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) 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.
Halozyme Therapeutics (NASDAQ: HALO) has raised its full-year 2024 financial guidance and updated its 5-year financial outlook, driven by a new European patent for its ENHANZE® drug delivery platform. The European Patent No. 4269578 will be validated in 37 countries and extends until March 6, 2029. This patent ensures the original royalty rate for DARZALEX SC in Europe, leading to increased revenue projections.
For 2024, Halozyme forecasts total revenue of $935 million to $1.015 billion, up 13% to 22% from 2023. Royalty revenue is expected to reach $520 million to $555 million, a 16% to 24% increase. Adjusted EBITDA is projected between $555 million and $615 million, a 30% to 44% growth, and non-GAAP diluted EPS is anticipated to range from $3.65 to $4.05, representing a 32% to 46% rise. The company's investor call on June 6 will provide further details.
