FDA Accepts OLC Resubmission, Sets March 25, 2027 PDUFA Date
UNCY sits 16% above its 52-week low of $3.35.
Summary
The FDA accepted Unicycive's resubmitted NDA for oxylanthanum carbonate and set a PDUFA target action date of March 25, 2027, under a Class II six-month review. This follows the September 29 8-K disclosing the resubmission with CMC data from a new third-party manufacturer that passed its March 2024 inspection with No Action Indicated. The FDA raised no concerns about OLC's preclinical or clinical data, so the remaining risk is manufacturing-site inspection, not the drug itself. The company still does not know whether the FDA will inspect the new vendor, and it says a clean inspection of the original vendor could support a shorter approval timeline. With a roughly $106M market cap and cash runway into 2027, the binary event now sits about five months out.
At the time of this announcement, UNCY was trading at $3.90 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $105.8M. The 52-week trading range was $3.35 to $8.74. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.