Halozyme(HALO)

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Halozyme Sues Merck for Patent Infringement over Subcutaneous Keytruda Formulation
Prnewswire· 2025-04-24 12:30
Complaint filed in New Jersey alleges Merck uses Halozyme's patented MDASE technology to develop SC Keytruda Halozyme is seeking damages and injunctive relief to stop the infringement SAN DIEGO, April 24, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme), a biotechnology company that pioneered the use of human hyaluronidase for subcutaneous drug delivery, today filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. (Merck) in U.S. District Court in New Jersey. Halozym ...
Halozyme Announces FDA Approval of argenx's VYVGART® Hytrulo Prefilled Syringe Co-Formulated with ENHANZE® for Self-Injection for Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy
Prnewswire· 2025-04-10 22:15
Core Insights - Halozyme Therapeutics, Inc. announced that argenx received FDA approval for VYVGART® Hytrulo prefilled syringe for self-injection, targeting adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) [1][2] Group 1: Product Details - VYVGART® Hytrulo is designed for a 20-to-30-second subcutaneous injection, allowing self-administration by patients or caregivers after proper training [2] - The approval is based on studies demonstrating bioequivalence to the vial version of VYVGART® and successful administration by participants in human factors validation studies [2] Group 2: Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences through its ENHANZE® drug delivery technology, which facilitates rapid subcutaneous delivery of biologics [3] - The company has impacted over one million patients globally through its technology, which is licensed to major pharmaceutical companies including Roche, Takeda, and Pfizer [3] Group 3: Additional Products and Technologies - Halozyme also develops drug-device combination products using advanced auto-injector technologies aimed at enhancing patient comfort and adherence [4] - The company has two proprietary commercial products, Hylenex® and XYOSTED®, and is engaged in ongoing development with partners like Teva Pharmaceuticals [4]
European Commission Approved Subcutaneous DARZALEX® (daratumumab)-based Quadruplet Regimen for the Treatment of Patients with Newly Diagnosed Multiple Myeloma, Regardless of Transplant Eligibility
Prnewswire· 2025-04-09 12:45
Subcutaneous DARZALEX® is co-formulated with Halozyme's ENHANZE® drug delivery technologySAN DIEGO, April 9, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) co-formulated with ENHANZE® in the frontline setting. The approval is for daratumumab SC in combination with bortezomib, lenalidom ...
European Commission Approves Subcutaneous RYBREVANT® (amivantamab) Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Prnewswire· 2025-04-07 13:29
SAN DIEGO, April 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT® (amivantamab), in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or e ...
Halozyme Announces Bristol Myers Squibb Received Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) with ENHANZE® Across Multiple Solid Tumor Indications
Prnewswire· 2025-03-31 12:30
A decision on the European marketing authorization extension for the subcutaneous formulation of Opdivo is expected by June 2, 2025 About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluid ...
Halozyme Joins the $1 Billion Club
FX Empire· 2025-03-21 11:35
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HALO's Q4 Earnings Beat, Higher Royalties Drive Revenue Growth
ZACKS· 2025-02-19 15:20
Halozyme Therapeutics (HALO) reported fourth-quarter 2024 adjusted earnings of $1.26 per share, which beat the Zacks Consensus Estimate of $1.16. The company had recorded adjusted earnings of 82 cents per share in the year-ago period.See the Zacks Earnings Calendar to stay ahead of market-making news.Total revenues in the fourth quarter increased 30% year over year to $298 million. Revenues surpassed the Zacks Consensus Estimate of $284 million.The top-line growth was primarily driven by higher royalty paym ...
Halozyme(HALO) - 2024 Q4 - Earnings Call Transcript
2025-02-19 00:55
Halozyme Therapeutics, Inc. (NASDAQ:HALO) Q4 2024 Earnings Conference Call February 18, 2025 4:30 PM ET Company Participants Tram Bui - Vice President, Investor Relations & Corporate Communications Helen Torley - President & Chief Executive Officer Nicole LaBrosse - Chief Financial Officer Conference Call Participants Sean Laaman - Morgan Stanley Brendan Smith - TD Cowen Mohit Bansal - Wells Fargo Jessica Fye - JPMorgan Michael DiFiore - Evercore ISI Jason Butler - Citizens JMP Operator Good afternoon. My n ...
Halozyme Therapeutics (HALO) Reports Q4 Earnings: What Key Metrics Have to Say
ZACKS· 2025-02-18 23:31
Core Insights - Halozyme Therapeutics reported revenue of $298.01 million for the quarter ended December 2024, marking a year-over-year increase of 29.6% and an EPS of $1.26 compared to $0.82 a year ago [1] - The reported revenue exceeded the Zacks Consensus Estimate of $284.02 million, resulting in a surprise of +4.93%, while the EPS also surpassed the consensus estimate of $1.16 with a surprise of +8.62% [1] Revenue Breakdown - Product sales, net amounted to $79.36 million, slightly below the average estimate of $75.16 million, reflecting a year-over-year change of -0.3% [4] - Royalties generated $170.42 million, exceeding the average estimate of $159.68 million, and showing a significant year-over-year increase of +39.6% [4] - Revenues from collaboration agreements reached $48.23 million, slightly below the average estimate of $49.20 million, but representing a substantial year-over-year increase of +69.9% [4] Stock Performance - Over the past month, shares of Halozyme Therapeutics have returned +6.4%, outperforming the Zacks S&P 500 composite's +4.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]
Halozyme Therapeutics (HALO) Q4 Earnings and Revenues Top Estimates
ZACKS· 2025-02-18 23:16
Group 1 - Halozyme Therapeutics reported quarterly earnings of $1.26 per share, exceeding the Zacks Consensus Estimate of $1.16 per share, and showing an increase from $0.82 per share a year ago, representing an earnings surprise of 8.62% [1] - The company achieved revenues of $298.01 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 4.93%, and up from $230.04 million in the same quarter last year [2] - Halozyme Therapeutics has outperformed the S&P 500, with shares increasing approximately 21.9% since the beginning of the year compared to the S&P 500's gain of 4% [3] Group 2 - The earnings outlook for Halozyme Therapeutics is mixed, with the current consensus EPS estimate for the upcoming quarter at $1.01 on revenues of $247.73 million, and for the current fiscal year at $5.01 on revenues of $1.19 billion [7] - The Medical - Biomedical and Genetics industry, to which Halozyme belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook for the sector [8]