argenx

Argenx has entered a partnership with startup Unnatural Products worth up to $1.5 billion to develop oral macrocyclic peptides for inflammatory and immunological diseases.

argenx announced plans to advance ARGX-119, a first-in-class muscle-specific kinase agonist antibody, to registrational studies following positive Phase 1b results in DOK7 congenital myasthenic syndromes.

LEO Pharma's investigational IL-22RA1 antagonist temtokibart achieved positive results for the primary endpoint at the three highest doses in a Phase 2b trial for moderate-to-severe atopic dermatitis.

• Scholar Rock has appointed David L. Hallal as CEO, transitioning from his role as Chairman of the Board, as the company prepares for the global launch of apitegromab for spinal muscular atrophy. • The company has bolstered its leadership team with three key appointments: Akshay Vaishnaw as President of R&D, R. Keith Woods as Chief Operating Officer, and Vikas Sinha as Chief Financial Officer. • Apitegromab, a first-in-class muscle-targeted treatment for SMA, has received FDA priority review following successful Phase 3 trials, with potential approval and launch expected later this year.

The FDA has approved a new pre-filled syringe formulation of efgartigimod (VYVGART Hytrulo) for self-injection in adults with generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.

Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases.

Immunovant's batoclimab demonstrated statistically significant improvement in myasthenia gravis symptoms in Phase III trial, with high-dose patients showing a 5.6-point improvement on the MG-ADL scale versus 3.6 points for placebo.

New clinical data demonstrates VYVGART and VYVGART Hytrulo maintain consistent safety profiles and sustained efficacy in generalized myasthenia gravis patients through 126 weeks of treatment.

The FDA granted Priority Review to nipocalimab for treating gMG in antibody-positive patients, expediting its potential availability to patients.

Japan's MHLW has approved VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) for treating adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).