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SAN DIEGO, CA - Cidara Therapeutics (NASDAQ:CDTX), Inc., a biopharmaceutical company, announced today the initiation of a Phase 2b clinical trial, known as the NAVIGATE study, to evaluate the efficacy and safety of its investigational drug CD388 for pre-exposure prophylaxis of influenza.
The NAVIGATE trial is set to be a randomized, double-blind, placebo-controlled study involving approximately 5,000 healthy adult participants who have not been vaccinated against influenza and are not at risk of complications from the virus. Participants will receive a single dose of either CD388 or a placebo at the onset of the flu season and will be monitored throughout the season for any occurrence of laboratory-confirmed or clinically-diagnosed influenza.
The aim of the study is to compare the rate of influenza cases among subjects who receive varying doses of CD388 to those who receive the placebo. The trial will include sites in both the United States and the United Kingdom.
Cidara Therapeutics has emphasized that while the study's objectives are clear, there are inherent risks and uncertainties in clinical development that could affect the outcomes. These include potential delays and the possibility of unfavorable trial results.
The company has cautioned investors and the public not to place undue reliance on forward-looking statements related to the anticipated progress and benefits of CD388. Any future updates on the trial will be in accordance with the regulations set forth by the Securities and Exchange Commission.
This news is based on a recent statement from Cidara Therapeutics and is reflective of the company's current expectations regarding the NAVIGATE clinical trial.
In other recent news, Cidara Therapeutics has made significant strides in its operations. The biotechnology firm announced a workforce reduction of approximately 30%, aiming to focus resources on the development of its influenza drug candidate, CD388. The restructuring, expected to be completed by November 2024, will cost the company around $1.2 million in severance and related benefits.
Cidara Therapeutics has also appointed Jim Beitel as its new Chief Business Officer, aligning with the company's focus on its Cloudbreak drug-Fc conjugate pipeline. This move follows a stock rating upgrade from Neutral to Buy by H.C. Wainwright, reflecting confidence in the Cloudbreak platform, particularly the CD388 program.
Moreover, the company has expanded its authorized shares of common stock from 20 million to 50 million, providing greater financial flexibility. This was approved during the Annual Meeting of Stockholders, along with the sanctioning of the company's 2024 Equity Incentive Plan.
Cidara Therapeutics has also sold its rezafungin program to Mundipharma and re-acquired its Phase 2b-ready influenza program from Johnson & Johnson (NYSE:JNJ). This strategic shift was followed by a $240 million private investment in public equity financing deal. These are part of the company's ongoing efforts to advance its clinical and preclinical initiatives.
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