- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) shareholders should email fletcher@fmoorelaw.com
NEW YORK, Oct. 20, 2026 /PRNewswire/ —
What is the Investigation About?
On June 30, 2026, before the market opened, Unicycive disclosed that the FDA had issued a second Complete Response Letter regarding its resubmitted application for oxylanthanum carbonate, an investigational treatment for patients with chronic kidney disease on dialysis. The letter cited the same third-party manufacturing deficiencies identified in the FDA’s previous letter issued in June 2025.
Following this news, the price of Unicycive stock fell $3.01 per share, or 39.1%, to close at $4.69 per share on June 30, 2026.
Unicycive also disclosed that the FDA had not yet inspected the third-party manufacturing facility as part of its review of the resubmitted application. This followed Unicycive’s December 2025 announcement that the manufacturer had made significant progress toward regaining FDA compliance. Unicycive stated that the second letter did not raise concerns about the treatment’s clinical efficacy or safety data.
If you own Unicycive Therapeutics, Inc. (NASDAQ: UNCY) securities, please contact Fletcher Moore at fletcher@fmoorelaw.com.
You may be able to seek monetary damages, corporate governance reforms, reimbursement to the company, and a court approved incentive award at no cost to you whatsoever. All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
MOORE LAW PLLC
30 Wall Street, 8th Floor
New York, NY 10005
fletcher@fmoorelaw.com
www.fmoorelaw.com
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SOURCE Moore Law PLLC
