Latest news with #ENHANZE
Malaysian Reserve
23-07-2025
- Business
- Malaysian Reserve
European Commission Approved DARZALEX Faspro® for Adult Patients with Smouldering Multiple Myeloma
DARZALEX Faspro® is co-formulated with Halozyme's ENHANZE® drug delivery technology Approval represents critical advancement in early intervention for multiple myeloma SAN DIEGO, July 23, 2025 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval of a new indication for DARZALEX Faspro® (daratumumab) co-formulated with ENHANZE®, as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma. 'This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma,' said Dr. Helen Torley, President and CEO of Halozyme. 'We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease.' SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow. The current standard of care for SMM, even in high-risk cases, is active monitoring (or 'Watch and Wait') to track for signs of biochemical progression and/or end-organ damage. This means therapeutic intervention is only offered when the disease progresses. The EC approval is supported by data from the Phase 3 AQUILA study (NCT03301220), evaluating the efficacy and safety of fixed-duration monotherapy daratumumab SC compared with active monitoring in those with high-risk SMM. For more information on the study and its findings, please view Johnson & Johnson's press release issued on July 23, 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 fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and broadening the treatment options for the indications referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words 'expect,' 'believe,' 'enable,' 'may,' 'will,' 'could,' 'intends,' 'estimate,' 'anticipate,' 'plan,' 'predict,' 'probable,' 'potential,' 'possible,' 'should,' 'continue,' and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram BuiVP, Investor Relations and Corporate Communications609-333-7668tbui@ Sydney
Yahoo
14-05-2025
- Business
- Yahoo
Halozyme, J&J slide as analyst cuts rating on CMS draft guidance
Shares of Halozyme Therapeutics (HALO) and Jonhson & Johnson (JNJ) are under pressure on Tuesday after Leerink downgraded the stocks to Underperform and Market Perform, respectively. This comes after the Centers for Medicare and Medicaid Services issued draft guidance for 2028 Inflation Reduction Act drug price controls, which the firm says creates risk that hyaluronidase combination products may not be protected from IRA price negotiations for 13 years after combo approval. Quickly and easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter DOWNGRADES ON CMS ACTION: On Tuesday, Leerink analyst David Risinger downgraded Halozyme to Underperform from Market Perform with a price target of $47, down from $63, and Leerink downgraded Johnson & Johnson to Market Perform from Outperform with a price target of $153, down from $169. The firm, however, is not making any changes to its revenue projections this time as it awaits final guidance from CMS in the second half of 2025. Leerink explains that the catalyst for its downgrades is that CMS issued draft guidance for 2028 IRA drug price controls that creates risk that hyaluronidase combination products may not be protected from IRA price negotiations for 13 years after combo approval. The 'surprise' is CMS draft guidance language suggests that combination products, which do not enhance efficacy, may be negotiated 13 years after the original active ingredient was approved, rather than 13 years after combination approval. The firm notes that Halozyme could face U.S. revenue pressure from Opdivo SC in 2028, Darzalex Faspro in 2029 and Ocrevus SC in 2031. In addition, CMS action may reduce new business opportunities to license ENHANZE. A caveat is that the Street already anticipates the company's Faspro royalty to decline from 5% to 2.5% in 2029 and go to zero in 2032. Its new investment thesis on Halozyme is that Leerink expects shares to underperform because it will be difficult for investors to assign value to the company's major growth drivers since they could start to roll over in 3-5 years. Regarding Johnson & Johnson, the firm notes Darzalex Faspro may be price controlled in 2029 rather than 2034 as it had been assuming. In the case of Darzalex, it was approved in November 2015, and Darzalex Faspro was approved in 2020. Leerink has been modeling that Darzalex Faspro will generate $10.7B in U.S. sales in 2028, or 16% of J&J Worldwide Pharma sales of $66.4B and 10% of total company sales of $96.8B. The firm believes that U.S. Darzalex's profit contribution could be approximately $8.6B in 2028, or 22% of its total company operating profit estimate of $39.1B. If it is price controlled in 2029, the drug's U.S. profit contribution could take a meaningful hit, it points out. Leerink's new investment thesis is that J&J's 5-year growth prospects are at risk of downward revisions if Darzalex Faspro is price controlled in 2029, and we are not anticipating an upward re-rating of the stock in the near-medium term. The firm also highlights that in its 2028 draft guidance, CMS included a new paragraph suggesting a possible reconsideration of its approach to fixedcombination drug negotiations. It believes this development raises concerns for multiple Halozyme's products and J&J's Darzalex Faspro. PRICE ACTION: In Tuesday morning trading, shares of Johnson & Johnson dropped almost 3% to $149.87, while Halozyme's stock has plunged about 27% and is now trading at $49.02. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on HALO: Disclaimer & DisclosureReport an Issue Coinbase, Caterpillar upgraded: Wall Street's top analyst calls Halozyme downgraded to Underperform from Market Perform at Leerink Cautious Optimism for Halozyme Amid Uncertainties: Hold Rating Maintained Halozyme Therapeutics Reports Strong Earnings and Growth Halozyme's Strong Financial Performance and Strategic Developments Justify Buy Rating with $75 Price Target Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
