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ALMS Surges as Envudeucitinib Meets Goals in Plaque Psoriasis Studies
ZACKS· 2026-01-07 17:56
Core Insights - Alumis (ALMS) shares increased by 95.3% following the announcement of positive top-line data from two phase III studies, ONWARD1 and ONWARD2, for envudeucitinib, aimed at treating moderate-to-severe plaque psoriasis [1][7]. Study Results - Both ONWARD1 and ONWARD2 studies met all primary and secondary endpoints with high statistical significance, showing envudeucitinib's effectiveness in achieving superior skin clearance compared to placebo [2]. - In the studies, 74% of patients achieved PASI 75 and 59% achieved sPGA 0/1 at week 16, with improvements noted over time; by week 24, approximately 65% achieved PASI 90 and over 40% achieved PASI 100 [3]. Comparison with Competitors - Envudeucitinib demonstrated superior skin clearance compared to Amgen's Otezla (apremilast) across all PASI endpoints at week 24, indicating a competitive edge in the psoriasis treatment market [4]. Stock Performance - Over the past six months, Alumis shares have surged by 366.4%, significantly outperforming the industry average increase of 19.1% [5]. Future Plans - The company plans to submit a New Drug Application (NDA) to the FDA for envudeucitinib in the second half of 2026, with ongoing evaluations in a phase IIb study for systemic lupus erythematosus (SLE) [9]. - Management believes envudeucitinib could transform treatment for IL-23/IL-17-driven diseases, highlighting its potential as a "pipeline-in-a-pill" [10].
Alumis Skin Drug Shows Clear Benefits In Late Trials, Stock Soars
Benzinga· 2026-01-06 15:47
Core Insights - Alumis Inc. (NASDAQ:ALMS) stock is experiencing a significant increase, trading at a new 52-week high of $17.91, up 115.58% [8] - The company released positive topline results from its Phase 3 ONWARD1 and ONWARD2 clinical trials for envudeucitinib, a treatment for moderate-to-severe plaque psoriasis [1][3] Clinical Trial Results - Envudeucitinib met all primary and secondary endpoints with high statistical significance in both ONWARD1 and ONWARD2 trials [3] - On average, 74% of patients achieved a Psoriasis Area and Severity Index (PASI) 75 response, and 59% achieved a static Physician's Global Assessment (sPGA) 0/1 at Week 16 [4] - At Week 24, approximately 65% of patients achieved PASI 90, and over 40% achieved PASI 100 across both trials [4] - Rapid responses were noted, with significant separation from placebo on PASI 90 as early as Week 4 [5] Comparative Efficacy - Envudeucitinib demonstrated superior skin clearance compared to Amgen Inc.'s Otezla (apremilast) on all PASI endpoints at Week 24 [5] - Consistent and clinically meaningful improvements were observed in patient-reported outcomes related to itch and quality of life [5] Safety Profile - Treatment with envudeucitinib was generally well tolerated through Week 24, with a safety profile consistent with Alumis' Phase 2 program [6] Future Developments - Alumis plans to present additional results from ONWARD1 and ONWARD2 at an upcoming medical meeting and intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2026 [7] - Topline data from the LUMUS Phase 2b trial of envudeucitinib in systemic lupus erythematosus (SLE) is expected in the third quarter of 2026 [7]
AMGEN ANNOUNCES 2026 FIRST QUARTER DIVIDEND
Prnewswire· 2025-12-09 21:01
Core Points - Amgen's Board of Directors declared a dividend of $2.52 per share for Q1 2026, payable on March 6, 2026, to stockholders of record as of February 13, 2026 [1] - Amgen is a leader in biotechnology, focusing on innovative medicines for serious diseases, with a strong pipeline targeting cancer, heart disease, osteoporosis, inflammatory diseases, and rare diseases [2] - The company has received multiple accolades, including being named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes [3] Company Overview - Amgen has over 40 years of experience in the biotechnology industry and continues to leverage technology and human genetic data for innovation [2] - The company is part of the Dow Jones Industrial Average and the Nasdaq-100 Index, highlighting its significance in the market [3] Contact Information - For further inquiries, Amgen's media contact is Elissa Snook at 609-251-1407, and investor contact is Casey Capparelli at 805-447-1746 [8]
AMGEN ANNOUNCES 2025 FOURTH QUARTER DIVIDEND
Prnewswire· 2025-10-31 20:01
Core Points - Amgen's Board of Directors declared a dividend of $2.38 per share for Q4 2025, payable on December 12, 2025, to stockholders of record as of November 21, 2025 [1] Company Overview - Amgen is a biotechnology company that discovers, develops, manufactures, and delivers innovative medicines for various diseases, having established the biotechnology industry over 40 years ago [2] - The company has a broad pipeline aimed at treating cancer, heart disease, osteoporosis, inflammatory diseases, and rare diseases [2] - Amgen has received recognition as one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes in 2024 [2] - It is part of the Dow Jones Industrial Average and the Nasdaq-100 Index, indicating its significant market capitalization and innovation [2] Financial Information - Amgen will report its third quarter 2025 financial results on November 4, 2025, after market close [6]
Regeneron Prevails over Amgen in Antitrust PCSK9 Lawsuit Protecting Biotech Innovation and Patient Access to Life-Saving Treatments
Globenewswire· 2025-05-15 18:02
Core Viewpoint - A federal court jury found Amgen liable for antitrust violations, awarding Regeneron $135.6 million in compensatory damages and $271.2 million in punitive damages due to Amgen's anticompetitive practices that hindered competition for Praluent [1][3]. Summary by Relevant Sections Antitrust Violations - Amgen was found to have violated multiple laws, including the Clayton Act and Sherman Act, by using cross-therapeutic bundled rebates to favor Repatha over Praluent, thereby preventing fair competition [1][2]. Jury Verdict and Damages - The jury awarded Regeneron a total of $406.8 million, comprising $135.6 million in compensatory damages and $271.2 million in punitive damages aimed at deterring similar future conduct [3]. Company Statements - Regeneron emphasized the importance of fair competition in the biotech industry, stating that anticompetitive tactics undermine patient access to innovative therapies and hinder medical advancements [4]. Product Information - Praluent, developed by Regeneron and Sanofi, is designed to lower LDL cholesterol levels by inhibiting PCSK9, and is approved in 60 countries [6][7]. Technology and Innovation - Regeneron's proprietary VelocImmune technology has been instrumental in developing fully human monoclonal antibodies, contributing to a significant portion of FDA-approved treatments [8][9].