Vanda Stock Draws Heavy Buzz Ahead Of FDA Verdict On Bysanti For Bipolar, Schizophrenia

The company said that if approved, Bysanti could be available for sale in the U.S. this year.

• The FDA has set a Feb. 21 target decision on the Bysanti NDA.
• Vanda submitted the NDA in March 2025 for Bysanti to treat acute bipolar I disorder and schizophrenia.
• In May, the FDA said the application had been filed and that no potential review issues were identified.

Shares of Vanda Pharmaceuticals Inc. (VNDA) drew heightened retail chatter early Thursday ahead of an upcoming U.S. Food and Drug Administration (FDA) decision related to Bysanti, the company’s investigational mental health drug for acute bipolar I disorder and schizophrenia. 

VNDA stock fell nearly 3% to $6.03 on Wednesday and shed another 0.3% in extended trading. 

FDA Review Underway For Bysanti NDA

The FDA has set Feb.21 as the target date for its decision on the New Drug Application (NDA).

In March 2025, Vanda submitted an NDA to the FDA seeking marketing approval of Bysanti for the treatment of acute bipolar I disorder and schizophrenia, supported by several clinical studies assessing the efficacy and safety of the drug.

In May 2025, Vanda said the FDA informed the company that the NDA had been filed and that, at that time, no potential review issues had been identified. Vanda said that if approved, Bysanti could be available for sale in the U.S. this year. 

How Bysanti Works

Bysanti is a drug in the atypical antipsychotic class. The company said its active ingredient, Milsaperidone, was first identified as a breakdown product of the existing drug Iloperidone and that, when taken by mouth, it is quickly converted into iloperidone in the body.

According to Vanda, clinical studies showed that Milsaperidone and Iloperidone were bioequivalent at both low and high doses, across single- and multiple-dose studies. 

The company said Bysanti’s effectiveness and safety for treating bipolar I manic and mixed episodes and schizophrenia are supported by earlier clinical studies of iloperidone. These include two studies in people experiencing acute episodes of schizophrenia, one study in patients with bipolar I disorder with manic or mixed episodes, and one study focused on preventing relapse in schizophrenia.

Vanda said the safety profile is further supported by data from several thousand patients exposed to iloperidone in clinical studies, as well as post-marketing experience representing more than 80,000 patient-year exposures.

Vanda Expands Bysanti Into Depression Study

Bysanti is also under development as a once-daily adjunctive treatment for major depressive disorder in patients with inadequate response to their current treatment. Vanda said a Phase III clinical study for this indication was initiated in the fourth quarter of 2024.

If approved, Bysanti would be eligible for five years of regulatory data exclusivity, and related patent applications, if issued, could extend into the 2040s.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment for VNDA shifted to ‘bullish’ from ‘extremely bullish’ over the past day amid ‘high’ message volume.

One user said, “If the stock pulls back to $5.30, it may present a solid buy-and-hold opportunity ahead of the decision.”

Meanwhile, another user said, “I have very bad feelings about Bysantis getting approved. Has not looked like a hopeful stock AT ALL that has a drug so shortly up for approval.”

VNDA stock has declined 32% so far this year.

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