Zosano Pharma (ZSAN) Stock Runs On FDA Acceptance Of NDA

Zosano ZSAN Stock News

Zosano Pharma Corp (NASDAQ: ZSAN) is making a run for the top in one of the few non-coronavirus-related high volume runs in the market today. The gains of around 25% come after the company announced that the Food and Drug Administration (FDA) has accepted a New Drug Application (NDA). Here’s what’s going on:

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ZSAN Stock Heads Up On NDA Acceptance

In a press release issued early this morning, Zosano said that the FDA accepted its NDA for Qtrypta. The application has now been accepted for filing and substantive review, taking the drug one step closer to the market.

Along with the acceptance of the application, ZSAN said that the FDA set a PDUFA review date of October 20, 2020. This PDUFA date reflects the standard 10-month review time that we see with New Drug Applications.

Qtrypta is the company’s experimental migraine headache pain reliever. In a pivotal study, 41.5% of patients given 3.8 mg of the drug achieved pain freedome at 2 hours. 68.3% of patients reported freedom from most bothersom symptoms at 2 hours. Moreover, 80.5% of patients reported pain relief at 2 hours.

In a statement, Steven Lo, President and CEO at ZSAN, had the following to offer:

The FDA’s filing of our NDA represents a significant milestone and an important step for Zosano and Qtrypta toward our goal of bringing an innovative therapy that we believe can make an important difference in the lives of patients who suffer from migraine. We believe Qtrypta, if approved, has the potential to offer patients rapid, sustained pain relief with no recurrence.

This submission also represents the first NDA to be submitted to the FDA for a pharmaceutical microneedle patch. We believe this technology, if approved, has the potential to transform how drugs, biologics and vaccines are delivered, and we look forward to further discussions with the FDA during its review of this submission. We are grateful for the patients who participated in our clinical trials, our clinical investigators and the entire Zosano team who have helped us realize this significant milestone.

Why This News Is So Exciting

First and foremost, Zosano Pharma announced the acceptance of an NDA. That’s a major milestone for any clinical-stage biotechnology company. With this acceptance, commercialization could be around the corner. However, that’s not the only reason to be excited here.

If all goes well, and the drug is approved, ZSAN will be entering a massive market. In fact, it is estimated that the Migraine drugs market will climb to be worth around $7.8 billion annually by the year 2025. By this time, Qtrypta will likely be reaching its prime if it’s approved.

Considering that ZSAN trades with a market cap of under $30 million, the opportunity to enter into such a massive market is huge. Even if the company were to only tap into a small fraction of this market, the revenue potential would be tremendous. So, it’s not surprising to see that investors are excited here.

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