NDA accepted for BioXcel schizophrenia/bipolar drug

New Haven’s BioXcel Therapeutics has taken a major step forward in its push to bring its first commercial drug to the marketplace.

The FDA recently accepted the company’s new drug application (NDA) for BXCL501, kicking off a months-long review by the agency.

“The filing of our NDA marks an important milestone toward our goal to provide a new treatment option for the millions of patients with schizophrenia and bipolar disorders struggling with acute agitation,” said CEO Vimal Mehta.