Halozyme Therapeutics, Inc. HALO

Upcoming catalysts

No catalyst is dated to the next 30 days or to an FDA action date.

Pipeline

Recent results and decisions

1. Aug 6, 2026
   positive Janssen reported pivotal Phase 1b/2 OrigAMI-4 results with durable responses for SC amivantamab in previously treated HNSCC (May 2026); no numbers given.In May 2026, Janssen announced pivotal results from the Phase 1b/2 OrigAMI-4 study showing that subcutaneous amivantamab and hyaluronidase-lpuj delivered durable responses in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy Filing
2. Aug 6, 2026
   submitted Janssen submitted an sBLA to the FDA for SC amivantamab in previously treated HNSCC (May 2026).delivered durable responses in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy and submitted a supplemental Biologics License Application (“sBLA”) to the U.S. Food and Drug Administration (“FDA”). Filing
3. May 11, 2026
   approval FDA approved sBLA for VYVGART Hytrulo in gMG covering all serotypes incl. triple seronegative (May 2026, partner argenx).In May 2026, argenx announced U.S. Food and Drug Administration (“FDA”) approval of a supplemental Biologics License Application (“sBLA”) for VYVGART® Hytrulo with ENHANZE® for the treatment of adult patients with generalized myasthenia gravis (“gMG”) including all serotypes Filing

7 more on record.