- The company expects the Bysanti drug to be available in the market in the third quarter of 2026.
- The drug is being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder.
- Earlier this year, the FDA refused to approve the company’s application seeking approval of the drug Hetlioz in treating jet lag.
Shares of Vanda Pharmaceuticals Inc. (VNDA) rose 38% after hours on Friday after the U.S. Food and Drug Administration approved the company’s Bysanti tablets for the treatment of certain mental health conditions.
The FDA approved the drug for acute treatment of manic or mixed episodes associated with bipolar I disorder, and for the treatment of schizophrenia in adults. The company expects the drug to be available in the market in the third quarter of 2026.
Bysanti belongs in the class of atypical antipsychotics and demonstrated bioequivalence to another schizophrenia drug called Iloperidone at both low and high doses, across single- and multiple-dose studies.
It is also now being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder. The ongoing study is expected to be completed by the end of this year.
Vanda’s Pipeline
Bysanti is the second Vanda drug to be approved in the span of a few months — its Nereus drug was approved in December for the prevention of motion sickness.
However, in early January, the FDA refused to approve the company’s application seeking approval of the drug Hetlioz in treating jet lag. While the FDA acknowledged positive results from Vanda’s clinical trials, it cited concerns that the controlled phase-advance protocols used in the studies do not fully replicate real-world jet travel conditions, including reduced oxygen pressure, noise, and lighting changes.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around VNDA stock jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘extremely high’ levels.
VNDA stock has gained 28% over the past 12 months.
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