Welcome to our dedicated page for Eton Pharmaceuticals SEC filings (Ticker: ETON), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
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Eton Pharmaceuticals, Inc. (NASDAQ: ETON) filed a Form 8-K to disclose a material event under Item 8.01. On 8 July 2025, the company announced that the U.S. Food and Drug Administration (FDA) accepted for review its New Drug Application (NDA) for ET-600, a proprietary, patented oral solution formulation of desmopressin. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 25 February 2026.
The acceptance of the NDA formally places ET-600 into the FDA review queue and confirms that the submission is sufficiently complete for substantive review. While no financial data were provided in this filing, ET-600 represents a potential commercial asset that could expand Eton鈥檚 rare disease/critical care portfolio if ultimately approved. The company attached the related press release as Exhibit 99.1 and provided routine exhibit and signature information.
Key points for investors:
- NDA accepted: De-risks the regulatory pathway by moving ET-600 from development to formal FDA review.
- PDUFA date set: Establishes a definitive decision timeline (鈮�7.5 months from filing date).
- No financial metrics: The 8-K contains no sales, earnings, or cost guidance related to ET-600 or the broader business.
- Next catalyst: Potential FDA approval decision on or before 25 February 2026.
The filing is non-dilutive鈥攊t involves no financing, equity issuance, or debt鈥攁nd does not alter previously reported financial statements. Nonetheless, regulatory progress on ET-600 can influence future revenue forecasts and valuation multiples once market potential data are released.
Eton Pharmaceuticals (NASDAQ:ETON) filed an 8-K to disclose that the company will be added to the Russell 3000 and Russell 2000 indexes effective after the U.S. market close on June 27 2025.
The filing, made under Item 8.01, includes a press release (Exhibit 99.1) and signals broader passive fund ownership, higher trading liquidity and increased institutional visibility. No financial results, strategic shifts or governance changes were reported.
Eton Pharmaceuticals, Inc. (NASDAQ: ETON) filed a Form 8-K to disclose an auditor transition effective 13 June 2025.
Dismissal of Crowe LLP: The Audit Committee terminated Crowe LLP after only one audit cycle (FY-2024). Crowe鈥檚 2024 opinion was clean (no adverse or qualified opinion), and the firm reported no disagreements or reportable events with management under Item 304(a)(1) of Regulation S-K. Crowe鈥檚 required concurrence letter is attached as Exhibit 16.1.
Appointment of Grant Thornton LLP: The Audit Committee simultaneously engaged Grant Thornton LLP as the new independent registered public accounting firm for FY-2025. The company confirms that, during FY-2023, FY-2024, and the subsequent interim period, it did not consult Grant Thornton on any accounting matters or potential opinions prior to the appointment.
Investor takeaways:
- The change appears procedural; the absence of disagreements reduces immediate red-flag risk.
- Auditor turnover after one year may still prompt investors to monitor governance continuity and upcoming audit fees or timelines.
- No financial restatements, outlook changes, or earnings data were disclosed in this filing.
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