REGENXBIO (NASDAQ:RGNX) reported that the U.S. Food and Drug Administration placed a clinical hold on its investigational MPS II gene therapy RGX-121 following spine MRI findings in five participants in the CAMPSIITE study.
Monte Rosa Therapeutics (NASDAQ:GLUE) announced that the first patient has been dosed in MODeFIRe-1, a Phase 2 trial evaluating investigational molecular glue degrader MRT-2359 with apalutamide in patients with AR mutation-positive metastatic castration-resistant prostate cancer.
VERAXA Biotech (NASDAQ:VRXA) and Secarna Pharmaceuticals announced a research milestone in their collaboration to develop antibody-oligonucleotide conjugates for autoimmune and chronic immune diseases.
TwinStrand Biosciences announced that the U.S. District Court for the District of Delaware entered final judgment in favor of TwinStrand and the University of Washington in their patent infringement case against Guardant Health (NASDAQ:GH), awarding more than $245.2 million in damages, royalties, and interest.
Spruce Biosciences (NASDAQ:SPRB) announced that it completed two pre-BLA meetings with the U.S. Food and Drug Administration supporting its planned submission of a Biologics License Application for tralesinidase alfa enzyme replacement therapy in Sanfilippo Syndrome Type B.
Insmed (NASDAQ:INSM) announced that Japan’s Ministry of Health, Labour and Welfare approved BRINSUPRI (brensocatib 25 mg) for adults and pediatric patients aged 12 years and older with non-cystic fibrosis bronchiectasis.
BriaCell (NASDAQ:BCTX) announced that Bria-MEL+ has passed a key genetic engineering milestone, moving the personalized whole-cell melanoma immunotherapy vaccine candidate toward potential clinical development.
Vanda Pharmaceuticals (NASDAQ:VNDA) announced that the European Commission granted orphan designation to imsidolimab for the treatment of generalized pustular psoriasis, following a positive opinion from the EMA Committee for Orphan Medicinal Products.
Scinai Immunotherapeutics (NASDAQ:SCNI) reported first-half 2026 revenue of $949 thousand, up from $773 thousand a year earlier, driven mainly by its acquired Yavne contract development and manufacturing organization operations.
Gilead Sciences (NASDAQ:GILD) announced that the European Commission approved Trodelvy (sacituzumab govitecan-hziy) combined with Keytruda (pembrolizumab) for adults with PD-L1-positive metastatic triple-negative breast cancer.
Precision BioSciences (NASDAQ:DTIL) announced that the first patient has been dosed in the Phase 1/2 FUNCTION-DMD trial evaluating PBGENE-DMD for Duchenne muscular dystrophy.
Oculis (NASDAQ:OCS) announced that the first patient has been treated in PIONEER-1, a registrational trial evaluating Privosegtor for acute optic neuritis in patients with and without multiple sclerosis.
