Core Insights - Cidara Therapeutics, Inc. will present a late-breaking abstract at the European Scientific Working Group on Influenza's 10th Influenza Conference in Valencia, Spain, from October 20-23, 2025 [1][2] Company Overview - Cidara Therapeutics is focused on developing drug-Fc conjugate (DFC) therapeutics using its proprietary Cloudbreak® platform [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] - CD388 received Fast Track Designation from the FDA in June 2023 and has shown positive top-line results from the Phase 2b NAVIGATE trial completed in June 2025 [2] - The company initiated its Phase 3 ANCHOR trial in September 2025 [2] - Cidara is headquartered in San Diego, California [2]

Core Insights - A significant rally occurred in the biotech and healthcare sectors on October 9, with multiple stocks reaching 52-week highs, driven by regulatory milestones, strategic announcements, and investor enthusiasm around clinical progress [1] Company Highlights - Aquestive Therapeutics Inc. (AQST) achieved a 52-week high of $6.86, closing at $6.69, following the announcement of a new U.S. patent for its PharmFilm, enhancing its position in oral drug delivery platforms [2] - Ascendis Pharma A/S (ASND) reached a 52-week high of $216.45, closing at $214.77, coinciding with the submission of a Marketing Authorisation Application to the European Medicines Agency for its investigational therapy targeting achondroplasia in children [3] - Cidara Therapeutics Inc. (CDTX) advanced 12.44% to close at $110.76, hitting a 52-week high of $111.35 after receiving Breakthrough Therapy designation from the FDA for its antiviral candidate CD388 [4] - Intellia Therapeutics Inc. (NTLA) surged 4.05% to end at $25.46, with a new 52-week high of $26.99, driven by optimism surrounding its in vivo CRISPR programs and recent trial updates [5] - Organigram Global Inc. (OGI) gained 4.12% to close at $2.02, reaching a 52-week high of $2.08, following the launch of its new hemp-derived delta-9 brand "happly" targeting mindful recreation consumers [6] - uniQure N.V. (QURE) rose 6.14% to finish at $63.65, with a 52-week high of $65.12, supported by analyst upgrades and renewed interest in its gene therapy candidate for Huntington's disease [7] - REGENXBIO Inc. (RGNX) closed slightly lower at $12.17 but reached a 52-week high of $12.84, presenting interim Phase II data for ABBV-RGX-314 at a major ophthalmology meeting [8] - Tempus AI Inc. (TEM) saw a decline of 3.85% to $99.28 after hitting a 52-week high of $104.32, despite being selected by ARPA-H for a federal precision cancer therapy initiative [9] - Tilray Brands, Inc. (TLRY) jumped 22.09% to close at $2.10, reaching a 52-week high of $2.32, reporting a return to profitability with record quarterly revenue of $210 million [9] - Zenas BioPharma (ZBIO) gained 7.18% to end at $27.76, hitting a 52-week high of $28.72 after announcing a licensing agreement and a $120 million private placement to support its autoimmune pipeline [10] - Brookdale Senior Living Inc. (BKD) rose 9.36% to close at $8.88, reaching a 52-week high of $9.09, reporting its highest occupancy rate in over a year at 82.5% [11]

Key Points It reported some highly encouraging news about its leading drug candidate. This is a flu treatment aimed at folks who can't or won't take vaccines. 10 stocks we like better than Cidara Therapeutics › The leading pipeline drug being developed by Cidara Therapeutics (NASDAQ: CDTX) got a real boost from a regulator on Thursday, and the biotech's share price moved accordingly. Cidara's stock closed the day more than 12% higher, during a session in which the bellwether S&P 500 (SNPINDEX: ^GSP ...

Core Insights - The U.S. FDA has granted Breakthrough Therapy designation to Cidara Therapeutics' CD388 for the prevention of influenza A and B in high-risk adults and adolescents, complementing its previously awarded Fast Track designation [1][2] Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, with CD388 as its lead candidate aimed at providing long-acting antiviral protection against seasonal and pandemic influenza [5] Clinical Development - CD388 has shown statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64 during the Phase 2b NAVIGATE trial, with top-line data released in June 2025 and further data to be presented at scientific conferences in October [2][5] - The Phase 3 ANCHOR trial for CD388 was initiated six months ahead of schedule, expanding the study population to include generally healthy adults over 65 years old, in addition to other high-risk groups [3] Regulatory Designation - The Breakthrough Therapy designation is intended to expedite the review of medicines that treat serious conditions and have shown preliminary clinical evidence indicating potential for substantial improvement over existing therapies, providing benefits such as priority review and organizational support from the FDA [4]

