The U.S. Food and Drug Administration has approved Vanda Pharmaceutical's drug for the treatment of two serious mental health conditions, the company said on Friday.

WASHINGTON, Feb. 20, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved BYSANTI™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. BYSANTI™ is a new chemical entity (NCE) that belongs in the class of atypical antipsychotics.

Vanda Pharmaceuticals reported weak FY25 results, with a GAAP EPS miss and heavy losses, despite 9% revenue growth driven by Fanapt. VNDA's valuation is deeply discounted, trading at 1.4x forward sales and 0.5x EV/sales, reflecting high regulatory and execution risk. Upcoming catalysts include the Nereus launch and Bysanti's PDUFA decision; approval could diversify revenues but is far from guaranteed.

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA - Get Free Report) has received an average rating of "Moderate Buy" from the seven brokerages that are currently covering the firm, MarketBeat Ratings reports. One research analyst has rated the stock with a sell rating, one has assigned a hold rating, four have given a buy rating and one has

Vanda Pharmaceuticals Inc. (VNDA) Q4 2025 Earnings Call Transcript

NEW YORK, Feb. 12, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ: VNDA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

Vanda Pharmaceuticals (VNDA) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of a loss of $2.18. This compares to a loss of $0.08 per share a year ago.

Full year 2025 Fanapt® net product sales increased by 24% to $117.3 million compared to full year 2024 Full year 2025 total revenues increased by 9% to $216.1 million compared to full year 2024 NEREUS™ (tradipitant) approved for the prevention of vomiting induced by motion Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026 WASHINGTON, Feb. 11, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2025. "2025 showed strong momentum at Vanda, led by Fanapt, with net product sales up 24% to $117.3 million, driven by a 28% rise in total prescriptions and 149% surge in new-to-brand prescriptions - reflecting accelerating growth in schizophrenia and bipolar I disorder.

Conference Call and Webcast to Follow WASHINGTON, Feb. 4, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the fourth quarter and full year 2025 on Wednesday, February 11, 2026, after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, February 11, 2026, during which management will discuss the fourth quarter and full year 2025 financial results and other corporate activities.

NEW YORK, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Vanda Pharmaceuticals Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com  or 646-581-9980, ext. 7980.