Unicycive Therapeutics (NASDAQ: UNCY) shares moved higher Thursday morning, up roughly 3 percent, after the company said the U.S. Food and Drug Administration accepted the resubmission of its New Drug Application for oxylanthanum carbonate, or OLC.
The FDA classified the resubmitted NDA as a Class II complete response and initiated a standard six-month review period. That timeline establishes a Prescription Drug User Fee Act, or PDUFA, target action date of June 27, 2026, for the agency's decision.
OLC is being developed as an oral phosphate binder intended to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis. According to the company, the NDA resubmission is supported by data from three clinical studies, a number of preclinical investigations, and chemistry, manufacturing and controls data. Unicycive said the FDA did not identify issues with the preclinical, clinical, or safety data that were included in the original submission.
"We are pleased that the agency has promptly accepted the resubmission of our NDA for OLC," said Shalabh Gupta, chief executive officer of Unicycive. "We are advancing our commercial preparation activities in anticipation of a potential launch of OLC later this year."
On its balance sheet, Unicycive reported an unaudited cash position of $41.3 million in cash, cash equivalents, and short-term investments as of the end of 2025. The company stated that these resources will fund continued advancement of commercial launch preparations for OLC and provide a cash runway into 2027.
Key takeaways
- FDA accepted the resubmitted NDA for OLC and assigned a PDUFA date of June 27, 2026, under a Class II complete response with a six-month review period.
- OLC is an investigational oral phosphate binder for dialysis patients with hyperphosphatemia; the NDA includes clinical, preclinical, and CMC data from multiple studies.
- Unicycive reported $41.3 million in unaudited cash, cash equivalents, and short-term investments at the end of 2025, which it says will support commercial preparations and extend runway into 2027.
Sectors affected: healthcare, biotechnology, specialty pharmaceuticals, and medical products serving renal care.
Risks and uncertainties
- The FDA review remains ongoing - acceptance of the resubmission does not guarantee approval and the agency's final determination will occur by the PDUFA target action date.
- Company cash is disclosed as unaudited and while the reported $41.3 million is expected to support commercial preparation activities, it establishes a defined runway into 2027 rather than longer-term financial certainty.
- Planned commercial activities and a potential launch timing described as "later this year" are contingent on regulatory outcomes and other factors not resolved by the acceptance of the resubmission.
The company emphasized that the FDA did not raise concerns regarding the preclinical, clinical, or safety data included in the original NDA filing. Unicycive is proceeding with commercial preparation work while awaiting the agency's decision on the resubmitted application.