Vanda Pharmaceuticals is riding a regulatory roller coaster over the last few months. December brought an FDA thumbs up for its new motion sickness drug Nereus. Then in January, the U.S. regulator re-upped its rejection of Vanda’s Hetlioz for jet lag disorder.
Now in February, the agency has issued another new drug approval to Vanda, signing off on Bysanti as a first-line treatment for schizophrenia or for manic or mixed episodes associated with bipolar I disorder.
The atypical antipsychotic tablet, also known as the chemical compound milsaperidone, has demonstrated in clinical trials its bioequivalence to Vanda’s Fanpat (iloperidone), which has been approved in the same two indications.
The bioequivalence is established once Bysanti is absorbed in the body. This linkage enables Vanda to leverage the established efficacy and safety profile of Fanpat, the company explained in a release.
“The Bysanti approval marks a significant step forward, offering patients and providers a reliable new treatment grounded in extensive clinical heritage,” Mihael Polymeropoulos, M.D., the CEO of Vanda, said in a statement. “Bysanti exemplifies a new era of accelerated innovation in drug development that can transform how we address unmet needs in behavioral health.”
Vanda’s share price increased by 39% to $8.51 since the announcement of the approval after the market closed on Friday. Over the last three months, the company’s stock has reflected its up-and-down fortunes.
After bottoming out at $4.34 in the middle of November, its share price increased to $8.82 on New Year’s Eve following the FDA green light for Nereus, then dipped to $5.76 a few days after the company reported its fourth-quarter earnings.
As for Bysanti, the company said it expects to launch the treatment in the third quarter of this year. With its latest patent not due to expire until 2044, Vanda said that Bysanti will provide a “robust foundation for long-term innovation and patient benefit.”
Vanda also is testing Bysanti as a daily add-on treatment for major depressive disorder, with a study in that indication expected to be wrapped up late this year. The atypical antipsychotic, with its ability to block dopamine and serotonin receptors, makes Bysanti “suitable for further investigation in conditions that include symptoms of hostility, agitation and hyperarousal,” Vanda added.
Earlier this month, Vanda revealed 2025 sales of Fanapt at $117 million, which were up 24%, sparked in part by gaining a new indication in 2024 for acute bipolar I, which came 15 years after its original approval for schizophrenia.
The company reported 2025 overall revenue at $216 million, which was up 9% year over year, and is projecting 2026 sales to come in at between $230 million and $260 million.