Zosano Pharma Corporation

Period: 02/13/2017 to 09/30/2020
Lead Plaintiff Deadline: 12/28/2020

SUMMARY OF CASE:

A securities class action has been filed against Zosano Pharma Corporation  (ZSAN) on behalf of persons and entities that purchased or otherwise acquired Zosano securities between February 13, 2017 through September 30, 2020.  This case has been filed in the USDC – N.D.CA.

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 is 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.

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 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.