Horizon Pharma PLC (NASDAQ:HZNP) stock was plummeting on Thursday following news of a drug trial failure.
Horizon Pharma PLC says that its Safety, Tolerability and Efficacy of Actimmune Dose Escalation in Friedreich’s Ataxia study (STEADFAST) did not meet its primary or secondary endpoints after 26 weeks. The goal of the Phase 3 trial was to test how well Actimmune could treat Friedreich’s ataxia.
Friedreich’s ataxia is a disease that patients inherit. It deals damage to the nervous system. The disease often starts in childhood and leads to the degrading of the nervous system over time. This can impair muscle coordination.
According to Horizon Pharma PLC, there wasn’t enough statistical difference between the start and end of STEADFAST to consider Actimmune as an effective treatment for Friedreich’s ataxia. As such, the biopharmaceutical company is no longer going to be continuing the study. This includes the 26-week extension study and the long-term safety study.
The decision concerning the effectiveness of Actimmune in treating Friedreich’s ataxia was made by Horizon Pharma PLC, an independent Data Safety Monitoring Board and the Friedreich’s Ataxia Research Alliance (FARA). HZNP also says it will still work with FARA to continue analyzing the data for future study use and publication.
Horizon Pharma PLC says that the discontinuation of STEADFAST will not harm its full-year 2016 adjusted net sales or adjusted EBITDA guidance. The company also claims that it will likely see growth in 2017 due to its current portfolio of medicines.
HZNP stock was down 18% as of Thursday morning, but is up 23% year-to-date.
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