Avidity's Lead Program Gets FDA Breakthrough Designation
By Colin Kellaher
Avidity Biosciences has won Food and Drug Administration breakthrough-therapy designation for delpacibart etedesiran, the biopharmaceutical company's lead clinical development program, for the treatment of myotonic dystrophy type 1.
Avidity on Wednesday said there are currently no approved therapies for myotonic dystrophy type 1, a progressive and often fatal neuromuscular disease.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.
San Diego-based Avidity said it is initiating a pivotal Phase 3 study of delpacibart etedesiran during the current quarter.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 08, 2024 06:40 ET (10:40 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
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
-
Where Top Stock Fund Managers Are Looking Next After the Fed Rate Cut
-
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
-
How GLP-1 Drugs Like Ozempic Are Boosting Biopharma Stocks