MOUNTAIN VIEW, Calif., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the appointment of Meredith Manning, M.B.A., to its Board of Directors.
"We are very pleased to welcome Meredith to our Board of Directors. Her extensive commercialization experience, track record of building successful biopharmaceutical organizations, and leadership through successful product launches will be invaluable to Unicycive," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive Therapeutics. "We look forward to benefiting from Meredith's strategic insight and first-hand experience as we advance OLC towards potential approval and prepare for the next stage of the Company's growth."
"I am honored to join Unicycive's Board of Directors at such an important time for the Company," said Ms. Manning. "With the recent NDA resubmission, Unicycive is advancing toward its goal of bringing oxylanthanum carbonate to patients and preparing for its transition to a commercial-stage company. I look forward to working with Shalabh and the Board to support the Company's strategy and create long-term value for patients and shareholders."
Ms. Manning will serve on each of the Audit, Compensation, and Nominating and Corporate Governance Committees, and will serve as the Chairperson of the Nominating and Corporate Governance Committee.
Ms. Manning has more than 25 years of global biopharmaceutical experience. Most recently, she served as Chief Commercial Officer of Soleno Therapeutics, Inc. from 2024 until its acquisition by Neurocrine Biosciences, Inc. in 2026. At Soleno, she built the commercial organization from inception and led the U.S. launch of VYKAT XR, the first FDA-approved treatment for hyperphagia in Prader-Willi syndrome. As a member of the executive team, she also contributed to asset evaluation, lifecycle planning and due diligence, and led the selection of ex-U.S. distribution partners.
Previously, Ms. Manning served as General Manager, and later, President, The Americas, and as a voting member of the U.S. Board of Directors of PharmaEssentia Corporation from 2020 to 2023. She built the U.S. organization from the ground up with general management and P&L responsibility for all U.S. functions. She was a key member of the team that secured FDA approval of BESREMi® (ropeginterferon alfa-2b-njft), led its U.S. commercial launch, and supported the company's capital-raising efforts. She previously served as Chief Commercial Officer of resTORbio, Inc.
Earlier in her career, Ms. Manning served as Vice President, Global Marketing and Product Strategy Lead, Hemophilia, at Shire (formerly Baxter/Baxalta), where she led a seven-brand portfolio across more than 65 countries. She also held senior U.S. marketing and field leadership roles at Vertex Pharmaceuticals Incorporated, including the launch of INCIVEK® (telaprevir), and director-level roles in oncology business development, marketing and managed care at Pfizer Inc. Ms. Manning holds a B.A. in political science from The Colorado College and an M.B.A. from the University of Chicago Booth School of Business.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive's second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing; the possibility that FDA may require inspection of any vendor prior to approval, which could delay or prevent approval of our NDA; the risk that the original third-party manufacturing vendor's reinspection may not occur within a timeframe that benefits our regulatory timeline, or may result in adverse findings; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Unicycive's Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contacts:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Media Contact:
Unicycive Therapeutics
media@unicycive.com
SOURCE: Unicycive Therapeutics, Inc.
