Vanda Pharmaceuticals (NASDAQ:VNDA) shares are trading higher during the premarket session on Monday following the announcement of FDA approval for Bysanti (milsaperidone), a new treatment for bipolar I disorder and schizophrenia.

FDA Approval

The FDA’s approval of Bysanti marks a significant milestone for Vanda, as it is positioned as a first-line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults.

Bysanti is a new chemical entity (NCE) that belongs to the class of atypical antipsychotics.

In clinical studies, Bysanti demonstrated bioequivalence to iloperidone across the therapeutic dosing spectrum, enabling it to leverage well-established knowledge of efficacy and safety derived from the clinical development program and more than 100,000 patient-years of real-world experience with the company’s Fanapt (iloperidone).

Fanapt net product sales were $33.2 million in the fourth quarter of 2025, a year-over-year increase of 25%.

Commercial Roadmap

The company anticipates commercial availability of Bysanti in the third quarter of 2026, with marketing exclusivity expected to be protected by regulatory data exclusivity and US patents expiring in 2044.

In addition to this approval, Bysanti is currently being tested as a once-daily adjunctive treatment for treatment-resistant major depressive disorder, with ongoing clinical studies expected to conclude by the end of this year.

Technical Analysis

The stock is currently trading 5.5% below its 20-day simple moving average (SMA) and 10.2% below its 100-day SMA, indicating some short-term weakness.

Over the past 12 months, shares have increased by 25%, and they are currently positioned closer to their 52-week highs than lows, suggesting a relatively strong performance in the longer term.

The RSI is at 50.00, which is considered neutral territory, indicating that the stock is neither overbought nor oversold.

Meanwhile, MACD is at 0.10, below its signal line at 0.15, indicating bearish pressure on the stock.

The combination of neutral RSI and bearish MACD suggests mixed momentum, indicating that traders should be cautious as the stock navigates its current technical setup.

• Key Resistance: $9.50
• Key Support: $7.50

Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $18.10. Recent analyst moves include:

• HC Wainwright & Co.: Buy (Raises Target to $22.00) (Jan. 5)
• B. Riley Securities: Buy (Raises Target to $14.00) (Dec. 31, 2025)
• Jefferies: Hold (Raises Target to $7.50) (Dec. 31, 2025)

VNDA Price Action: Vanda Pharmaceuticals shares were up 35.59% at $7.81 during premarket trading on Monday, according to Benzinga Pro data.

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