FDA decision on RYBREVANT FASPRO (ENHANZE) sBLA in head and neck cancer (partner: J&J)
Halozyme expects the FDA to decide on amivantamab + hyaluronidase-lpuj (RYBREVANT FASPRO, uses Halozyme ENHANZE) for head and neck squamous cell carcinoma (OrigAMI-4) in Q1 2027 (Jan–Mar) (no exact date yet). An approval lets the company start selling it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Halozyme Therapeutics, Inc. HALO
- Drug
- amivantamab + hyaluronidase-lpuj (RYBREVANT FASPRO, uses Halozyme ENHANZE)
- For
- head and neck squamous cell carcinoma (OrigAMI-4)
- Stage
- sBLA under FDA priority review
- When
- Q1 2027 · the company gave a window, not a day; the calendar never invents one
- Source note
- J&J submitted the sBLA around May 2026; Halozyme management said FDA granted priority review (~6-month review clock), implying a decision around late 2026/early 2027. No exact PDUFA date has been publicly announced.
- Checked
- Checked by a person when it was added
- Source: fool.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- HALO headlines on this site
First Hypercon platform clinical trial starts, expected in the first half of 2027 (no exact date yet). A company milestone for Halozyme (Hypercon high-concentration formulation platform for undisclosed partner programs (incl. Vertex collaboration)): a step in the program rather than a decision or a data readout.
More details
- Entry
- First Hypercon platform clinical trial starts · Company milestone
- Drug
- Hypercon high-concentration formulation platform
- For
- undisclosed partner programs (incl. Vertex collaboration)
- Stage
- Clinical starts
- When
- H1 2027 · the company gave a window, not a day
- Source note
- Halozyme management guidance on Q2 2026 call: "First Hypercon clinical starts in the first half of 2027."
- Checked
- Checked by a person when it was added
- Verify it
- Source: fool.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- HALO headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page