Zosano tanks as FDA rejects Qtrypta NDA

USA-based Zosano Pharma (Nasdaq: ZSAN) took another nosedive, with its shares falling 28% pre-market yesterday after it received what was a largely expected rejection by the US Food and Drug Administration of its acute migraine treatment candidate.

Zosano received a complete response letter (CRL) from the FDA in connection with the Qtrypta (zolmitriptan transdermal microneedle system) New Drug Application (NDA). The shares were down a further 2.5% at $0.43 this morning.

The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA’s discipline review letter in September, which caused a 52% crash for the stock.