Welcome to our dedicated page for Halozyme Thrp news (Ticker: HALO), a resource for investors and traders seeking the latest updates and insights on Halozyme Thrp stock.
Halozyme Therapeutics, Inc. (HALO) delivers innovative drug delivery solutions through its proprietary ENHANZE® technology, transforming subcutaneous administration of biologics. This dedicated news hub provides investors and healthcare professionals with essential updates on clinical developments, strategic partnerships, and regulatory milestones.
Access timely press releases covering earnings reports, ENHANZE® licensing agreements, and oncology pipeline advancements. Our curated collection features updates on FDA submissions, collaboration expansions with global pharmaceutical leaders, and technology applications across autoimmune disorders and cancer treatments.
Key updates include partnership announcements with industry leaders, clinical trial progress for subcutaneous therapies, and financial performance insights. The resource serves investors tracking royalty revenue models and analysts monitoring competitive positioning in biopharmaceutical delivery systems.
Bookmark this page for direct access to verified corporate communications and objective reporting on Halozyme's mission to enhance treatment experiences through advanced drug delivery platforms. Regularly updated to reflect the company's latest achievements in patient-centric biotechnology innovation.
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.
Halozyme Therapeutics (NASDAQ: HALO) announced that Bristol Myers Squibb received a positive CHMP opinion recommending approval for a new subcutaneous formulation of Opdivo® (nivolumab) developed with ENHANZE® technology across multiple adult solid tumor indications in the EU.
The subcutaneous formulation, which utilizes Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), would offer cancer patients a faster and more flexible treatment option. The European Commission's decision on marketing authorization is expected by June 2, 2025.
The recommendation is supported by positive Phase 3 CheckMate -67T trial results. The formulation was previously approved in the U.S. on December 27, 2024 under the brand name Opdivo Qvantig.
Halozyme Therapeutics (NASDAQ: HALO) has announced its participation in the upcoming TD Cowen 45th Annual Healthcare Conference. Dr. Helen Torley, president and chief executive officer, will deliver a presentation on Wednesday, March 5 at 8:50am PT / 11:50am ET.
The company will provide a live audio webcast of the presentation through their Investor Relations website section. The webcast recording will remain accessible for 90 days following the conference, allowing investors and interested parties to review the presentation at their convenience.
Halozyme (HALO) reported strong financial results for Q4 and full year 2024, achieving record revenue of $1.015 billion. Q4 total revenue increased 30% YOY to $298 million, with royalty revenue up 40% to $170.4 million. Full year net income rose 58% to $444.1 million.
The company's growth was driven by strong performance of DARZALEX SC, Phesgo, and VYVGART Hytrulo. Four additional ENHANZE regulatory product approvals were secured in the U.S. and EU in 2024. The company maintains its 2025 guidance, projecting total revenue of $1,150-1,225 million (13-21% growth) and royalty revenue of $725-750 million (27-31% growth).
In December 2024, Halozyme entered an Accelerated Share Repurchase agreement for $250 million under its $750 million approved program. The company's cash position strengthened to $596.1 million by year-end 2024, up from $336.0 million in 2023.
Halozyme Therapeutics (NASDAQ: HALO) has announced it will release its fourth quarter and full year 2024 financial and operating results on Tuesday, February 18, 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 view a live webcast through the investor section of Halozyme's website.
Halozyme Therapeutics (NASDAQ: HALO) announced that Janssen-Cilag International NV received a positive CHMP opinion recommending marketing authorization for a subcutaneous formulation of RYBREVANT® (amivantamab) in Europe. The recommendation covers two treatments: combination therapy with LAZCLUZE® for first-line treatment of advanced NSCLC with specific EGFR mutations, and monotherapy for advanced NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure.
The subcutaneous formulation, developed using Halozyme's ENHANZE® technology, demonstrates significant advantages with an approximate five-minute administration time and a five-fold reduction in infusion-related reactions. The recommendation is supported by positive results from the Phase 3 PALOMA-3 study.
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