Halozyme Therapeutics Inc

A Dutch patent court has ruled in favor of Halozyme Therapeutics, finding that Merck's subcutaneous formulation of Keytruda infringes one of Halozyme's MDASE patents covering technology used to deliver drugs through subcutaneous injection. The ruling orders Merck to stop manufacturing and selling Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands, and bars Merck from letting its affiliates continue selling the drug in those markets, including through its European marketing authorization. The order does not affect the intravenous version of Keytruda, which remains available to patients because it is not covered by Halozyme's patent or the injunction. It marks the second legal victory for Halozyme over Keytruda SC, following a December 2025 German preliminary injunction that stopped Merck from distributing or offering the drug in Germany, and Halozyme has also filed a separate U.S. patent infringement lawsuit alleging that Keytruda SC, marketed as Keytruda Qlex, infringes 15 of its MDASE patents. Merck said it strongly disagrees with the Dutch decision, considers Halozyme's patent invalid globally and the infringement allegation without merit, and is evaluating its next steps. The ruling is a setback for Merck as it seeks to expand Keytruda's use ahead of the loss of U.S. patent protection for the original formulation, with biosimilar competition potentially beginning in December 2028; the IV and SC versions together generate nearly half of Merck's topline. Halozyme said the MDASE technology in the Merck dispute is separate from its ENHANZE technology and licensing program, which is a major source of royalty revenue and has been used in 10 commercialized products across more than 100 markets, including Johnson & Johnson's Darzalex and argenx's Vyvgart. Halozyme shares have surged 65% year to date compared with the industry's 1% growth.

Halozyme Therapeutics extended its ENHANZE collaboration with argenx to cover two more exclusive targets, bringing the total to eight. Under the expanded agreement, Halozyme is eligible for milestone payments tied to development and commercial progress, plus royalties on net sales of ENHANZE-based products. The deal adds fresh attention to the company's partnership-driven revenue model, which already generates more than $1 billion annually in ENHANZE royalties. Recent headlines also include a Dutch court injunction against Merck's Keytruda SC and the return of commercial leader Jim Daly to Halozyme's board. The stock last closed at $110.79, up 40.92% over the past 90 days, with a five-year total shareholder return of 200.24%.

A Dutch court ruled in favor of Halozyme Therapeutics in late September 2026, issuing an injunction that halts manufacture and sale of Merck's subcutaneous Keytruda across eight European countries following a patent dispute. The decision affects one of Merck's key immuno-oncology formulations in important European markets, though it leaves the central near-term catalyst around late-stage oncology and cardiometabolic launches unchanged. Separately, Merck secured a new global license for SciBrunch's preclinical KRAS G12D inhibitor SPR2015, a deal carrying a US$400 million upfront charge that will weigh on reported earnings in the near term. Merck's narrative projects $75.3 billion in revenue and $22.5 billion in earnings by 2029, requiring 4.2% yearly revenue growth and a $19.3 billion earnings increase from $3.2 billion today, with a $155.68 fair value implying 10% upside. Some of the most optimistic analysts model roughly US$82.1 billion in revenue and US$30.2 billion in earnings by 2029, weighting pipeline breadth and AI-enabled efficiency more heavily than access risks such as the subcutaneous Keytruda ruling.

Halozyme priced $1.3 billion of convertible senior notes due 2033 on September 17, upsizing the offering from an originally planned $1.05 billion as demand came in. The notes carry a 1.50% coupon and convert at $139.84 a share, a 27.5% premium to that day's $109.68 close, with capped call transactions capping dilution protection at $208.39 a share. The company will use part of the proceeds to retire $151.7 million of its 2027 notes and $220.0 million of its 2028 notes, at a combined repurchase cost near $652.5 million. The sale follows second-quarter revenue of $481.0 million, up 48% from $325.7 million a year earlier, with royalty revenue up 50% to $307.7 million and non-GAAP diluted earnings per share of $2.28 versus $1.54. Halozyme raised full-year guidance to adjusted EBITDA of $1.225 billion to $1.280 billion, up 86% to 95% over 2025, and signed five new ENHANZE and Hypercon collaborations through July, including deals with Vertex, Oruka, GSK and Incyte.

