Zosano Pharma Corp.

ZSAN

On September 30, 2020, Zosano Pharma Corp. (NASDAQ: ZSAN) stunned the market when it announced that it had received “a discipline review letter (DRL) from the U.S. Food and Drug Administration” in connection with Zosano’s new drug application for Qtrypta™. Per Zosano’s announcement, the FDA “raised questions regarding unexpected high plasma concentrations of zolmitriptan observed in five study subjects from two pharmacokinetic studies and how the data from these subjects affect the overall clinical pharmacology section of the application.” The FDA further “raised questions regarding differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company’s clinical trials.” On this news, the price of Zosano stock fell approximately 57%, to close at just 70 cents per share on October 1, 2020.

Then on October 21, 2020, Zosano announced that it had received a Complete Response Letter from the FDA, in which the FDA recommended that Zosano conduct a repeat bioequivalence study between three of the lots used during development. Shares of Zosano common stock fell another 27%, to close at just $0.4441.

Lead Plaintiff deadline
December 28, 2020
class period
February 13, 2017
to
September 30, 2020
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