Unicycive Therapeutics (NASDAQ: UNCY) filed a 505(b)(2) New Drug Application resubmission for its investigational phosphate binder oxylanthanum carbonate (OLC) on December 29 2025, following the completion of a vendor‑compliance program that addressed the FDA’s concerns in a June 2025 Complete Response Letter. The resubmission signals that the third‑party manufacturing vendor has met the agency’s inspection readiness requirements and that the company can proceed with the regulatory review on schedule.
The FDA’s June 2025 CRL cited a single deficiency related to the vendor’s compliance status. A Type A meeting in September 2025 confirmed that no additional issues had been identified, and the vendor’s corrective actions—documented in a formal compliance plan—were accepted by the agency. With the vendor’s issues resolved, Unicycive can now submit the OLC NDA and expects the FDA to acknowledge receipt within 30 days, followed by a six‑month review period that would place a PDUFA action date in the first half of 2026.
Unicycive’s financial position remains solid, with $42.7 million in cash and cash equivalents as of September 30 2025. The company’s burn rate, driven by research and development expenses and increased labor and professional services costs, supports a cash runway that extends into 2027. The Q3 2025 earnings report highlighted a net loss of $6.0 million for the three months ended September 30, up from a $4.1 million loss in the same period a year earlier, largely attributable to the higher operating expenses and a change in the fair value of warrant liabilities. The extended runway gives Unicycive the financial flexibility to complete the regulatory process and prepare for a potential commercial launch of OLC.
The OLC platform offers a differentiated profile in the hyperphosphatemia market, leveraging proprietary nanoparticle technology to achieve high phosphate‑binding potency with a reduced pill burden. This advantage addresses a significant unmet need among dialysis patients, where uncontrolled phosphate levels are associated with increased morbidity and mortality. The company’s strong global patent portfolio, with composition‑of‑matter patents protecting exclusivity until 2031 and potential term extensions to 2035, positions OLC to capture a sizable share of the $450 million‑plus U.S. hyperphosphatemia market if approved.
Investors previously reacted negatively to a regulatory update on October 28 2025, when Unicycive disclosed the vendor compliance issue that led to the CRL. The market’s concern centered on the potential for manufacturing delays and the impact on the approval timeline. The recent progress in vendor compliance and the resubmission of the NDA are expected to mitigate those headwinds, improving investor confidence in the company’s regulatory strategy and financial outlook.
Shalabh Gupta, M.D., CEO, emphasized that the vendor’s corrective actions have restored FDA confidence and that the company’s extended cash runway provides a buffer to navigate the remaining regulatory steps. “With the vendor’s compliance improvements, we can move forward with the OLC NDA as planned,” he said. “The extended runway into 2027 gives us the time to complete the approval process and prepare for a potential launch, ensuring we can bring this important treatment option to dialysis patients as soon as possible.”
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