Amgen, Inc.

The weight-loss treatment market is expected to see 16 new drugs by 2029, expanding the market to $200 billion by 2031, driven by interest sparked by Novo Nordisk and Eli Lilly. Amgen and Pfizer are among companies testing their drug candidates, which could lower prices amid criticism over high costs.

Regeneron Pharmaceuticals' PE, PB, and PS ratios are low, suggesting potential undervaluation. However, its low ROE indicates lower profitability. High EBITDA and gross profit levels indicate strong financial performance, but low revenue growth may be a concern.

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).

Up to 16 new GLP-1 drugs could launch by 2029, capturing nearly a third of a $200B market by 2031, dominated by Novo Nordisk and Eli Lilly. Competitors like Roche, Amgen, Pfizer, AstraZeneca, Boehringer, Viking Therapeutics, and Structure Therapeutics may launch rival weight-loss drugs within 3-4 years. Novo Nordisk and Lilly are expected to retain 68% of weight-loss sales, but the market may see price declines of 10%-15% by 2027 due to competition.

Tarlatamab-dlle (Imdelltra; Amgen) demonstrated a manageable safety profile, sustained disease control, and positive survival outcomes in patients with first-line maintenance extensive-stage small cell lung cancer (ES-SCLC) at the World Conference on Lung Cancer 2024. The drug, a bispecific T cell engager, showed a median overall survival of 15.2 months and an objective response rate of 40% in phase 2 of the DeLLphi-303 study. Tarlatamab-dlle received accelerated FDA approval earlier this year for ES-SCLC that has progressed after platinum-based chemotherapy, with a median overall survival of 14.3 months and a median duration of response of 9.7 months.

Tyra Biosciences appoints Dr. Doug Warner as Chief Medical Officer, overseeing clinical portfolio and joining executive management team. Dr. Warner brings 20+ years of clinical development experience in oncology and skeletal diseases.