Zosano Pharma (ZSAN) Stock Tumbles On FDA Discipline Letter

Zosano ZSAN Stock News

Zosano Pharma Corp (NASDAQ: ZSAN) is having an overwhelmingly rough start to the trading session this morning, and for good reason. The company announced that it received a discipline review letter from the FDA. Here’s what’s going on:

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ZSAN Stock Tanks On Discipline Letter

In the press release, Zosano Pharma said that it recieved a discipline review letter from the FDA with regard to the Qtrypta New Drug Aplication. The company said that the DRL was issued by the FDA in order to convey preliminary comments on deficiencies identified during the NDA review.

Ultimately, there were to major concerns with the NDA:

  • The FDA raised questions surrounding enexpected high plasma concentrations of zolmitriptan observed in five study subjects from two pharmacokinetic studies. The FDA also outlined concerns with how the data from these subjects affects the overall clinical pharmacology section of the application.
  • ZSAN said that the FDA also raised questions surrounding differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company’s clinical trials.

In the release, the company said that the DRL reflects preliminary comments, but does not reflect the FDA’s final decision. Nonetheless, these are major issues with the New Drug Application and there’s a strong probability that the FDA will not approve Qtrypta with the data that is currently available surrounding the drug.

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

We are disappointed in this notification and are in the process of evaluating and addressing FDA’s comments. We believe Qtrypta represents an attractive therapeutic alternative for patients suffering from migraines and look forward to working with FDA through the NDA review process.

This Is Painful News

Zosano has spent massive amounts of time and money to bring Qtrypta to this point. Unfortuantely, with the discipline letter from the FDA, there are more questions around this investment than answers.

Ultimately, there’s a strong chance that the company will either have to develop new data or may decide to scrap the product as a whole. If this happens, it is either a major loss to the company and its investors or a major coming expense. Either way, those who invest in ZSAN stock are unhappy and for good reason.

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