March 30, 2021 - An amended consolidated complaint was filed.

October 29, 2020 - An investor in shares of Zosano Pharma Corporation (NASDAQ: ZSAN) filed a lawsuit in the U.S. District Court for the Northern District of California over alleged violations of Federal Securities Laws by Zosano Pharma Corporation in connection with certain allegedly false and misleading statements made between February 13, 2017 and September 30, 2020.

Fremont, CA based Zosano Pharma Corporation, a clinical stage biopharmaceutical company, focuses on providing therapeutics to patients suffering from migraine using its intracutaneous microneedle system. 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 Pharma Corporation 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 Pharma Corporation 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 October 21, 2020, Zosano Pharma Corporation 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. Shares of Zosano Pharma Corporation (NASDAQ: ZSAN) declined from $1.88 per share on September 18, 2020, to as low $0.36 per share on October 28, 2020.

According to the complaint the plaintiff alleges on behalf of purchasers of Zosano Pharma Corporation (NASDAQ: ZSAN) common shares between February 13, 2017 and September 30, 2020, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between February 13, 2017 and September 30, 2020, the Defendants failed to disclose to investorsthat the Company’s clinical results reflected differences in zolmitriptan exposures observed between subjects receiving different lots, that pharmocokinetic studies submitted in connection with the Company’s NDA included patients exhibiting unexpected high plasma concentrations of zolmitriptan, 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, that, as a result, regulatory approval of Qtrypta was reasonably likely to be delayed, and that as a result of the foregoing, Defendants’ public statements were materially false and misleading at all relevant times.