Unicycive Therapeutics Appoints Director; Resubmits NDA for Oxylanthanum

What Happened

• Unicycive Therapeutics, Inc. filed a Form 8‑K reporting two material items: the appointment of Meredith S. Manning as an independent director and the company’s resubmission of a New Drug Application (NDA) for oxylanthanum carbonate.
• Meredith S. Manning was appointed on September 28, 2026, effective October 1, 2026. She will serve on the Audit, Compensation and Nominating & Corporate Governance Committees and will chair the Nominating & Corporate Governance Committee. Ms. Manning has over 25 years of global biopharma experience, most recently as Chief Commercial Officer of Soleno Therapeutics (2024–2026) where she led the U.S. launch of VYKAT™ XR, and prior senior commercial roles at PharmaEssentia, resTORbio, Shire, Vertex and Pfizer. She holds a B.A. from The Colorado College and an M.B.A. from Chicago Booth.
• The company issued a press release on September 29, 2026 announcing the resubmission of the NDA for oxylanthanum carbonate; that press release is furnished as Exhibit 99.1 to the 8‑K.

Key Details

• Director appointment: announced Sept 28, 2026; effective Oct 1, 2026.
• Committee roles: Audit, Compensation, Nominating & Corporate Governance (Chair).
• Background: >25 years biopharma experience; recent roles include Chief Commercial Officer at Soleno Therapeutics and President, The Americas at PharmaEssentia.
• Regulatory update: NDA for oxylanthanum carbonate resubmitted and disclosed via company press release on Sept 29, 2026.

Why It Matters

• Board strengthening: Adding an experienced commercial executive could help Unicycive plan commercialization and value-creation strategies if its product candidates advance toward approval and launch.
• Regulatory milestone: Resubmitting an NDA is a key procedural step in pursuing FDA approval for oxylanthanum carbonate; investors should watch for subsequent FDA feedback, review timelines, and any related clinical or data disclosures.
• No related-party issues: The filing states there are no arrangements or related-party transactions involved in Ms. Manning’s selection and no immediate material transactions involving her or her family reported.