HALO · Company research

Halozyme Therapeutics, Inc.

2 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

ApprovalHALOHalozymeQ1 2027

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.

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Entry

FDA decision on RYBREVANT FASPRO (ENHANZE) sBLA in head and neck cancer (partner: J&J) · Regulatory approval

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

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.

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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
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Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneHALOHalozymeH1 2027

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.

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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."

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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

Past catalysts

MilestoneHALOHalozymeJun 15, 2026

Halozyme sees zero-to-minimal royalty hit from CMS IPAY 2029 proposed rule, on Jun 15, 2026. A company milestone for Halozyme (ENHANZE royalty portfolio for n/a): a step in the program rather than a decision or a data readout.

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Entry

Halozyme sees zero-to-minimal royalty hit from CMS IPAY 2029 proposed rule · Company milestone

Drug

ENHANZE royalty portfolio

For

n/a

Stage

n/a

When

Jun 15, 2026

Source note

Responding to the CMS Medicare Drug Price Negotiation proposed rule issued June 12, 2026, Halozyme said it projects zero to minimal royalty revenue impact through at least 2035 and no impact on its ability to sign new ENHANZE deals.

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Source: prnewswire.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

ApprovalHALOHalozymeMay 8, 2026

The FDA approved Halozyme’s VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) with ENHANZE for generalized myasthenia gravis on May 8, 2026. The company can now sell it in that market.

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Entry

FDA expands VYVGART/VYVGART Hytrulo label to all gMG serotypes · Regulatory approval

Drug

VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) with ENHANZE

For

generalized myasthenia gravis

Stage

Phase 3 · the last stage before a drug can be approved

When

May 8, 2026

Source note

argenx won an sBLA approval broadening VYVGART and the ENHANZE-enabled VYVGART Hytrulo to all adult gMG serotypes including triple seronegative patients, expanding the royalty base for Halozyme's largest ENHANZE product.

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Source: biospace.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

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsHALOHalozymeMay 4, 2026

Halozyme reported results from its Phase 2/3 study of TAK-881 (SCIG 20% with recombinant human hyaluronidase) for primary immunodeficiency disease on May 4, 2026. The study met its main goal.

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Entry

Partner Takeda: pivotal Phase 2/3 of TAK-881 met primary PK endpoint · Clinical trial results (readout / topline data)

Drug

TAK-881 (SCIG 20% with recombinant human hyaluronidase)

For

primary immunodeficiency disease

Stage

Phase 2/3 · a combined mid- to late-stage study

When

May 4, 2026

Source note

Takeda's TAK-881-3001 pivotal Phase 2/3 trial of a 20% subcutaneous immunoglobulin facilitated with recombinant human hyaluronidase met its primary endpoint, showing PK comparability to HYQVIA; Takeda plans US/EU/Japan filings in FY2026.

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Source: takeda.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

ApprovalHALOHalozymeMar 6, 2026

The FDA approved Halozyme’s DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) with ENHANZE for relapsed/refractory multiple myeloma on Mar 6, 2026. The company can now sell it in that market.

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Entry

FDA approves TECVAYLI + DARZALEX FASPRO (ENHANZE) in r/r multiple myeloma · Regulatory approval

Drug

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) with ENHANZE

For

relapsed/refractory multiple myeloma

Stage

Phase 3 · the last stage before a drug can be approved

When

Mar 6, 2026

Source note

Halozyme announced J&J won FDA approval for teclistamab plus DARZALEX FASPRO — which is co-formulated with Halozyme's rHuPH20/ENHANZE — in relapsed/refractory multiple myeloma after at least one prior line, based on Phase 3 MajesTEC-3.

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Source: prnewswire.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

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Things of Interest

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

No phase 2+ trials cached for this company.

Company news

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