Stealth Bio up 34% premarket on ‘positive’ elamipretide data

Thinly traded nano cap Stealth BioTherapeutics (NASDAQ:MITO) is up 34% premarket on increased volume in reaction to positive results from a retrospective natural history study assessing the efficacy of subcutaneous injections of elamipretide relative to a natural history control in patients with Barth syndrome, a rare inherited disorder characterized by an enlarged heart and muscle weakness.

Subjects receiving elamipretide for up to a year during the TAZPOWER study and open-label extension showed an average improvement of more than 80 meters in the six-minute walk test (6MWT) compared to less than one meter in subjects in the natural history group evaluated over the same time frame (p=0.0005).

Treated patients also showed statistically significant improvements in muscle strength and sit-to-stand evaluations.

Results from additional analyses will be presented at a future medical conference.

TAZPOWER failed to achieve the primary endpoint of a statistically significant improvement in the 6MWT at week 12 versus placebo.

Elamipretide has Orphan Drug and Fast Track status in the U.S. for the indication.

https://seekingalpha.com/news/3542654-stealth-bio-up-34-premarket-on-positive-elamipretide-data