The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Zosano Pharma Corporation (ZSAN)
Nov 12, 2020, 10:45 ET
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On September 30, 2020, the Company revealed that it received "a discipline review letter (DRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA)." According to the Zosano'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 stock price fell $0.92 per share, or 57%, to close at $0.70 per share on October 1, 2020.
On October 21, 2020, the Company disclosed receipt of a Complete Response Letter ("CRL") from the FDA. As a result of the inconsistencies identified in the DRL, the FDA recommended that the Zosano conduct a repeat bioequivalence study between three of the lots used during development.
On this news, Zosano's stock price fell $0.17 per share, or 27%, to close at $0.4441 per share on October 21, 2020.
The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company's clinical results reflected differences in zolmitriptan exposures observed between subjects receiving different lots; (2) that pharmocokinetic studies submitted in connection with the Company's NDA included patients exhibiting unexpected high plasma concentrations of zolmitriptan; (3) that, as a result of the foregoing differences among patient results, the FDA was reasonably likely to require further studies to support regulatory approval of Qtrypta; (4) that, as a result, regulatory approval of Qtrypta was reasonably likely to be delayed; and (5) as a result of the foregoing, Defendants' public statements were materially false and misleading at all relevant times.
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If you purchased or otherwise acquired Zosano securities during the Class Period, you may move the Court no later than December 28, 2020 to request appointment as lead plaintiff in this putative class action lawsuit. To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to the pending class action lawsuit, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to [email protected], or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.
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SOURCE The Law Offices of Frank R. Cruz, Los Angeles
