FDA Rejects Zosano Pharma's Application For Zolmitriptan Microneedle System Again, Shares Plunge

The FDA has issued a response letter to Zosano Pharma Corp ZSAN regarding its resubmission of the 505(b)(2) New Drug Application for M207 (zolmitriptan microneedle system). 

• The response letter stated that the FDA did not consider the resubmitted M207 application a complete response to the deficiencies identified in the FDA’s October 2020 Complete Response Letter.
• The FDA will not begin a substantive review of the application until a complete response is received.
• The FDA’s response letter stated that the Company’s strategy for establishing a pharmacokinetic bridge to Zomig Nasal Spray 5 mg by relying primarily on data from a recently completed Phase 1 PK study was not acceptable.
• The agency said that there are differences between the design of Study CP-2021-001, which compared the PK of M207 to two sequential doses of 5 mg Zomig NS, and the criteria for re-dosing outlined in the labeling instructions for 5 mg Zomig Nasal Spray.
• Also See: Zosano Pharma Announces Publication Of Early Data On Influenza Vaccine.
• The Company is evaluating the next steps as part of its financial and strategic planning. However, there can be no assurances that the Company’s resources will enable it to continue pursuing FDA approval for M207. 
• As previously disclosed, the Company has retained SierraConstellation Partners LLC to explore financial and strategic alternatives.
• Price Action: ZSAN shares are down 31.9% at $0.15 during the premarket session on the last check Tuesday.