Sarepta Therapeutics (SRPT) stock is soaring 19.58% in pre-market trading on Wednesday, fueled by a series of positive developments that have significantly boosted investor confidence in the gene therapy maker. The surge comes after the U.S. Food and Drug Administration (FDA) gave the green light for Sarepta to resume shipments of its gene therapy, Elevidys, and following the departure of a key FDA official.

The FDA's decision to allow the resumption of Elevidys shipments for ambulatory patients with Duchenne muscular dystrophy (DMD) has removed a major cloud of uncertainty hanging over Sarepta. This move came after an investigation concluded that a recent patient death in Brazil was unrelated to the Elevidys treatment. William Blair analyst Sami Corwin noted, "The FDA's recommendation and the resumption of commercial treatment in the U.S. virtually eliminate the risk of Elevidys being formally withdrawn from the market." This development is crucial for Sarepta, as Elevidys is the company's largest revenue generator.

Adding to the positive sentiment, the departure of Vinay Prasad, the FDA's chief medical and science officer, is being viewed as favorable for biotech companies, particularly those in the gene therapy space. BMO Capital Markets commented, "We think that Prasad's departure is a big positive for biotech in general and cell and gene therapies in particular, given that Prasad's appointment was perceived as a 'worst-case scenario' by investors." This change in FDA leadership is expected to potentially lead to a more favorable regulatory environment for companies like Sarepta.

In response to these developments, several Wall Street analysts have upgraded their outlook on Sarepta. Barclays raised its rating to Equal Weight from Underweight and increased its price target to $22 from $10. Bernstein also raised its target price to $18 from $13. These upgrades reflect growing optimism about Sarepta's prospects and its ability to overcome recent challenges. As the company works to rebuild confidence among patients, doctors, and investors in the coming months, today's stock surge suggests that the market is increasingly bullish on Sarepta's future.