Halozyme Therapeutics, Inc. HALO
Halozyme Therapeutics, Inc. (Nasdaq: HALO) is a drug developer. Its lead program, ENHANZE drug delivery technology platform, is in Phase 3 for Platform: enabling SC delivery across multiple partnered programs. Its next catalyst on record is Janssen amivantamab SC: FDA decision on sBLA for head and neck squamous cell carcinoma (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Janssen amivantamab SC — FDA decision on sBLA for head and neck squamous cell carcinoma (date not stated). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Hylenex recombinant (rHuPH20) | SC hydration, drug dispersion, urography | protein/peptide | Approved |
| XYOSTED (testosterone enanthate) | Testosterone replacement therapy | small molecule | Approved |
| Roche Herceptin SC / Phesgo / MabThera SC / RITUXAN HYCELA / TECENTRIQ HYBREZA / OCREVUS ZUNOVO | Oncology, multiple sclerosis | antibody | Approved |
| Takeda HYQVIA | Primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy | protein/peptide | Approved |
| Janssen DARZALEX FASPRO | Multiple myeloma, amyloidosis, smoldering myeloma | antibody | Approved |
| Janssen RYBREVANT FASPRO (amivantamab SC) | Non-small cell lung cancer, head and neck squamous cell carcinoma | antibody | Approved |
| BMS Opdivo Qvantig / Opdivo SC | Multiple solid tumors | antibody | Approved |
| argenx VYVGART Hytrulo / VYVDURA | Generalized myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, ocular myasthenia gravis (pending) | antibody | Approved |
| Takeda TAK-881 | Primary immunodeficiency disease | protein/peptide | Phase 3 |
| Acumen sabirnetug (ACU193) SC | Alzheimer's disease | antibody | Phase 2 |
| Pfizer tilrekimig SC | Atopic dermatitis, asthma, COPD | antibody | Phase 1 |
| ViiV VH4524184 SC | HIV treatment/prevention | small molecule | Phase 1 |
Recent results and decisions
- Oct 31, 2026submitted Takeda filed a Biologics License Application with the FDA for TAK-881 for the treatment of Primary Immunodeficiency Disease.
In October 2026, Takeda announced a Biologics License Application was filed with the Food and Drug Administration ("FDA") for TAK-881 for the treatment of Primary Immunodeficiency Disease.
Filing - Oct 31, 2026approval FDA approved TECENTRIQ HYBREZA in combination with fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III dMMR colon cancer, the twelfth indication for TECENTRIQ.
In October 2026, Roche announced the FDA has approved TECENTRIQ® (atezolizumab) and TECENTRIQ HYBREZA® (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair ("dMMR") colon cancer.
Filing - Sep 30, 2026submitted argenx submitted a supplemental Biologics License Application for VYVGART in ocular myasthenia gravis to the FDA.
In the third quarter of 2026, argenx submitted a supplemental Biologics License Application for VYVGART® in ocular myasthenia gravis to the FDA.
Filing
10 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.