Unicycive Therapeutics Provides Regulatory Update On Lanthanum Dioxycarbonate Program; Says FDA Has Asked The Company To Provide Additional Information
Portfolio Pulse from Benzinga Newsdesk
Unicycive Therapeutics has been asked by the FDA to provide additional information on its Lanthanum Dioxycarbonate program. The request came after the FDA reviewed a study report submitted by the company, which showed no evidence of gastrointestinal neoplasms in mice. The FDA noted quantitative differences in the GI adverse findings observed with Lanthanum Dioxycarbonate compared to Lanthanum Carbonate.
June 29, 2023 | 9:07 pm
News sentiment analysis
Sort by:
Ascending
NEGATIVE IMPACT
Unicycive Therapeutics has been asked by the FDA to provide additional information on its Lanthanum Dioxycarbonate program, which could potentially delay the approval process.
The FDA's request for additional information could potentially delay the approval process for Unicycive's Lanthanum Dioxycarbonate program. This could have a negative impact on the company's stock in the short term as investors may see this as a setback.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100