For the last five weeks, Neurocrine Biosciences, Inc. (NASDAQ:NBIX) has been riding high with some of its major treatments getting approval from the Food and Drug Administration. However, the biotech’s Ingrezza Tourette syndrome treatment did not get an approval after failing to beat placebo in its mid-stage trial.
The turn of events has been linked to stiff competition from Teva Pharmaceutical Industries Ltd (ADR)(NYSE:TEVA) SD-809. Ineffective dosing of the drug has also been pinned by investigators as another possible reason for the failure. Nonetheless, the company says the flop is not a loss but a setback and within no time it will resurface with a better design.
An analysis of Ingrezza’s missed goal
Apparently, the Tourette syndrome treatment can be used on any extreme conditions associated with a longtime use of particular Tourette’s medications. It is also ideal for tardive dyskinesia, involuntary movements of the face, tongue, and lips.
However, the mid-stage study outlined that the drug failed to cut line of improvement of tics in a pediatric trial. A conclusion by Needham analyst Alan Carr revealed the need for a higher dose of Ingrezza in children so as to see a change in tics.
Surprisingly, Neurocrine has taken the result very positively. The company’s chief medical officer, Christopher F.O’Brien says, “We have developed a complete exposure-response model from this study that we believe accurately defines the appropriate dose range to be tested in the next clinical study that will be started next year.”
Expectations of better results in 2022
A majority of analysts were nearly certain that Ingrezza would grab the FDA’s approval with ease by 2021. This was however not the case and the impact of the failure was felt in Neurocrines shares, which dropped 9%. Carr says that it is also likely to hit back on the stock from 62 to 58 as well as sales.
Nonetheless, there is optimism of success in the approval after the second trial of higher doses, which is set to begin before the close of the year. If all falls into place the Ingrezza is expected to get an approval by 2022. Meanwhile, Neurocrine’s stock closed at $48.89 a fall of $4.64 or 8.67%.
