Company Highlights - Cidara Therapeutics Inc. (CDTX) reached a 52-week high of $87.19 as it advances its development plan for CD388, a non-vaccine preventive treatment for seasonal influenza, with enrollment in a Phase 3 study expected to start by September 2025 targeting 6,000 participants [1] - Maze Therapeutics Inc. (MAZE) saw its stock rise to a 52-week high of $27.09 following positive Phase 1 clinical results for MZE782, an oral therapy for Phenylketonuria and chronic kidney disease, with plans to enter Phase 2 studies in 2026 [3][4] - Medpace Holdings Inc. (MEDP) is set to report Q3 2025 financial results on October 22, 2025, and has raised its full-year guidance twice, indicating strong operational momentum, with the stock hitting a 52-week high of $506.55 [5][6] - Monopar Therapeutics Inc. (MNPR) rebounded from potential Nasdaq delisting to a 52-week high of $73.75, planning to seek approval for ALXN1840 for Wilson disease in early 2026, supported by long-term clinical data [7][8] - Prenetics Global Limited (PRE) projects 2025 revenue between $85 million and $100 million, a significant increase from $30.6 million in 2024, with its new wellness brand IM8 Health on track for $100 million in annual recurring revenue [9][10] - Protagonist Therapeutics Inc. (PTGX) is nearing a major milestone with Icotrokinra for psoriasis, having submitted a regulatory application to the FDA and EMA in July 2025, with the stock reaching a 52-week high of $66.70 [11][12] - uniQure N.V. (QURE) announced positive results from its Phase I/II study of AMT-130 for Huntington's disease, planning to submit a Biologics License Application in Q1 2026, with the stock soaring over 200% to a 52-week high of $51.21 [13][14] - Rezolute Inc. (RZLT) surged to a 52-week high of $9.02 ahead of topline results from its pivotal Phase III trial for hypoglycemia treatment, expected in December [15][16] - United Therapeutics Corp. (UTHR) reached a 52-week high of $442.01 as anticipation builds for data from the TETON-2 study of nebulized Tyvaso in idiopathic pulmonary fibrosis, with positive results reported earlier [17][18]

Core Insights - Cidara Therapeutics announced an accelerated timeline for a Phase 3 registrational trial for its experimental flu therapy CD388, leading to a ~15% increase in stock price [2] Company Summary - Cidara Therapeutics is focusing on the development of CD388, an experimental therapy aimed at treating influenza [2] - The update on the trial timeline followed a successful End-of-Phase 2 meeting with regulatory authorities [2]

Core Insights - Cidara Therapeutics (CDTX) shares have increased over 173% this year and reached a five-year high due to plans for expanding testing of its non-vaccine flu prevention drug [1][4] - Following a meeting with the FDA, Cidara has accelerated its Phase 3 testing plans by six months, aiming to align with the Northern Hemisphere flu season [2] - The FDA has encouraged the inclusion of older adults in the study, and Cidara believes a single final-phase study of its drug, CD388, could suffice for approval [2] Financial Projections - RBC Capital Markets analyst Brian Abrahams projects that over 5 million people could be on the drug in the future, estimating potential worldwide sales of $3.78 billion [3] - Abrahams has raised his price target for Cidara stock from $115 to $137, rating it as an outperform [3] Stock Performance - Cidara stock surged more than 17% to $86.11, marking its highest point since August 2020, and has more than tripled year-to-date [4] - The stock has achieved a perfect IBD Digital Relative Strength Rating of 99, indicating top performance over the past 12 months [4]

Core Insights - Cidara Therapeutics is advancing its Phase 3 trial for CD388 following FDA feedback, expanding the study population to include adults over 65 years and increasing the potential patient pool from approximately 50 million to over 100 million in the U.S. [1][2][3] Group 1: Phase 3 Study Details - The Phase 3 study will be a global, multicenter, randomized, double-blind, placebo-controlled trial evaluating a single 450-milligram dose of CD388 administered subcutaneously at the start of the flu season [2][3] - Enrollment is set to begin by the end of September 2025 in the Northern Hemisphere, with a target of 6,000 subjects, representing a six-month acceleration from the previous timeline [2][6] - An interim analysis will be conducted after the Northern Hemisphere flu season to assess trial size and enrollment for the Southern Hemisphere [2][3] Group 2: Company Background and Product Information - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with CD388 being a long-acting antiviral aimed at universal prevention of influenza [4] - CD388 received Fast Track Designation from the FDA in June 2023, and positive results from the Phase 2b NAVIGATE trial were announced in June 2025 [4] - The company is also developing additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors [4]

Investors might want to bet on Cidara Therapeutics (CDTX) , as it has been recently upgraded to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Since a chan ...

Core Insights - Cidara Therapeutics presented promising efficacy and safety results for CD388, a non-vaccine influenza preventative, during the ISRV conference, highlighting its potential for long-term protection against influenza and H5N1 strains [1][2] Group 1: CD388 Efficacy and Safety - The Phase 2b NAVIGATE study involved over 5,000 healthy adults aged 18-64, randomized to receive either CD388 (150mg, 300mg, or 450mg) or placebo, demonstrating statistically significant protection against influenza illness over 24 weeks [1][3] - CD388 was well tolerated, with the primary endpoint focusing on preventative efficacy against laboratory-confirmed influenza [1][3] Group 2: Preclinical Data on H5N1 - Preclinical studies in ferrets showed that a single subcutaneous dose of CD388 at 3 mg/kg provided 75% protection against lethal H5N1 infection, while a 10 mg/kg dose resulted in 100% survival [3] - CD388-treated ferrets exhibited reduced weight loss and clinical symptoms compared to untreated controls, indicating its potential effectiveness against highly pathogenic strains [3] Group 3: Future Plans and Presentations - Cidara plans to disclose additional safety, pharmacokinetics, and virology data from the Phase 2b NAVIGATE study at upcoming conferences [2] - The company will host a lunch symposium at the conference to discuss CD388's broad influenza protection capabilities [5]

Group 1 - The presentation is part of the Morgan Stanley Healthcare Conference, indicating a focus on the healthcare sector [1] - Ryuk Byun serves as a Managing Director at Morgan Stanley's Investment Banking Division, highlighting the company's leadership in investment banking [1] Group 2 - A brief disclosure was mentioned, suggesting that important information will be provided during the conference [1] - Attendees are encouraged to refer to the Morgan Stanley research disclosure website for important disclosures, emphasizing transparency in communications [2]

Group 1 - The presentation is part of the Morgan Stanley Healthcare Conference, indicating a focus on the healthcare sector [1] - Ryuk Byun serves as a Managing Director at Morgan Stanley's Investment Banking Division, highlighting the company's leadership in investment banking [1] Group 2 - A brief disclosure was mentioned, suggesting that important information will be provided during the session [1] - Attendees are encouraged to reach out to their Morgan Stanley sales representative for any questions, indicating a proactive approach to client engagement [2]

Core Viewpoint - BAE Systems is targeting to launch an autonomous submarine by 2026, driven by increasing global concerns over underwater threats following a series of attacks [1] Group 1: Company Developments - BAE Systems is focusing on the development of autonomous submarine technology to address rising security concerns from various countries [1] - The company aims to capitalize on the growing demand for advanced underwater defense solutions [1] Group 2: Industry Trends - There is a notable increase in interest from nations regarding underwater threats, which is influencing defense strategies and investments [1] - The market for autonomous military technologies, particularly in naval defense, is expected to expand significantly in the coming years [1]

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]