Halozyme Thrp Stock Price, News & Analysis

Halozyme Therapeutics (NASDAQ: HALO) announced that Bristol Myers Squibb has received European Commission approval for a subcutaneous formulation of Opdivo® (nivolumab) developed with Halozyme's ENHANZE® technology. The approval covers multiple adult solid tumor indications and makes Opdivo® the first and only PD-1 inhibitor approved for subcutaneous use in the European Union.

The new formulation allows for a 3-to-5-minute subcutaneous injection, offering a more convenient alternative to traditional administration methods. The approval is supported by the Phase 3 CheckMate -67T trial and is valid across all 27 EU member states, plus Iceland, Liechtenstein and Norway. This follows the U.S. FDA approval of Opdivo Qvantig™ in December 2024.

Halozyme (NASDAQ: HALO) reported strong Q1 2025 results and raised its 2025 financial guidance. Total revenue increased 35% YOY to $265 million, with royalty revenue up 39% to $168 million. Net income grew 54% to $118 million, and GAAP diluted EPS rose 55% to $0.93. The company announced a new $250 million share repurchase program. Halozyme raised its 2025 guidance, projecting total revenue of $1,200-$1,280 million (18-26% YOY growth), royalty revenue of $750-785 million, and adjusted EBITDA of $790-840 million. Growth was driven by strong performance of blockbuster brands including Darzalex SC, Phesgo, and VYVGART Hytrulo, along with four recently launched products. The company also filed a patent infringement lawsuit against Merck regarding SC Keytruda development.

Halozyme Therapeutics (NASDAQ: HALO) announced that its President and CEO, Dr. Helen Torley, will present at the upcoming BofA Securities 2025 Healthcare Conference. The presentation is scheduled for Tuesday, May 13 at 4:20pm PT / 7:20pm ET. The company will provide a live audio webcast of the presentation on their Investor Relations website, with replays available for 90 days after the conference.

Halozyme Therapeutics (NASDAQ: HALO) has announced it will release its first quarter 2025 financial and operating results on Tuesday, May 6, 2025, after market close. The company will host a conference call the same day at 1:30 p.m. PT/4:30 p.m. ET to discuss the results. Investors can access the call through pre-registration and join the live webcast through the Investors section of Halozyme's corporate website.

Halozyme Therapeutics (NASDAQ: HALO) announced that argenx received a positive CHMP opinion recommending European Commission approval for VYVGART® with ENHANZE® for chronic inflammatory demyelinating polyneuropathy (CIDP) treatment. The subcutaneous injection, available as a vial or prefilled syringe, is designed for adult patients with progressive or relapsing active CIDP after prior treatment with corticosteroids or immunoglobulins.

VYVGART represents the first targeted IgG Fc-antibody fragment for CIDP and the first novel mechanism of action in over 30 years. The recommendation is based on the ADHERE clinical trial, the largest CIDP patient study to date. The European Commission's decision, expected within two months, will apply to all 27 EU Member States plus Iceland, Norway, and Liechtenstein.

Halozyme Therapeutics (NASDAQ: HALO) has filed a patent infringement lawsuit against Merck in U.S. District Court in New Jersey over the subcutaneous formulation of Keytruda. The complaint alleges that Merck's subcutaneous (SC) Keytruda infringes multiple patents related to Halozyme's MDASE technology, which were filed beginning in 2011.

The lawsuit comes as Merck plans to launch SC Keytruda in 2025 following completed phase 3 clinical testing. Halozyme claims Merck developed the SC formulation without permission, despite being aware of Halozyme's patents. The company is seeking damages and injunctive relief to stop the infringement.

Importantly, the disputed MDASE patent rights are separate from Halozyme's ENHANZE® licensing program and will not impact existing licensees or related revenues. The patents stem from Halozyme's research involving nearly 7,000 modifications to human hyaluronidases, which enable rapid subcutaneous administration of therapeutic drugs.

Halozyme Therapeutics (NASDAQ: HALO) announced FDA approval of VYVGART® Hytrulo prefilled syringe for self-injection, co-formulated with ENHANZE® technology. The treatment is approved for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive and adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

The new prefilled syringe enables a 20-to-30-second subcutaneous self-injection, allowing patients to self-administer after proper training. This development stems from argenx's exclusive partnership with Halozyme's ENHANZE® drug delivery technology. The approval is supported by bioequivalence studies comparing the prefilled syringe to VYVGART® Hytrulo in vial form, along with human factors validation studies demonstrating successful administration by gMG and CIDP patients or their caregivers.

Halozyme Therapeutics (NASDAQ: HALO) announced that the European Commission (EC) has approved an indication extension for DARZALEX® (daratumumab) subcutaneous (SC), which is co-formulated with Halozyme's ENHANZE® technology. The approval covers the use of daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for treating adult patients with newly diagnosed multiple myeloma.

This approval follows a previous indication extension in October 2024 for transplant-eligible patients, based on the Phase 3 PERSEUS study. The subcutaneous formulation eliminates the need for lengthy IV infusions, offering a more convenient treatment option for newly diagnosed multiple myeloma patients.

Halozyme Therapeutics (NASDAQ: HALO) announced that the European Commission has approved the subcutaneous formulation of RYBREVANT® (amivantamab), co-formulated with their ENHANZE® drug delivery technology. The approval covers two key indications:

• First-line treatment for advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations, in combination with LAZCLUZE®
• Monotherapy for advanced NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure

The approval is backed by Phase 3 PALOMA-3 study results, demonstrating reduced administration time and decreased infusion-related reactions. This marks Halozyme's tenth approved partner product utilizing their ENHANZE® technology.