Shares of Zosano Pharma (NASDAQ:ZSAN) surged on Thursday morning following the publication late yesterday of clinical data on long-term use of its Qtrypta migraine treatment. ZSAN stock, which has spent most of this year below $1 a share, was up more than 28% to 95 cents in pre-market trading.
An article titled “Long Term Safety, Tolerability, and Efficacy of Intracutaneous Zolmitriptan (M207) in the Acute Treatment of Migraine” was published in The Journal of Headache and Pain, according to a company announcement.
“The data published provide safety and efficacy findings for Qtrypta when given repeatedly over the course of a year for the acute treatment of migraine,” said Don Kellerman, Zosano’s VP of clinical development and medical affairs. “The similarity of these findings with those from the pivotal ZOTRIP study — across primary and secondary outcome measurements — provide supportive evidence regarding the performance of Qtrypta and if approved, its potential as a valuable long-term treatment option for patients.”
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.
Earlier ZSAN Stock Surge Followed FDA Query
ZSAN stock saw a surge in January after announcing it had asked the U.S. Food and Drug Administration for a so-called Type A meeting to get the regulator’s 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.
The results just published could contribute to Zosano’s case as it prepares to address the last remaining clinical request from the FDA regarding the resubmission of the NDA for Qtrypta.
Management said on April 26 that it had received feedback from the agency’s Division of Neurology II on the protocol for the pharmacokinetic study required to support the resubmission.
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. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
InvestorPlace contributor Robert Lakin is a veteran financial writer and editor, including previous stints with Bloomberg News and as a buyside equity research editor.
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