Vanda Pharma completes transfer of FDA Marketing Authorization for Ponvory

Vanda Pharmaceuticals (VNDA) announced that ownership of the U.S. New Drug Application and Investigational New Drug Applications for Ponvory has been transferred to Vanda from a Johnson & Johnson (JNJ) company, which now fully allows Vanda to commercialize Ponvory in the U.S. Vanda acquired U.S. and Canadian rights to Ponvory from a Johnson & Johnson company on December 7, 2023. Ponvory is approved by the FDA and Health Canada to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. In anticipation of the commercial launch of Ponvory for RMS in Q3, Vanda is initiating a host of commercial activities including the creation of a specialty sales force, a prescriber awareness program and a comprehensive marketing program.