Tag: tyrosine kinase

BEERSE, BELGIUM, June 26, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced new data across 12 abstracts at the European Academy of Neurology (EAN) 2026 Congress that offer additional insight into the use of IMAAVY^®▼(nipocalimab) throughout clinically relevant points in the generalised myasthenia gravis (gMG) treatment journey. The analyses include adults with anti-AChR^a or anti-MuSK^b antibody-positive gMG who were early in their disease course or had lower baseline symptom burden – providing insight into the potential importance of addressing pathogenic immunoglobulin G (IgG) early in disease progression where use of advanced therapies may be less common.^1,2 Additional research to be shared include outcomes shortly after common infections, which are a known cause of disease exacerbations in gMG, and plans to address evidence gaps in the use of nipocalimab during pregnancy.^3,4

ROCKVILLE, Md. and SUZHOU, China, June 14, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies to address unmet medical needs in cancer, announced today that seventeen clinical updates from its core assets were presented at the 31^st Congress of the European Hematology Association (EHA2026), including eight poster presentations. The presentations featured data from ongoing clinical studies of olverembatinib (HQP1351), the first third-generation BCR-ABL1 inhibitor approved in China, and lisaftoclax (APG-2575), the first approved China-developed Bcl-2 selective inhibitor. The EHA2026 Congress convened in Stockholm, Sweden, from June 11 to 14, 2026.

Basel, June 12, 2026 – Novartis today presented data from the RemIND trial at the European Academy of Allergy and Clinical Immunology (EAACI) Congress showing that Rhapsido^®  (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global Phase III CIndU clinical trial⁷. In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. These results demonstrate that Rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation H1-antihistamines⁷.

“Chronic inducible urticaria (CIndU) is a form of chronic hives in which everyday triggers—such as pressure, heat, cold, or sunlight—can lead to itchy wheals, and there are currently no approved targeted treatment options,” said Prof. Dr. med. Martin Metz, Deputy Director, Institute of Allergology, Charité–Universitätsmedizin Berlin, Germany. “The RemIND results across the three most common CIndU subtypes highlight the potential of Rhapsido as an important new treatment option for patients with significant unmet need.”

The three most prevalent CIndU subtypes are symptomatic dermographism (SD), cold urticaria, and cholinergic urticaria, with SD being the most common⁸. Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Rhapsido for the treatment of SD subtype and will continue additional filings to health authorities globally throughout 2026. Rhapsido is approved for use in the U.S., European Union, China and several other countries for the treatment of chronic spontaneous urticaria (CSU), in adult patients with inadequate response to H1-antihistamines.

“Rhapsido significantly improves symptom control for patients living with the three most common subtypes of chronic inducible urticaria, and it has the potential to become the first approved targeted therapy. This is a major step forward for CIndU patients who have limited options,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “The CIndU data presented today are consistent with Rhapsido’s proven efficacy and favorable safety profile in chronic spontaneous urticaria and demonstrate Novartis’ commitment to developing truly meaningful innovation for patients with complex immune-mediated diseases.”

Primary endpoint results at Week 12 in the RemIND trial¹

PRESS RELEASE

ROCKVILLE, Md. and SUZHOU, China, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global registrational Phase III study of lisaftoclax (APG-2575), a proprietary Bcl-2 inhibitor, in combination with azacitidine (AZA), for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).