Teva Pharmaceutical Industries Limited (TEVA) has submitted its New Drug Application to the U.S. Food and Drug Administration for Ecopipam for the treatment of pediatric Tourette syndrome.
Ecopipam is an investigational drug that functions as a selective dopamine antagonist, specifically targeting the D1 receptor to inhibit dopamine signaling. It is being developed to address the repetitive and compulsive behaviors linked to Tourette syndrome. The drug has received orphan drug designation and fast track designation from the FDA for treating pediatric patients with Tourette syndrome.
The company noted the NDA submission was supported by the encouraging results from the Phase 3 data, which met the primary efficacy endpoint by significantly delaying relapse in pediatric patients treated with ecopipam.
TEVA closed Thursday's trade at $31.48, down 3.32%. In the pre-market, shares are currently trading at $31.45, down 0.02%. For more such biotech stock news, visit rttnews.com.
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