Strong Revenue Growth and Launch Success:
-
reported
revenue of
$452 million for Q2 2025, marking a twofold increase year-over-year, and
$584 million for the first half of 2025, an increase of nearly
70% versus the prior year.
- This growth was driven by the excellent early commercial performance of Tryngolza, the first FDA-approved treatment for familial chylomicronemia syndrome, and positive market dynamics.
Expanding Pipeline and Regulatory Milestones:
- Donidalorsen is expected to be the second independent launch after Tryngolza, with an FDA approval anticipated next month, marking progress in the company's regulatory development.
- The advancement of several wholly-owned Phase III pipeline programs and potential launches from the late-stage partner pipeline is expected to further expand Ionis's impact and reach.
FCS Launch and Market Penetration:
- Tryngolza reported
net product sales of
$19 million in Q2, reflecting a threefold increase in revenues quarter-over-quarter.
- This success is attributed to effective patient identification efforts, a strong product profile, and favorable payer dynamics, with over 90% of patients paying
$0 out-of-pocket.
Potential of SHTG and AP Events:
-
anticipates significant reductions in triglycerides for sHTG patients based on the outcomes of the ESSENCE study, with the potential for substantial impact on acute pancreatitis events.
- The company expects to have accumulated more acute pancreatitis events in the combined CORE and CORE2 study than in the FCS BALANCE study, which could support a positive trend in Olezarsen's impact on AP.
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