Every material Form 8-K Eton Pharmaceuticals, Inc. has filed with the SEC since November 02, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Eton Pharmaceuticals reported third quarter 2026 revenue of $57.9 million, up from $22.5 million a year earlier, and raised its 2026 revenue guidance to more than $175 million from more than $145 million. GAAP net income of $35.2 million, or $1.06 per diluted share, was boosted by a $12.9 million income tax benefit from releasing a valuation allowance, while non-GAAP diluted EPS was $0.50.
Q3 2026 revenue was $57.9 million versus $22.5 million in Q3 2025, driven mainly by the addition of HEMANGEOL sales.
Adjusted EBITDA was $28.5 million, or 49% of revenue, compared with $2.9 million, or 13%, a year earlier.
2026 revenue guidance was raised to more than $175 million from more than $145 million; Adjusted EBITDA margin guidance was raised to at least 40% from at least 35%.
Cash and cash equivalents were $55.6 million as of September 30, 2026.
Eton Pharmaceuticals reported preliminary results from a four-week, placebo-controlled pilot study of ET-700, its investigational zinc acetate formulation for Wilson disease, in healthy volunteers. ET-700 showed fewer treatment-related adverse events than GALZIN but reduced hepatic copper uptake by less (12% versus 46%), and the company plans additional study arms in 2027. The filing states the findings are preliminary and do not establish clinical efficacy in patients with Wilson disease.
Treatment-related adverse events: 1 of 12 ET-700 participants versus 8 of 12 GALZIN participants
Hepatic copper uptake decreased 12% with ET-700 and 46% with GALZIN; placebo rose 11%
Intention-to-treat analysis of 35 participants showed GALZIN had a greater effect than ET-700 (p=0.023)
Company plans additional study arms in 2027 evaluating faster-release formulations
Eton Pharmaceuticals announced ET-900, a new development program evaluating its mecasermin injection, the active ingredient in INCRELEX, for infantile and epileptic spasms, and said it licensed related patent rights from Baylor College of Medicine. A research Investigational New Drug application has been submitted to the FDA for an investigator-sponsored Phase 2 study, with initial enrollment and dosing targeted for the first quarter of 2027. The filing contains no financial figures, so its near-term financial effect is not quantified, and Eton retains commercial rights to ET-900 according to the press release.
Research IND submitted to the FDA for an investigator-sponsored Phase 2 study of mecasermin in children with refractory epileptic spasms
Study expected to enroll up to 20 patients ages 2–18 across three sites: University of Chicago, Baylor College of Medicine, and UCLA
Initial enrollment and patient dosing targeted for the first quarter of 2027
Preclinical animal data cited in the press release showed approximately 50% reduction in daily spasm counts
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