Cidara Therapeutics Stock Soars 42% After Major Enrollment Milestone

Cidara Therapeutics Inc. (NASDAQ:CDTX) experienced a significant share price surge of 42.23% in after-hours trading on Thursday, closing at $150.75. This spike comes as the company reported major developments in its clinical studies and financial backing that have bolstered investor confidence.

Major Stakeholders and Ownership Changes

A recent filing by RA Capital Management L.P. revealed that it, along with co-founders Peter Kolchinsky and Rajeev Shah, collectively holds a 10.7% stake in Cidara. The Schedule 13D Amendment No. 4, submitted on November 10, indicates beneficial ownership of 3.37 million shares out of a total of 31.43 million shares outstanding as of November 3. The filing clarified that this stake adjustment was due to dilution rather than any changes in stock ownership.

Clinical Progress and FDA Support

Investor optimism has been fueled by the announcement from CEO Jeffrey Stein that the ANCHOR study has surpassed 50% enrollment, with a goal of reaching 6,000 participants by December. The study’s expansion to include healthy adults over 65 has effectively doubled the potential patient pool in the U.S. from approximately 50 million to over 100 million. The study currently accepts participants from 150 sites across North America and Europe, including the United States and the United Kingdom, with an interim analysis planned for the first quarter of 2026.

Additionally, Cidara’s drug CD388 recently received Breakthrough Therapy designation from the FDA, following the successful completion of the Phase 2b NAVIGATE study, which met all primary and secondary endpoints. This designation is expected to expedite the development process. The company has also received substantial financial support from the Biomedical Advanced Research and Development Authority, totaling up to $339.2 million, which includes $58.1 million in base funding allocated over a 24-month period to bolster U.S. manufacturing efforts.

Financial Health and Stock Performance

As of September 30, 2024, Cidara reported a robust cash and investment balance of $476.5 million, a significant increase from $196.2 million at the close of 2023. Despite this financial strength, the company reported a net loss of $83.2 million for the third quarter, largely attributed to $45 million in acquired in-process research and development (IPR&D) expenses and $35.5 million in research and development costs.

Over the past year, Cidara’s stock has experienced remarkable growth, skyrocketing by 631.98%. Gains over the past six months stand at 448.9%, with a year-to-date increase of 288.2%. Following this substantial rise, the stock has slightly corrected, decreasing 4.2% over the last month. The shares have fluctuated between $13.82 and $121.21 within the past year, leading to a market capitalization of approximately $3.33 billion.

In conclusion, the combination of significant clinical advancements, strategic partnerships, and a strong financial position has positioned Cidara Therapeutics as a key player in the biotechnology sector, attracting increased interest from investors.