Unicycive shares surge 10.13% intraday after announcing OLC NDA resubmission and positive clinical data.

Unicycive Therapeutics surged 10.13% intraday after announcing plans to resubmit its New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year-end, following positive FDA discussions that narrowed the prior Complete Response Letter (CRL) to a single manufacturing deficiency. The company presented new clinical data at the American Society of Nephrology (ASN) Kidney Week 2025, showing OLC reduces pill burden by 7-fold in volume and 2-fold in count compared to existing therapies. Additionally, Unicycive reported $42.7 million in cash, extending its runway into 2027, and highlighted EU regulatory clearance of its third-party manufacturing vendor. These developments—focused regulatory progress, differentiated clinical results, and robust liquidity—collectively drove the sharp intraday rally, signaling improved near-term approval prospects for OLC and reducing development risks.