The FDA's own letter · Complete Response Letter, NDA 218607 (PDF), dated June 27, 2025, released under FDA's CRL transparency program. The company announced the decision on June 30, 2025; the FDA acted on June 27, 2025.
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 and pre-approval inspection of a facility listed in the submission (name redacted), FDA conveyed deficiencies to the facility; satisfactory responses to the Form 483, and possibly CGMP re-inspection and an additional pre-approval inspection, are required before the application can be approved.
Labeling comment reserved until the application is otherwise adequate. The letter names no clinical efficacy or safety deficiency.
Daily close, T-120 (1/13/25) through T+5. Run-up high $9 on 6/10/25, low $4.61 on 4/10/25 (T-120 to T-1). FDA decision 6/30/25. Historical price action, not a forecast.
Not in this review cycle. On June 30, 2025 the FDA issued a Complete Response Letter, declining to approve the application for source-verified in its current form. A CRL is not final; the primary source is linked on this page.
How did UNCY stock react to the FDA decision?
On the decision day UNCY moved -29.9%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.