LLY - Vanda Pharma stock rises after FDA accepts gastroparesis drug for review

2023-12-05 05:53:10 ET

Vanda Pharma ( NASDAQ: VNDA ) shares jumped 19% premarket on Tuesday as the FDA accepted the new drug application (NDA) for tradipitant, an experimental drug for the treatment of gastroparesis.

Tradipitant is a neurokinin 1 antagonist licensed by Vanda ( VNDA ) from Eli Lilly ( LLY ) in 2012. The drug is currently in clinical development for gastroparesis and motion sickness.

The NDA submission includes results from clinical efficacy studies 2301 and 3301, evidence from a large 12-week open label study and data from the Expanded Access program.

The FDA now has until September 18, 2024 to respond to the application. If approved, tradipitant will be the first novel drug to be approved by the FDA for the treatment of gastroparesis in over 40 years and to be accepted for review by the FDA for gastroparesis in over 30 years.

"We are very pleased with the FDA's acknowledgment of the completeness of our application and we look forward to a substantive review. Tradipitant, if approved, will be the first novel drug for patients with gastroparesis since 1979," said Mihael Polymeropoulos, Vanda's pesident, CEO and chairman of the board.

The FDA's action on this application will mark the third NDA or supplemental new drug application decision expected by Vanda ( VNDA ) in 2024.

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