VNDA Obtains FDA Nod for Motion Sickness Drug, Stock Gains

Core Insights - Vanda Pharmaceuticals, Inc. (VNDA) received FDA approval for its drug tradipitant, branded as Nereus, for preventing motion sickness-induced vomiting, marking the first new pharmacologic therapy for this condition in over 40 years [1][2][8] - Following the announcement, VNDA shares surged 18% in after-hours trading on December 30 and continued to rise in pre-market trading on December 31 [1][8] Company Developments - The efficacy of Nereus is backed by three clinical studies, including two phase III trials conducted at sea, demonstrating its effectiveness in individuals with a history of motion sickness [3] - VNDA is also exploring tradipitant for other conditions, including gastroparesis and nausea associated with GLP-1 receptor agonists, which are common side effects in obesity and diabetes treatments [4] - VNDA's stock has increased by 38.6% over the past three months, outperforming the industry growth of 13.9% [5] Regulatory Updates - VNDA has established a collaborative framework with the FDA to resolve disputes regarding tradipitant and Hetlioz, with an expedited re-review of the clinical hold on tradipitant's long-term studies now set for completion by December 5, 2025 [6][9] - The FDA has agreed to pause ongoing administrative proceedings related to VNDA's new drug application for tradipitant in gastroparesis until January 7, 2026 [10] - VNDA has submitted a Biologics License Application (BLA) for imsidolimab, a novel treatment for generalized pustular psoriasis, expanding its portfolio in rare diseases [13] Future Prospects - VNDA has multiple upcoming regulatory catalysts, including FDA reviews for Bysanti (milsaperidone) targeting bipolar I disorder and schizophrenia, with a target action date of February 21, 2026 [14]