Also known as Hyalase, Vitrase, and Amphadase.
Cohort 5 reported 77% confirmed ORR (14% CR) in non‑HPV HNSCC with subcutaneous amivantamab + pembrolizumab and carboplatin; median follow‑up 10.6 months; safety consistent with known profiles.
VYVGART sales up 54% YoY; sBLA filings and Phase‑3 readouts scheduled through Dec 2026–2027; cash $3.7B and combined R&D+SG&A guide ≈$4B for 2026.
Phase 3 ALKIVIA shows clinically meaningful, rapid improvements in IMNM and dermatomyositis, seen by Week 4 and sustained to Week 52; primary endpoint met (TIS +15.4).
Pivotal IgGNITE results in patients ≥16 show similar IgG exposure to HYQVIA with 50% less infusion volume, shorter administration times, comparable safety and planned FY2026 regulatory filings.
Modeling of MajesTEC‑3 trial data estimates a high cure fraction and nearly fourfold median OS benefit for teclistamab plus daratumumab FASPRO versus standard care in relapsed/refractory myeloma.
Final overall survival data for RYBREVANT plus chemotherapy in EGFR exon 20 insertions and tolerability updates for subcutaneous RYBREVANT FASPRO with prophylactic strategies.
Primary endpoint met in Phase 3 ALKIVIA: efgartigimod improved mean Total Improvement Score at Week 52 versus placebo; benefit emerged by Week 4 and was sustained across IMNM and DM.
OrigAMI-4 showed 42% response rate with >1/3 complete responses; FDA review shortened to ~6 months; drug targets EGFR and MET and is co-formulated with hyaluronidase.
CHMP recommendation follows MajesTEC-3 Phase 3 data showing HR 0.17 for PFS and HR 0.46 for OS at ~3 years in adults with RRMM after ≥1 prior therapy, with manageable safety.
GPRC5D bispecific plus anti‑CD38 combo cut progression risk and delivered 24‑month PFS up to 81% and OS up to 89% in earlier‑line relapsed/refractory multiple myeloma.
