Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · Other Events
Item 5.02 Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers. On September 28, 2026, Unicycive Therapeutics, Inc. (the “Company”) appointed Meredith S. Manning as an independent director on the Company’s board of directors, effective October 1, 2026. Ms.…
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.
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Item 5.02Item 5.02 - Departure/Election of Directors
Item 5.02 Departure
of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
On
September 28, 2026, Unicycive Therapeutics, Inc. (the “Company”) appointed Meredith S. Manning as
an independent director on the Company’s board of directors, effective October 1, 2026. Ms. Manning will serve on each of the Audit,
Compensation and Nominating and Corporate Governance Committees, and also as the Chairperson of the Nominating and Corporate Governance
Committee.
Meredith
S. Manning, M.B.A., 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 played a key role in asset evaluation, lifecycle planning, and due diligence, and
led the selection of ex-U.S. distribution partners. Previously, Ms. Manning served as President, The Americas, and a voting member of
the U.S. Board of Directors of PharmaEssentia Corporation from 2020 to 2023. In this role, she built the U.S. company 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,
including engagement with U.S. and global investors. Prior to joining PharmaEssentia, she 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.
The
Company believes that Ms. Manning is qualified to serve on its Board of Directors because of her extensive experience building and leading
biopharmaceutical organizations, her record of successful product launches across rare disease, oncology, and hematology, and her general
management, global commercialization, and value-creation expertise.
There
is no arrangement or understanding between Ms. Manning and any other person, other than the Company’s directors acting solely in
their capacity as such, pursuant to which she was selected as a director of the Company. Ms. Manning is not related by blood, marriage
or adoption to any director or executive officer.
The
Company is not aware of any transaction, or currently proposed transaction, in which the Company was or is to be a participant and in
which Ms. Manning, or any member of her immediate family, had or will have a direct or indirect material interest that would be required
to be reported under Item 404(a) of Regulation S-K.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events
.
On
September 29, 2026, the Company issued a press release announcing resubmission of a New Drug Application for Oxylanthanum Carbonate. A
copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein (except
for the fourth paragraph therein).
Filed exhibits (1)
EX-99.1 (by filename) ea030696701ex99-1.htm
Exhibit 99.1
Unicycive
Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate
Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC) data from a new drug product manufacturing vendor
The resubmission package includes 12 months of OLC drug product stability data from the new manufacturing vendor
Company anticipates FDA acceptance of the NDA within 30 days of resubmission; new assigned PDUFA date expected to be 6 months from resubmission
Current cash position allows runway into 2H 2027
MOUNTAIN VIEW, Calif., September 29, 2026 -- Unicycive
Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing
therapies for patients with kidney disease, today announced the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate
(OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney
disease (CKD) on dialysis. The Company anticipates United States Food and Drug Administration (FDA) acceptance of the NDA within 30 days
and a new assigned PDUFA date to be six months from the date of resubmiss…