Unicycive resubmits OLC NDA with new CMC vendor; PDUFA expected 6 months after Sept 29, 2026 filing

Unicycive Therapeutics, Inc.

Resubmission includes CMC data and 12-month stability data from a new third-party drug product manufacturer; FDA acceptance expected within 30 days.
New vendor's facility received FDA 'No Action Indicated' status after a March 2024 inspection; both vendors will be kept for supply chain redundancy.
The June 2026 CRL cited the same third-party manufacturing deficiencies as the June 2025 CRL; FDA did not raise clinical efficacy or safety concerns.
Meredith S. Manning was appointed an independent director effective Oct 1, 2026, and will chair the Nominating and Corporate Governance Committee.
Unaudited cash, cash equivalents and marketable securities totaled $61.4 million as of June 30, 2026, funding runway into 2H 2027.

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