Lawsuit filed for Investors in shares of Zosano Pharma Corporation (NASDAQ: ZSAN)

An investor, who purchased shares of Zosano Pharma Corporation (NASDAQ: ZSAN), filed a lawsuit over alleged violations of Federal Securities Laws by Zosano Pharma Corporation.

Investors who purchased shares of Zosano Pharma Corporation (NASDAQ: ZSAN) have certain options and for certain investors are short and strict deadlines running. Deadline: December 28, 2020. NASDAQ: ZSAN investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

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.

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.

Those who purchased shares of Zosano Pharma Corporation (NASDAQ: ZSAN) have certain options and should contact the Shareholders Foundation.

Media Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.