NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed in the United States District Court for the Southern District of California on behalf of investors that purchased Zosano Pharma Corp. (NASDAQ: ZSAN) securities between February 13, 2017 and September 30, 2020 (the “Class Period”). Investors have until December 28, 2020 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Zosano is a clinical stage pharmaceutical company. Its lead product candidate is Qtrypta (M207), a formulation of zolmitriptan coated onto the Company’s microneedle patch. Its pivotal efficacy trial, called ZOTRIP, 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 (“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 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.
The complaint, filed on October 29, 2020, 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 during the Class Period and suffered a loss, are a long-term stockholder, have information, 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 Brandon Walker, Melissa Fortunato, or Marion Passmore by email at email@example.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.