Sarepta Therapeutics, Inc. - Common Stock (SRPT)

JPMorgan upgraded Sarepta to ‘Neutral’ from ‘Underweight’ with a $24 price target.

Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.

Risk appetite took a breather Tuesday, with major U.S. stock indices retreating modestly from record highs as investors braced for a pivotal stretch of earnings and macro events.

Curious to know what's happening on the US markets in the middle of the day on Tuesday? Join us as we explore the top gainers and losers in today's session.

Sarepta stock soared after the FDA said the biotech company can resume shipments of a controversial gene therapy drug.

In today's session, there are notable price gaps in the US markets on Tuesday. Take a closer look at the stocks that are gap up and gap down.

Before the US market kicks off on Tuesday, let's examine the pre-market session and unveil the notable performers among the top gainers and losers.

Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug Administration's (FDA) recommendation to lift the voluntary hold on Elevidys, Sarepta's gene therapy for Duchenne Muscular Dystrophy.

Sarepta stock’s after-hours jump came as the FDA notified the company that it could lift the voluntary pause on the shipments.

U.S. markets closed mixed on Monday, with the Dow Jones Industrial Average slipping 0.1% to 44,837.56.

The FDA concluded that a recent patient death in Brazil was unrelated to Sarepta’s Elevidys treatment, allowing the company to resume U.S. shipments for boys who can still walk.

Sarepta Therapeutics shares are halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) recommended the removal of a voluntary hold for Elevidys.

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy treatment.

The update comes as Sarepta faces mounting regulatory scrutiny, including an ongoing FDA investigation and a recommendation from European regulators to reject approval of Elevidys.

Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular dystrophy patients.

Roche announced on Friday that it plans to continue working with the EMA to explore a potential path forward.

Shares are down another double-digit percentage after bad news continued piling on for gene therapy Elevidys.

Let's have a look at what is happening on the US markets before the opening bell on Friday. Below you can find the top gainers and losers in today's pre-market session.