Vanda Pharmaceuticals stock surges after the FDA approves its new Bipolar I drug

SelfRugger

2026-02-21 04:29:20

Vanda Pharmaceuticals stock surges after the FDA approves its new Bipolar I drug

Investing.com

Sat, February 21, 2026 at 11:22 AM GMT+9 2 min read

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VNDA

-5.57%

Investing.com – Vanda Pharmaceuticals (NASDAQ: VNDA) just announced that it has received FDA-approval for its new drug known as BYSANTI. The drug is meant to treat Bipolar I manic episodes as well as Schizophrenia symptoms in adults.

The approval marks Vanda’s second FDA win in less than two months, following the December approval of NEREUS™.

A long-term revenue moat

This is a major breakthrough for Vanda, given that the new drug has been categorised as a “New Chemical Entity”, a designation that usually comes with robust patient protection. The company’s patent of the new drug extends up to 2044. Therefore, it does not have to deal with generic competitors for almost two decades.

Vanda stock surged 44% after-hours as investors piled into the stock after the announcement.

BYSANTI™, also known as “milsaperidone” was approved much faster than most new drugs because it is closely related to an older drug called Fanapt.

Leveraging a proven pedigree

While BYSANTI is a new entity, it demonstrates bioequivalence to iloperidone (marketed as Fanapt®). This allows Vanda to enter the market with a “trusted safety profile” backed by over 100,000 patient-years of real-world data. The drug works by modulating dopamine and serotonin pathways, but its unique “strong alpha-adrenergic binding” could make it a preferred choice for patients suffering from acute agitation and hostility.

Commercial outlook and pipeline expansion

The drug’s future is promising given that it is currently being tested as a treatment for major depressive disorder, with the results expected by the end of 2026, which could significantly expand its market size and future revenues.

The bottom line

With a market cap currently reflecting a “Sell” or “Flat” analyst consensus, this back-to-back approval streak could force a re-evaluation of VNDA’s growth trajectory. The 2044 patent expiration is the key highlight here, offering a degree of terminal value that is often rare in small-cap biotech.

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