FOLD Slowly Unfolding, EBS Continues Contract Spree, HZNP Plunges On Trial Data

(RTTNews) - Amicus Therapeutics (FOLD) has reported positive preliminary data from a global Phase 1/2 study of ATB200/AT2221 in the treatment of Pompe disease.

The preliminary data from the study reveals that biomarkers of muscle damage are generally stable or trending towards improvement. No serious adverse events have been observed in the trial.

FOLD closed Thursday's trading at $6.05, up 3.24%.

Emergent BioSolutions Inc. (EBS) has signed a follow-on contract with the Centers for Disease Control and Prevention to supply roughly 29.4 million doses of BioThrax, worth $911 million, to the Strategic National Stockpile through September 2021.

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease. In addition, the Biomedical Advanced Research and Development Authority (BARDA) is seeking to procure approximately $100 million of BioThrax for delivery into the Strategic National Stockpile within 24 months from the date of contract award, which the company anticipates will be in the first half of 2017.

Looking ahead, the company expects BioThrax sales to range between $220 million and $235 million. The anthrax vaccine had sales of $293.9 million in 2015.

EBS closed Thursday's trading at $27.22, up 2.64%.

Galapagos NV (GLPG) is all set to receive a $10 million milestone payment from Gilead Sciences (GILD), following the initiation of a phase 2b/3 study with Filgotinib in ulcerative colitis.

The study, dubbed SELECTION, initiated by Gilead will investigate efficacy and safety of 100 mg and 200 mg Filgotinib once-daily compared to placebo in 1,300 patients with moderately to severely active disease, including those with prior biological therapy failure.

A phase III study of Filgotinib in Crohn's disease, dubbed DIVERSITY, was started by Gilead in November, and a phase III program of Filgotinib in rheumatoid arthritis, known by the name FINCH, was started in August.

GLPG closed Thursday's trading at $58.95, up 1.22%.

Shares of Horizon Pharma plc (HZNP) plunged over 22% on failure of the company's phase III trial of Actimmune in Friedreich's ataxia to meet its primary endpoint.

In the trial, dubbed STEADFAST, there was no statistically significant change from baseline in the modified Friedreich's Ataxia Rating Scale at 26 weeks in patients treated with Actimmune compared to treatment with placebo.

Actimmune is approved in the U.S. for use in two rare diseases - to reduce the frequency and severity of serious infections associated with Chronic Granulomatous Disease, and to slow the worsening of severe, malignant osteopetrosis.

Sales of Actimmune are $80.5 million this year-to-date, up a modest 1% over the comparable year-ago period.

HZNP closed Thursday's trading at $15.03, down 22.49%.

Valeant Pharmaceuticals International Inc.'s (VRX) (VRX.TO) phase III study of IDP-118 lotion in the treatment of plaque psoriasis has achieved the primary endpoint.

According to the trial results, IDP-118 has shown statistical significance in achieving a "clear" to "almost clear" score based on an Investigator Global Assessment (IGA) at 8 weeks, and at least 2 grade improvement in the IGA at weeks 12, 6, 4 and 2 as secondary endpoints.

Another confirmatory pivotal phase 3 study of IDP-118 is underway, and results are expected next year.

VRX closed Thursday's trading at $15.44, up 2.39%.