Zosano Pharma Completes Site Qualification Batches at CMO in Pursuit of NDA for Qtrypta™

Jun 20, 2019 | Drug Delivery

Laboratory

Zosano Pharma Corporation (ZSAN), a clinical-stage biopharma venture recently announced it completed manufacturing of site qualification batches at its commercial manufacturing site for Qtrypta, the company’s investigational treatment for migraines in late-stage development. These batches are intended to demonstrate the robustness and reproducibility of the manufacturing process which will be included as part of its planned submission of a New Drug Application (NDA) for Qtrypta in Q4 2019.

Zosano Finances

Thinly capitalized, the stock price is presently at $3.06 with a market capitalization of $54.2 million on losses of nearly $35 million. Based on a Yahoo Finance review they posses $11 million in the bank. Founded in 2006, they have raised over $166 million. The company went public in 2015 raising $50 million at $11 per share. They had a wild ride up only to plummet and hover where it is today.

About Qtrypta

Qtrypta is Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary ADAM technology. Zosano’s ADAM technology consists of titanium microneedles coated with drug, and in the case of Qtrypta, its formulation of zolmitriptan. The drug-coated microneedles penetrate into the epidermis and dermis, where the investigational drug is dissolved and enters into the bloodstream. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8mg dose of Qtrypta met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. In November 2017, the Company announced the initiation of its long-term safety study evaluating Qtrypta and expects to file an NDA for Qtrypta in the fourth quarter of 2019.

About Zosano

Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on providing administration of therapeutics to patients using its intracutaneous delivery system, which consists of titanium microneedles coated with a drug that can enable rapid systemic administration to patients. The company’s lead product candidate is Qtrypta (M207), which is Zosano’s proprietary formulation of zolmitriptan delivered via its intracutaneous delivery technology for the treatment of migraine disease. In February 2017, the company announced statistically significant results from the ZOTRIP pivotal study and in February 2019, Zosano announced the completion of the final milestone in its long-term safety study.

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