ENHANZE®

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Halozyme Therapeutics Added to Russell 1000® Index
Prnewswire· 2025-06-30 20:05
Group 1 - Halozyme Therapeutics, Inc. has been added to the U.S. large-cap Russell 1000® Index, effective after market close on June 27, 2025, as part of the 2025 FTSE Russell indexes annual reconstitution [1][2] - The Russell 1000® Index includes approximately 1,000 of the largest U.S. securities based on market capitalization and serves as a benchmark for large-cap stock performance [1][2] - Dr. Helen Torley, President and CEO of Halozyme, stated that joining the Russell 1000 Index reflects the company's leadership in rapid large-volume subcutaneous drug delivery and its track record of durable growth [2] Group 2 - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of injected drugs [3] - The company has licensed its ENHANZE® technology to major pharmaceutical companies, including Roche, Takeda, and Pfizer, impacting over one million patients globally [3][4] - Halozyme develops drug-device combination products using advanced auto-injector technologies aimed at enhancing patient comfort and adherence [4] Group 3 - The company is headquartered in San Diego, CA, with additional offices in Ewing, NJ, and Minnetonka, MN, where its operations facility is located [5]
Halozyme Announces argenx Received European Commission Approval for VYVGART® Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Prnewswire· 2025-06-20 17:15
Core Insights - The European Commission has approved VYVGART® (efgartigimod alfa) for subcutaneous injection as a monotherapy for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins [1][4] - VYVGART is the first targeted IgG Fc-antibody fragment for CIDP and introduces a novel mechanism of action for CIDP treatment in over 30 years [2] - The approval is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date, and is valid across all 27 EU Member States, as well as Iceland, Norway, and Liechtenstein [4] Company Overview - Halozyme Therapeutics, Inc. specializes in biopharmaceutical solutions aimed at improving patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [5] - The company has impacted over one million patients through its commercialized products and has licensed its ENHANZE® technology to major pharmaceutical companies including Roche, Takeda, and Pfizer [5] - Halozyme also develops drug-device combination products using advanced auto-injector technologies to enhance patient comfort and adherence [6] Strategic Partnerships - The approval of VYVGART represents a significant milestone in Halozyme's partnership with argenx, expanding access to CIDP treatment in Europe [3] - The company continues to collaborate with various pharmaceutical and biotechnology firms to leverage its ENHANZE® technology for improved drug delivery [5][6]
Halozyme to Participate at Upcoming Investor Conferences
Prnewswire· 2025-05-28 20:05
SAN DIEGO, May 28, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Dr. Helen Torley, president and chief executive officer, is scheduled to participate and host investor meetings at the following investor conferences.Details on the Company's participation are as follows: Event: Benchmark 2025 Healthcare House Call Virtual Conference Format: 1x1 Meetings Date: Thursday, May 29, 2025 Event: Goldman Sachs 46th Annual Global Hea ...
Halozyme Announces Bristol Myers Squibb Received European Commission Approval for Subcutaneous Opdivo® (nivolumab) Co-Formulated with ENHANZE® Across Multiple Solid Tumor Indications
Prnewswire· 2025-05-28 12:30
Group 1 - Halozyme Therapeutics announced that Bristol Myers Squibb received European Commission approval for a new subcutaneous formulation of Opdivo® (nivolumab) for multiple adult solid tumors [1][2] - The subcutaneous injection of Opdivo® can be administered in 3 to 5 minutes, providing a more convenient option for cancer patients [2] - The approval is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway [3] Group 2 - The positive decision from the European Commission is supported by results from the Phase 3 CheckMate -67T trial [2] - Halozyme's ENHANZE® technology, which facilitates subcutaneous drug delivery, has been licensed to several leading pharmaceutical companies [4] - Halozyme has impacted over one million patients through its commercialized products and aims to improve patient experiences with rapid subcutaneous delivery [4]
Halozyme(HALO) - 2025 Q1 - Earnings Call Presentation
2025-05-06 20:17
Halozyme Therapeutics, Inc. First Quarter Financial & Operating Results NASDAQ: HALO May 6, 2025 1 Forward-Looking Statements In addition to historical information, the statements set forth in this presentation include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance and growth rates (including the Company's 2025 financial guidance and longer term financial outlook through 2028 and the assumptions used in deriving such guidan ...
HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG FIRST QUARTER 2025 RESULTS
Prnewswire· 2025-05-06 20:01
Core Insights - Halozyme Therapeutics reported a strong financial performance for Q1 2025, with total revenue increasing by 35% year-over-year to $265 million, driven by a 39% increase in royalty revenue to $168 million [1][8] - The company announced a new $250 million share repurchase program, part of a larger $750 million initiative approved in February 2024 [6][2] - Halozyme raised its financial guidance for 2025, projecting total revenue between $1,200 million and $1,280 million, representing year-over-year growth of 18% to 26% [1][11] Financial Performance - Net income for Q1 2025 increased by 54% year-over-year to $118 million, with adjusted EBITDA rising by 40% to $162 million [1][8] - GAAP diluted EPS rose by 55% year-over-year to $0.93, while non-GAAP diluted EPS increased by 41% to $1.11 [1][8] - Cash, cash equivalents, and marketable securities totaled $747.9 million as of March 31, 2025, up from $596.1 million at the end of 2024 [8] Product and Pipeline Developments - The company highlighted strong growth from its three blockbuster brands: Darzalex SC, Phesgo, and VYVGART Hytrulo, along with contributions from four recently launched products [2][3] - Halozyme's pipeline includes two products in Phase 3 trials, with ongoing development and progress reported by partners [3][2] - Recent approvals and positive opinions from regulatory bodies for various products are expected to create additional growth catalysts [6][9] Corporate Activities - Halozyme filed a patent infringement lawsuit against Merck for alleged use of its MDASE™ technology in developing Subcutaneous Keytruda [6] - The company completed its first $250 million accelerated share repurchase under the approved program in March 2025 [6][2] - Recent corporate highlights include positive regulatory developments for Phesgo® and VYVGART® in Europe and the U.S. [6][9]
Halozyme to Participate in the BofA Securities 2025 Healthcare Conference
Prnewswire· 2025-05-05 21:15
Company Overview - Halozyme Therapeutics, Inc. is a biopharmaceutical company focused on advancing disruptive solutions to enhance patient experiences and outcomes for both emerging and established therapies [3] - The company is known for its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 to facilitate subcutaneous delivery of injected drugs and fluids, aiming to improve patient experience through rapid delivery and reduced treatment burden [3] - Halozyme has impacted one million patient lives through post-marketing use of ten commercialized products across more than 100 global markets [3] Product and Technology - Halozyme has licensed its ENHANZE® technology to major pharmaceutical and biotechnology companies, including Roche, Takeda, Pfizer, and AbbVie, among others [3] - The company also develops and commercializes drug-device combination products using advanced auto-injector technologies, which offer advantages such as improved convenience, reliability, and patient comfort [4] - Halozyme has two proprietary commercial products, Hylenex® and XYOSTED®, and is engaged in ongoing product development programs with partners like Teva Pharmaceuticals and McDermott Laboratories Limited [4] Upcoming Events - Dr. Helen Torley, the president and CEO of Halozyme, will present and host investor meetings at the BofA Securities 2025 Healthcare Conference on May 13, 2025, at 4:20 PM PT / 7:20 PM ET [1] - A live audio webcast of the presentation will be available on the company's Investor Relations website, with replays accessible for 90 days post-conference [2]
Halozyme to Report First Quarter 2025 Financial and Operating Results
Prnewswire· 2025-04-28 12:30
Company Overview - Halozyme Therapeutics, Inc. is a biopharmaceutical company focused on improving patient experiences and outcomes through innovative solutions [3] - The company is known for its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 to facilitate subcutaneous delivery of drugs and fluids [3] - Halozyme has impacted over one million patients through its technology, which is used in ten commercialized products across more than 100 global markets [3] Product Development - Halozyme develops, manufactures, and commercializes drug-device combination products, leveraging advanced auto-injector technologies to enhance convenience, reliability, and patient comfort [4] - The company has two proprietary commercial products: Hylenex® and XYOSTED®, along with partnered products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited [4] Upcoming Financial Results - Halozyme will release its first quarter 2025 financial and operating results on May 6, 2025, after the market closes [1] - A conference call to discuss these results will take place on the same day at 1:30 p.m. PT/4:30 p.m. ET, with live access available through pre-registration [1][2]
Halozyme Announces argenx Received Positive CHMP Opinion for VYVGART® (efgartigimod alfa) Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Prnewswire· 2025-04-28 11:30
Core Insights - Halozyme Therapeutics, Inc. announced that argenx received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending European Commission (EC) approval of VYVGART® 1000mg for treating chronic inflammatory demyelinating polyneuropathy (CIDP) [1][4] - VYVGART® is the first targeted IgG Fc-antibody fragment for CIDP and represents the first novel mechanism of action for CIDP treatment in over 30 years [2] - The CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date [4] Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of injected drugs [5] - The company has licensed its ENHANZE® technology to major pharmaceutical companies including Roche, Takeda, and Pfizer, impacting over one million patients globally [5] - Halozyme also develops drug-device combination products aimed at enhancing patient comfort and adherence [6] Market Implications - The EC decision on the marketing authorization application is expected within approximately two months, which will apply to all 27 EU Member States and additional countries [1][4] - The approval of VYVGART® could provide a groundbreaking treatment option for patients with rare autoimmune diseases across Europe [3]