CBO421

Search documents
Cidara Therapeutics, Inc. (CDTX) Accelerates Phase 3 Trial for Single-Dose Flu Antiviral CD388
Yahoo Finance· 2025-09-30 16:46
We recently compiled a list of the 12 Best Performing Healthcare Stocks to Buy Right Now. Cidara Therapeutics, Inc. is one of them. Cidara Therapeutics, Inc. (NASDAQ:CDTX) is a biotechnology company leveraging its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics. Its lead candidate, CD388, is a long-acting antiviral designed to provide universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral replication. In September 2025, CDT ...
Cidara Therapeutics to Participate in September Investor Conferences
Globenewswire· 2025-09-04 12:00
Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics [2] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose by inhibiting viral proliferation [2] - Cidara received Fast Track Designation from the FDA for CD388 in June 2023 and announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025 [2] - Additional DFCs are being developed for oncology, with Cidara receiving investigational new drug application clearance for CBO421 in July 2024, targeting CD73 in solid tumors [2] Upcoming Events - Cidara management will participate in the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 4:00 PM ET in a corporate presentation format [1] - The company will also take part in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 7:00 AM ET in a fireside chat format [1] - Cidara will engage in one-on-one investor meetings during these conferences [1]
Cidara Therapeutics to Report Second Quarter 2025 Financial Results and Host Quarterly Conference Call on August 7, 2025
Globenewswire· 2025-07-24 12:00
Core Insights - Cidara Therapeutics, Inc. will report its Q2 2025 financial results and operational highlights on August 7, 2025, followed by a conference call at 5:00 PM Eastern Time [1][2] Company Overview - Cidara Therapeutics is focused on developing drug-Fc conjugates (DFCs) using its proprietary Cloudbreak platform, with its lead candidate CD388 aimed at universal prevention of influenza [3] - CD388 received Fast Track Designation from the FDA in June 2023 and positive top-line results from its Phase 2b NAVIGATE clinical trial were announced in June 2025 [3] - The company has also developed additional DFCs for oncology, including CBO421, which received IND clearance in July 2024 to target CD73 in solid tumors [3]
Cidara Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)
Globenewswire· 2025-07-01 20:59
Core Points - Cidara Therapeutics, Inc. granted non-qualified stock option awards and restricted stock units (RSUs) totaling 12,100 shares to two new employees under the 2020 Inducement Incentive Plan, with a grant date of June 30, 2025 [1][2] - The stock option has an exercise price of $48.71 per share, equal to the closing price on the grant date, and will vest over four years [1] - The Inducement Plan is specifically for granting equity awards to individuals who were not previously employees or who have had a bona fide period of non-employment [2] Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak platform to develop drug-Fc conjugates (DFCs), including the lead candidate CD388, aimed at universal prevention of seasonal and pandemic influenza [3] - CD388 received Fast Track Designation from the FDA in June 2023, and the Phase 2b NAVIGATE trial enrollment was completed in December 2024 [3] - The company has also developed additional DFCs for oncology, including CBO421, which received investigational new drug application clearance in July 2024 [3]
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 Two Upcoming Investor Conferences
Globenewswire· 2025-05-13 12:00
Core Insights - Cidara Therapeutics, Inc. is participating in two upcoming investor conferences: RBC Global Healthcare Conference on May 21, 2025, and Jefferies Global Healthcare Conference on June 4, 2025 [1][2] - The company will also engage in one-on-one investor meetings during these events [2] Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, which include targeted small molecules or peptides linked to a human antibody fragment [3] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose, having received Fast Track Designation from the FDA in June 2023 and completing Phase 2b enrollment in December 2024 [3] - Additional DFCs are being developed for oncology, with IND clearance received for CBO421 in July 2024, targeting CD73 in solid tumors [3]
Cidara Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-08 20:15
Core Insights - Cidara Therapeutics reported financial results for Q1 2025, highlighting ongoing developments in its CD388 program and the Phase 2b NAVIGATE clinical trial [1][6][11] Recent and Expected Corporate Highlights - The data cutoff for the Phase 2b NAVIGATE trial was established on April 30, 2025, with top-line results expected in late June 2025 [2][4][5] - CD388 is positioned as a differentiated therapeutic option for influenza prevention, with discussions ongoing with the U.S. FDA regarding the statistical analysis plan [2][5] - Preclinical data published in Nature Microbiology indicates CD388's potential as a universal antiviral for influenza prevention [4][5] - Two posters on CD388 were presented at the 38th International Conference on Antiviral Research in March 2025, showcasing study design and preliminary safety data [5] - Recent promotions within the company include Nicole Davarpanah as Chief Medical Officer and Corrina Pavetto as Senior Vice President, Clinical Development [5] Financial Results - Cash, cash equivalents, and restricted cash totaled $174.5 million as of March 31, 2025, down from $196.2 million at the end of 2024 [11][16] - Collaboration revenue was zero for Q1 2025, compared to $1.0 million in Q1 2024, following the termination of the Janssen Collaboration Agreement [11] - R&D expenses increased to $24.6 million in Q1 2025 from $5.9 million in Q1 2024, primarily due to the ongoing Phase 2b NAVIGATE study [11][14] - General and administrative expenses rose to $6.2 million in Q1 2025 from $3.6 million in Q1 2024, driven by higher personnel costs [11][14] - The net loss for Q1 2025 was $23.5 million, compared to a net loss of $10.3 million in Q1 2024 [11][14]