Vanda Announces FDA Grants Landmark Hearing for HETLIOZ® in Jet Lag Disorder, the First Drug Approval Hearing in Over 40 Years

WASHINGTON, March 3, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has granted the company's request for a formal evidentiary public hearing to review the Center for Drug Evaluation and Research's (CDER) proposal to refuse approval of Vanda's supplemental new drug application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of jet lag disorder. The FDA confirmed the decision to grant a hearing in a letter from the Office of the Commissioner dated March 2, 2026.

PRNewsWire • Mar 3, 2026

Vanda Pharmaceuticals Announces Participation in the 2026 Citizens Life Sciences Conference

WASHINGTON, Feb. 26, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in the 2026 Citizens Life Sciences Conference in Miami on Wednesday, March 11, 2026. A corporate presentation is scheduled for 2:15 p.m.

PRNewsWire • Feb 26, 2026

Vanda Pharmaceuticals Breaks Through With FDA Approval, Decision Date For Skin Drug

Vanda Pharmaceuticals (NASDAQ: VNDA) shares are up during Wednesday's premarket session following the FDA's approval of Bysanti, a new oral treatment for bipolar I disorder and schizophrenia, as well as the company's rare skin disease drug is under FDA review.

Benzinga • Feb 25, 2026

Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular Psoriasis

WASHINGTON, Feb. 25, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026. GPP is a rare, chronic, life-threatening autoinflammatory skin disorder characterized by sudden flares of widespread pustules, erythema, and systemic symptoms such as fever and fatigue.

PRNewsWire • Feb 25, 2026

Vanda Pharmaceuticals stock's explosive rally may be more hype than substance

Vanda Pharmaceuticals (NASDAQ: VNDA) opened some 45% higher today after the biotech firm said it has received the FDA's approval for its treatment of schizophrenia and bipolar I disorder. The BYSANTI (milsaperidone) announcement is a welcome reprieve for VNDA that's been under pressure this year as investors weighed “disappointing” Q4 earnings against a backdrop of clinical uncertainty.

Invezz • Feb 23, 2026

Vanda Pharmaceuticals FDA Approval Dawns A New Era For Bipolar And Schizophrenia Treatment

Vanda Pharmaceuticals (NASDAQ: VNDA) shares are trading higher during the premarket session on Monday following the announcement of FDA approval for Bysanti (milsaperidone), a new treatment for bipolar I disorder and schizophrenia.

Benzinga • Feb 23, 2026

Vanda Pharmaceuticals: Soaring On Bysanti Approval, But You Shouldn't Feel Dizzy

Vanda Pharmaceuticals Inc. has received FDA approval for BYSANTI, a new atypical antipsychotic targeting bipolar I disorder and schizophrenia. VNDA now markets five products, but BYSANTI's differentiation from Fanapt is questioned due to similar active molecules and looming patent expiry. 2025 saw Fanapt sales up 24%, but VNDA posted a $(220.5m) net loss and expects higher cash burn in 2026, raising funding concerns.

Seeking Alpha • Feb 23, 2026

US FDA approves Vanda's psychiatric drug

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.

Reuters • Feb 20, 2026

Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia - A New Chemical Entity Opening New Horizons in Psychiatric Innovation

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.

PRNewsWire • Feb 20, 2026

Vanda Pharma: High Risk, Heavily Discounted - Stock Ahead Of PDUFA This Week

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.

Seeking Alpha • Feb 19, 2026