BENSALEM, Pa.–(BUSINESS WIRE)–Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Zosano Pharma Corporation (“Zosano” or the “Company”) (NASDAQ: ZSAN) securities between February 13, 2017 and September 30, 2020, inclusive (the “Class Period”). Zosano investors have until December 28, 2020 to file a lead plaintiff motion.
Investors suffering losses on their Zosano investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to email@example.com.
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 $0.4440 per share on October 21, 2020.
The complaint filed in this class action 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.
If you purchased Zosano securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.
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