Shares of Vanda Pharmaceuticals Inc. (VNDA) are up over 40% in after-hours trading on Friday, following a regulatory update.
The FDA has approved the company's BYSANTI, a first-line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.
BYSANTI is a new chemical entity (NCE) that belongs to the class of atypical antipsychotics and is expected to become commercially available in the third quarter of this year.
The drug is expected to be protected by regulatory data exclusivity and U.S. patents, with the last patent expiring in 2044, supporting long-term innovation and patient benefits.
BYSANTI is the second new drug approval for Vanda in less than 2 months, following the December 2025 approval of NEREUS for the prevention of motion-induced vomiting.
A phase 3 trial evaluating BYSANTI for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is underway, with results expected this year.
VNDA has traded in a range of $3.81 to $9.60 in the last 1 year. The stock closed Friday's trading at $5.76, down 5.57%. In after-hours, VNDA was up over 40% at $8.30.
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