Latest Headlines

Latest Headlines

Sarepta jumps on fresh optimism for an early approval

Sarepta's up-and-down quest to get eteplirsen in the hands of patients with Duchenne muscular dystrophy is looking a little sunnier thanks to more promising data and an optimistic reading of some FDA tea leaves, news that sent the biotech's shares up 35% on Thursday.

UPDATED: Sarepta tanks after FDA squelches hopes for early eteplirsen approval

In what has been one of the most hotly contested issues among biotech investors this year, many had bet big that the FDA would push through an accelerated approval for eteplirsen based on some very promising results from a mid-stage study. The study, though, only included a dozen boys, making the prospect of an early approval problematic at best.

New DMD data give Sarepta an edge in GlaxoSmithKline showdown

Drisapersen and eteplirsen have been angling to become the first approved therapy for lethal, muscle-wasting cases of Duchenne muscular dystrophy. So when investigators pulled back the covers from a new block of data on GlaxoSmithKline's drisapersen, the analysts immediately went to work to see how it stacked up against Sarepta's eteplirsen.

Sarepta shares spike on upbeat results from DMD extension study

Shares of Sarepta were boosted this morning after the biotech announced that it reaped another round of promising results from a closely-watched Phase IIb study of its experimental treatment for Duchenne muscular dystrophy.

Sarepta slips as FDA seeks more data on eteplirsen

Sarepta Therapeutics has kept hopes alive for gaining accelerated approval for its lead drug eteplirsen for Duchenne muscular dystrophy.

UPDATED: GlaxoSmithKline measures 36-meter leap over placebo in Duchenne walking test

GlaxoSmithKline investigator John Kraus reviewed the long-awaited mid-stage results for its Duchenne muscular dystrophy drug drisapersen this afternoon, revealing that boys taking the experimental therapy benefited with a significant improvement in walking distance compared to a placebo arm.

Sarepta's high-noon decision on eteplirsen draws a big biotech crowd

The clock is ticking for Sarepta, a multitude of biotech investors and the boys who suffer from Duchenne muscular dystrophy.

Sarepta capitalizes on hot streak with $125M financing

Sarepta Therapeutics has seen demand for its stock spike since the company revealed impressive long-term data two months ago from a mid-stage study of its therapy eteplirsen in patients with Duchenne muscular dystrophy.

Sarepta rockets up as extension study delivers promising results for DMD

It took a few extra months of treatment, but a group of patients in a key Phase IIb study of Sarepta Therapeutics' (formerly AVI) Duchenne muscular dystrophy therapy eteplirsen registered much better walking distance compared to a placebo arm.

AVI tanks after positive PhIIb fails to improve outcomes for DMD

AVI Biopharma heralded the news that its lead therapy hit the primary endpoint in a Phase IIb study, increasing levels of dystrophin in a tiny trial for Duchenne muscular dystrophy, but the boys did not experience a significant improvement in walking ability,