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Supernus lifts guidance after 18% Q3 revenue growth; ONAPGO secures orphan exclusivity

🇺🇸 Supernus Pharmaceuticals, Inc. (SUPN) · Thu 29 Oct 2026

The US drugmaker reported third-quarter revenue of $226.8 million, as the FDA recognised orphan exclusivity for ONAPGO and the Indivior merger approaches its expected 2 November close.

Supernus Pharmaceuticals reported total revenue of $226.8 million for the third quarter of 2026, an increase of 18% on the same period a year earlier. The company announced the results on 29 October 2026 and raised its full-year guidance.

On the regulatory side, the US Food and Drug Administration has recognised seven years of orphan-drug exclusivity for ONAPGO, which is indicated for motor fluctuations in advanced Parkinson's disease. Orphan exclusivity is a statutory period during which the FDA generally does not approve another application for the same drug for the same orphan indication, with limited exceptions.

Supernus has also submitted a supplemental new drug application (sNDA) to add a second supplier for ONAPGO. The company indicated that approval could come by mid-2027.

Separately, the all-stock merger with Indivior was approved by shareholders on 15 October. Supernus expects the transaction to close on 2 November 2026. The summary available does not give further detail on terms, integration plans or the revised guidance figures.

What it means for your team

  • Regulatory teams should note the seven-year orphan exclusivity recognised for ONAPGO, which shapes the competitive and lifecycle outlook in advanced Parkinson's disease.
  • The sNDA for a second supplier is a supply-chain and CMC milestone; a decision is possible by mid-2027, according to the company.
  • Market-access and portfolio teams should track the expected 2 November closing of the Indivior merger and any resulting changes to the combined company's product range and guidance.

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

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

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