Aurinia Pharmaceuticals Tumbles After Major Setback

On Monday, Aurinia Pharmaceuticals (AUPH) announced positive phase 2b results in patients with lupus nephritis. The company was testing its drug Voclosporin in combination with standard of care -- Roche (RHHBY) drug known as CellCept. While the trial results were positive the stock still ended up closing lower by 55.75% to $1.81 per share. 

The reason for closing lower was not because of the efficacy of the drug. The efficacy of the drug was superb, it's just that there were 13 patient deaths in the trial. This caused a mass panic sell by many investors, and this typically happens when there is no clarity with respect to a biotech company. At least 10 of the deaths were in the low dose arm of the study, leading some to believe that the drug is extremely toxic at lower levels. 

Aurinia Pharmaceuticals along with several analysts dispute this claim, that the drug caused the death of these patients. They state that these patients were ill to begin with, and that the underlying disease is what caused death in the study. The company believes that the drug is very safe, and it couldn't have caused these patients' death. 

The trial pitted Voclosporin with Cellcept against a placebo compound together with Cellcept. The final result was that the low dose combo saw 32.6% of patients achieve complete remission. The high dose arm saw a 27.3% complete remission. Placebo was on the lower end with a complete remission of 19.3%.

The company now states that it will present this data to the FDA by the end of the year. It will confirm with the FDA the next steps of the clinical trial, and for possible registration. Considering that there were no patterns with the deaths observed, the company is leaning towards the deaths being caused by the illness and not the drug itself. 

Disclosure: None

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