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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

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).

Jul 16, 2026 12:30 PM • prnewswire.com
NEREUS™ Powers Forward: Sponsors No. 47 IndyCar Entry, Celebrating 47 Years Since Last New U.S. Motion Sickness Treatment

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.

Jul 15, 2026 12:30 PM • prnewswire.com
Vanda Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Investigational Therapy for Charcot-Marie-Tooth Disease Type 2S

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.

Jul 07, 2026 12:30 PM • prnewswire.com
Vanda Pharmaceuticals Announces Orphan Drug Designation in Japan for Imsidolimab in Generalized Pustular Psoriasis

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.

May 27, 2026 03:00 AM • prnewswire.com
Vanda: A Long-Term Pharma Growth Idea, Despite Q1 Earnings Miss

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.

May 13, 2026 09:34 AM • seekingalpha.com
Vanda Pharmaceuticals Announces Participation at May 2026 Investor Conferences

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.

May 07, 2026 02:44 PM • prnewswire.com
Vanda Pharmaceuticals Reports First Quarter 2026 Financial Results

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.

May 06, 2026 12:01 PM • prnewswire.com
Vanda Pharmaceuticals Announces U.S. Commercial Availability of NEREUS™ (tradipitant), the First New Pharmacologic Treatment for People with Motion Sickness in More Than 40 Years

Vanda Pharmaceuticals Announces U.S. Commercial Availability of NEREUS™ (tradipitant), the First New Pharmacologic Treatment for People with Motion Sickness in More Than 40 Years

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.

May 04, 2026 04:00 AM • prnewswire.com
Vanda Pharmaceuticals Announces U.S. Commercial Availability of NEREUS™ (tradipitant), the First New Pharmacologic Treatment for People with Motion Sickness in More Than 40 Years

Vanda Pharmaceuticals Announces U.S. Commercial Availability of NEREUS™ (tradipitant), the First New Pharmacologic Treatment for People with Motion Sickness in More Than 40 Years

Consumers can now order NEREUS™ directly at nereus.us WASHINGTON, May 1, 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.

May 01, 2026 12:35 PM • prnewswire.com
Vanda Pharmaceuticals to Announce First Quarter 2026 Financial Results on May 6, 2026

Vanda Pharmaceuticals to Announce First Quarter 2026 Financial Results on May 6, 2026

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.

Apr 29, 2026 12:30 PM • prnewswire.com
Vanda Pharmaceuticals announces the publication of "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in NEJM Evidence

Vanda Pharmaceuticals announces the publication of "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in NEJM Evidence

WASHINGTON, April 28, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of the original research article titled "Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis" in New England Journal of Medicine (NEJM) Evidence1. The findings of this pivotal phase III study are included in the Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), submitted to the U.S. Food and Drug Administration (FDA) with a target action date of December 12, 2026.

Apr 28, 2026 03:12 PM • prnewswire.com
Contrasting Vanda Pharmaceuticals (NASDAQ:VNDA) and Atrinsic (NASDAQ:PTIX)

Contrasting Vanda Pharmaceuticals (NASDAQ:VNDA) and Atrinsic (NASDAQ:PTIX)

Vanda Pharmaceuticals (NASDAQ: VNDA - Get Free Report) and Atrinsic (NASDAQ: PTIX - Get Free Report) are both small-cap medical companies, but which is the better business? We will compare the two companies based on the strength of their valuation, dividends, institutional ownership, analyst recommendations, risk, earnings and profitability. Insider and Institutional Ownership 88.1% of Vanda Pharmaceuticals

Apr 13, 2026 09:09 PM • defenseworld.net

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