VNDA News & Events

Vanda Pharmaceuticals announced that the FDA has accepted the filing of its Biologics License Application, or BLA, for imsidolimab for the treatment of Generalized Pustular Psoriasis, or GPP, with a target action date of December 12. 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. The pathogenesis of GPP is increasingly understood through its genetic characterization (OMIM #614204), and its molecular etiology is mainly attributed to excessive activity of the interleukin-36, or IL-36, pathway.1 The majority of GPP cases for which a causal single gene defect has been identified are caused by various consequential genetic variants in the IL36RN gene, encoding the IL-36 receptor antagonist. Imsidolimab is a fully humanized IgG4 monoclonal antibody that inhibits IL-36 receptor signaling and is believed to achieve its therapeutic effects in GPP where IL-36 signaling is unbalanced. If approved, imsidolimab could address a significant unmet medical need in this rare and life-threatening disorder with potential benefits over currently existing treatments. Imsidolimab was studied in global clinical studies conducted in the United States, France, Spain, Poland, Turkey, Malaysia, Thailand, Georgia, Tunisia, Taiwan, and Morocco. In the pivotal efficacy studies GEMINI-1 and GEMINI-2, a single intravenous dose of imsidolimab led to rapid disease clearance, with 53% of patients achieving clear or almost clear skin at Week 4 compared to 13% on placebo. If imsidolimab is approved, it will be the third new drug product approved for Vanda in the past 12 months, following NEREUS and BYSANTI.

The major averages were sharply lower, with the Big Three indices all slipping 1% or more following the latest updates on the tariff front. After the Supreme Court struck down broad tariff authority previously used by the administration, the administration promptly announced a new 15% global tariff plan under a different statute. Markets also appeared to be reacting to another wave of AI worries, with the latest bout triggered by a Citrini Research report that paints a picture of an AI-driven economic downturn, with mass white collar layoffs creating a deflationary cascade.The tariff developments have spilled over into commodity markets, with safe haven assets such as gold and silver seeing support as traders brace for policy-driven volatility and reposition for uncertainty.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:President Trump raised the so-called "Worldwide tariff" onMeanwhile, Trump demanded that Netflixfire board member Susan Rice orNovo Nordisksaid its REDEFINE 4 trialGileadArcellxin a deal with an implied equity value of $7.8B payable at closingAmazonannouncedin Louisiana for data centers2. WALL STREET CALLS:Alphabetto Overweight at Wells FargoAletheiaNvidiato Buy into Q4 earnings reportDeereto Underperform at JefferiesVF Corp.to Underweight at JPMorganYork Space Systemswith mostly Buy and equivalent ratings as Wall Street rolls out coverage3. AROUND THE WEB:AppleCEO Tim Cook's increased mentions of Visual Intelligence, AI technology that can see the surrounding environment and use that context to take action, hint it will be a major part of Apple's new wearables, Bloomberg saysMerckis planning to split its human-health business into two divisions, one that will house its cancer drugs and the other will sell noncancer products, WSJ reportsJPMorganCEO is looking to persuade investors that spending $2B a week is necessary to drive the bank's future growth after previously telling shareholders to "trust him" that the investment would pay off, FT saysParamount Skydanceis preparing to submit an improved offer above $30/share for Warner Bros. Discoveryby Monday's 11:59p.m. ET deadline, aiming to outbid Netflix, Variety reportsInvestor Ed Garden has built a stake in Fortune Brands Innovationsand is seeking to replace incoming CEO Amit Banati, citing concerns about leadership, WSJ says4. MOVERS:Enhabitincreases after entering anby Kinderhook Industries in an all-cash transaction for a total of $1.1BVanda Pharmaceuticalsgains after the FDAPayPalhigher after Bloomberg reported the company isSatellogicfalls after announcing theDocuSignlower after Jefferiesthe stock to Hold5. EARNINGS/GUIDANCE:Domino's Pizzareportedand raised its quarterly dividend 15%Dominionand provided guidance for FY26Emera, with CEO Scott Balfour commenting, "Without question, 2025 was a strong year for Emera"Freshpet, with EPS beating consensusFreightosand provided guidance for Q1 and FY26INDEXES:The Dow fell 821.91, or 1.66%, to 48,804.06, the Nasdaq lost 258.80, or 1.13%, to 22,627.27, and the S&P 500 declined 71.76, or 1.04%, to 6,837.75.

The major averages were sharply lower, with the Big Three indices all slipping 1% or more following the latest updates on the tariff front. After the Supreme Court struck down broad tariff authority previously used by the administration, the ruling also introduced uncertainty around trade policy when the administration promptly announced a new 15 % global tariff plan under a different statute.The tariff developments have spilled over into currency and commodity markets, with the U.S. dollar softening and safe haven assets such as gold and silver seeing support as traders brace for policy-driven volatility and reposition for uncertainty.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:President Trump raised the so-called "Worldwide tariff" onMeanwhile, Trump demanded that Netflixfire board member Susan Rice orNovo Nordisksaid its REDEFINE 4 trial did not achieveGileadArcelexin a deal with an implied equity value of $7.8B payable at closingDomino's Pizzareportedand raised its quarterly dividend 15%2. WALL STREET CALLS:Alphabetto Overweight at Wells FargoAletheiaNvidiato Buy into Q4 earnings reportDeereto Underperform at JefferiesVF Corp.to Underweight at JPMorganYork Space Systemswith mostly Buy and equivalent ratings as Wall Street rolls out coverage3. AROUND THE WEB:AppleCEO Tim Cook's increased mentions of Visual Intelligence, AI technology that can see the surrounding environment and use that context to take action, hint it will be a major part of Apple's new wearables, Bloomberg saysMerckis planning to split its human-health business into two divisions, one that will house its cancer drugs and the other will sell noncancer products, WSJ reportsJPMorganCEO is looking to persuade investors that spending $2B a week is necessary to drive the bank's future growth after previously telling shareholders to "trust him" that the investment would pay off, FT saysParamount Skydanceis preparing to submit an improved offer above $30/share for Warner Bros. Discoveryby Monday's 11:59p.m. ET deadline, aiming to outbid Netflix, Variety reportsInvestor Ed Garden has built a stake in Fortune Brands Innovationsand is seeking to replace incoming CEO Amit Banati, citing concerns about leadership, WSJ says4. MOVERS:Enhabitincreases after entering an agreement to bein an all-cash transaction for a total of $1.1BVanda Pharmaceuticalsgains after thePayPal (PYPL) higher after Bloomberg reported the company isSatellogicfalls after announcing theDocuSignlower after Jefferiesthe stock to Hold5. EARNINGS/GUIDANCE:Dominionand provided guidance for FY26Emera, with CEO Scott Balfour commenting, "Without question, 2025 was a strong year for Emera"Freshpet, with EPS beating consensusFreightosand provided guidance for Q1 and FY26Axsome Therapeutics, with EPS and revenue beating consensusINDEXES:Near midday, the Dow was down 1.45%, or 717.60, to 48,908.37, the Nasdaq was down 1.11%, or 253.14, to 22,632.92, and the S&P 500 was down 1.00%, or 69.12, to 6,840.39.