ImmunityBio Shares Rally as FDA Accepts N-803 Resubmission
By Colin Kellaher
ImmunityBio shares rose sharply Thursday after the clinical-stage immunotherapy company said the U.S. Food and Drug Administration accepted its resubmitted application seeking approval of N-803 in certain patients with bladder cancer.
Shares of the San Diego company were recently changing hands at $1.90, up 20%.
ImmunityBio, which is seeking FDA approval of N-803 in combination with Bacillus Calmette-Guerin, or BCG, for the treatment of certain patients with BCG-unresponsive non-muscle invasive bladder cancer, said the agency set a new target action date of April 23, 2024, for the application.
The FDA in May turned away ImmunityBio's initial application, flagging deficiencies related to its inspection of the company's third-party contract-manufacturing organizations and providing recommendations regarding additional chemistry, manufacturing and controls issues and assays to be resolved.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 26, 2023 11:48 ET (15:48 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
5 Stocks to Buy While They’re Trading at Big Discounts
-
Markets Brief: Tech Stocks Lead Ahead of Nvidia Earnings
-
How Anti-Obesity Drugs Are Innovating the Healthcare Market
-
What’s Happening In the Markets This Week
-
Why Immigration Has Boosted Job Gains and the Economy
-
What to Invest in During High Inflation
-
Never Mind Market Efficiency: Are the Markets Sensible?
-
Starbucks Stock Could Use a Pick-Me-Up After Big Selloff; Is it a Buy?
-
Should You Buy and Hold an Artificial Intelligence Portfolio?
-
3 Cheap and Dependable Dividend-Growth Stocks to Buy
-
The Best Bank Stocks to Buy
-
After Earnings, Is Roblox Stock a Buy, Sell, or Fairly Valued?
-
After Earnings, Is Lyft Stock a Buy, a Sell, or Fairly Valued?
-
8 Stock Picks in the Apparel Industry
-
Baidu Earnings: Advertising Weakness Offset by Continued Growth In Cloud Business
-
Going Into Earnings, Is Target Stock a Buy, a Sell, or Fairly Valued?