Zosano Pharma Corporation
|Company Name||Zosano Pharma Corporation|
|Class Period||February 13, 2017 to September 30, 2020|
|Lead Plaintiff Motion Deadline||December 28, 2020|
On September 30, 2020, after the market closed, Zosano disclosed receipt of a discipline review letter (“DRL”) from the FDA regarding its NDA for Qtrypta and stated that approval was not likely. According to the Company’s press release, 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 also “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 Company’s share price fell $0.92, or 57%, to close at $0.70 per share on October 1, 2020, on unusually heavy trading volume.
On October 21, 2020, Zosano disclosed receipt of a Complete Response Letter (“CRL”) from the FDA. As a result of the previously identified deficiencies, the FDA recommended that Zosano conduct a repeat bioequivalence study between three of the lots used during development.
On this news, the Company’s share price fell $0.17, or 27%, to close at $0.04440 per share on October 21, 2020, on unusually heavy trading volume.
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