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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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was source-verified approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for source-verified in its current form, was announced on June 30, 2025. 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.