Jun. 30 at 9:14 PM
Unicycive Therapeutics (Nasdaq:
$UNCY ) received an FDA Complete Response Letter for OLC tied to third-party manufacturing; the FDA raised no concerns on the drug’s efficacy or safety and requested no new data.
Unicycive Therapeutics, Inc. (Nasdaq: UNCY) announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration regarding its resubmitted New Drug Application for oxylanthanum carbonate (OLC), its investigational phosphate binder for hyperphosphatemia in patients with chronic kidney disease on dialysis. The FDA did not raise concerns regarding OLC’s clinical efficacy or safety data and did not request additional data from the company.
Unicycive Therapeutics is a B2i Digital Featured Company. See the company’s profile at https://b2idigital.com/unicycive
The release notes:
• The CRL is based on the same third-party manufacturing deficiencies identified in the prior CRL issued in June 2025, and the FDA had not yet conducted its inspection of that vendor during the resubmission review
• The FDA raised no concerns regarding OLC’s clinical efficacy or safety, and requested no additional data from Unicycive
• Labeling discussions are underway, with the most recent FDA communication received on June 29 regarding carton and container labeling
• Unicycive said it remains in active discussion with the FDA and is optimistic that, following a successful inspection of the third-party manufacturing vendor, it will be able to expeditiously resubmit the NDA
• OLC is supported by data from three clinical studies and is being pursued through the FDA’s 505(b)(2) pathway, with composition-of-matter patent exclusivity to 2031 and potential extension to 2035
“We remain confident in the efficacy and safety of OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “We are in active and ongoing discussion with the FDA regarding label and packaging, and we are optimistic that there will be a successful inspection of the third-party manufacturing vendor and that we will be able to expeditiously resubmit the NDA.”
Uncontrolled hyperphosphatemia affects nearly all patients with end-stage renal disease and is associated with increased hospitalization and mortality, with more than 450,000 people in the U.S. requiring medication to control their phosphate levels.
Read the full press release at https://ir.unicycive.com/news/detail/123/unicycive-therapeutics-receives-complete-response-letter
Unicycive Therapeutics is a clinical-stage biotechnology company developing novel treatments for kidney disease. Its lead investigational candidate, oxylanthanum carbonate (OLC), is a novel phosphate binder for hyperphosphatemia in patients with chronic kidney disease on dialysis. A second candidate, UNI-494, is in development for acute kidney injury and holds FDA orphan drug designation. More information is at https://unicycive.com, with investor materials at https://ir.unicycive.com. Investor inquiries: Kevin Gardner, LifeSci Advisors,
[email protected].
Disclosure: David Shapiro, Chief Executive Officer of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted UNCY stock, in line with B2i Digital’s practice of investing alongside its Featured Companies. See the complete Disclosure at https://b2idigital.com/disclaimer. B2i Digital is not a broker-dealer or investment adviser.
$XOMA,
$RMTI,
$LNTH,
$XBI