Minerva Neurosciences Gets FDA Confirmation for NDA for Roluperidone
By Chris Wack
Minerva Neurosciences said Wednesday that it received confirmation from the Food and Drug Administration that its New Drug Application for roluperidone for the treatment of schizophrenia has been filed in accordance with its recent Appeal Granted letter.
The company said the FDA also assigned a standard review classification.
The FDA has assigned a Prescription Drug User Fee Act goal date of Feb. 26, 2024.
The FDA advised that it identified potential review issues that had been previously cited in its refuse-to-file decision letter, which included those discussed at the Type C meeting in March 2022.
Minerva shares were up 18% to $8.01 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
May 10, 2023 08:42 ET (12:42 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
After Earnings, Is Alphabet Stock a Buy, a Sell, or Fairly Valued?
-
When Will the Fed Start Cutting Interest Rates?
-
What’s the Difference Between the CPI and PCE Indexes?
-
Powell Unfazed By Sticky Inflation, but Rate Cuts Are Far Off
-
After Earnings, Is Microsoft Stock a Buy, a Sell, or Fairly Valued?
-
Best- and Worst-Performing Stocks of April 2024
-
Magnificent 7 Stocks Earnings Updates: AI Remains the Focus
-
Small-Cap and Value Stocks Are Undervalued
-
Apple Earnings: iPhone Growth Forecasts Drive Change in Fair Value
-
4 Utility Stocks to Play the AI Data Center Boom
-
Albemarle Earnings: We Expect Improved Results In the Rest of Year Following Cyclically Low Profits
-
Novo Nordisk Earnings: Raised Fair Value Estimate Still a Contrast to Market Overenthusiasm
-
After Earnings, Is Verizon Stock a Buy, a Sell, or Fairly Valued?
-
Look Inside Berkshire Hathaway’s Portfolio Before Its Annual Meeting
-
How to Invest Like Warren Buffett
-
Cognizant Earnings: Improved Profitability Buttresses Results as Customer Spending Remains Muted