Unicycive expects to resubmit OLC NDA by year-end after constructive FDA Type A meeting; cash $42M

Unicycive Therapeutics, Inc.

Cash and cash equivalents ~$42M as of Sept 30, 2025; runway into 2027 supports NDA resubmission, potential FDA approval, and launch.
FDA Type A meeting resolved single CRL deficiency re: third-party manufacturing vendor compliance; no other concerns identified.
Company plans to resubmit NDA for Oxylanthanum Carbonate (OLC) before year-end; potential PDUFA date in H1 2026.
FDA confirmed no issues with pre-clinical, clinical, or safety data submitted in original NDA.

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