Unicycive Therapeutics Receives Confirmatory Guidance on Renazorb Regulatory Pathway [MarketWatch]
Unicycive Therapeutics, Inc. (UNCY)
Company Research
Source: MarketWatch
clinical-stage biotechnology company developing therapies for patients with kidney disease, today provided an update on the development and regulatory filing pathway for Renazorb (lanthanum dioxycarbonate). Renazorb is a second-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). In a recent Type C interaction with the U.S. Food and Drug Administration (FDA), Unicycive sought the FDA's feedback on the sufficiency of the Renazorb data package to support a 505(b)(2) new drug application (NDA) submission. Unicycive provided results from in vitro studies conducted to support the comparability of Renazorb and its active lanthanum moiety to the approved product Fosrenol® . Based on these data, the FDA confirmed in their response that the phosphate-binding mechanism and stoichiometry of Renazorb is comparable to Fosrenol®. The FDA also confirme
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News
- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) had its "speculative buy" rating re-affirmed by analysts at Benchmark Co.. They now have a $3.00 price target on the stock.MarketBeat
- Unicycive Therapeutics to Present at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference [Yahoo! Finance]Yahoo! Finance
- Unicycive Therapeutics to Present at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity ConferenceGlobeNewswire
- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) is now covered by analysts at Piper Sandler. They set an "overweight" rating and a $9.00 price target on the stock.MarketBeat
- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $4.50 price target on the stock.MarketBeat
UNCY
Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- UNCY's page on the SEC website