CRL was manufacturing compliance, with a June 29, 2026 PDUFA catalyst.
UNCY’s OLC FDA timeline is the core catalyst—manufacturing CRL was over compliance, with a June 29, 2026 PDUFA date setting up approval upside.
The FDA’s prior complete response letter cited a single manufacturing-vendor compliance issue, not problems with OLC’s clinical data, safety, or efficacy. After a late-2025 Type A meeting, UNCY resubmitted in December 2025, and the FDA accepted it with a June 29, 2026 PDUFA date.
Target $41.506mo
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