- Trial Phase
- Approved
- Time to Market
- Already approved and marketed since August 2015. The latest label expansion (VESALIUS-CV primary prevention) was approved October 9, 2026.
- Why 4/10
- Repatha is an already-approved, commercially marketed drug with no pending regulatory decision or pivotal readout in the next 12 months. The most recent binary catalyst (FDA label expansion for VESALIUS-CV data) occurred on October 9, 2026, which is now past. As a mature commercial asset in a diversified large-cap biotech, Repatha's share-price impact comes from quarterly sales growth rather than a hard binary event, capping the impact score at 4.
Repatha has no upcoming hard binary catalyst (PDUFA or pivotal readout) in the next 12 months; the October 9, 2026 FDA label expansion for VESALIUS-CV primary-prevention data is already past. Watch quarterly sales growth as a commercial-performance indicator, and monitor Novartis's ORION-4 cardiovascular outcomes readout for Leqvio (expected mid-2026 or later), which could shift the PCSK9 competitive landscape. Amgen's Q3 2026 earnings (reported November 3, 2026) showed Repatha sales of $1.085 billion, beating expectations.
Price Chart
Executive Summary
Repatha (evolocumab) is Amgen's blockbuster PCSK9-inhibitor monoclonal antibody for lowering LDL cholesterol and reducing cardiovascular risk. First approved by the FDA in August 2015, it generated $3.0 billion in 2025 sales (up 36% year-over-year) and $1.085 billion in Q3 2026 alone (up 37%). The FDA approved a label expansion on October 9, 2026 adding VESALIUS-CV primary-prevention data for adults without a prior heart attack or stroke. With no pending regulatory binary catalyst, Repatha is a mature commercial asset driving steady growth for a diversified Amgen portfolio, but faces competition from Novartis's twice-yearly Leqvio (inclisiran) and eventual biosimilar threats.
How It Works
Repatha is a monoclonal antibody (a lab-made protein) that blocks a protein called PCSK9. Normally, PCSK9 destroys LDL receptors on liver cells, reducing the liver's ability to clear "bad" LDL cholesterol from the blood. By blocking PCSK9, Repatha increases the number of available LDL receptors, allowing the liver to remove more LDL cholesterol and lowering cardiovascular risk. It is given as a subcutaneous injection every two weeks or once monthly.
Trial Status
Repatha is FDA-approved and commercially marketed. The Phase 3 VESALIUS-CV trial (NCT03872401, n=12,301) completed in July 2025 and showed Repatha reduced the risk of first major adverse cardiovascular events by 31% in high-risk primary-prevention patients. A pre-specified analysis presented in August 2026 showed reduced risk of death. The FDA approved the VESALIUS-CV label expansion on October 9, 2026.
The Two-Sided Case
Upcoming Catalysts
- No upcoming PDUFA or pivotal readout for Repatha in the next 12 months. The October 9, 2026 FDA label expansion is the most recent catalyst. Watch quarterly sales growth and potential competition from Novartis's Leqvio ORION-4 outcomes data.
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Amgen PRESS-RELEASE AMGN ·Originating report