing on its proprietary Cloudbreak® platform for drug-Fc conjugate therapeutics [1] - The company’s lead candidate, CD388, aims to provide universal prevention of seasonal and pandemic influenza with a single dose [1] Group 1: Clinical Development - In September 2025, Cidara announced an accelerated and expanded Phase 3 trial for CD388, moving the study start up by six months to align with the fall flu season [2] - The participant pool for the trial now includes adults over 65 and high-risk individuals aged 12 and older, effectively doubling the potential U.S. patient market to over 100 million [2] - The FDA indicated that a single successful Phase 3 trial may suffice for biologics license application approval, streamlining CD388's path to market [2] Group 2: Market Performance - Dosing for the Phase 3 ANCHOR trial began in September 2025, enrolling 6,000 participants to prevent seasonal influenza in high-risk populations [3] - Positive results from the Phase 2b NAVIGATE study and encouraging preclinical data against H5N1 influenza have bolstered investor confidence, leading analysts to raise the company's price targets up to $167 [3] - The stock recently surged over 19% amid strong market anticipation [3] Group 3: Diversification and Growth Potential - Beyond influenza, Cidara is advancing other DFC programs, including CBO421 for oncology, which targets CD73 in solid tumors and has received investigational new drug clearance [4] - This diversification underscores the company's growth potential across multiple therapeutic areas, positioning Cidara as a notable player in innovative biotech development [4]
Cidara Therapeutics (NASDAQ:CDTX) Sees Positive Outlook from JMP Securities
Financial Modeling Prep· 2025-09-25 01:11
Core Insights - Cidara Therapeutics is focused on developing innovative anti-infective therapies, particularly through its Cloudbreak® platform for drug-Fc conjugates aimed at serious infections [1] - The company has received an optimistic price target of $153 from JMP Securities, indicating a potential increase of 73.23% from its current trading price [2][6] - Cidara's Phase 3 trial for CD388, a non-vaccine treatment for seasonal influenza, has been accelerated to start in fall 2025 following a positive meeting with the FDA [3][6] Company Developments - The Phase 3 trial for CD388 will now include a broader population, targeting adults over 65, individuals with high-risk co-morbidities, and those with compromised immune systems, which may enhance the drug's market appeal [4][6] - As of the latest update, Cidara's stock is priced at $88.58, reflecting a 20.53% increase, with a market capitalization of $2.25 billion [5]
Cidara Therapeutics Announces Inclusion in the Russell 2000® and Russell 3000® Indexes
GlobeNewswire News Room· 2025-06-30 12:00
Company Overview - Cidara Therapeutics, Inc. is a biotechnology company utilizing its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics [1][4] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose [4] - Cidara is headquartered in San Diego, California [4] Recent Developments - Cidara has been added to the Russell 2000® and Russell 3000® Indexes, marking an important milestone for the company [1][3] - The inclusion in these indexes enhances visibility with institutional investors following a successful $400 million financing and positive data from the Phase 2b NAVIGATE trial [3] Clinical Trials and Regulatory Status - CD388 received Fast Track Designation from the U.S. FDA in June 2023 [4] - Enrollment for the Phase 2b NAVIGATE trial was completed in December 2024 [4] - Cidara has developed additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors and received investigational new drug application clearance in July 2024 [4]
Cidara Announces Closing of Upsized Public Offering and Full Exercise of Underwriters' Option to Purchase Additional Shares
Globenewswire· 2025-06-26 21:15
Group 1 - Cidara Therapeutics, Inc. closed its underwritten public offering of 9,147,727 shares at a price of $44.00 per share, raising gross proceeds of $402.5 million [1] - The offering included the full exercise of the underwriters' option to purchase an additional 1,193,181 shares [1] - The offering was conducted under a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [3] Group 2 - Cidara is utilizing its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 aimed at universal prevention of influenza [5] - CD388 received Fast Track Designation from the FDA in June 2023, and the Phase 2b NAVIGATE trial enrollment was completed in December 2024 [5] - Cidara has also developed additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors and received investigational new drug application clearance in July 2024 [5]
Cidara Announces Pricing of Upsized Public Offering of Common Stock
Globenewswire· 2025-06-25 00:00
Core Viewpoint - Cidara Therapeutics, Inc. has announced a public offering of 7,954,546 shares of its common stock priced at $44.00 per share, aiming to raise approximately $350 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering is expected to close on June 26, 2025, subject to customary closing conditions [2]. - Cidara has granted underwriters a 30-day option to purchase an additional 1,193,181 shares at the public offering price [2]. - J.P. Morgan, Morgan Stanley, Guggenheim Securities, and Cantor are acting as joint book-running managers for the offering [3]. Group 2: Regulatory Information - The offering is made pursuant to a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [4]. Group 3: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 aimed at universal prevention of influenza [6]. - CD388 received Fast Track Designation from the FDA in June 2023, and the company completed enrollment for its Phase 2b NAVIGATE trial in December 2024 [6]. - Cidara is also developing additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors [6].
Cidara Announces Proposed Public Offering of Common Stock
Globenewswire· 2025-06-23 20:15
Core Viewpoint - Cidara Therapeutics, Inc. plans to initiate an underwritten public offering to sell $250 million of its common stock, with a potential additional 15% option for underwriters [1][2] Group 1: Offering Details - The public offering is subject to market conditions and other factors, with no assurance on completion or terms [1] - The offering is made under a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [3] - Joint book-running managers for the offering include J.P. Morgan, Morgan Stanley, Guggenheim Securities, and Cantor Fitzgerald [2] Group 2: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with a focus on antiviral and oncology applications [5] - The lead DFC candidate, CD388, aims for universal prevention of seasonal and pandemic influenza and received Fast Track Designation from the FDA in June 2023 [5] - Cidara completed enrollment for its Phase 2b NAVIGATE trial in December 2024 and received investigational new drug application clearance for CBO421 targeting solid tumors in July 2024 [5]
Cidara Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference
Globenewswire· 2025-04-01 20:05
Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies [3] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose by inhibiting viral proliferation [3] - Cidara is headquartered in San Diego, California [3] Recent Developments - Cidara will participate in the 24th Annual Needham Virtual Healthcare Conference on April 9, 2025, at 11:00 AM ET [1] - The company has completed enrollment of its 5000 patient Phase 2b NAVIGATE trial for CD388 in December 2024 [3] - Cidara received Fast Track Designation from the U.S. FDA for CD388 in June 2023 [3] - In July 2024, Cidara received IND clearance for CBO421, targeting CD73 in solid tumors [3] Investor Engagement - Cidara will engage in one-on-one investor meetings during the Needham conference [2] - Investors interested in meetings should contact their Needham representative directly [2]