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Eton Pharmaceuticals Inc. (ETON) stock soars during after-hour session. Let’s see what’s happening?

Eton Pharmaceuticals Inc. (NASDAQ: ETON) stock declined by 16.84% at last close whereas the ETON stock price surged by 1.13% in the after-hours trading session. Eton Pharmaceuticalscutting-edge pharmaceutical business specializing in the development and marketing of therapies for rare disorders.

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What is happening?

On May 28, 2021, The U.S. Food & Drug Administration (FDA) has issued ETON a Complete Response Letter (CRL) in reply to its submission of a New Drug Application (NDA) for dehydrated alcohol injection for the cure of methanol intoxication. The FDA has concluded its evaluation of the application and found that it cannot be authorized in its current form, according to the CRL. Due to what ETON claims are COVID-related travel limitations, a Pre-Approval Inspection (PAI) of the product’s European contract manufacturer is underway. All additional FDA issues mentioned in the letter, according to ETON, will be fully addressed in a statement in the coming months.


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Recent Past Development

Financial Results

On May 14, 2021, Eton Pharmaceuticals announced its first-quarter 2021 financial results. Given below is the summary:

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