LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces that it has filed a class action lawsuit in the United States District Court for the Northern District of California captioned Carr v. Zosano Pharma Corporation, et al., (Case No. 3:20-cv-07625) on behalf of persons and entities that purchased or otherwise acquired Zosano Pharma Corporation (“Zosano” or the “Company”)(NASDAQ: ZSAN) securities between February 13, 2017 and September 30, 2020, inclusive (the “Class Period”). Plaintiff pursues claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”).
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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, 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.
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.
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If you purchased Zosano securities during the Class Period, you may move the Court no later than 60 days from the date of this notice to ask the Court to appoint you as lead plaintiff. To be a member of the Class 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. If you purchased Mesoblast 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 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 info@frankcruzlaw.com, 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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