Itepekimab

Regeneron acquired exclusive rights to HS-20094, a dual GLP-1/GIP receptor agonist from Hansoh Pharmaceuticals, for $80 million upfront and up to $1.93 billion in milestone payments.

The AERIFY-1 phase 3 trial met its primary endpoint, demonstrating a statistically significant 27% reduction in moderate or severe COPD exacerbations at week 52 in former smokers treated with itepekimab compared to placebo.

Sanofi's amlitelimab demonstrated clinically meaningful efficacy in heterogeneous inflammatory asthma, showing over 70% reduction in exacerbations in patients with specific biomarkers at week 60 of the TIDE-Asthma phase 2 study.

• The COPD market is projected to reach $30.2 billion by 2033 across seven major markets, with biologics targeting specific patient subgroups leading the growth. • Sanofi/Regeneron's itepekimab shows promise for former smokers with COPD, demonstrating a 30% reduction in exacerbations and 110ml improvement in FEV1 in Phase II trials. • Roche's astegolimab, an anti-ST2 monoclonal antibody in Phase III development, offers a potentially stronger effect on type 2 inflammation compared to IL-33 targeting therapies.

• Pfizer is prioritizing its oral obesity drug, danuglipron, with late-stage studies planned for the second half of 2025, aiming for a novel mechanism of action. • Regeneron anticipates Phase III data readouts for itepekimab in COPD and fianlimab in melanoma, potentially expanding its portfolio alongside Dupixent. • BioNTech is advancing its mRNA-based cancer immunotherapies, including BNT327/PM8002 for solid tumors and BNT323/DB-1303, an ADC for endometrial cancer. • Sarepta Therapeutics reported strong initial sales for Elevidys in Duchenne muscular dystrophy and is pursuing a Phase III trial for limb-girdle muscular dystrophy.