New York, New York--(Newsfile Corp. - December 26, 2020) - Pomerantz LLP announces that a class action lawsuit has been filed against Zosano Pharma Corporation ("Zosano" or the "Company") (NASDAQ: ZSAN) and certain of its officers. The class action, filed in United States District Court for the Northern District of California, and docketed under 20-cv-07850, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise acquired Zosano securities between February 13, 2017 and September 30, 2020, inclusive (the "Class Period"), seeking to pursue claims against the Defendants under the Securities Exchange Act of 1934 (the "Exchange Act").
If you are a shareholder who purchased Zosano securities during the class period, you have until December 28, 2020, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at email@example.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Zosano is a clinical-stage pharmaceutical company. Its proprietary intracutaneous delivery system purports to offer rapid absorption of drug, consistent drug delivery, improved ease of use, and room-temperature stability. Its intracutaneous patch consists of an array of titanium microneedles that are coated with Zosano's proprietary formulation of a previously approved drug that is attached to an adhesive patch. The patch purports to offer rapid and consistent delivery of the drug via the microneedles that penetrate the skin, resulting in dissolution and absorption of the drug.
Zosano's lead product candidate is Qtrypta (M207), a formulation of zolmitriptan coated onto the Company's microneedle patch. The Company's 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.
The complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading because they misrepresented and failed to disclose the following adverse facts pertaining to the Company's business, operations, and prospects, which were known to Defendants or recklessly disregarded by them. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company's clinical results reflected differences in zolmitriptan exposures observed between subjects receiving different lots; (ii) pharmocokinetic studies submitted in connection with the Company's NDA included patients exhibiting unexpected high plasma concentrations of zolmitriptan; (iii) 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; (iv) as a result, regulatory approval of Qtrypta was reasonably likely to be delayed; and (v) as a result of the foregoing, Defendants' public statements were materially false and misleading at all relevant times.
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 per share, or 56.79%, to close at $0.70 per share on October 1, 2020, on unusually heavy trading volume.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
Robert S. Willoughby
888-476-6529 ext. 7980
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/71033