Core Insights - Cidara Therapeutics has received a funding award of up to $339 million from BARDA to support the development of its investigational drug CD388 for influenza prevention [1][2][3] Funding Details - The agreement includes a Base contract of $58 million over 24 months for onshoring CD388 manufacturing to the U.S. and conducting clinical trials [2] - Option periods funding could provide an additional $281 million for further clinical and non-clinical studies of CD388, contingent on requests from Cidara and government approval [2] Product Overview - CD388 is a drug-Fc conjugate designed to provide long-acting protection against all known strains of seasonal and pandemic influenza [4][5] - It is not a vaccine and is expected to be effective regardless of the immune status of individuals, making it suitable for vulnerable populations [4][5] Clinical Development - CD388 has shown potential as a non-vaccine preventative for both pandemic and seasonal influenza, with positive results from the Phase 2b NAVIGATE trial reported in June 2025 [3][5] - The drug has received Fast Track Designation from the FDA, indicating its potential to address unmet medical needs [5]

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]

Core Insights - Cidara Therapeutics (NASDAQ: CDTX) experienced a nearly 7% increase in stock price following positive news regarding its investigational flu treatment, CD388, which outperformed the S&P 500 index's 0.6% increase [1] Group 1: Clinical Development - Cidara announced the initiation of a phase 3 trial for CD388, with the first patients dosed just after market close on Thursday [2] - CD388 is a non-vaccine preventive treatment targeting seasonal influenza, particularly for high-risk populations [3] - The phase 3 trial is designed as a double-blind, placebo-controlled study to assess the drug's safety and efficacy, including participation from both youth and adults, with a goal of having immunocompromised individuals make up at least 10% of participants [4] Group 2: Product Advantages - A significant advantage of CD388 is that, being a non-vaccine treatment, its effectiveness does not rely on the patient's immune response, making it suitable for individuals who do not respond to vaccines or those who are hesitant about vaccination [5] - The timing of the trial launch is strategic, coinciding with the peak flu season, which could enhance the product's appeal if successful in the study and subsequently approved for commercialization [6] Group 3: Market Considerations - The healthcare company highlights the vast addressable market for a non-vaccine flu preventative, indicating potential for significant demand [7]

Core Insights - Cidara Therapeutics (CDTX) shares have increased by 217.8% in 2025, primarily due to positive developments regarding its clinical-stage candidate CD388 for seasonal influenza prevention [1][6]. Company Overview - CD388 is an investigational drug developed using Cidara's proprietary Cloudbreak platform, designed as a long-acting small molecule inhibitor targeting influenza, offering broad protection against both seasonal and pandemic flu strains [2]. - The drug has the potential to provide season-long protection from a single injection, with efficacy not reliant on an immune response, making it suitable for individuals with varying immune statuses [2]. Clinical Development - The stock price surge began in June 2025 after Cidara reported successful results from its mid-stage study (phase IIb NAVIGATE) of CD388, achieving its primary endpoint with statistically significant prevention efficacy across all three dose groups (150 mg, 300 mg, and 450 mg) [3][4]. - The NAVIGATE study also met all secondary endpoints, demonstrating sustained prevention efficacy through 28 weeks, particularly at the highest dose, with no unexpected adverse events reported [4]. Future Plans - Following a positive End-of-Phase II meeting with the FDA, Cidara has accelerated its late-stage development plan for CD388, initiating the pivotal phase III ANCHOR study six months earlier than planned [8]. - The ANCHOR study will broaden enrollment criteria to include individuals aged 12 and older with high-risk comorbidities, as well as adults over 65 without specific comorbidities, potentially increasing the U.S. patient pool for CD388 from approximately 50 million to over 100 million [9]. - The global phase III ANCHOR study aims to enroll about 6,000 patients, with an interim analysis planned after the Northern Hemisphere flu season [10]. Market Impact - The successful completion of the phase III ANCHOR study could support regulatory filing for CD388 in high-risk populations, contributing to the stock price rally [8].

Core Insights - Cidara Therapeutics has initiated a Phase 3 trial for CD388, a non-vaccine preventative for seasonal influenza targeting high-risk populations [1][2] - The trial will enroll 6,000 participants, including adults over 65 and those with high-risk co-morbidities [1] - CD388 has shown positive results in a previous Phase 2b trial, indicating its potential as a significant preventative option for influenza [2] Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with CD388 being the lead candidate [4] - CD388 is designed to provide long-acting antiviral protection against seasonal and pandemic influenza with a single dose [4] - The company had over $500 million in cash as of the end of Q2 2025, sufficient to fund the Phase 3 program through completion [2] Trial Details - The Phase 3 trial, named ANCHOR, is a global, multicenter, randomized, double-blind, placebo-controlled study [2] - Participants will receive a one-time 450-milligram subcutaneous dose of CD388, with a minimum of 10% being immune-compromised [2] - An interim analysis will be conducted after the Northern Hemisphere flu season to assess trial size and enrollment for the Southern Hemisphere [2]

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]