Sunovion and PsychoGenics Announce that SEP-363856 Has Received FDA Breakthrough Therapy Designation for the Treatment of People with Schizophrenia
SUMITOMO CHEM UNSP/ADR (SOMMY)
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Company Research
Source: Business Wire
— SEP-363856 offers an innovative approach to the treatment of schizophrenia including the potential to be the first agent for the treatment of schizophrenia that does not bind to dopamine 2 (D2) receptors — — Schizophrenia affects more than 2 million people in the United States — MARLBOROUGH, Mass. & PARAMUS, N.J.--(BUSINESS WIRE)-- Sunovion Pharmaceuticals Inc. (Sunovion) and PsychoGenics Inc. (PsychoGenics), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for SEP-363856, a novel agent for the treatment of people with schizophrenia. Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on one or more clinically sign
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