Zosano Pharma Investors Who Have Suffered Losses Greater Than $50,000 Encouraged To Contact Kehoe Law Firm, P.C.
Kehoe Law Firm, P.C. is investigating potential securities claims on behalf of investors of Zosano Pharma Corporation (NASDAQ: ZSAN) to determine whether the Company engaged in securities fraud or other unlawful business practices.
Zosano investors who purchased, or otherwise acquired, the Company’s securities and suffered losses greater than $50,000 are encouraged to complete Kehoe Law Firm’s Securities Class Action Questionnaire or contact Kevin Cauley, Director, Business Development, (215) 792-6676, Ext. 802, [email protected], securi[email protected], [email protected], to discuss the securities investigation or potential legal claims.
On September 30, 2020, Zosano disclosed that it “. . . received 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’).” According to Zosano, 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, Zosano’s stock price fell $0.92 per share, or 57%, to close at $0.70 per share on October 1, 2020.
On October 21, 2020, Zosano announced receipt of a Complete Response Letter (“CRL”) from the FDA. According to Zosano, “[t]he CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA’s discipline review letter received by the Company in September. Specifically, the CRL noted differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the Company’s trials and inadequate pharmacokinetic bridging between the lots that made interpretation of some safety data unclear.”
Further, Zosano reported that “[t]he CRL referenced unexpected high plasma concentrations of zolmitriptan observed in five study subjects enrolled in the Company’s pharmacokinetic studies. The FDA recommended that the Company conduct a repeat bioequivalence study between three of the lots used during development. The NDA included data on a total of 774 subjects across 5 trials who were administered or dosed with Qtrypta.”
On this news, Zosano’s stock price fell $0.17 per share, or 27%, to close at $0.4441 per share on October 21, 2020.