Regeneron Pharmaceuticals

Dupixent phase 3 study (LIBERTY-CUPID C) confirms significant improvements in itch and hives for CSU patients, meeting primary and key secondary endpoints with a nearly 50% reduction in itch and urticaria activity scores compared to placebo. Data supports regulatory resubmission in the US by year-end, aiming for Dupixent to become the first targeted therapy for CSU in a decade.

Sanofi and Regeneron's Dupixent showed significant improvement in chronic spontaneous urticaria patients in a Phase 3 trial, with 30% achieving complete response versus 18% on placebo, moving closer to FDA approval.

Dupixent reduced COPD exacerbations and improved lung function in adults with type 2 inflammation, according to BOREAS and NOTUS phase 3 studies. Dupixent was approved by the European Medicines Agency as an add-on treatment for uncontrolled COPD patients on maximal inhaled therapy. The pooled analysis showed a 31% reduction in exacerbations and a 147 mL improvement in lung function compared to placebo, with safety consistent with known profiles.

Dupixent Phase 3 trial (LIBERTY-CUPID Study C) met primary and key secondary endpoints for treating uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) with antihistamines, showing significant reductions in itch and hives. Dupixent-treated patients reported a 50% reduction in itch and urticaria activity scores compared to placebo, with 30% achieving complete response. Safety results were consistent with known profiles, and detailed results will be submitted to the FDA by year-end 2024.

Dupixent showed significant improvements in disease remission and symptoms in bullous pemphigoid, meeting primary and secondary endpoints, with five times more patients achieving remission compared to placebo. It's the first medicine to show a significant steroid-sparing effect and could be the first targeted treatment for BP in the U.S. and EU if approved.

Various drugs and their statuses are listed, including IN-001 for anaphylaxis (Fast Track), Finereonone for heart failure (Phase 3), Tirzepatide for heart failure and obesity (Phase 3), TMB-001 for congenital ichthyosis (Phase 3), Bentracimab for ticagrelor reversal (Priority Review), Fabhalta for immunoglobulin A nephropathy (accelerated approval), RLS-0071 for acute graft-vs-host disease (Fast Track and Orphan Drug), CHIKV VLP for chikungunya (Priority Review), Diazoxide choline for Prader-Willi syndrome (Priority Review), Mirdametinib for neurofibromatosis type 1 (Priority Review), Setmelanotide for genetic obesity (Priority Review), AR882 for gout (Fast Track), SPN-830 for Parkinson disease (NDA review), BGB-16673 for chronic lymphocytic leukemia (Fast Track), Cabozantinib for neuroendocrine tumors (NDA review), Linvoseltamab for multiple myeloma (Complete Response Letter), Nivolumab plus ipilimumab for hepatocellular carcinoma (BLA review), Midomafetamine for PTSD (Complete Response Letter), and Tezepelumab-ekko for COPD (Breakthrough Therapy).

Bayer announced positive results from the phase I/II SOHO-01 study on BAY 2927088, an oral TKI for HER2-mutant NSCLC, showing a 72.1% ORR and manageable safety profile. The EU also approved Eylea 8mg for nAMD and DME, extending treatment intervals up to five months. Bayer aims to strengthen its pharma portfolio through label expansions and new drug development, despite recent stock declines.

Regeneron's Libtayo showed durable survival benefits in advanced NSCLC, with median OS of 26 months vs. 13 months for chemotherapy, and no new safety signals observed at five years.

Dupixent showed a 31% reduction in COPD exacerbations and improved lung function in a pooled analysis of BOREAS and NOTUS phase 3 studies, reinforcing its clinical benefit for uncontrolled COPD patients with type 2 inflammation.