ZSAN Price Correlated With Financials For Zosano Pharma
Free historical financial statements for Zosano Pharma Corp. See how revenue, income, cash flow, and balance sheet financials have changed over 29 quarters since 2015. Compare with ZSAN stock chart to see long term trends.
Zosano Pharma Corporation (the “Company”) is a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics and other bioactive molecules to patients using its proprietary transdermal microneedle system (“System”).
The Company submitted a 505(b)(2) New Drug Application (“NDA”) for M207 to the U.S. Food and Drug Administration (the “FDA”) on December 20, 2019, and on October 20, 2020, the Company received a Complete Response Letter (“CRL”) from the FDA with respect to the NDA.
On January 18, 2022, the Company resubmitted its NDA to the FDA under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. On February 17, 2022, the Company received a response letter from the FDA stating that they did not consider the resubmitted M207 NDA to be a complete response to the deficiencies identified in the FDA’s October 20, 2020 CRL, and that the FDA will not begin substantive review of the application until a complete response is received. The Company is evaluating its next steps in relation to the FDA's response letter.
The Company does not anticipate realizing product revenues unless and until the FDA approves the M207 NDA and the Company begins commercializing M207, which events may never occur.