Altimmune Gets FDA Fast-Track Designation for Pemvidutide in NASH
By Colin Kellaher
Altimmune has won U.S. Food and Drug Administration fast-track designation for its lead product candidate pemvidutide in the treatment of nonalcoholic steatohepatitis, the chronic liver condition commonly known as NASH.
The Gaithersburg, Md., clinical-stage biopharmaceutical company on Thursday said it is studying the efficacy and safety of pemvidutide in NASH in a Phase 2b placebo-controlled biopsy-driven trial.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
There are currently no FDA-approved drugs to treat NASH, which is caused by a buildup of fat in the liver and is estimated to affect 17 million Americans.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 26, 2023 08:00 ET (12:00 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
For Bond Investors, Delayed Rate Cuts Demand a Different Playbook
-
What’s Happening In the Markets This Week
-
How the Tokyo Stock Exchange Is Pushing for Better Shareholder Returns
-
Magnificent 7 Stocks Earnings Updates: AI Remains the Focus
-
Where We See Opportunities After an Ugly Month for Stocks
-
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?
-
Berkshire Hathaway Earnings: Strong Insurance Results Continue to Lift Revenue and Profitability
-
10 Questions for Berkshire Hathaway’s 2024 Annual Meeting
-
After Earnings, Is Ford Stock a Buy, a Sell, or Fairly Valued?
-
3 Dividend Stocks for May 2024
-
Amgen Earnings: Obesity Drug Update Is Highly Encouraging
-
What’s Going on With Apple, Tesla, and Alphabet?
-
Apple Earnings: A Weak 2024, but Optimism for 2025
-
4 Utility Stocks to Play the AI Data Center Boom