Vanda urges FDA to drop proposal for extending drug review timelines; shares down

Vanda Pharmaceuticals

09/04/2026 16:19

** Shares of drugmaker Vanda Pharmaceuticals VNDA.O fall 1.4% to $7.19 in early trading

** Co says it asked the FDA to withdraw a proposal that would lengthen reviews of new drug applications

** Says the plan would scrap a law requiring drug reviews within 180 days and instead allow reviews to stretch 10–12 months

** Adds the change could delay patient access to medicines and raise uncertainty for smaller drugmakers

** The proposal would replace a formal appeal process for rejected drugs with a less rigorous internal review - VNDA

** Including session's move, stock down ~19% YTD

(Reporting by Sahil Pandey in Bengaluru)

((Sahil.Pandey@thomsonreuters.com))