Unicycive Therapeutics Inc Aktie News

Initiating coverage on Unicycive Therapeutics, Inc. with a Buy rating and $6 price target, as the recent FDA CRL is manufacturing-related and resolvable. OLC's ultra-low pill burden and strong patient preference position it for significant market share in the $2.7B phosphate binder market for dialysis patients. DCF valuation supports attractive upside even with conservative 20% peak market shar...

LOS ALTOS, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the publication of pivotal trial data describing the safety and tolerability of oxylanthanum carbonate (OLC) in chronic kidney disease (CKD) patients on dialy...

LOS ALTOS, Calif., July 08, 2025 (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 it has regained compliance with the Nasdaq Stock Market (“Nasdaq”) continued listing standard for minimum share price under Rule 5550(a)(2) of the Nasdaq List...

LOS ALTOS, Calif., July 07, 2025 (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 that Shalabh Gupta, M.D., Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, ...

ATLANTA, June 30, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY) complied with federal securities laws. On June 30, 2025, Unicycive “announced that the U.S. Food and Drug Administration (FDA) has issued a CRL for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with ch...

--Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC)

Shares Expected to Begin Trading on Split-Adjusted Basis on June 20, 2025 Shares Expected to Begin Trading on Split-Adjusted Basis on June 20, 2025

- The U.S. Food and Drug Administration (FDA) identified deficiencies at a third-party manufacturing vendor - FDA to provide final decision by PDUFA action date of June 28, 2025 LOS ALTOS, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY or the “Company”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today anno...