Inhibrx Granted FDA Fast Track Designation for INBRX-101
By Chris Wack
Inhibrx said Tuesday that the U.S. Food and Drug Administration granted Fast Track designation to INBRX-101, an optimized recombinant human AAT-Fc fusion protein, for the treatment of patients with emphysema due to alpha-1 antitrypsin deficiency.
Fast track designation is granted by the FDA upon a sponsor's request to speed up the development and review of drugs intended to treat serious or life-threatening diseases.
Investigational drug products with fast track designation may benefit from early and frequent communication with the FDA and are eligible for rolling submission and review of its future marketing application.
The clinical-stage biopharmaceutical company's study is a registration-enabling trial for INBRX-101, begun in April, and is designed as a head-to-head superiority study examining INBRX-101 against plasma-derived AAT.
The initial read-out from the trial is expected to occur in late 2024. The primary endpoint is the mean change in the average functional AAT concentration as measured by anti-neutrophil elastase capacity from baseline to average serum trough fAAT concentration at steady state.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
May 30, 2023 09:31 ET (13:31 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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
-
Why We Expect the Job Market’s Slowdown to Renew in 2024
-
5 Undervalued Stocks to Buy to Play a Little Defense
-
10 Top-Performing Dividend Stocks of the Month
-
Marathon Petroleum Earnings: No Change to Competitive Position, but Shares Look Expensive
-
Charlie Munger and How Not to Invest
-
Look Inside Berkshire Hathaway’s Portfolio Before Its Annual Meeting
-
After Earnings, Is AT&T Stock a Buy, a Sell, or Fairly Valued?
-
Mastercard Earnings: A Stable Environment Highlights the Firm’s Strengths
-
Pfizer Earnings: Solid Results Supported by Steady Tracking Toward $4 Billion In Cost Cuts
-
Starbucks Earnings: Not a Lot to Like About Results as Global Traffic Sputters