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SAN DIEGO - Cidara Therapeutics, Inc. (NASDAQ:CDTX), a $273 million market cap biotechnology company whose stock has surged over 80% in the past year according to InvestingPro data, announced Monday that its Phase 2b NAVIGATE trial for CD388, an investigational influenza prevention treatment, met its primary and all secondary efficacy endpoints.
The double-blind, placebo-controlled study evaluated a single dose of CD388 in healthy unvaccinated adults aged 18 to 64. Results showed that single doses of 450mg, 300mg, and 150mg provided 76%, 61%, and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to placebo.
The drug maintained protection up to 28 weeks with statistical significance and was well-tolerated across all dose groups with no safety signals observed. No drug-related serious adverse events were reported, and injection site reaction rates were similar across treatment and placebo groups.
"As a long-acting antiviral drug, CD388 was designed to provide once per season protection against all strains of influenza in all people, irrespective of immune status," said Jeffrey Stein, Ph.D., president and CEO of Cidara. The company maintains a strong balance sheet with more cash than debt, according to InvestingPro analysis, though it continues to invest heavily in research and development.
Unlike vaccines, CD388 is a drug-Fc conjugate (DFC) that combines multiple copies of a neuraminidase inhibitor with a human antibody fragment. This approach does not rely on an immune response, potentially making it effective regardless of a person’s immune status.
Nicole Davarpanah, M.D., J.D., chief medical officer of Cidara, noted the potential significance for high-risk individuals, including those with compromised immune systems or underlying health conditions.
The company has submitted an end of Phase 2 meeting request to the FDA to discuss Phase 3 trial design and timing. Cidara expects to present additional results from the NAVIGATE trial at upcoming scientific conferences later this year. With analyst price targets ranging from $35 to $50 and the next earnings report scheduled for August 8, investors following CDTX can access comprehensive analysis and additional insights through InvestingPro’s detailed research reports.
The information in this article is based on a press release statement from Cidara Therapeutics.
In other recent news, Cidara Therapeutics has attracted attention with several analyst ratings and updates on its CD388 flu therapeutic candidate. H.C. Wainwright initiated coverage on Cidara with a buy rating, highlighting the novel approach of CD388 in preventing all strains of influenza A and B, and set a price target of $41.00. Meanwhile, Citizens JMP analysts reaffirmed their Market Outperform rating with a $47.00 price target, citing optimism from discussions with experts about CD388’s long half-life and tissue distribution advantages. Needham analysts also raised their price target to $36, maintaining a Buy rating and expressing optimism for the upcoming Phase 2b trial results of CD388. JMP Securities sustained its Market Outperform rating with a $47.00 price target, emphasizing confidence in the upcoming Phase 2b trial results and the drug’s potential impact on flu prevention. The NAVIGATE trial for CD388, a drug-Fc-conjugate, is expected to provide results soon, with analysts highlighting its potential to offer a new approach to flu prevention. Key opinion leaders have expressed enthusiasm for CD388’s high potency and resistance profile, which could make it a significant player in influenza prevention. The market is closely watching these developments, as the outcomes could influence Cidara’s future trajectory in the biotechnology sector.
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