05-05-2025
- Business
- Yahoo
Halozyme to Participate in the BofA Securities 2025 Healthcare Conference
SAN DIEGO, May 5, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Dr. Helen Torley, president and chief executive officer, will present and host investor meetings at the BofA Securities 2025 Healthcare Conference. The presentation is scheduled for Tuesday, May 13 at 4:20pm PT / 7:20pm ET. A live audio webcast will be available on the Investor Relations section of the Company's website. Replays of the audio webcasts will be available for 90 days following the conference. 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 fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Contacts: Tram BuiVP, Investor Relations and Corporate Communications609-359-3016tbui@ Samantha View original content to download multimedia: SOURCE Halozyme Therapeutics, Inc. Sign in to access your portfolio
Yahoo
18-02-2025
- Business
- Yahoo
Here's Why Halozyme Therapeutics (HALO) is a Strong Growth Stock
For new and old investors, taking full advantage of the stock market and investing with confidence are common goals. While you may have an investing style you rely on, finding great stocks is made easier with the Zacks Style Scores. These are complementary indicators that rate stocks based on value, growth, and/or momentum characteristics. Different than value or momentum investors, growth-oriented investors are concerned with a stock's future prospects, and the overall financial health and strength of a company. Thus, they'll want to focus on the Growth Style Score, which analyzes characteristics like projected and historical earnings, sales, and cash flow to find stocks that will see sustainable growth over time. San Diego, CA-based Halozyme Therapeutics is a biopharmaceutical company, focused on the development and commercialization of novel treatments for oncology indications by targeting tumor microenvironment. The company also licenses its novel drug delivery technology, ENHANZE, for subcutaneous (SC) administration of drugs. HALO boasts a Growth Style Score of B and VGM Score of B, and holds a Zacks Rank #3 (Hold) rating. Its bottom-line is projected to rise 49.1% year-over-year for 2024, while Wall Street anticipates its top line to improve by 20.8%. One analyst revised their earnings estimate upwards in the last 60 days, and the Zacks Consensus Estimate has increased $0.02 to $4.13 per share for 2024. HALO boasts an average earnings surprise of 14.9%. Halozyme Therapeutics is also cash rich. The company has generated cash flow growth of 48.7%, and is expected to report cash flow expansion of 19.7% in 2024. Investors should take the time to consider HALO for their portfolios due to its solid Zacks Rank rating, notable growth metrics, and impressive Growth and VGM Style Scores. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report To read this article on click here. Zacks Investment Research Sign in to access your portfolio
Yahoo
18-02-2025
- Business
- Yahoo
Here's Why Halozyme Therapeutics (HALO) is a Strong Value Stock
Taking full advantage of the stock market and investing with confidence are common goals for new and old investors alike. Many investors also have a go-to methodology that helps guide their buy and sell decisions. One way to find winning stocks based on your preferred way of investing is to use the Zacks Style Scores, which are indicators that rate stocks based on three widely-followed investing types: value, growth, and momentum. Value investors love finding good stocks at good prices, especially before the broader market catches on to a stock's true value. Utilizing ratios like P/E, PEG, Price/Sales, and Price/Cash Flow, the Value Style Score identifies the most attractive and most discounted stocks. San Diego, CA-based Halozyme Therapeutics is a biopharmaceutical company, focused on the development and commercialization of novel treatments for oncology indications by targeting tumor microenvironment. The company also licenses its novel drug delivery technology, ENHANZE, for subcutaneous (SC) administration of drugs. HALO is a Zacks Rank #3 (Hold) stock, with a Value Style Score of B and VGM Score of A. Shares are currently trading at a forward P/E of 11.6X for the current fiscal year compared to the Medical - Biomedical and Genetics industry's P/E of 22.6X. Additionally, HALO has a PEG Ratio of 0.4 and a Price/Cash Flow ratio of 18.3X. Value investors should also note HALO's Price/Sales ratio of 7.8X. Value investors don't just pay attention to a company's valuation ratios; positive earnings play a crucial role, too. One analyst revised their earnings estimate upwards in the last 60 days for fiscal 2024. The Zacks Consensus Estimate has increased $0.08 to $4.13 per share. HALO has an average earnings surprise of 14.9%. HALO should be on investors' short lists because of its impressive earnings and valuation fundamentals, a good Zacks Rank, and strong Value and VGM Style Scores. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report To read this article on click here. Zacks Investment Research Sign in to access your portfolio
