Amgen Acquires Dark Blue Therapeutics for $840M; Alumis and J&J Report Positive Phase 3 and Phase 2b Trial Results

$840 Million! Amgen Acquires New Star in Oncology Protein Degradation

Amgen announced today the acquisition of biotechnology company Dark Blue Therapeutics for a total amount of up to $840 million. The company focuses on developing potential “first-in-class” small-molecule targeted protein degradation drugs for cancer treatment.This acquisition will bring a research-stage small molecule candidate drug targeting and degrading two driver proteins, MLLT1/3, specific to acute myeloid leukemia (AML), into Amgen's pipeline. Preclinical studies have shown that the drug exhibits positive anti-tumor activity in leukemia models and has a distinct mechanism of action compared to existing therapies, providing scientific rationale for its use as monotherapy or combination therapy to overcome drug resistance and prolong remission duration. Amgen stated that it will integrate Dark Blue Therapeutics into its existing R&D system to further strengthen the company’s capabilities in early-stage oncology research.

Small Molecule Reaches Primary Endpoint in Phase 3 Trial! NDA Submission Imminent

Alumis today announced positive topline results from two Phase 3 clinical trials, ONWARD1 and ONWARD2, evaluating envudeucitinib, its next-generation highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis. Based on this data progress,Alumis Plans to Submit New Drug Application (NDA) to U.S. FDA in the Second Half of 2026.

Results showed that envudeucitinib achieved all primary and secondary endpoints with high statistical significance in both studies. In ONWARD1 and ONWARD2, the drug demonstrated significantly superior skin clearance compared to placebo at week 16 (p<0.0001) and showed advantages in the co-primary endpoints of achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and a static Physician's Global Assessment (sPGA) score of 0/1. Combined data from both studies indicated,On average, 74% of patients achieved PASI 75, 59% of patients achieved sPGA 0/1, and the efficacy deepened further over time.At the same time, the placebo-corrected response rates for the co-primary endpoints were consistent across both trials.

Johnson & Johnson's Autoimmune Monoclonal Antibody Reaches Primary Endpoint, Phase 3 Trial Initiated

Johnson & Johnson announced positive topline results from the Phase 2b JASMINE study conducted in adult patients with systemic lupus erythematosus (SLE). The JASMINE study is a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-ranging study that enrolled 228 adult patients with active SLE. The results showed,The study successfully reached its primary endpoint, which was achieved by treated patients at week 24.Systemic Lupus Erythematosus Responder Index(SRI-4) The proportion of composite responses showed a statistically significant difference compared to placebo.At the same time, the study also achieved multiple key secondary and exploratory endpoints, including indicators showing that nipocalimab has a potential steroid-sparing effect. In addition, the safety and tolerability of nipocalimab in this study were consistent with previous Phase 2 studies, and no new safety signals were observed.According to the press release, this is the first to achieve positive results in the treatment of active SLE.Neonatal Fc Receptor (FcRn) blocker research. Johnson & Johnson has launched the relevant Phase 3 clinical program.

Nipocalimab is an antibody therapy targeting the neonatal Fc receptor.It works by binding to FcRn, preventing autoantibodies taken up by monocytes and endothelial cells from being released back into the bloodstream, instead degrading them within the cells. This antibody therapy has the potential to treat a variety of autoimmune antibody-mediated immune diseases. The FDA has granted this therapy Breakthrough Therapy designation for the treatment of pregnant women at high risk of severe hemolytic disease of the fetus and newborn (HDFN), as well as moderate to severe Sjögren's syndrome.

References:

[1] Alumis’ Envudeucitinib Delivers Leading Skin Clearance Among Next-Generation Oral Plaque Psoriasis Therapies in Phase 3 Program. Retrieved January 6, 2026 from https://investors.alumis.com/news-releases/news-release-details/alumis-envudeucitinib-delivers-leading-skin-clearance-among-next

[2] AMGEN ACQUIRES DARK BLUE THERAPEUTICS, BOLSTERING ONCOLOGY PIPELINE. Retrieved January 6, 2026 from https://www.prnewswire.com/news-releases/amgen-acquires-dark-blue-therapeutics-bolstering-oncology-pipeline-302652998.html

[3] Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study. Retrieved January 6, 2026 from https://www.prnewswire.com/news-releases/johnson--johnson-unveils-new-data-showing-nipocalimab-is-the-first-and-only-investigational-fcrn-blocker-with-potential-to-reduce-systemic-lupus-erythematosus-sle-activity-in-a-phase-2-study-302652952.html

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