Unicycive Stock Down As FDA Finds Issues At Third-party Manufacturing Vendor, Precludes Label Talks

(RTTNews) - Shares of Unicycive Therapeutics, Inc. (UNCY) were losing around 20 percent in the pre-market activity on the Nasdaq after the company announced that the U.S. Food and Drug Administration identified deficiencies at a third-party manufacturing vendor.

The company revealed the issue in an update on its New Drug Application or NDA for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. . Given the identified deficiencies, the FDA indicated that any label discussions between the FDA and the company are precluded. Unicycive said it has responded to all FDA information requests and expects a final decision from the FDA by the PDUFA action date of June 28.

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease

Oxylanthanum Carbonate or OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

The company's NDA submission package is based on data from three clinical studies, multiple preclinical studies, and the chemistry, manufacturing and controls data.

The clinical-stage biotechnology company focused on kidney disease noted that the agency, following an inspection, had identified deficiencies in cGMP compliance at a third-party manufacturing vendor, one of its CDMO's third-party subcontractors and not its Drug Substance vendor.

Shalabh Gupta, Chief Executive Officer of Unicycive, said, "We are discussing with our partners to help resolve FDAs concerns and remain confident in the promise of OLC based on the extensive clinical and preclinical data we've generated, said. We believe OLC is a promising new treatment option and we are eager to bring it as quickly as we can to patients with CKD on dialysis who are living with hyperphosphatemia."