Vanda Wins FDA Approval for Bysanti Antipsychotic Therapy

Vanda ( (VNDA) ) has issued an update.

On February 20, 2026, Vanda Pharmaceuticals announced that the U.S. Food and Drug Administration approved Bysanti (milsaperidone) tablets as a first-line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. The new chemical entity, an atypical antipsychotic that rapidly converts to iloperidone and shares its established safety profile, leverages extensive clinical and real-world data from Fanapt, is being further studied as an adjunctive therapy in treatment-resistant major depressive disorder, and is expected to reach the U.S. market in the third quarter of 2026 with patent and data exclusivity protection into 2044, marking Vanda’s second drug approval in under two months and strengthening its position in psychiatric therapeutics.

Vanda highlighted Bysanti’s receptor binding profile, including strong alpha-adrenergic activity relative to dopamine and serotonin, as a rationale for exploring additional indications characterized by hostility, agitation and hyperarousal symptoms. The company emphasized that the drug’s approval, coming shortly after the December 2025 clearance of Nereus, underpins a period of accelerated innovation that could expand treatment options for millions of U.S. adults living with bipolar I disorder and schizophrenia while supporting Vanda’s growth prospects in the competitive antipsychotic market.

The most recent analyst rating on (VNDA) stock is a Buy with a $24.00 price target. To see the full list of analyst forecasts on Vanda stock, see the VNDA Stock Forecast page.

Spark’s Take on VNDA Stock

According to Spark, TipRanks’ AI Analyst, VNDA is a Neutral.

The score is held back primarily by weak financial performance—deep 2025 losses, heavy cash burn, and declining equity—despite low leverage. Offsetting factors include a constructive longer-term technical trend and earnings-call positives (2026 growth guidance, strong Fanapt momentum, and Nereus approval), though valuation remains constrained by losses and regulatory/execution risks.

To see Spark’s full report on VNDA stock, click here.

More about Vanda

Vanda Pharmaceuticals Inc. is a global biopharmaceutical company focused on developing and commercializing innovative therapies that address high unmet medical needs in areas such as behavioral health. The Nasdaq-listed firm’s portfolio includes treatments for psychiatric and neurological disorders, reflecting a strategic emphasis on long-term innovation and specialty care markets.

Average Trading Volume: 1,761,520

Technical Sentiment Signal: Hold

Current Market Cap: $356.4M

Learn more about VNDA stock on TipRanks’ Stock Analysis page.