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Friday, December 9, 2022

Zosano Pharma Corp. (ZSAN) Stock Trends Lower Ahead of Type C Meeting with U.S FDA

Zosano Pharma Corp. (ZSAN) stock prices were down by 3.98% some time after market trading commenced on October 4th, 2021. This brought the price per share down to USD$0.68 early on in the trading day.

ZSAN Stock’s Type C Meeting

October 4th, 2021 saw ZSAN stock announce having been granted a Type C written response only meeting with the United States Food and Drug Administration. The correspondence will be in regard to the resubmission of the M207 505b2 New Drug Application. It will commence following the receipt of preliminary top-line results from the pharmacokinetic study.


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M207 Clinical Trial

The pharmacokinetic study enrolled 48 healthy volunteers and evaluated roughly 2500 samples making use of M207. The M207 was produced with two different pieces of manufacturing equipment. The study was designed to evaluate the safety profile and pharmacokinetics of drug exposure levels, as compared to an intranasal control formulation of two 5 mg doses of zolmitriptan. The safety report indicated the treatment to be generally well tolerated, proving consistent with previously conducted studies.

Details of the Study

The preliminary data from the pharmacokinetic analysis showed that there were no outliers with plasma concentrations of zolmitriptan were higher than expected. The metric was a particular focus of the FDA, as identified in the Complete Response Letter for the original M207 NDA. Drug plasma concentration levels from the M207 produced with equipment A came out to be within expected ranges and were comparable to the intranasal control. Drug plasma concentration levels of M207 produced with the other piece of equipment were lower as compared to control and equipment A-produced M207. Equipment B-produced M207 was still within ranges consistent with approved therapeutic dose levels of zolmitriptan.

ZSAN Stock Builds on Success

The lack of outliers with unexpectedly high plasma concentrations of M207 is highly promising. ZSAN stock has requested a meeting with the FDA to review the data, which includes the preliminary bioequivalence data from the lots produced. The company plans to refine its strategy moving forward with the resubmission of the NDA after written feedback from the FDA is received.

Future Outlook for ZSAN Stock

ZSAN stock has reported a promising quarter, further consolidated by the progress made with its M207 clinical trial. The company is poised to capitalize on opportunities for further development following the resubmission of an NDA. Current and potential investors are hopeful that management will be able to effectively leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value.

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