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Halozyme Announces argenx Receives FDA Approval for VYVGART® Hytrulo Co-Formulated with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy
Prnewswire· 2024-06-22 05:15
VYVGART® Hytrulo is the first and only neonatal Fc receptor (FcRn) blocker that is delivered as a subcutaneous injection, approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP)CIDP is the second FDA-approved indication for VYVGART® Hytrulo with ENHANZE®SAN DIEGO, June 21, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx received U.S. Food and Drug Administration (FDA) approval for VYVGART® Hytrulo (efgartigimod alfa and hyaluronidas ...
Here's Why Halozyme Therapeutics (HALO) is a Strong Value Stock
ZACKS· 2024-06-17 22:46
For new and old investors, taking full advantage of the stock market and investing with confidence are common goals. Zacks Premium provides lots of different ways to do both.The research service features daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, all of which will help you become a smarter, more confident investor.Zacks Premium also includes the Zacks Style Scores.What are the Zacks Style Scores?The Zack ...
Halozyme Therapeutics (HALO) is a Top-Ranked Momentum Stock: Should You Buy?
ZACKS· 2024-06-11 22:51
It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.Featuring daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, the research service can help you become a smarter, more self-assured investor.Zacks Premium includes access to the Zacks Style Scores as we ...
Halozyme (HALO) Raises 2024 Financial Guidance, Stock Up 13%
ZACKS· 2024-06-07 22:00
Halozyme Therapeutics’ (HALO) shares jumped 12.7% on Jun 6 after it raised its full-year 2024 financial guidance and updated its five-year financial outlook.This was based on the company’s announcement made earlier this week that it has been granted a new patent in the EU that covers the ENHANZE rHuPH20 product, which is produced using the company's proprietary ENHANZE manufacturing methods.Per Halozyme, the new patent is included in all of HALO's existing and future ENHANZE licenses, meaning that all of it ...
Halozyme Therapeutics (HALO) Up 8.7% Since Last Earnings Report: Can It Continue?
ZACKS· 2024-06-07 00:36
It has been about a month since the last earnings report for Halozyme Therapeutics (HALO) . Shares have added about 8.7% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Halozyme Therapeutics due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. Halozyme's Q1 Earnings Bea ...
Halozyme's (HALO) ENHANZE Product Gets New Patent Grant in EU
ZACKS· 2024-06-06 22:35
文章核心观点 - 公司获得一项新的欧盟专利,涵盖其ENHANZE rHuPH20产品,该专利将保护公司的核心技术至2029年3月 [1][2][3] - 这项新专利将惠及公司所有现有和未来的ENHANZE许可合作伙伴,增强公司的竞争优势和产品安全性 [2][3] - 公司预计将能够维持其与强生公司达成的DARZALEX SC在欧盟的原有特许权使用费率,直至2029年专利到期 [6][7] - 公司其他ENHANZE许可协议的特许权使用费率也不会受到影响,维持公司整体财务预期和稳定性 [8][9] - 公司第一季度的特许权使用费收入同比增长21%,全年预计在500-525百万美元区间 [10] 公司相关 - 公司获得一项新的欧盟专利,涵盖其ENHANZE rHuPH20产品,该专利将保护公司的核心技术至2029年3月 [1][2][3] - 这项新专利将惠及公司所有现有和未来的ENHANZE许可合作伙伴,增强公司的竞争优势和产品安全性 [2][3] - 公司预计将能够维持其与强生公司达成的DARZALEX SC在欧盟的原有特许权使用费率,直至2029年专利到期 [6][7] - 公司其他ENHANZE许可协议的特许权使用费率也不会受到影响,维持公司整体财务预期和稳定性 [8][9] - 公司第一季度的特许权使用费收入同比增长21%,全年预计在500-525百万美元区间 [10] 行业相关 - 公司ENHANZE技术被多家领先制药公司如罗氏、武田、辉瑞、强生、艾伯维、礼来、Bristol-Myers Squibb等用于开发皮下给药制剂 [4] - 公司从这些合作伙伴的7款商业化产品中获得特许权使用费收入 [5]
Halozyme Raises Full Year 2024 Financial Guidance and Updates 5-Year Financial Outlook
Prnewswire· 2024-06-06 20:30
Company Granted New European Patent for ENHANZE® Drug Delivery Platform SAN DIEGO, June 6, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that the Company is raising its full year 2024 financial guidance and updating its 5-year financial outlook based on the grant of European Patent No. 4269578, covering the ENHANZE® rHuPH20 product obtained from Halozyme's ENHANZE® manufacturing methods that the Company provides to its current and future licensees. The new pate ...
Halozyme Announces Issuance of New European Patent for ENHANZE® Drug Delivery Platform
Prnewswire· 2024-06-06 04:05
Conference Call Scheduled for Thursday, June 6 at 5:30am PT/8:30am ET SAN DIEGO, June 5, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the grant of European Patent No. 4269578, covering the ENHANZE® rHuPH20 product obtained from Halozyme's ENHANZE® manufacturing methods that the Company provides to its current and future licensees. The new patent is licensed under all of Halozyme's ENHANZE® licenses. It will be validated in 37 European countries and expires on ...
FDA Provides Feedback and Reaches Consensus on Nexalin's Design for Planned Anxiety and Insomnia Clinical Studies of its Gen-3 HALO Clarity™ Headset Device
GlobeNewswire News Room· 2024-06-03 20:30
HOUSTON, TX, June 03, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the "Company" or "Nexalin") (Nasdaq: NXL; NXLIW) announces that the U.S. Food and Drug Administration (FDA) has provided feedback and reached consensus on the design for its planned clinical studies in anxiety and insomnia for its new Gen-3 HALO Clarity™ ("HALO"), a non-invasive, Deep Intracranial Frequency Stimulation (DIFS™) headset device designed to address the global mental health epidemic. After the studies are completed and eval ...
Halozyme Announces Bristol Myers Squibb Received Updated Action Date from the U.S. Food and Drug Administration for Subcutaneous Nivolumab Co-Formulated with ENHANZE®
prnewswire.com· 2024-05-21 19:15
Updated Prescription Drug User Fee Act goal date of December 29, 2024SAN DIEGO, May 21, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Bristol Myers Squibb was reassigned a Prescription Drug User Fee Act goal date from the U.S. Food and Drug Administration for their Biologics License Application for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, across ...