Halozyme Therapeutics shares have risen 36.4% in the past month, driven by investor confidence in its ENHANZE drug-delivery technology and a raised full-year 2026 outlook. The company reported robust second-quarter 2026 results, with royalty revenues up 46.7% year over year to $373.8 million in the first half and total product sales up 63% to $260.1 million. Halozyme now expects 2026 revenues of $1.84-$1.91 billion, up from prior guidance of $1.71-$1.81 billion, and royalty revenues of $1.22-$1.25 billion versus $1.13-$1.17 billion previously. The company has collaboration agreements with large pharma companies including Johnson & Johnson, argenx, and Roche, which use ENHANZE for subcutaneous formulations of drugs such as Darzalex, Vyvgart Hytrulo, and Phesgo. Year to date, Halozyme shares have rallied 57.7% compared with the industry's rise of 13.8%.

Halozyme Therapeutics reported second-quarter revenue of $481 million, beating analyst estimates by 19% and growing 47.7% year over year, driven by record royalty growth from its ENHANZE platform. Adjusted EPS of $2.28 beat estimates by 25.5%, and the company raised full-year revenue guidance to $1.87 billion at the midpoint, a 6.4% increase. During the earnings call, analysts focused on royalty revenue acceleration, target exclusivity, Hypercon pipeline launches, deal cadence, and Merck litigation. CEO Helen Torley highlighted that five to seven product launches by the mid-2030s underpin a $1 billion royalty target, with both new and existing partner deals contributing.

Halozyme Therapeutics and Incyte Corporation announced a global collaboration and licensing deal to develop a subcutaneous formulation of Incyte's INCA033989, a first-in-class monoclonal antibody targeting mutant calreticulin-expressing myeloproliferative neoplasms. Under the agreement, Halozyme will provide its proprietary ENHANZE drug delivery technology, while Incyte will hold an option to nominate two additional targets. Halozyme will receive an upfront payment, milestone payments, and royalties on commercial sales. Both companies reported record second-quarter 2026 results, with Halozyme's revenue up 48% to $481 million and Incyte's total revenue up 38% to $1.67 billion. Halozyme raised its full-year revenue guidance to $1.835–$1.910 billion, and Incyte raised its net sales guidance to $5.13–$5.26 billion.

Several biotech stocks reached 52-week highs on August 7, 2026, driven by strong quarterly results and clinical progress. Halozyme Therapeutics surged 20% to $103.30 after reporting second-quarter revenue of $481 million, a 48% year-over-year increase, and estimating full-year 2026 revenues of $1.83 billion to $1.91 billion, representing 31% to 37% growth. Fennec Pharmaceuticals rose over 6% to $11.66 following a 71% jump in first-quarter net sales to $15.1 million from its PEDMARK therapy, with second-quarter results due August 11. Avalyn Pharma climbed over 3% to $34.15 after its April IPO raised about $316 million, while advancing inhaled therapies AP01 and AP02 in Phase 2 trials. Amylyx Pharmaceuticals hit $24.60 as it progresses the Phase 3 LUCIDITY trial for Avexitide and completed enrollment in a Phase 1 ALS study. Chemed Corporation reached $552.72 after revising its full-year revenue growth estimate to 8.25% to 9.25%, with a Medicare cap billing limitation of $7,000, and reporting an 8.8% second-quarter revenue increase to $673 million.

Halozyme Therapeutics reported second-quarter 2026 revenue of US$481 million, up from US$325.72 million a year earlier, and raised its full-year revenue guidance to a range of US$1.835 billion to US$1.910 billion, up from a prior range of US$1.710 billion to US$1.810 billion. Net income for the quarter was US$229.91 million, with diluted earnings per share of US$1.90, compared with US$1.33 a year ago. For the first half of 2026, revenue reached US$857.71 million and diluted earnings per share were US$3.11. The company also completed two share repurchase programs: from May 1, 2026 to June 30, 2026, it bought back 2,525,425 shares, or 2.13% of its shares, for US$175.01 million, finishing the repurchase announced on May 11, 2026; and from April 1, 2026 to June 30, 2026, it repurchased a further 2,274,575 shares, or 1.92% of its shares, for US$157.63 million, completing the 13,452,356-share, US$750 million buyback program announced on February 20, 2024. Halozyme stock surged 20.24% in one day following the results.

