Zosano Pharma Corporation (ZSAN)
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Zosano Pharma Corporation ("Zosano" or "the Company") (NASDAQ: ZSAN). The investigation concerns whether Zosano and certain of its officers and/or directors have violated federal securities laws.
On September 30, 2020, Zosano issued a press release announcing receipt of “a discipline review letter (DRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA). A DRL is used by the FDA to convey preliminary comments on deficiencies identified during the NDA review with respect to a particular review discipline.” Specifically, Zosano advised investors that “[t]he DRL described two concerns with respect to the clinical pharmacology section of the NDA. First, 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. Second, the FDA raised questions regarding differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company’s clinical trials.” On this news, Zosano’s stock price fell $0.92 per share, or 56.79%, to close at $0.70 per share on October 1, 2020.
If you are aware of any facts relating to this investigation, or purchased Zosano shares, you can assist this investigation by contacting the firm. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm’s expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.