Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 by the U.S. Food and Drug Administration for the Prevention of Delayed Graft Function in Kidney Transplant Pati...
Unicycive Therapeutics, Inc. (UNCY)
Company Research
Source: Yahoo! Finance
therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating K ATP channels in mitochondria to restore mitochondrial function. “We are pleased to announce that the FDA has granted orphan drug designation to UNI-494 for the prevention of delayed graft function after kidney transplantation, an unmet medical need for which there are no FDA-approved drugs,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Obtaining ODD is an important milestone in the development of UNI-494 that may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval. DGF is one of the most serious complicati
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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