Sarepta Therapeutics shares plunge as gene therapy trial falls short of primary goal
By Eleanor Laise
Company plans to seek label expansion for Duchenne muscular dystrophy treatment
Sarepta Therapeutics Inc. shares (SRPT) dropped more than 40% premarket on Tuesday after the company said a trial of its gene therapy for Duchenne muscular dystrophy fell short of its main goal.
The therapy, Elevidys, helped patients' movement and walking ability but failed to produce a statistically significant improvement versus placebo in an ambulatory assessment after 52 weeks of treatment, Sarepta said in a release Monday.
The trial involved patients age 4 through 7 years with Duchenne muscular dystrophy, a genetic disorder that can cause severe muscle weakness, with symptoms starting in early childhood.
Based on the overall trial results, Sarepta said it plans to seek a label expansion so that Elevidys can treat all patients. The U.S. Food and Drug Administration in June approved Elevidys for treatment of patients age 4 through 5 years. The trial results support the conclusion that Elevidys "modifies the trajectory of Duchenne and benefits patients across age groups living with this ferociously degenerative disease," Doug Ingram, Sarepta's president and CEO, said in a statement.
The trial data were "extremely disappointing," Leerink Partners analysts wrote in a note Monday, but "we are not writing off the FDA's historical flexibility" in Duchenne muscular dystrophy. The analysts maintained an outperform rating on Sarepta shares but cut their price target to $130, from $185.
Sarepta stock is down 16.9% in the year to date, while the S&P 500 SPX has gained 8.5%.
-Eleanor Laise
This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.
(END) Dow Jones Newswires
10-31-23 0825ET
Copyright (c) 2023 Dow Jones & Company, Inc.-
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
-
Markets Brief: AI Leaders Excel In Earnings Season So Far
-
What History Tells Us About the Fed’s Next Move
-
What’s Happening In the Markets This Week
-
Alphabet’s New Dividend: What Investors Need to Know
-
Going Into Earnings, Is Palantir Stock a Buy, a Sell, or Fairly Valued?
-
Amazon Earnings: AWS Growth Accelerates and Profit Margins Improve
-
SiriusXM Earnings: Decent Results With Plan for Technology and Content Investment to Drive Growth
-
Coca-Cola Earnings: Solid Volume On Innovation and Digital Engagement
-
Is Berkshire Hathaway a Buy Before the Annual Meeting?
-
Investment Opportunities in the Drug Distribution Industry
-
Why the End of Quantitative Tightening Matters
-
Eli Lilly Earnings: Strong Weight-Loss Drug Sales Expand Margins
-
After Earnings, Is Meta Stock a Buy, a Sell, or Fairly Valued?