Unicycive Therapeutics, Inc. (@unicycive) (@Nasdaq: $UNCY) has a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027 for oxylanthanum carbonate (OLC), its investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, now that the U.S. Food and Drug Administration (FDA) (@FDA) has accepted the company's New Drug Application (NDA) resubmission. The FDA has deemed the resubmission a Class II with a six-month review period from the resubmission date.
Unicycive Therapeutics, Inc. is a B2i Digital (@b2idigital) Featured Company. See the company's in-depth profile at: https://t.co/AAYr0aFZWk
Under the 505(b)(2) regulatory pathway, the NDA for OLC is supported by clinical, preclinical and Chemistry, Manufacturing, and Controls (CMC) data:
• Three clinical studies: a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis
• Multiple preclinical studies
• The resubmission includes CMC data from a new third-party drug product manufacturing vendor
Regarding the review, Shalabh Gupta, M.D., Chief Executive Officer of Unicycive, stated: "We hope to continue working with the FDA toward potential approval of this important medication to patients with CKD on dialysis who need additional treatment options for managing hyperphosphatemia."
Read the full release: https://t.co/1JdCozTcM6
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 https://t.co/XXVrVhHuHE and follow us on LinkedIn and X.
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David Shapiro (@davidshapiroNYC), Chief Executive Officer of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted UNCY stock, in line with B2i Digital’s practice of investing alongside its Featured Companies. B2i Digital is not a broker-dealer or investment adviser. This post is informational and not an offer or solicitation regarding any security. See the complete Disclosure at https://t.co/ljTVqQL4Si.
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Watch on Hoover+: https://t.co/7WErIWPINz