🚀 Sarepta Therapeutics Skyrockets After FDA Greenlights Elevidys Sales Revival

Biotech bulls just got a fresh shot of adrenaline.

Sarepta Therapeutics shares are mooning after regulators cleared the path for its gene therapy Elevidys to hit the market again. The FDA's surprise reversal sends a clear signal: the agency's playing ball with innovative treatments—when it suits them.

From clinical hold to cash cow

Remember when the FDA pressed pause over safety concerns? Neither do investors today. The stock's parabolic move proves Wall Street's golden rule: regulatory risk disappears faster than a trader's conscience during a short squeeze.

The gene therapy gold rush

This isn't just about one drug—it's a watershed moment for the entire sector. With Elevidys back in play, Sarepta's sitting on a potential blockbuster while rivals scramble to play catch-up. The company's market cap just added another comma, and you can bet the C-suite's bonus targets just got revised upward.

Funny how FDA approvals always seem to arrive just in time for earnings season, isn't it? Either way, biotech just got its latest 'buy the rumor, sell the news' catalyst—trade accordingly.

Key Takeaways

• Sarepta Therapeutics shares jumped in intraday trading Tuesday after the company said it was resuming shipments of one of its drugs.
• Sales were paused last week as the FDA reviewed a third death of a patient who was taking its muscular dystrophy medication Elevidys.
• Oppenheimer analysts upgraded the stock, and said a resumption of shipments is likely the "desired outcome" for patients who use the drug.

Shares of Sarepta Therapeutics (SRPT) surged 20% Tuesday morning after the company said it had been informed by the Food and Drug Administration that it could resume shipping a drug it paused sales of last week.

Last Monday, Sarepta announced that it was voluntarily pausing shipments of Elevidys, days after the company pushed back on an FDA request for it to do so. The drug has been the subject of an FDA review since a third patient who was taking the drug as a treatment for Duchenne Muscular Dystrophy died earlier this month.

The company said after the bell Monday that the FDA has concluded that that death was unlikely to be related to the drug, and said it will "continue dialogue on next steps in the safety labeling process and risk-mitigation approach" for the medication.

"We are very pleased that FDA chose to rapidly and comprehensively complete that review and to recommend that we remove our voluntary pause and resume shipment" of the drug for ambulatory patients, Sarepta CEO Doug Ingram said.

Oppenheimer analysts upgraded the stock to "outperform" with a $37 price target, up from $30 previously following the news of shipments resuming. The analysts said they believe the news was the "desired outcome" for patients who were briefly without access to the drug and said they expect shares to gain on the news.

Sarepta previously said a patient died in March and another died last month, both of acute liver failure. Shares of the drugmaker were boosted earlier this month when Sarepta announced a restructuring plan, saying it WOULD cut about 500 jobs and pause the development of several of its drugs.

With Tuesday's move, shares are still down about 85% since the start of this year.