Vanda Pharmaceuticals (NASDAQ:VNDA) shares are up during Wednesday’s premarket session following the FDA’s approval of Bysanti, a new oral treatment for bipolar I disorder and schizophrenia, as well as the company’s rare skin disease drug is under FDA review.
This approval marks a significant milestone for Vanda, as it positions the company to potentially capture a substantial market share in these therapeutic areas, which is reflected in the stock’s positive movement following the news.
Seeks FDA Approval For Rare Skin Disease Drug
On Wednesday, the U.S. Food and Drug Administration (FDA) accepted Vanda Pharmaceuticals’ Biologics License Application (BLA) for imsidolimab for Generalized Pustular Psoriasis (GPP), with a target action date of December 12.
GPP is a rare inflammatory skin disorder, sometimes called von Zumbusch psoriasis, characterized by the sudden eruption of widespread, sterile, pus-filled blisters (pustules) on erythematous skin and systemic symptoms such as fever and fatigue
In the pivotal efficacy studies GEMINI-1 and GEMINI-2, a single intravenous dose of imsidolimab led to rapid disease clearance, with 53% of patients achieving clear or almost clear skin at Week 4 compared to 13% on placebo.
Efficacy was maintained throughout an approximately 2-year maintenance period with monthly doses, and no flares occurred in the active treatment arm.
FDA Approves Vanda’s Bysanti for Bipolar, Schizophrenia
The FDA’s approval of Bysanti is expected to make it a first-line therapy for acute treatment of manic or mixed episodes associated with bipolar I disorder and schizophrenia in adults.
The company anticipates that Bysanti will be commercially available in the third quarter of 2026, with marketing exclusivity projected to last until 2044.
In clinical studies, Bysanti demonstrated bioequivalence to iloperidone, leveraging the established efficacy and safety data from Vanda’s previous drug, Fanapt, which saw net product sales of $33.2 million in the fourth quarter of 2025, reflecting a 25% increase year-over-year.
The company is also exploring Bysanti as a treatment for major depressive disorder, with ongoing clinical studies expected to conclude by the end of this year.
The broader market experienced gains on the previous trading day, with the S&P 500 rising by 0.34% and the Nasdaq gaining 0.42%. Vanda’s stock movement aligns with this positive sentiment, suggesting that the approval news has resonated well with investors amid a generally favorable market backdrop.
VNDA Shows Short-Term Weakness in Technical Analysis
Currently, Vanda Pharmaceuticals is trading 5.5% below its 20-day simple moving average (SMA) and 10.2% below its 100-day SMA, indicating short-term weakness. Over the past 12 months, shares have increased by 25% and are currently positioned closer to their 52-week highs than lows.
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: $8.00
Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $18.11. Recent analyst moves include:
- HC Wainwright & Co.: Buy (Raises Target to $24.00) (Feb. 23)
- B. Riley Securities: Buy (Raises Target to $14.00) (Dec. 31, 2025)
VNDA Price Action: Vanda Pharmaceuticals shares were up 4.53% at $8.53 at the time of publication on Wednesday, according to Benzinga Pro data.
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