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. develops and commercializes drug-delivery technologies for subcutaneous administration of biologics and other injectable therapies. News about HALO commonly covers ENHANZE licensing agreements, Hypercon and Surf Bio hyperconcentration collaborations, partner product regulatory approvals, royalty-based revenue updates, and financial guidance.
The company also reports developments tied to its proprietary products Hylenex and XYOSTED, drug-device combination products using auto-injector technologies, and collaborations with pharmaceutical and biotechnology companies in oncology, inflammatory disease and other therapeutic areas.
Halozyme Therapeutics (NASDAQ: HALO) announced that the European Patent Office (EPO) revoked one of Janssen's co-formulation patents for DARZALEX® SC. The company affirms this decision will not impact its 2024 royalty revenue guidance of $520-555 million or its projection to exceed $1 billion in royalty revenues by 2027. The company maintains that U.S. and European royalty revenues from DARZALEX FASPRO® and SC will remain unaffected through 2032. The decision does not affect Halozyme's composition of matter patents for ENHANZE® or other licensees' ability to obtain co-formulation patents.
Halozyme Therapeutics (NASDAQ: HALO) has announced it will release its third quarter 2024 financial and operating results on Thursday, October 31, 2024, 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 company's investor relations website.
Halozyme Therapeutics (NASDAQ: HALO) announced an expansion of its global collaboration with argenx for the ENHANZE® drug delivery technology. argenx has nominated four new targets, bringing the total to six exclusively licensed targets, including the neonatal Fc receptor (FcRn) for VYVGART® Hytrulo. Halozyme will receive a total upfront payment of $30 million for exclusive rights to these targets.
The agreement includes potential future milestone payments of up to $85 million per nominated target and a tiered mid-single digit royalty rate based on annual net sales. This expansion strengthens Halozyme's relationship with argenx, a leader in immunology, and supports argenx's goal of expanding their immunology pipeline with subcutaneous delivery of therapeutics.
Halozyme Therapeutics (NASDAQ: HALO) announced FDA approval of Roche's OCREVUS ZUNOVO™, a subcutaneous formulation incorporating Halozyme's ENHANZE® technology, for treating relapsing and primary progressive multiple sclerosis. This new formulation offers a twice-yearly, 10-minute injection, expanding treatment options to centers without IV infrastructure. The approval is based on the Phase III OCARINA II trial, which demonstrated non-inferior blood levels and a comparable safety and efficacy profile to the IV formulation. The subcutaneous version showed 97% suppression of relapse activity and MRI lesions through 48 weeks, with over 92% of patients reporting satisfaction with the administration method.
Halozyme Therapeutics (NASDAQ: HALO) announced FDA approval for Roche's Tecentriq Hybreza™, the first subcutaneous anti-PD-(L)1 cancer immunotherapy. This treatment, incorporating Halozyme's ENHANZE® technology, can be administered in about 7 minutes, compared to 30-60 minutes for standard IV infusion. Tecentriq Hybreza™ is approved for all adult indications of IV Tecentriq®, including certain types of lung, liver, skin, and soft tissue cancers. The approval is based on Roche's Phase IB/III IMscin001 study, which demonstrated comparable blood levels of Tecentriq® when given subcutaneously, with a consistent safety and efficacy profile to the IV formulation.
Halozyme Therapeutics (NASDAQ: HALO) has announced its participation in three upcoming investor conferences in September 2024. The company's leadership, including Dr. Helen Torley, President and CEO, and Tram Bui, VP of Investor Relations, will be presenting and hosting investor meetings at these events.
The conferences include the 2024 Wells Fargo Healthcare Conference in Boston on September 4, the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 5, and the H.C. Wainwright 26th Annual Global Investment Conference in New York on September 10. Presentations at Wells Fargo and H.C. Wainwright will be in a fireside chat format, while the Morgan Stanley event will feature 1x1 meetings only.
Live audio webcasts of the presentations will be available on Halozyme's website, with replays accessible for 90 days after each conference.
Halozyme Therapeutics reported strong Q2 2024 financial results, with total revenue of $231 million, a 5% year-over-year increase. Royalty revenue grew 12% to $125 million. The company maintained its recently increased 2024 financial guidance, projecting total revenue of $935-$1,015 million (13-22% YOY growth) and adjusted EBITDA of $555-$615 million (30-44% YOY growth).
Key highlights include partner approvals for Ocrevus SC in Europe and the UK, and VYVGART Hytrulo for CIDP in the U.S. Halozyme expects 10 approved products with ENHANZE by 2025, including potential U.S. approvals for Roche's Tecentriq SC and Ocrevus SC in September 2024.
Halozyme Therapeutics (NASDAQ: HALO) has announced the upcoming release of its second quarter 2024 financial and operating results on Tuesday, August 6, 2024, after the market closes. The company will host a conference call on the same day at 1:30 p.m. PT/4:30 p.m. ET to discuss the results. Investors and interested parties can pre-register for the call using a provided link. Additionally, a live webcast and replay of the conference call will be available through the "Investors" section of Halozyme's corporate website.
Halozyme announced that the European Commission has approved Roche's OCREVUS® SC, co-formulated with Halozyme's ENHANZE® enzyme, for treating relapsing and primary progressive multiple sclerosis. This new subcutaneous injection offers a 10-minute administration alternative to the traditional intravenous infusion, maintaining the same twice-yearly schedule. The approval is based on Phase III OCARINA II trial data, demonstrating comparable efficacy and safety between the SC and IV formulations. This new option aims to improve patient accessibility and treatment flexibility.
Halozyme Therapeutics announced that argenx received FDA approval for VYVGART® Hytrulo, co-formulated with Halozyme's ENHANZE®, for treating chronic inflammatory demyelinating polyneuropathy (CIDP). This is the first neonatal Fc receptor blocker approved as a subcutaneous injection for CIDP. The ADHERE study, the largest clinical trial on CIDP, showed a 69% clinical improvement rate and a 61% reduction in relapse risk compared to placebo. This is the second FDA-approved indication for VYVGART® Hytrulo with ENHANZE®, the first being for generalized myasthenia gravis. The safety profile remained generally consistent with previous studies.