HST-101

Novartis's LEQVIO (inclisiran), the first FDA-approved siRNA therapy for LDL-C reduction, is projected to reach USD 2.2 billion in US market size by 2034, offering a novel mechanism with biannual dosing that enhances patient adherence.

The FDA has accepted the regulatory application for lerodalcibep, a novel therapeutic candidate aimed at reducing LDL cholesterol levels in patients with hypercholesterolemia.

The FDA has accepted LIB Therapeutics' BLA for lerodalcibep, a PCSK9 inhibitor, with a PDUFA date set for December 12, 2025.

Lerodalcibep demonstrated similar LDL-C reduction compared to evolocumab in HoFH patients in a Phase 3 trial.

Denali Therapeutics' DNL-151 Phase III trial for Parkinson's disease was terminated, leading to a 14-point decrease in its Likelihood of Approval (LoA).