Travere shares fall after US FDA extends review of kidney drug

The U.S. FDA has extended its review of Travere Therapeutics' Sparsentan for use in focal segmental glomerulosclerosis and set a new decision date of April 13; Travere said it had responded to the agency's request for more data and reported no safety or manufacturing queries.

The U.S. Food and Drug Administration has extended its review of Travere Therapeutics' application to broaden use of its kidney drug Sparsentan for focal segmental glomerulosclerosis (FSGS). Travere said the extension followed its recent response to the FDA's request for more data on the drug's clinical benefit. The company also reported that the agency had not requested additional safety or manufacturing information. Reuters reported that the announcement coincided with a near 20% drop in Travere's share price. Key details: - The FDA set a new decision date of April 13. - Travere responded to an FDA request for more data on clinical benefit. - The company said no additional safety or manufacturing information was requested. - Reuters reported shares fell nearly 20% in afternoon trading after the announcement. Summary: The extension delays a final regulatory decision on Sparsentan's use in FSGS and coincided with a drop in the company's share price. A final decision by the FDA is scheduled for April 13, and Travere said it will continue to work with the agency during the extension period.