Amgen, Inc.

Nemolizumab therapy showed continuous improvements in atopic dermatitis symptoms up to 56 weeks, with 47% achieving clear or almost clear skin and 73% improving EASI scores by 75%. Nemolizumab, an IL-31 receptor antagonist, demonstrated a favorable safety profile with no unexpected adverse events, positioning it as a valuable long-term treatment option for atopic dermatitis.

MP Nigdelis received honoraria from RG Ärztefortbildung GmbH and travel grants from Organon and Gedeon Richter. M Doerk received travel grants from Gedeon Richter, Organon, and Eisai, and is a member of DGGG, AGE, and Deutsche Gesellschaft für Senologie. S Burghaus received honoraria from FOMF and is a member of DGGG, AGEM, AGE, Stiftung Endometriose Forschung, AGUB, AGO, and DKK. M Sillem, CEO of EuroEndoCert Gmbh, received payments from Bayer, Gedeon Richter, Hologic, and EndoHealth. B Haj Hamoud received travel grants from Gedeon Richter, Astrazeneca, Johnson & Johnson, and Storz, and is a member of DGGG, AGE, and Stiftung Endometriose Forschung. EF Solomayer receives grants from the University of Saarland, Storz, and Erbe, and fees from Roche, Pfizer, Celgene, Amgen, Astra Zeneca, Esai, Johnson & Johnson, Novartis, Tesaro, Teva, Medac GmbH, MSD, Vifor, Gedeon Richter, Takeda, and AGE, among others. GL Olmes received grants from AstraZeneca, Universitätsklinikum Freiburg, and RG Ärztefortbildung GmbH, and is a member of DGGG, AGE, and AGEM, with scientific collaboration with Karl Stotz.

Sanofi and Regeneron's Dupixent is the first biologic approved in the U.S. for COPD, potentially benefiting 300,000 adults with poorly controlled disease. Dupixent showed a 30-34% reduction in COPD exacerbations in Phase III studies and is consistent with existing safety profiles. The approval adds to Dupixent's list of FDA-approved indications, including asthma and eczema, with anticipated sales of $3.5 billion from the COPD approval. Competitors like GSK, AstraZeneca, and Amgen are also developing treatments for COPD.

Amgen announced positive phase 3 MINT trial data for inebilizumab in generalized myasthenia gravis (gMG), planning regulatory filings. The trial, largest placebo-controlled biologic therapy study in gMG, showed significant improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores and safety. Additionally, the MITIGATE trial demonstrated inebilizumab's efficacy in immunoglobulin G4-related disease (IgG4-RD), with 87% reduction in flare risk at 52 weeks, also showing no new safety signals.

New concepts in rheumatoid arthritis (RA) management, including early treatment and targeting stromal cells, could revitalize current approaches, according to Arthur Kavanaugh, MD, at the 2024 Congress of Clinical Rheumatology West.

GLP-1 drugs like Ozempic and Mounjaro are gaining attention as blockbuster drugs face patent cliffs. These drugs, initially for diabetes, now show significant weight loss, positioning them as next-gen treatments. Competition is fierce, with Novo Nordisk and Eli Lilly leading, but other companies like Amgen, Roche, Pfizer, and AstraZeneca are entering the market. Expanding the conditions these drugs treat could influence insurance coverage. The snack industry may need to innovate as GLP-1 drugs reduce processed food consumption. The patent cliff threatens big pharma, but Medicare negotiations and biologic drugs offer strategies. Innovations like pill-form obesity drugs and mRNA cancer treatments are on the horizon. Oncology and immunology remain dominant, but obesity is emerging as a significant driver. Stock picks include Roche, mRNA companies, and Pfizer.

FDA approves Dupixent for COPD, making it the first biologic medicine for the condition in the U.S. This expansion is expected to boost sales, which reached almost $12 billion globally last year. Dupixent targets Type 2 inflammation in a subset of COPD patients, showing reduced exacerbations and improved lung function in trials. European regulators approved Dupixent for COPD in July, but U.S. approval required additional efficacy data. The approval comes as Regeneron faces market value loss due to a court case, increasing pressure on its pipeline.

Cardurion Pharmaceuticals appoints Ron Renaud to its Board of Directors, leveraging his 25+ years of biotech experience to advance cardiovascular disease therapeutics.

BioAge Labs, focusing on GLP-1 agonists for weight management, raised over $200 million in IPO to develop azelaprag, a drug targeting apelin receptor for metabolic benefits. Azelaprag, licensed from Amgen, showed potential in preventing muscle atrophy and enhancing weight loss when combined with Eli Lilly's Zepbound. BioAge plans Phase 2 studies with Zepbound and Novo Nordisk's Wegovy, aiming for an all-oral obesity treatment by 2025-2026. The company, co-founded by CEO Kristen Fortney, leverages a data-driven platform for aging science insights.

Convergent Therapeutics announced the first patient dosed with CONV01-α in the Phase II CONVERGE-01 trial for PSMA PET-positive mCRPC, and a $40 million Series A extension by Novo Holdings, increasing the total Series A raise to $130 million. Jim Trenkle, PhD, joins the Convergent Board of Directors. The CONVERGE-01 trial is designed to assess CONV01-α's safety and efficacy in mCRPC patients. Richard Messmann, MD, MHS, MSc, joins as Chief Medical Officer, bringing 25+ years of oncology drug development experience.