Clinical Trial News

Bristol Myers Squibb announced positive Phase III results for Sotyktu in psoriatic arthritis, showing greater treatment response vs. placebo. Sotyktu, an oral TYK2 inhibitor, is FDA-approved for plaque psoriasis and saw $170m in sales in 2023, projected to rise to $2.2bn by 2030.

A phase II study presented at the American Society of Hematology annual meeting showed that a chemotherapy-free combination of ponatinib and blinatumomab for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia led to high rates of deep minimal residual disease negativity and durable remissions without the need for stem cell transplant in most patients. The 3-year overall survival rate was 88%, with only two of 76 patients requiring transplant. Predictors of relapse included elevated white blood cell count, VPREB1 deletion, and CNS disease at diagnosis.

Cytokinetics announced EMA validation of aficamten's MAA for obstructive HCM, supported by SEQUOIA-HCM trial results. The drug, a cardiac myosin inhibitor, aims to improve exercise capacity and relieve HCM symptoms.

Bristol Myers Squibb announced positive Phase III results for Sotyktu (deucravacitinib) in psoriatic arthritis, showing greater treatment response compared to placebo. Sotyktu, an oral TYK2 inhibitor, is approved for plaque psoriasis and saw $170m in sales in 2023, projected to rise to $2.2bn by 2030.

The FDA approved the first generic liraglutide injection, a GLP-1 receptor agonist for type 2 diabetes, addressing shortages and enhancing patient access to affordable treatments. The approval includes warnings about thyroid C-cell tumors and other risks.

In 2024, FDA approved several cancer treatments including Elahere for gynecologic cancers, Udenyca biosimilar for on-body administration, Onivyde for metastatic pancreatic cancer, Enhertu for HER2-positive solid tumors, and Darzalex Faspro for multiple myeloma, based on clinical trial results showing improved survival and response rates.

The FDA approved concizumab-mtci (Alhemo) for hemophilia A or B with inhibitors, offering a subcutaneous injection alternative to IV infusion. Results from the Phase 3 explorer7 trial showed an 86% reduction in annual bleeding rate (ABR) with concizumab prophylaxis, with common adverse reactions being injection site reactions and urticaria.

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ZUMA-2 study, cohort 3, showed durable responses to brexucabtagene autoleucel in BTK inhibitor–naive mantle cell lymphoma patients, with 91% objective response rate and 73% complete response at 15.5 months median follow-up. No new safety signals detected.

FDA granted accelerated approval to encorafenib (Braftovi) with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation. Efficacy was confirmed in the BREAKWATER trial, showing 61% objective response rate in the treatment arm vs. 40% in the control arm. Common adverse reactions include peripheral neuropathy and nausea. Recommended dose is 300 mg of encorafenib daily with cetuximab and mFOLFOX6.