VNDA

WASHINGTON, July 7, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to VCA-894A, Vanda's investigational antisense oligonucleotide therapy for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), a rare, serious, and progressive inherited neurological disorder. The designation was granted by the FDA's Office of Orphan Products Development and Office of Pediatric Therapeutics.

WASHINGTON, May 27, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to imsidolimab, a high‑affinity humanized immunoglobulin G4 (IgG4) monoclonal antibody, for the treatment of generalized pustular psoriasis (GPP). Imsidolimab inhibits interleukin‑36 (IL‑36) receptor signaling, addressing the deficiency in the endogenous IL‑36 receptor antagonist regulator that is commonly observed in patients with GPP.1 The MHLW grants orphan drug designation to medicines intended to treat rare diseases with significant unmet medical need.

Vanda Pharmaceuticals is rated a buy, supported by new drug approvals, a diversified clinical pipeline, and strong top-line growth potential. VNDA's near-zero debt and undervalued price/book ratio offer balance sheet strength and significant upside, with Wall St. forecasting considerable price appreciation as of Tuesday's data. Earnings and cash flow trends remain weak, with persistent operating losses, high R&D costs, and no profitability expected until at least 2030.

Vanda Pharmaceuticals Inc. (VNDA) Q1 2026 Earnings Call Transcript

Fanapt ® net product sales rose 26% to $29.6 million; total prescriptions increased 32% and new-to-brand prescriptions surged 76% NEREUS™ (tradipitant) launched via nereus.us, an innovative direct-to-consumer platform – the first new prescription medicine in more than 40 years for the prevention of vomiting induced by motion, with convenient online ordering and rapid direct home delivery Full-year 2026 revenue guidance raised to $240-$290 million, including $10-30 million from newly launched NEREUS™ BYSANTI™ (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia on February 20, 2026 Imsidolimab BLA for Generalized Pustular Psoriasis accepted for FDA review; PDUFA target action date of December 12, 2026 WASHINGTON, May 6, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2026. "Vanda delivered strong commercial execution in the first quarter, highlighted by 26% growth in Fanapt sales, the groundbreaking U.S. launch of NEREUS with its pioneering direct-to-consumer platform at nereus.us, and the FDA approval of BYSANTI," said Mihael H.

The mean of analysts' price targets for Vanda (VNDA) points to a 105% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Consumers can now order NEREUS™ directly at nereus.us WASHINGTON, May 4, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that NEREUS™ (tradipitant) is now commercially available across the United States for the prevention of vomiting induced by motion in adults, marking the first new prescription medicine approved for this condition in more than 40 years. An innovative direct-to-consumer order platform is now available through nereus.us.

Conference Call and Webcast to Follow WASHINGTON, April 29, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2026 on Wednesday, May 6, 2026, after the market closes. Vanda will host a conference call at 4:30 PM ET on Wednesday, May 6, 2026, during which management will discuss the first quarter 2026 financial results and other corporate activities.

Incyte (INCY) came out with quarterly earnings of $1.81 per share, beating the Zacks Consensus Estimate of $1.38 per share. This compares to earnings of $1.16 per share a year ago.

WASHINGTON, April 9, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today highlighted a legislative proposal contained in the FDA's FY 2027 Congressional Budget Justification. The proposal would eliminate the simple statutory requirement that the FDA must review a new drug application (NDA) within 180 days of filing.