Expert: Fully human IgG2 monoclonal antibody targeting PCSK9. Prevents PCSK9-mediated degradation of hepatic LDLR, increasing LDL-C clearance. SC Q2W or QM dosing.

Everyday: Blocks a protein (PCSK9) that normally destroys LDL receptors on liver cells. With PCSK9 blocked, your liver can pull more bad cholesterol out of your blood — like unclogging a drain.

Targets: ["PCSK9"]

Primary EP: [{"id":"odyssey-mace","name":"MACE (CHD death, non-fatal MI, ischemic stroke, unstable angina hospitalization)","type":"PRIMARY","unit":"HR","results":[{"notes":"903 events (9.5%)","value":9.5,"arm_id

Efficacy: ODYSSEY Outcomes met primary endpoint: 15% reduction in MACE (HR 0.85, 95% CI 0.78-0.93, p=0.0003). Numerically reduced all-cause mortality (3.5% vs 4.1%). Established that PCSK9 inhibition reduces CV events in post-ACS patients on maximally tolerated statins.

Safety: ODYSSEY Outcomes (n=18,924, median 33 months): Well-tolerated. Injection site reactions 3.8% vs 2.1%. Myalgia 6% vs 5%. Allergic reactions leading to discontinuation 0.6% vs 0.2%. No neurocognitive sa

Split structure: REGN holds US commercial rights, Sanofi holds ex-US rights. Revenue shown is REGN US net sales. +254% YoY driven by improved access/formulary wins. PCSK9 class tailwind from ODYSSEY Outcomes CV benefit data. Competes with Repatha (AMGN), Leqvio (NVS siRNA), Nexletol (ESPR). ODYSSEY Outcomes showed 15% MACE reduction in ACS patients.

{"keyRisks":[{"category":"Injection site reactions","description":"Erythema, itching, swelling, pain at injection site.","incidenceRate":"3.8%"},{"category":"Allergic reactions","description":"Hypersensitivity reactions including pruritus, rash, urticaria. Rare anaphylaxis.","incidenceRate":"0.6% (leading to discontinuation)"},{"category":"Myalgia","description":"Muscle pain. Similar rates to placebo in ODYSSEY Outcomes.","incidenceRate":"5-6%"},{"category":"Neurocognitive events","description":"Monitored extensively. No signal in ODYSSEY Outcomes (18,924 patients, 33 months). FDA removed initial concern.","incidenceRate":"No signal"}],"monitoring":["Lipid panel Q4-12W after initiation to assess response","Injection site for hypersensitivity","LDL-C may go very low — not a safety concern per ODYSSEY data"],"classWarnings":["PCSK9 inhibitor: very low LDL-C achievable (<25 mg/dL) — no adverse signal from very low LDL-C levels"],"hasBoxedWarning":false}