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Tag: safety profile

Mabwell’s 9MW5211 Receives IND Clearance from NMPA for Inflammatory Bowel Disease

SHANGHAI, June 4, 2026 /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its independently developed innovative...

Lundbeck presents positive Phase IIb data for bocunebart (Lu AG09222; anti-PACAP mAb) in migraine prevention at the AHS congress

The intravenous part of the Phase IIb clinical dose-finding trial PROCEED met its primary endpoint, with bocunebart demonstrating a statistically significant reduction in monthly...

World’s First CLDN18.2 ADC for Regulatory Review: Innovent Biologics Announces IBI343 (arcotatug tavatecan) Met Primary Endpoint in International Phase 3 Study in Advanced Refractory...

SAN FRANCISCO and SUZHOU, China, June 4, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and...

EULAR 2026: Dapirolizumab Pegol Shows Potential to Reduce Flare Rates and Maintain Disease Control in Systemic Lupus Erythematosus

BRUSSELS, Belgium and CAMBRIDGE, Mass., June 04, 2026 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (Nasdaq: BIIB) today announced data, comprising two posters and three abstracts, at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, demonstrating the clinical profile of dapirolizumab pegol (DZP), an investigational biologic in patients with systemic lupus erythematosus (SLE).

2026 ASCO LBA | Juncell Therapeutics’ GC101 TIL Therapy Achieves Primary Endpoint in the Pivotal Phase II Trial for PD-1 Antibody Failed Advanced Melanoma

SHANGHAI, June 3, 2026 /PRNewswire/ -- On June 1 (Chicago time), in a Late-Breaking Abstract (LBA) oral presentation at the 2026 American Society of Clinical...

Levicept to Present Data Suggesting LEVI-04 May Modify Disease in Osteoarthritis at EULAR 2026

Further clinical efficacy and pharmacology data also to be presented
Further clinical efficacy and pharmacology data also to be presented

JJP Biologics Announces Positive Interim Phase 1b Data for Nebaprubart (JJP-1212), an Anti-CD89 Antagonist, in Linear IgA Disease (LAD)

Warsaw, Poland – June 03, 2026 – JJP Biologics, ("JJPBio" or the "Company") a clinical-stage, immune-focused biotech that engineers precision antibodies to correct derailed immune pathways that drive autoimmune diseases and cancer, today announces positive interim data from its ongoing Phase 1b trial evaluating nebaprubart, also known as JJP-1212, its investigational potential first-in-class anti-CD89 antagonist, in patients diagnosed with Linear IgA Disease (LAD), a rare autoantibody-mediated skin disease.

Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study

Nipocalimab – the first and only neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus – is designed to target and...

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

CHENGDU, China, June 3, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that at the 2026 American Society...

Cumberland Pharmaceuticals and Vanderbilt Health Announce Potential New Therapy to Prevent Cancer Metastasis

Positive Results from Phase 2a Clinical TrialStudy met its primary endpoint demonstrating safety and tolerability of ifetroban in patients with high-risk solid tumorsTrial revealed promising...

AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Acute Treatment of Migraine in Adults

AQUIPTA® (atogepant) is now approved in the European Union for the acute treatment of migraine in adults, with or without aura, and for the...

Nxera’s Vamorolone Granted Key Regulatory Designations Supporting Faster Access for Duchenne Muscular Dystrophy Patients in South Korea

Tokyo, Japan and Cambridge, UK, 2 June 2026 – Nxera Pharma Co., Ltd. (“Nxera” or the “Company”)  announces that the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea has granted Orphan Drug Designation (ODD) and Global Innovative Products on Fast Track (GIFT) designation to vamorolone for the treatment of Duchenne muscular dystrophy (DMD). The Company plans to submit a Marketing Authorization Application (MAA) for vamorolone in South Korea during 2026.

/C O R R E C T I O N — Ranok Therapeutics/

In the news release, Ranok Therapeutics Announces Positive Interim Phase 1 Data Of Its KRAS G12D Inhibitor RNK08954 In Patients With KRAS G12D-Mutated Metastatic...

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