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Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company with a market capitalization of $1.86 billion and impressive year-to-date returns of 173%, announced Wednesday updates to its planned Phase 3 registrational trial of CD388, following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration. According to InvestingPro data, the stock is trading near its 52-week high of $76, reflecting strong investor confidence in the company’s development pipeline. The company will proceed with an expanded and accelerated development plan, seeking biologics license application approval based on a single Phase 3 study.
Based on FDA feedback, the study population will broaden to include adults over 65 years of age without specific comorbidities, in addition to individuals over 12 years old with high-risk comorbidities or compromised immune systems. This expansion substantially increases the number of patients potentially eligible to receive CD388 in the United States from approximately 50 million to over 100 million. The expanded potential market has contributed to analyst optimism, with price targets ranging from $66 to $115 per share.
The Phase 3 study will be a global, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of a single 450-milligram dose of CD388 administered via subcutaneous injection at the onset of flu season. Cidara plans to begin enrollment by the end of September in the Northern Hemisphere, with continuation into the spring of 2026 in the Southern Hemisphere, targeting a total enrollment of 6,000 subjects. This represents a six-month acceleration from the previous plan to initiate the trial in the spring of 2026.
An interim analysis will be conducted after the Northern Hemisphere flu season to assess trial size and assumptions, which will inform enrollment for the Southern Hemisphere portion.
Participants will be randomized in a 1:1 ratio to receive either CD388 or placebo. The primary endpoint is laboratory-confirmed influenza with a body temperature of at least 37.2°C (99°F) and new or worsening respiratory or systemic symptoms.
Cidara stated that its existing cash, cash equivalents, and restricted cash are expected to fully fund the planned Phase 3 development program through completion. The company’s strong financial position is evidenced by its current ratio of 16.45 and more cash than debt on its balance sheet. For deeper insights into Cidara’s financial health and growth potential, InvestingPro subscribers have access to over 30 additional financial metrics and exclusive analysis in the comprehensive Pro Research Report.
This information is based on a statement issued by the company in a filing with the Securities and Exchange Commission.
In other recent news, Cidara Therapeutics has announced the acceleration of its Phase 3 trial for the influenza prevention drug CD388, moving the start date up by six months to September 2025. This decision follows an End-of-Phase 2 meeting with the FDA, aiming to enroll 6,000 participants for the trial. Meanwhile, Cidara presented promising results for CD388 at the International Society for Respiratory Viruses conference, where the drug demonstrated significant protection against influenza over 24 weeks in a Phase 2b NAVIGATE trial. In analyst updates, WBB Securities raised its price target for Cidara Therapeutics to $123, maintaining a Strong Buy rating, citing impressive efficacy data from Cidara’s antiviral treatments. Citizens JMP also increased its price target to $66, pointing to the potential of Cidara’s Cloudbreak technology and ongoing CD388 development. Guggenheim raised its price target to $70 following Cidara’s second-quarter earnings release and ongoing FDA discussions. These developments highlight Cidara’s progress in advancing its influenza prevention solutions and its potential impact on the market.
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