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.
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
On May 14, 2021, Eton Pharmaceuticals announced its first-quarter 2021 financial results. Given below is the summary:
- Eton announced $11.9 million in revenue in the first quarter of 2021, with $9.5 million coming from the sales of its neurology oral liquid solutions and $1.5 million coming from Bausch Health for the introduction of Alaway Preservative Free. The firm made $0.1 million in revenue in the previous year’s first quarter.
- G&A expenditure were $4.1 million in the first quarter of 2021, up from $2.6 million the year before. G&A expenditures during the first quarter of 2021 comprised $0.7 million in non-cash charges, owing to higher expenditures associated with the marketing of ALKINDI SPRINKLE.
- R&D expenditure were $0.9 million in the first quarter of 2021, compared to $6.3 million the previous-year period. One-time licensing fees of $4.8 million for the purchase of marketing rights to ALKINDI SPRINKLE were included in the prior-year period. Without any new business development transactions, ETON forecasts R&D spending to be significantly lower in 2021 than they were in 2020.
- Eton recorded a $5.1 million profit in the first quarter of 2021, relative to a $9.0 million loss in the first quarter 2020. In the first quarter of 2021, Eton recorded diluted earnings per share (EPS) of $0.19, relative to a loss of $0.50 per share in the prior year period.
- As of March 31, 2021, Eton has $25.1 million in cash and cash equivalents.