UNICYCIVE THERAP. NEW

The FDA issued a second Complete Response Letter for the kidney drug oxylanthanum carbonate (OLC) and rejected approval due to deficiencies at a third-party manufacturer. The agency raised no concerns about OLC’s clinical efficacy or safety, but, because inspections of the supplier are still pending, it did not require additional clinical data. CEO Shalabh Gupta stressed confidence in the drug’s efficacy and safety, while the stock fell about 46% intraday and was trading near its 52-week low. Brokerage H.C. Wainwright remains optimistic but sees increased uncertainty around the timeline for any potential approval. » Más en de.investing.com

Unicycive Therapeutics announced that Gaurav Aggarwal has resigned his seat on the supervisory board. In the mandatory filing with the SEC the company said the resignation was not due to disagreements with Unicycive, management or the supervisory board; no further personnel changes were disclosed. » Más en de.investing.com

Unicycive’s stock rose about 3% after the company said the FDA accepted the resubmission of the New Drug Application for Oxylanthanumcarbonate (OLC) as a Class II complete response. The agency set a six-month review period and a PDUFA target date of June 27, 2026. OLC is an experimental oral phosphate binder to treat hyperphosphatemia in dialysis patients. Unicycive reported $41.3 million in cash at the end of 2025, which the company said should support preparation for a possible launch and funding into 2027. » Más en de.investing.com