Shares of Vanda Pharmaceuticals (VNDA) got a nice little boost Wednesday morning. Why? Because the company just got a double dose of good news from the Food and Drug Administration. The agency gave the green light to one of Vanda's new drugs and set a firm date to decide on another.
First up, the FDA approved Bysanti, Vanda's new oral treatment for bipolar I disorder and schizophrenia in adults. This isn't just another me-too drug—the company expects it to become a first-line therapy for acute manic or mixed episodes. Think of it as the go-to option doctors reach for first.
Here's the interesting part: Bysanti is bioequivalent to an existing drug called iloperidone. That might sound like a boring technical detail, but it's actually a smart shortcut. It means Bysanti can leverage all the established safety and efficacy data from Vanda's previous drug, Fanapt. And Fanapt has been doing pretty well for itself, with net sales hitting $33.2 million in the last quarter of 2025—that's a 25% jump from the year before.
Vanda plans to have Bysanti on the market by the third quarter of 2026. Once it's out there, the company gets to enjoy marketing exclusivity all the way until 2044. That's a long runway. Oh, and they're not stopping with bipolar and schizophrenia—they're also testing Bysanti as a treatment for major depressive disorder, with studies expected to wrap up by the end of this year.
But wait, there's more. The FDA also accepted Vanda's application for a completely different drug called imsidolimab. This one treats a rare and nasty skin condition called Generalized Pustular Psoriasis, or GPP. Sometimes it's called von Zumbusch psoriasis, which sounds like a villain from a fantasy novel but is actually a real disease where patients suddenly break out in widespread, sterile, pus-filled blisters. It comes with systemic symptoms like fever and fatigue, making it as miserable as it sounds.
The FDA set a target action date of December 12 to make its decision. So by Christmas, Vanda should know if it has another approved drug on its hands.
The clinical data for imsidolimab looks promising. In the pivotal studies, a single intravenous dose led to rapid disease clearance. At Week 4, 53% of patients on the drug had clear or almost clear skin, compared to just 13% on placebo. That's a pretty dramatic difference. The effect held up during a maintenance period of about two years with monthly doses, and—importantly—no disease flares occurred in the treatment group.
Now, let's talk about the stock. Vanda shares were up about 4.5% to $8.53 on the news. That positive move came amid a generally upbeat market, with the S&P 500 and Nasdaq both gaining ground the previous day.
But if you look under the hood, the technical picture is a bit mixed. The stock is currently trading 5.5% below its 20-day simple moving average and 10.2% below its 100-day average, which suggests some short-term weakness. The Relative Strength Index is sitting right at 50, which is neutral territory—not overbought, not oversold. Meanwhile, the MACD indicator is showing bearish pressure.
So the momentum signals are giving conflicting reads. For the technically inclined, key resistance sits at $9.50, while support is at $8.00.
Zooming out, the stock is up 25% over the past 12 months and is trading closer to its 52-week highs than its lows. And analysts seem to like what they see. The consensus rating is a Buy, with an average price target of $18.11—that's more than double the current price. Recently, HC Wainwright & Co. raised its target to $24.00, and B. Riley Securities bumped theirs to $14.00.
So here's the story: Vanda just got one drug approved and another one into the FDA's review queue with a set decision date. That's two significant regulatory milestones in one day. The stock reacted positively, though it's navigating some technical headwinds. For a biotech company, days like this are what you work for—when the regulators say "yes" and the market says "we see you."












