Zosano Pharma Corporation (ZSAN) Misled Shareholders about its Lead Drug Candidate
Throughout the relevant period, Zosano touted the efficacy of its lead product candidate Qtrypta (M207), a formulation of zolmitriptan coated into the Company’s microneedle patch. Zosano’s drug trial for Qtrypta began in July 2016. In December 2019, Zosano submitted its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) seeking regulatory approval for Qtrypta. On September 30, 2020, Zosano disclosed receipt of a discipline review letter from the FDA regarding its NDA for Qtrypta and stated that approval was not likely. Specifically, the Company’s clinical results reflected differences in zolmitriptan exposures observed between subjects receiving different lots and that patients exhibited unexpected high plasma concentrations of zolmitriptan. On this news, Zosano’s shares fell 57% per share on October 21, 2020.
