Scholar Rock has removed the OAI-classified Catalent Indiana facility from apitegromab’s US filing, preserving its September 30 FDA target through an alternate manufacturer while withdrawing and preparing to resubmit the European application.
GlycoNex has dosed the first patient in a multinational Phase I trial of GNX1021, moving its lead glycan-directed antibody-drug conjugate from laboratory studies into human testing. The milestone begins a far more consequential phase in which investigators must establish whether targeting branched Lewis B/Y can produce a usable therapeutic window in advanced gastrointestinal cancers.
See how ITI-9001 could reshape Japanese cedar allergy treatment and what its Phase 1 trial must prove on safety, efficacy and durability.
Find out how GlycoNex’s SPD8 Phase III data could intensify denosumab biosimilar competition in osteoporosis and oncology care.
Discover how BioCardia, Inc.’s Heart3D platform could reduce variability in cardiac cell therapy. Read the full analysis on what this means next.