Shares of Zosano Pharma (NASDAQ:ZSAN) surged on Tuesday morning following the news that the clinical-stage biopharmaceutical firm would resubmit its application to the U.S. Food and Drug Administration for acute migraine treatment. ZSAN stock looked set to extend Monday’s more-than-10% increase.
Zosano has asked the regulator for a so-called Type A meeting to get FDA input on the requirements to resubmit the new drug application for Qtrypta, the company’s proprietary investigational formulation of zolmitriptan delivered utilizing its proprietary transdermal microneedle system.
Migraines are a very common condition, with 15.3% of Americans aged 18 years or older reporting a migraine or severe headache in the previous three months, according to the Centers for Disease Control and Prevention. And that figure has remained stable for almost two decades. Migraines cost the U.S. some $36 billion in lost productivity.
“We have been working diligently to prepare the meeting package required at the time a Type A meeting request is submitted to FDA. We are sharply focused on the resubmission of the NDA for Qtrypta and have been preparing strategies to address the comments received,” said Steven Lo, president and CEO of Zosano, in a company press release.
In late September, Zosano disclosed that the receipt of a discipline review letter from the FDA regarding its NDA for Qtrypta. At the time, it stated that approval was not likely.
The Bottom Line on ZSAN Stock
As with any penny stock, and particularly those in the biopharma space, tread carefully. As quickly as a name like ZSAN stock could appreciate, the next minute those gains could be gone.
On the date of publication, Robert Lakin did not have (either directly or indirectly) any positions in the securities mentioned in this article.
InvestorPlace contributor Robert Lakin is a veteran financial writer and editor, following fintech, agtech and property tech startups.
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