The U.S. Food and Drug Administration has extended the deadline for the expedited re‑review of the partial clinical hold that limits long‑term studies of Vanda’s neurokinin‑1 antagonist tradipitant. The new target completion date is December 5, 2025, up from the original November 26, 2025, a change prompted by personnel and leadership transitions within the Center for Drug Evaluation and Research.
The company’s new‑drug application for tradipitant remains on schedule, with a PDUFA target action date of December 30, 2025. Labeling discussions between Vanda and the FDA have formally begun, marking a key step toward potential approval and the first new pharmacologic treatment for motion sickness in more than four decades.
Vanda’s financial profile underscores the significance of this regulatory progress. The company reports a gross profit margin of 94.4 % but a trailing‑12‑month operating margin of –57.1 % and a net margin of –39.7 %. Revenue growth over the past three years has declined 10.2 %, reflecting the company’s early‑stage status and the need for additional capital to support commercialization of tradipitant.
The regulatory update follows a series of setbacks, including the FDA’s rejection of Vanda’s tradipitant NDA for gastroparesis in September 2024 and disputes over the company’s other product, Hetlioz. Tradipitant is also in development for nausea and vomiting associated with GLP‑1 receptor agonists, and recent data suggest it can halve vomiting rates in patients on Wegovy. The FDA’s leadership change—Richard Pazdur’s appointment to head CDER—has added a new dynamic to the review process.
The combination of an extended hold re‑review deadline, an unchanged PDUFA target, and the initiation of labeling discussions signals a clear path toward approval. If approved, tradipitant could unlock a sizable market and provide Vanda with a first‑in‑class product, potentially transforming the company’s revenue trajectory and competitive position in the motion‑sickness treatment space.
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