U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma

FDA approval based on Phase 3 data demonstrating statistically significant improvements in progression ‑free survival and overall survival versus standard of care regimens SAN DIEGO, March 6, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy.1 "The newly approved TECVAYLI plus DARZALEX FASPRO treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings. DARZALEX FASPRO, incorporating the ENHANZE technology, continues to set new standards in multiple myeloma treatment and outcomes," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme The approval is based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab versus investigator's choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with RRMM who have received at least one prior line of therapy.

PRNewsWire • Mar 6, 2026

Halozyme Therapeutics, Inc. (HALO) Presents at TD Cowen 46th Annual Health Care Conference Transcript

Halozyme Therapeutics, Inc. (HALO) Presents at TD Cowen 46th Annual Health Care Conference Transcript

Seeking Alpha • Mar 4, 2026

Halozyme to Participate in Upcoming Investor Conferences

SAN DIEGO, Feb. 25, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Dr. Helen Torley, President and Chief Executive Officer, is scheduled to present and host investor meetings at the following investor conferences: Event: TD Cowen 46th Annual Healthcare Conference Format: Fireside Chat and 1x1 Meetings Presentation Date: Tuesday, March 3, 2026 Presentation Time: 8:10am PT / 11:10am ET Location:   Boston, MA   Event: Leerink Partners Global Healthcare Conference Format: Fireside Chat and 1x1 Meetings Presentation Date: Tuesday, March 10, 2026 Presentation Time: 10:00am PT / 1:00pm ET Location:   Event: Format:   Presentation Date: Presentation Time: Location: Miami, FL   The Citizens Life Sciences Conference Fireside Chat and 1x1 Meetings Wednesday, March 11, 2026 8:20am PT / 11:20am ET Miami, FL Live audio webcasts of the presentations will be available in the Investor Relations section of the Company's website. Replays of the audio webcasts will be available for 90 days following the conference.

PRNewsWire • Feb 25, 2026

Halozyme's Q4 Earnings Miss, Higher Royalties Drive Y/Y Revenues

HALO swings to Q4 loss on acquisition charge, but revenues surge 52%, fueled by royalties and product sales and top estimates.

Zacks Investment Research • Feb 18, 2026

Halozyme Delivers Record FY2025 As 2026 Sets Up A Major Profitability Surge

Halozyme Therapeutics is entering a powerful earnings inflection, driven by surging royalty revenue and strategic acquisitions expanding its drug delivery platform. FY25 revenue grew 38% to $1.397 billion, with royalty revenue up 52%; recent acquisitions extend IP life and diversify the technology portfolio. 2026 guidance targets $1.71–$1.81 billion in revenue, over 70% EBITDA growth, and nearly 100% EPS growth, highlighting operating leverage and platform scalability.

Seeking Alpha • Feb 18, 2026

Halozyme Therapeutics, Inc. (HALO) Q4 2025 Earnings Call Transcript

Halozyme Therapeutics, Inc. (HALO) Q4 2025 Earnings Call Transcript

Seeking Alpha • Feb 18, 2026

HALOZYME REPORTS FULL YEAR 2025 RECORD REVENUE OF $1.4 BILLION AND REITERATES STRONG 2026 FINANCIAL GUIDANCE

Full Year 2025 Total Revenue Increased 38% YOY to Record $1.397 billion Full Year 2025 Royalty Revenue Increased 52% YOY to Record $868 million Completed Acquisitions of Elektrofi's Hypercon™ Technology and  Surf Bio's Hyperconcentration Technology Reiterating 2026 Financial Guidance Ranges: Total Revenue of $1.710 - $1.810 billion, YOY Growth of 22% - 30% Adjusted EBITDA of $1.125 - $1.205 billion, YOY Growth of 71% - 83%1 Non-GAAP Diluted EPS of $7.75 - $8.25, YOY Growth of 87% - 99%1 SAN DIEGO, Feb. 17, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the full year and fourth quarter ended December 31, 2025, and provided an update on its recent corporate activities. "2025 was a pivotal year for Halozyme as we delivered record total revenue of $1.4 billion, which was the result of continued growth in our ENHANZE business.

PRNewsWire • Feb 17, 2026

Here's What Key Metrics Tell Us About Halozyme Therapeutics (HALO) Q4 Earnings

The headline numbers for Halozyme Therapeutics (HALO) give insight into how the company performed in the quarter ended December 2025, but it may be worthwhile to compare some of its key metrics to Wall Street estimates and the year-ago actuals.

Zacks Investment Research • Feb 18, 2026

Halozyme Therapeutics (HALO) Reports Q4 Loss, Tops Revenue Estimates

Halozyme Therapeutics (HALO) came out with a quarterly loss of $0.24 per share versus the Zacks Consensus Estimate of $2.15. This compares to earnings of $1.26 per share a year ago.

Zacks Investment Research • Feb 17, 2026

Here's Why Halozyme Therapeutics (HALO) is a Strong Momentum Stock

Whether you're a value, growth, or momentum investor, finding strong stocks becomes easier with the Zacks Style Scores, a top feature of the Zacks Premium research service.

Zacks Investment Research • Feb 16, 2026