New York, February 23, 2026, 16:52 (ET) — After-hours
- Vanda shares closed up about 41% as traders chased FDA approval of its new antipsychotic, Bysanti
- A regulatory filing detailed the approval and pointed to a U.S. launch in the third quarter
- Analysts cheered the catalyst, but flagged questions on demand versus Vanda’s older drug Fanapt
Vanda Pharmaceuticals Inc (VNDA.O) shares closed up 41% on Monday after a regulatory filing said the U.S. Food and Drug Administration approved its new antipsychotic pill, Bysanti. The stock ended at $8.15, up $2.39, with roughly 47.6 million shares traded — about 26 times its average daily volume, according to market data. (Finviz)
The size of the move matters because Vanda has lived in small-cap territory for years, and FDA decisions can reset the conversation fast. A second branded product in psychiatry gives the company another near-term launch to sell, not just another pipeline slide.
It also lands Vanda in a messy part of the market. Antipsychotics are crowded, payers can be slow, and prescribers tend to stick with what they know unless a new drug offers a clear reason to switch.
In the press release attached to the filing, Vanda said Bysanti (milsaperidone) is approved for adults with schizophrenia and for acute manic or mixed episodes tied to bipolar I disorder. Chief executive Mihael H. Polymeropoulos called it “a reliable new treatment grounded in extensive clinical heritage,” and the company said it expects U.S. commercial availability in the third quarter and marketing exclusivity backed by data exclusivity and patents, with the latest expiring in 2044; it also said a depression study is expected to complete by the end of the year. (SEC)
Bysanti “rapidly interconverts” to iloperidone, and works by blocking key brain receptors tied to dopamine and serotonin signalling, according to drug information published after the approval. The label carries the class’s familiar boxed warning about increased mortality in elderly patients with dementia-related psychosis. (Drugs)
Not everyone is sold on the commercial story. Jefferies analyst Andrew Tsai said ahead of the approval it will be interesting how Bysanti sales shape up because it is “essentially more or less the same drug” as Fanapt, and he raised the question of why patients would choose Bysanti if Fanapt goes generic around late 2027 or 2028; Tsai models about $200 million of Bysanti sales by 2033. (Reuters)
Some analysts moved quickly the other way. H.C. Wainwright raised its price target on Vanda to $24 from $22 and kept a buy rating after the FDA decision, according to a note reported on Monday. (TipRanks)
Vanda framed the approval as part of a run of recent regulatory wins, calling Bysanti its second new drug approval in less than two months after Nereus in December. (PR Newswire)
But the trade from here is less about the FDA headline and more about execution — access, pricing, and whether doctors see enough separation from existing options to write it. Any stumble in launch timing, slower coverage decisions, or a sharper-than-expected hit from future generic competition would make Monday’s move look stretched.
Investors now watch for Vanda to firm up its commercialization plan ahead of the third-quarter rollout and for results from its depression study later this year — the next two markers that could put numbers behind the approval.
