VNDA Stock Surges on BLA Filing for Imsidolimab as FDA Path Accelerates for Rare Skin Disorder Treatment

Vanda Pharmaceuticals shares rallied 6.10 percent to $6.61 in pre-market trading on Monday following a significant regulatory milestone. The company has successfully filed its Biologics License Application with the FDA, seeking approval of imsidolimab as a therapeutic intervention for generalized pustular psoriasis—a severe and chronic autoinflammatory skin condition affecting a limited patient population.

The regulatory submission is underpinned by compelling clinical evidence. The global Phase 3 GEMINI-1 and GEMINI-2 trials demonstrated that a single intravenous administration of imsidolimab achieved swift and substantial disease clearance in patients. These encouraging findings provided the clinical foundation necessary for the BLA filing.

Recognizing the urgent medical need, Vanda has requested priority review status from the FDA for the imsidolimab application. Should the regulatory authority grant this expedited designation, the review timeline would compress to six months, potentially paving the way for FDA approval as early as the middle of 2026. This accelerated pathway reflects the high unmet need in treating this debilitating condition.

CEO Mihael Polymeropoulos highlighted the company’s readiness: “We are optimistic about FDA approval and plan to fully deploy our established commercial infrastructure to make this breakthrough therapy accessible to patients suffering from this serious disorder.” The statement underscores Vanda’s commitment to bringing imsidolimab to market efficiently once regulatory clearance is obtained, positioning the company to capture the opportunity in the rare dermatological disease space.