Vanda Pharmaceuticals Announces EMA Positive Opinion for Orphan Drug Designation of Imsidolimab for Generalized Pustular Psoriasis - A Milestone Recognition of GPP as a Distinct Rare Disease in Europe

WASHINGTON, July 16, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Committee for Orphan Medicinal Products at the European Medicines Agency (EMA) has adopted a positive opinion recommending orphan drug designation for imsidolimab, the company's investigational medicinal product, a high-affinity humanized immunoglobulin G4 (IgG4) monoclonal antibody, for the treatment of generalized pustular psoriasis (GPP). This marks the first time the EMA has granted orphan drug designation recognition for a drug to treat GPP in the European Union (EU).

PRNewsWire • Jul 16, 2026

NEREUS™ Powers Forward: Sponsors No. 47 IndyCar Entry, Celebrating 47 Years Since Last New U.S. Motion Sickness Treatment

WASHINGTON, July 15, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that NEREUS™ (tradipitant), the first new prescription medication approved for prevention of vomiting induced by motion in 47 years, will sponsor the No. 47 entry in the NTT IndyCar Series with Rahal Letterman Lanigan Racing.

PRNewsWire • Jul 15, 2026

Vanda Pharmaceuticals Announces Participation in the B. Riley Securities 2026 Mind, Muscle & Vision Summit

WASHINGTON, July 10, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate in a fireside chat at the B. Riley Securities Mind, Muscle & Vision Summit in Boston, Massachusetts on Thursday, July 16, 2026.

PRNewsWire • Jul 10, 2026

Vanda Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Investigational Therapy for Charcot-Marie-Tooth Disease Type 2S

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.

PRNewsWire • Jul 7, 2026

Vanda Pharmaceuticals Announces Orphan Drug Designation in Japan for Imsidolimab in Generalized Pustular Psoriasis

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.

PRNewsWire • May 27, 2026

Vanda: A Long-Term Pharma Growth Idea, Despite Q1 Earnings Miss

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.

Seeking Alpha • May 13, 2026

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

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

Seeking Alpha • May 7, 2026

Vanda Pharmaceuticals Announces Participation at May 2026 Investor Conferences

WASHINGTON, May 7, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the company will participate at the following upcoming investor conferences in May 2026: The Bank of America Securities Global Health Care Conference 2026 in Las Vegas, Nevada on Tuesday, May 12, 2026. The HCW 4th Annual BioConnect Investor Conference at Nasdaq in New York City on Tuesday, May 19, 2026.

PRNewsWire • May 7, 2026

Vanda Pharmaceuticals Reports First Quarter 2026 Financial Results

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.

PRNewsWire • May 6, 2026

Vanda Pharmaceuticals (VNDA) Reports Q1 Loss, Lags Revenue Estimates

Vanda Pharmaceuticals (VNDA) came out with a quarterly loss of $0.82 per share versus the Zacks Consensus Estimate of a loss of $0.53. This compares to a loss of $0.5 per share a year ago.

Zacks Investment Research • May 6, 2026