Vanda Announces Submission of Biologics License Application to the FDA for Imsidolimab for the Treatment of Generalized Pustular Psoriasis [Yahoo! Finance]
Vanda Pharmaceuticals Inc. (VNDA)
Last vanda pharmaceuticals inc. earnings: 2/25 04:01 pm
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Source: Yahoo! Finance
Food and Drug Administration (FDA) for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP). Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36RA regulator commonly seen in GPP patients due to IL36RN gene mutations. The BLA is supported by positive results from the global Phase 3 GEMINI-1 and GEMINI-2 studies, where a single intravenous dose of imsidolimab led to rapid disease clearance, achieving clear or almost clear skin, with efficacy maintained throughout an approximately 2-year maintenance study period with monthly doses. Imsidolimab demonstrated a favorable safety profile with no clinically meaningful safety signals. 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. Driven primarily by loss-of-function mutations in IL36RN, GPP represents a significan
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News
- Vanda Announces Submission of Biologics License Application to the FDA for Imsidolimab for the Treatment of Generalized Pustular PsoriasisPR Newswire
- Vanda Pharmaceuticals Announces Participation in the J.P. Morgan Healthcare ConferencePR Newswire
- FDA Lifts Partial Clinical Hold on Tradipitant for Motion Sickness [Yahoo! Finance]Yahoo! Finance
- FDA Lifts Partial Clinical Hold on Tradipitant for Motion SicknessPR Newswire
- Vanda Pharmaceuticals (NASDAQ:VNDA) had its "buy" rating reaffirmed by analysts at HC Wainwright.MarketBeat
VNDA
Earnings
- 10/29/25 - Miss
VNDA
Sec Filings
- 12/4/25 - Form 8-K
- 11/28/25 - Form 8-K
- 10/30/25 - Form 10-Q
- VNDA's page on the SEC website