Unicycive resubmits OLC NDA to FDA with new manufacturing vendor; adds director
Unicycive Therapeutics resubmitted its New Drug Application for oxylanthanum carbonate (OLC) on September 29, 2026, with chemistry and manufacturing data from a new third-party drug product vendor. The company expects FDA acceptance within 30 days and a new PDUFA date six months from resubmission, following a June 2026 Complete Response Letter. The company also appointed Meredith S. Manning as an independent director effective October 1, 2026.
Key points
- NDA resubmitted September 29, 2026, including CMC data from a new third-party drug product manufacturing vendor and 12 months of OLC drug product stability data.
- Company anticipates FDA acceptance within 30 days; new PDUFA date expected six months from resubmission.
- June 2026 CRL cited the same third-party manufacturing deficiencies as the June 2025 CRL; the original vendor's FDA inspection had not occurred as of September 29, 2026.
- Meredith S. Manning appointed independent director effective October 1, 2026; cash, equivalents and marketable securities were $61.4 million as of June 30, 2026.
The filing
Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 29, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.