Wednesday, September 30, 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.
NDA For OLC Has Been Resubmitted. Unicycive has resubmitted its NDA (New Drug Application) for OLC (oxylanthanum carbonate) to control phosphate levels in patients with chronic kidney disease (CKD) on dialysis. Typically, the FDA accepts the submission for filing within 30 days and provides a PDUFA date, the statutory date for the agency to respond. This date is expected to be six months later, for a PDUFA date around March 30, 2026.
An Alternate Manufacturing Vendor Has Been Added. The resubmission included CMC (Chemistry, Manufacturing, and Controls) product data from a new third-party manufacturing vendor similar to the original vendor, including OLC manufacturing and 12-month stability studies. The NDA also includes data from bridging studies showing the vendors’ products are equivalent, as recommended by the FDA.
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