News about Clinical Trials

Intellia Therapeutics Secures U.S. FDA Clearance to Resume Phase III Trial of CRISPR Therapy for ATTR-CM

The FDA lifted the clinical hold on Intellia’s phase III MAGNITUDE trial evaluating CRISPR-based therapy nex-z for transthyretin amyloidosis with cardiomyopathy, enabling the company to resume patient enrollment with enhanced safety measures.

Clinical Trials | 05/03/2026 | By News Bureau |  215

Roche's Fenebrutinib Shows Promise in Third Phase III MS Trial

Roche reported positive Phase III FENhance 1 results, with fenebrutinib reducing relapses by 51 percent in relapsing multiple sclerosis, consistent with prior FENhance 2 and FENtrepid data. The company plans regulatory submissions, positioning fenebrutinib as a potential first-in-class BTK inhibitor for relapsing and primary progressive MS.

Clinical Trials | 02/03/2026 | By News Bureau |  185

MindRank Doses First Patient in Phase III Trial of AI-Designed Oral GLP-1RA MDR-001 in China

MindRank has initiated its Phase III MOBILE trial of MDR-001, an AI-designed oral GLP-1 receptor agonist, evaluating long-term efficacy and safety in 750 obesity and type 2 diabetes patients in China.

Clinical Trials | 02/03/2026 | By News Bureau |  502

Johnson & Johnson Submits sBLA to US FDA for IMAAVY in Warm Autoimmune Hemolytic Anemia

Johnson & Johnson has filed a supplemental biologics application seeking US approval of IMAAVY (nipocalimab) for warm autoimmune hemolytic anemia, a rare disorder with no currently approved treatments.

Clinical Trials | 26/02/2026 | By News Bureau |  223

Hansa Biopharma's Imlifidase BLA Accepted by US FDA for Priority Review

FDA accepts Hansa Biopharma’s BLA for imlifidase, supported by strong Phase III ConfIdeS data demonstrating significant kidney function improvement in highly sensitized transplant patients.

Clinical Trials | 20/02/2026 | By News Bureau |  358

Novartis' Remibrutinib Shows Positive Phase III Results in Chronic Inducible Urticaria

Pivotal RemIND trial meets primary endpoint across three major CIndU subtypes, positioning oral remibrutinib as a potential first targeted therapy for inducible chronic hives.

Clinical Trials | 19/02/2026 | By News Bureau |  395

FDA Accepts Bristol Myers Squibb's NDA for Iberdomide Combination in Relapsed/Refractory Multiple Myeloma

Iberdomide, an investigational oral CELMoD therapy, is under FDA review in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma.

Clinical Trials | 19/02/2026 | By News Bureau |  162

Duvakitug Shows Durable Efficacy in Ulcerative Colitis and Crohn's Disease in Long-Term Study

Long-term extension data show sustained remission and endoscopic response with duvakitug in ulcerative colitis and Crohn’s disease, strengthening its position as a potential next-generation TL1A therapy.

Clinical Trials | 18/02/2026 | By News Bureau |  361

Genentech's Gazyva Shows Strong Phase III Results in Primary Membranous Nephropathy

Phase III MAJESTY trial shows Gazyva significantly improves complete remission rates in primary membranous nephropathy, potentially paving the way for the first targeted therapy for the condition.

Clinical Trials | 17/02/2026 | By News Bureau |  157

Lilly's Retevmo Shows Significant Benefit in Early-Stage RET+ Lung Cancer in Phase III Trial

LIBRETTO-432 study demonstrates statistically significant improvement in event-free survival as adjuvant therapy for stage II–IIIA RET fusion-positive NSCLC.

Clinical Trials | 17/02/2026 | By News Bureau |  275