DEER PARK, Ill. - Eton Pharmaceuticals , Inc. (NASDAQ:ETON), a company specializing in rare disease treatments, announced that its New Drug Application (NDA) for ET-400, a proprietary formulation of hydrocortisone oral solution, has been accepted by the U.S. Food and Drug Administration (FDA). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025, for the potential approval of the drug.
ET-400 is designed as a liquid formulation of hydrocortisone intended primarily for pediatric use. The company's CEO, Sean Brynjelsen, expressed optimism about the drug's prospects, stating that approval could significantly impact the oral hydrocortisone market. Eton Pharmaceuticals anticipates that ET-400, in conjunction with ALKINDI SPRINKLE®, could reach combined annual peak sales exceeding $50 million.
The pharmaceutical company, which currently markets five rare disease products, has received a patent for ET-400 that extends through 2043. In addition to ET-400, Eton has other product candidates in late-stage development, including ET-600 and ZENEO® hydrocortisone autoinjector.
The information in this article is based on a press release statement from Eton Pharmaceuticals.
In other recent news, Eton Pharmaceuticals has canceled its stock and warrant sale, following an unsuccessful bid for the assets of Eiger BioPharmaceuticals, Inc. The company had planned to issue and sell 1,287,500 shares of common stock at $3.50 per share, which would have raised approximately $4.5 million.
In addition, pre-funded warrants for 2,462,500 shares were set to be issued, generating around $8.6 million. A credit facility expansion of $21.9 million was also in the pipeline, increasing the total to $27.0 million. However, these transactions were contingent upon Eton Pharmaceuticals winning the Eiger BioPharmaceuticals auction, which did not occur.
Consequently, the transactions have been terminated and the anticipated funding from the share sale, warrant issuance, and increased borrowing capacity will not materialize. These recent developments significantly affect Eton Pharmaceuticals' immediate financial strategies and potential growth opportunities.
InvestingPro Insights
Eton Pharmaceuticals, Inc. (NASDAQ:ETON) has recently garnered attention with the FDA's acceptance of its New Drug Application for ET-400. As investors and analysts watch the company's progress, InvestingPro provides key financial metrics and insights that could inform investment decisions.
With a market capitalization of $88.12 million, Eton is positioned as a moderate player in the pharmaceutical industry. The company's Price to Earnings (P/E) ratio stands at 95.28, reflecting a high earnings multiple that suggests investors are expecting higher earnings growth in the future.
This is supported by the company's impressive revenue growth over the last twelve months as of Q1 2024, which is reported at 40.71%. Additionally, the company has demonstrated a substantial EBITDA growth of 135.74% during the same period, indicating improved profitability and operational efficiency.
InvestingPro Tips highlight that Eton holds more cash than debt on its balance sheet, which is a positive sign of financial stability. Moreover, the company is trading at a low P/E ratio relative to near-term earnings growth, offering a potentially attractive entry point for value investors.
It is worth noting, however, that analysts are not expecting the company to be profitable this year, and net income is anticipated to drop. With Eton not paying dividends to shareholders, the focus for potential investors may be on capital gains rather than income.
For those interested in further analysis and additional InvestingPro Tips, visit https://www.investing.com/pro/ETON for a comprehensive look at Eton Pharmaceuticals. There are 6 more tips available, which could provide deeper insights into the company's valuation and future prospects. Remember to use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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