Alector, GSK Get FDA Breakthrough Designation for Latozinemab
By Colin Kellaher
Alector and GSK have won U.S. Food and Drug Administration breakthrough-therapy designation for their latozinemab drug candidate for certain patients with one of the most common causes of early onset dementia.
The companies on Wednesday said the designation covers the potential treatment of frontotemporal dementia with a progranulin gene mutation.
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.
Alector and GSK said frontotemporal dementia affects 50,000 to 60,000 people in the U.S. and 110,000 people in the European Union, and that patients with a progranulin gene mutation represent 5% to 10% of all people with the rare neurodegenerative disease.
Alector, a South San Francisco, Calif., clinical-stage biotechnology company, had signed an agreement with U.K. drug major GSK in July 2021 to develop and commercialize progranulin-elevating monoclonal antibodies, including latozinemab.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 07, 2024 07:49 ET (12:49 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