Unicycive Therapeutics: FDA Issues CRL For Oxylanthanum Carbonate NDA

(RTTNews) - Unicycive Therapeutics (UNCY) announced the FDA has issued a CRL for its New Drug Application for OLC to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. Oxylanthanum Carbonate - or OLC - is an investigational oral phosphate binder that leverages nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. The CRL cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate.

"We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL," said Shalabh Gupta, CEO of Unicycive.

Unicycive currently has an unaudited cash balance of approximately $20.7 million, with cash runway currently expected into the second half of 2026.

For More Such Health News, visit rttnews.com.