H.C. Wainwright Reiterates Buy Rating on Unicycive Therapeutics (UNCY)

H.C. Wainwright analyst Ed Arce reiterated a Buy rating and $2.50 price target on Unicycive Therapeutics (NASDAQ: UNCY).

The analyst commented: "Unicycive announced on September 3 that it submitted an NDA for Oxylanthanum Carbonate (OLC), Unicycive's lanthanum-based phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. This submission is filed under the 505(b)(2) regulatory pathway, with Fosrenol as the reference listed drug (RLD). Importantly, the timing of OLC's NDA filing places its potential approval within our current projection timeframe in mid-2025. OLC's NDA submission is supported by data from three clinical studies: a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a pivotal study in CKD patients on dialysis. In addition, data from multiple preclinical studies and CMC-related specifications and practices are also included in OLC's NDA docket. Unicycive also announced that the FDA granted a waiver for the NDA's PDUFA fees, resulting in total savings of approximately $4M. Finally, we note that Unicycive's current cash runway is estimated to extend "into 2026", thus Unicycive faces no financial overhang prior to OLC's potential FDA approval. For now, we await the NDA's formal acceptance by the FDA that we expect by November 2 (or 60 days from today) along with a PDUFA date assignment to further narrow OLC's potential approval timing as the next milestone for OLC and Unicycive. Affirm Buy rating and $2.50 PT."

For an analyst ratings summary and ratings history on Unicycive Therapeutics click here. For more ratings news on Unicycive Therapeutics click here.

Shares of Unicycive Therapeutics closed at $0.32 yesterday.

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