The Supreme Court will hear Hikma's appeal in the 'skinny label' patent fight over Amarin's Vascepa. The ruling could affect generic drug competition and investment in new drug indications.
The Supreme Court unanimously held in Hikma v. Amarin that induced infringement requires affirmative steps, not foreseeable or passive statements. The ruling raises the pleading bar for brand owners and extends beyond pharmaceutical skinny labels.
Supreme Court unanimously reversed the Federal Circuit in Hikma v. Amarin, ruling that 'skinny label' generic marketing does not induce patent infringement absent active steps to encourage it. The decision requires affirmative conduct, not mere plausible interpretations, to support inducement claims.
Arrowhead Pharmaceuticals presented long-term data showing plozasiran achieved 83% median triglyceride reduction in severe hypertriglyceridemia patients with no acute pancreatitis events over two years. The RNA interference therapy demonstrated durable improvements in atherogenic lipoproteins and consistent safety profile. The company plans to complete Phase 3 studies by mid-2026 and submit for regulatory approval.
CRISPR Therapeutics reported a Q4 2025 loss of $1.37 per share, missing estimates, with revenues of $0.9 million falling short of expectations. The company's partner Vertex recorded $54 million in Casgevy sales for the quarter, with regulatory submissions for pediatric label expansion planned for early 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07680829 |
A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia |
NOT_YET_RECRUITING | PHASE3 |
| NCT07604974 |
A Study to Assess the Safety, Tolerability and Efficacy of ION775 |
RECRUITING | PHASE2 |
| NCT07269210 |
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia |
RECRUITING | PHASE2 |
| NCT06880770 |
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis |
RECRUITING | PHASE3 |
| NCT06555640 |
A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia |
COMPLETED | PHASE2 |
| NCT06347016 |
Study of Plozasiran in Adults With Severe Hypertriglyceridemia |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06347003 |
Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05852431 |
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia |
COMPLETED | PHASE3 |
| NCT05681351 |
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05552326 |
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia |
COMPLETED | PHASE3 |
