FDA Extends Review Period for Applied Therapeutics Genetic Disease Treatment
By Ben Glickman
Applied Therapeutics said regulators had extended the period for reviewing its application for a rare metabolic disease treatment.
The biopharmaceutical company said Thursday that the Food and Drug Administration now has a target action date of Nov. 28 for its application, compared with the previous date of Aug. 28.
The company's application is for govorestat in the treatment of Galactosemia, a rare genetic condition that makes patients unable to metabolize the simple sugar galactose. The condition can lead to neurological complications such as speech and cognition issues.
Applied Therapeutics has received priority review status from the FDA for its new drug application.
The FDA needed additional time to review supplemental analyses of previously submitted data, which were provided by the company in response to routine information requests, the company said. Regulators determined the new information constituted a major amendment to its application, which can lead to a revised review timeline.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
March 28, 2024 17:09 ET (21:09 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
6 Top-Performing Large-Growth Funds
-
What’s the Difference Between the CPI and PCE Indexes?
-
Micron Earnings: Great Guidance but Stock Now Looks Fairly Valued
-
August PCE Report Forecasts Show More Good News on Inflation
-
AI Stocks May Be Down, but Don’t Count Them Out
-
4 Stocks to Buy as the Fed Cuts Interest Rates
-
Markets Brief: The Uncertain Path to Neutral Interest Rates
-
What’s Happening in the Markets This Week
-
Morningstar’s Guide to Investing in Stocks
-
Our Top Pick for Investing in US Renewable Energy
-
How to Measure a Stock’s Uncertainty
-
How to Determine Whether a Stock Is Cheap, Expensive, or Fairly Valued
-
Why a Company’s Management and Capital Allocation Matter
-
How to Determine What a Stock Is Worth
-
How to Measure a Company’s Competitive Advantage
-
How to Think Like a Stock Analyst