Unicycive Therapeutics Shares Plunge 45% After FDA CRL Over Manufacturing
UNCY•Unicycive Therapeutics shares plunged 45% after the FDA issued a second Complete Response Letter for its oxylanthanum carbonate NDA citing manufacturing facility deficiencies. The company holds $57.1 million in cash, equivalents and marketable securities to fund operations into 2027 and expects a successful vendor inspection for an expedited NDA resubmission.
1. Regulatory Setback
Unicycive received a second Complete Response Letter from the FDA for its oxylanthanum carbonate NDA due to unresolved deficiencies at a third-party manufacturing facility identified in June 2025.
2. Safety and Efficacy
The FDA raised no concerns about OLC’s clinical safety or efficacy and requested no additional clinical trial data.
3. Financial Position
The company reported $57.1 million in cash, cash equivalents and marketable securities, expected to fund operations into 2027.
4. Next Steps and Outlook
Management is in active discussions on labeling and packaging, aims to secure a successful vendor inspection, and plans to resubmit the NDA expeditiously once compliance issues are resolved.
