The stock value of Regulus Therapeutics Inc. (NASDAQ: RGLS) has increased significantly, rising by 116.67% to $2.99 per share during the current trading session. This remarkable ascent coincides with the publication of encouraging clinical trial results and a calculated equity move.
A final shares purchase agreement for a private placement with a limited group of accredited and institutional investors has been made public by the firm. Both new and old institutional investors, including well-known names like Deep Track Capital, Adage Capital Partners L.P., and New Enterprise Associates (NEA), have participated in the oversubscribed funding round.
Regulus expects gross proceeds of around $100 million at completion, which is anticipated around March 14, 2024, subject to usual closing conditions. Alongside this financial advancement, Regulus has released encouraging topline data from the second patient cohort in their Phase 1b MAD research using RGLS8429, a medication used to treat autosomal dominant polycystic kidney disease (ADPKD).
In order to evaluate RGLS8429’s safety, tolerability, and pharmacokinetics /pharmacodynamics at different dose levels, this research looks at a number of indicators, including total kidney volume, cyst architecture, urinary polycystins 1 and 2 (PC1 and PC2), and overall kidney function. The results from this group show enhanced activity of RGLS8429, and significant kidney volume decreases correlated with elevated PC1 and PC2 levels, indicating possible effectiveness.
Based on these positive outcomes, RGLS intends to modify the trial procedure to include up to 30 patients. Furthermore, Regulus has initiated discussions with the FDA regarding an accelerated approval pathway for RGLS8429, following a constructive Type D meeting. This means that the drug’s promise has been acknowledged by the regulatory agency, and it allows for an accelerated approval process based on a single Phase 2 trial.
Healthcare practitioners that treat patients with ADPKD must prioritize the development of innovative treatments. The encouraging results of Regulus’ clinical studies provide optimism for better treatment choices in the road. Awaiting more developments in the battle against ADPKD, stakeholders are excited about the company’s research and regulatory talks.
