TLDR
- The FDA approved Vanda Pharmaceuticals’ Bysanti (milsaperidone) for schizophrenia and acute bipolar I disorder.
- Vanda’s stock surged roughly 44% in after-hours trading following the announcement.
- Bysanti converts to iloperidone in the body, making it chemically similar to Vanda’s existing drug, Fanapt.
- Vanda plans to launch Bysanti in the U.S. in Q3 2026, with a phase 3 trial ongoing for major depressive disorder.
- Despite the stock pop, Vanda carries financial red flags including a negative operating margin and a low Altman Z-Score.
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Vanda Pharmaceuticals got a big win on Friday. The U.S. FDA approved its new antipsychotic drug, Bysanti, for the treatment of schizophrenia and acute bipolar I disorder.
Vanda Pharmaceuticals Inc., VNDA
The market reacted fast. VNDA stock jumped roughly 44% in after-hours trading following the news.
Bysanti’s generic name is milsaperidone. It belongs to the atypical antipsychotic class of drugs, which work by blocking dopamine and serotonin receptors in the brain.
Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder a… https://t.co/81N1EAKzAT
— Vanda Pharmaceuticals (@vandapharma) February 21, 2026
Here’s where it gets interesting. Milsaperidone converts into iloperidone once absorbed by the body — and iloperidone is the active ingredient in Vanda’s already-approved drug, Fanapt.
In other words, the two drugs end up producing similar drug levels in the patient. Vanda says Bysanti has a safety profile comparable to Fanapt.
Vanda plans to launch Bysanti in the U.S. during the third quarter of 2026. The company is also running a phase 3 trial testing Bysanti as a once-daily add-on treatment for major depressive disorder, with results expected later this year.
Questions About Market Fit
Not everyone is convinced Bysanti will carve out serious market space.
Jefferies analyst Andrew Tsai pointed out ahead of the approval that Bysanti is “essentially more or less the same drug with similar efficacy and safety” as Fanapt. He questioned why patients would choose Bysanti, especially if Fanapt goes generic around late 2027 or 2028.
Tsai projects Bysanti could reach around $200 million in sales by 2033.
Competitors in the antipsychotic space include Bristol-Myers Squibb’s Cobenfy and Johnson & Johnson’s Caplyta, both approved for schizophrenia and bipolar disorder.
Financial Health Worth Watching
The stock surge is eye-catching, but Vanda’s financials tell a more cautious story.
Revenue came in at $216.11 million, but the company posted a 3-year revenue growth rate of -6.3%. The operating margin sits at -69.95%, and the net margin at -102.02%.
Vanda does show a strong gross margin of 93.96%, which reflects solid product-level profitability before operating costs kick in.
On the balance sheet, the current ratio is 2.39 and the debt-to-equity ratio is a low 0.04, pointing to manageable short-term obligations. But the Altman Z-Score of 0.21 puts the company in the financial distress zone, and a Piotroski F-Score of 3 signals weak business operations.
Institutional investors hold about 76% of the stock. The analyst consensus target price sits at $13.63, suggesting upside from pre-announcement levels.
The 14-day RSI was at 35.52 before the approval news hit, indicating the stock had been approaching oversold territory.
Vanda’s market cap stood at approximately $340.46 million before the after-hours surge.
The company’s existing portfolio includes HETLIOZ for Non-24-Hour Sleep-Wake Disorder and Smith-Magenis Syndrome, alongside Fanapt.
