Thursday, October 22, 2026
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
OLC Resubmission Given March 25, 2027 PDUFA Date. Unicycive announced that the FDA has accepted its NDA (New Drug Application) resubmission for OLC (oxylanthanum carbonate) for review. This follows the 30-day period after resubmission in which the FDA determined that it was sufficiently complete for review. The application received a PDUFA (Prescription Drug User Fee Act) date of March 25, 2027. This is the date the FDA must respond to the application by statute and aligns with the TDAPA program deadlines.
The NDA Contains Data From A New Manufacturing Partner. As we had expected, the resubmission was classified as Class 2 and received a six-month review. The CMC (Chemistry, Manufacturing, and Controls) section includes product manufacturing data from a new third-party manufacturing partner. The FDA inspected this manufacturer’s plant in March 2024 and gave a “No Action Indicated” status, the equivalent of a passing grade.
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