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Eton Pharmaceuticals Q3 sales rise 158% to $57.9M, guidance raised

🇺🇸 Eton Pharmaceuticals, Inc. (ETON) · Thu 05 Nov 2026

The rare-disease company lifted its 2026 outlook and flagged two 2027 FDA decision dates, for a KHINDIVI label expansion and the newly licensed LIBERVANT NDA.

Eton Pharmaceuticals reported third-quarter 2026 product sales of $57.9 million on 5 November 2026, up from $22.5 million in the same period a year earlier, an increase of 158%.

The company raised its full-year 2026 guidance to more than $175 million in revenue and an adjusted EBITDA margin of at least 40%.

On the regulatory side, Eton cited two upcoming FDA dates. A PDUFA goal date of 28 May 2027 applies to the proposed label expansion for KHINDIVI. A PDUFA date of 29 March 2027 applies to the NDA for LIBERVANT, which Eton has newly licensed, covering children aged 6 to 11. A PDUFA date is the target by which the FDA aims to complete its review of an application.

Eton also reported progress across its pipeline, naming ASN-001, ET-900, ET-700, harmonisation of the INCRELEX label and Glyburide Oral Suspension. The material available does not give further detail on the status of these programmes.

What it means for your team

  • Regulatory teams tracking paediatric and rare-disease filings should note the 29 March 2027 (LIBERVANT, ages 6 to 11) and 28 May 2027 (KHINDIVI label expansion) PDUFA dates.
  • The INCRELEX label harmonisation work may be relevant to teams managing label consistency across markets, though details were not provided.
  • Market-access teams may watch how the raised 2026 guidance, with revenue above $175 million, translates into portfolio growth in rare-disease niches.

Company's press release (SEC filing): Eton Pharmaceuticals, Inc. ↗

Article written by VigiEye from the official source (Eton Pharmaceuticals, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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