Several biotech stocks reached 52-week highs on July 24, 2026, driven by upcoming quarterly reports and regulatory milestones. Inhibikase Therapeutics hit $2.53 after its lead candidate IKT-001 received FDA Orphan Drug designation for pulmonary arterial hypertension, with a global Phase 3 trial underway. Jazz Pharmaceuticals reached $256.75, supported by 19% first-quarter revenue growth to $1.1 billion and progress with Zanidatamab in breast cancer studies. Halozyme Therapeutics climbed to $82.99 following a 42% year-over-year revenue increase to $376 million in the first quarter and full-year guidance of $1.71 billion to $1.81 billion. Corcept Therapeutics touched $97.63, with first-quarter revenue rising to $164 million from $157 million a year earlier, ahead of its July 29 earnings report. Liquidia Corporation hit $91.10, buoyed by $130 million in first-quarter YUTREPIA sales and a net income of $52 million.

Halozyme Therapeutics has entered a global collaboration and license agreement with Incyte to develop additional subcutaneous formulations of Incyte's INCA033989, a first-in-class mutant calreticulin-targeted monoclonal antibody for a cancer indication. The partnership will evaluate subcutaneous dosing using Halozyme's proprietary ENHANZE drug delivery technology in patients with mutCALR-expressing myeloproliferative neoplasms. Incyte gains rights to develop and commercialize the ENHANZE technology with its mutCALR program and holds an option to nominate up to two additional targets. Halozyme will receive an undisclosed upfront payment, milestone payments, and royalties on future net sales. Halozyme's royalty revenues reached $240.7 million in the first quarter of 2026, up 43% year over year, driven by demand for partnered products including subcutaneous Darzalex and Phesgo.

Halozyme Therapeutics is one of the 8 Most Undervalued Growth Stocks to Buy for the Next 10 Years. On June 16, H.C. Wainwright analyst Mitchell Kapoor reiterated a Buy rating on Halozyme Therapeutics and assigned a target price of $95. The stock has risen 46% in the last 12 months. On June 13, Johnson & Johnson announced that Halozyme-partnered Darzalex Faspro, when used with its cancer drug Talvey, significantly improved survival outcomes in a late-stage trial for patients with multiple myeloma, reducing the risk of death by up to 53% compared with standard treatment. The combination also reduced the risk of cancer worsening or death by up to 72%, and at 24 months, about 89% of patients were alive compared with 79% receiving standard care. The positive trial results could benefit Halozyme by supporting continued adoption of Darzalex Faspro, which uses the company's ENHANZE technology.

AbbVie reported first-quarter revenues of $15 billion, up 12.4% year on year and exceeding analysts' expectations by 1.7%. Among the 11 therapeutics stocks tracked, Moderna delivered the fastest revenue growth with $389 million, a 260% increase that beat estimates by 55.8%. United Therapeutics posted the weakest performance, with revenues of $781.5 million, down 1.6% and missing expectations by 1.9%. Vertex Pharmaceuticals reported $2.99 billion in revenue, up 8.2% and beating estimates by 1.2%, while Halozyme Therapeutics recorded $376.7 million, up 42.2% and exceeding expectations by 6.1%. Overall, the group's revenues surpassed consensus estimates by 14.5%, and share prices have risen an average of 18.9% since the latest earnings results.

Halozyme Therapeutics has appointed David Ramsay as President Drug Delivery, effective June 30, 2026. In this newly created role, Mr. Ramsay will have an enterprise-wide, cross-technology mandate, responsible for driving the growth of Halozyme's drug delivery technologies by establishing clear strategic priorities and assuring best-in-class business development and alliance management. He will report to Helen Torley, President and Chief Executive Officer. Mr. Ramsay brings more than 30 years of strategic financial leadership across the biotechnology and life sciences sectors, and most recently served as Halozyme's Interim Chief Financial Officer from March 23 to June 8, 2026.