Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
The FDA's own letter · Complete Response Letter, NDA 218607 (PDF), dated June 29, 2026, released under FDA's CRL transparency program. The company announced the decision on June 30, 2026; the FDA acted on June 29, 2026.
What the letter says has to be fixed (the letter's own section headings; read against the PDF, not openFDA's OCR text):
Facility inspections. Following a CGMP inspection of a facility listed in the application (name redacted), FDA conveyed deficiencies to the facility; satisfactory responses to the Form 483 are required, FDA may need to conduct a pre-approval inspection, and satisfactory outcomes of both the pre-approval and CGMP surveillance inspections are needed before approval.
This is the second letter on the same NDA: it acknowledges the December 29, 2025 resubmission that answered the June 27, 2025 letter. Labeling and carton comments reserved until the application is otherwise adequate; the proposed proprietary name was found conditionally acceptable on March 25, 2026. The letter names no clinical efficacy or safety deficiency.
Daily close, T-120 (1/13/26) through T+5. Run-up high $8.56 on 5/18/26, low $5.65 on 1/13/26 (T-120 to T-1). Announced 6/30/26 (FDA action 6/29/26). Historical price action, not a forecast.
FDA record of the action: the FDA issued a Complete Response Letter on June 29, 2026, per CRL letter CRL_NDA218607_20260629 (FDA letter). The sponsor announced it on June 30, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Questions
Was Oxylanthanum Carbonate (OLC) approved by the FDA?
Not in this review cycle. On June 29, 2026 the FDA issued a Complete Response Letter, declining to approve the application for Oxylanthanum Carbonate (OLC) in its current form. The company announced it on June 30, 2026. A CRL is not final; the primary source is linked on this page.
Which company is behind Oxylanthanum Carbonate (OLC)?
Oxylanthanum Carbonate (OLC) is an Unicycive Therapeutics Inc. (UNCY) program. The FDA decision came on June 29, 2026; the company's own announcement is linked on this page.
How did UNCY stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), UNCY moved +36.3%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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