Vanda Pharmaceuticals has received regulatory clearance from the U.S. Food and Drug Administration for BYSANTI, a medication intended for adults experiencing manic episodes associated with Bipolar I disorder as well as symptoms of schizophrenia. The company said the approval comes days after a prior regulatory win, making this its second FDA clearance in less than two months following the December approval of NEREUS.
The approval confers New Chemical Entity status on BYSANTI - also known as milsaperidone - a designation that typically brings extended periods of market exclusivity. Vanda holds a patent on the new compound that extends to 2044, effectively shielding the medicine from generic competition for nearly two decades.
Investors reacted swiftly. Vanda's shares climbed 44% in after-hours trading immediately following the announcement as market participants adjusted to the prospect of a long-lived revenue stream tied to the newly approved therapy.
While BYSANTI is a distinct chemical entity, the company noted that it demonstrates bioequivalence to iloperidone, marketed as Fanapt. That relationship appears to have accelerated the review timeline compared with the pace typical for novel therapies. The drug's mechanism involves modulation of dopamine and serotonin pathways, and its pronounced alpha-adrenergic binding is highlighted as a characteristic that may make it an option for patients who present with acute agitation or hostility.
Beyond the immediate indication, Vanda is pursuing further clinical development for BYSANTI. The drug is currently under investigation as a treatment for major depressive disorder, with topline results expected by the end of 2026. Positive data in that indication could broaden the patient population eligible for the medicine and potentially increase future revenue streams.
Analysts had previously assigned a market-cap assessment that reflected a "Sell" or "Flat" consensus for the company. The back-to-back approvals could prompt market participants and research analysts to revisit those valuations and growth expectations, given the extended exclusivity conferred by the 2044 patent expiration.
For now, the immediate market response has been decisive, but the company’s longer-term commercial performance will depend on rollout, uptake among prescribers, and the outcomes of ongoing clinical studies. The patent horizon and the bioequivalence to an established agent provide a clear framework for how BYSANTI will be positioned in the market as it moves from approval to commercialization.