Auspex Pharmaceuticals Inc (NASDAQ:ASPX) shares soared in Wednesday’s pre-market session after the biopharmaceutical company late Tuesday reported positive top-line efficacy and safety results from its Phase 3 registration trial evaluating SD-809 for the treatment of chorea associated with Huntington’s disease.
ASPX was up 88% at $47.17 in recent pre-market trading, set to easily surpass its all-time high of $35.78 if the gain is sustained after the open.
The primary efficacy endpoint in the study was met, plus significant improvements in both patient and clinical global impressions of change and quality of life were observed, the company said. It noted the study showed a favorable safety and tolerability profile, including low rates of depression, somnolence, akathisia/restlessness and anxiety.
In addition, Auspex released results from an analysis of the completed four-week Switch portion of its ARC-HD study, which also has an ongoing long-term safety component. Data from that study showed patients who switched from the current standard of care, tetrabenazine, to SD-809 maintained chorea control at both week one and week four.
In other earlier morning news, SeaWorld Entertainment (SEAS) gained over 1% pre-market Wednesday after the company noted that the previously-announced restructuring program, which will save about $50 million a year by the end of 2015, will include 300 job cuts across its 11 theme parks.
The theme-park operator said the job cuts will cost the company about $12 million before taxes.
In addition, SeaWorld said it will accelerate a previously-announced $250 million share buyback program, so it will begin on Dec. 17 instead of Jan. 1. The company is authorized to repurchase up to $15 million of stock before the end of the year.
The company also said it will postpone its regular Q4 dividend to January, due to limitations set under its debt covenants.
SEAS shares were up 1.4% at $15.65 in recent pre-market trade, moving away from the low end of the 52-week range of $15.32-$35.30.