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 hyaluronidase-qvfc) co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). "With this approval, CIDP patients in the U.S. will have access to the fi ...

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Value Score Growth Score Momentum Score VGM Score How Style Scores Work with the Zacks Rank But it can feel overwhelming to pick the right stocks for you and your investing goals with over 800 top-rated stocks to choose from. Since the Scores were created to work together with the Zacks Rank, the direction of a stock's earnings estimate revisions should be a key factor when choosing which stocks to buy. Stock to Watch: Halozyme Therapeutics (HALO) Momentum investors should take note of this Medical stock. H ...

However, Halozyme has clarified that its EPS guidance does not consider the impact of potential future share repurchases. Year to date, shares of HALO have rallied 39.2% against the industry's 3.8% decline. In the past 30 days, the Zacks Consensus Estimate for ALX Oncology's 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73. Year to date, shares of ALXO have plunged 37.7%. Halozyme Therapeutics' (HALO ...

Core Viewpoint - Halozyme Therapeutics reported strong earnings for Q1 2024, with adjusted earnings surpassing estimates, although total revenues fell short of expectations. The company continues to show growth potential, particularly in royalty revenues and adjusted EBITDA. Financial Performance - Adjusted earnings for Q1 2024 were 79 cents per share, exceeding the Zacks Consensus Estimate of 69 cents, and up from 47 cents per share in the same period last year [2] - Total revenues increased by 21% year over year to $195.9 million, driven by higher royalty payments and milestone payments, but missed the Zacks Consensus Estimate of $202 million [3] - Royalty revenues reached $120.6 million, a 21% increase from the previous year, accounting for approximately 61.5% of total revenues [4] - Product sales were $58.6 million, down 3.6% from the prior year, missing estimates [5] - Revenues from collaborative agreements rose significantly to $16.7 million from $1.7 million year over year [5] - Adjusted EBITDA was $115.7 million, reflecting a 55.7% increase from the prior year [5] Cash Position - As of March 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $463.5 million, up from $336 million as of December 31, 2023 [6] 2024 Guidance - Halozyme expects total revenues for 2024 to be between $915 million and $985 million, indicating year-over-year growth of 10% to 19% [7] - Royalty revenues are anticipated to be in the range of $500 million to $525 million [7] - Adjusted EBITDA is projected to be between $535 million and $585 million, representing year-over-year growth of 26% to 37% [7] - The company forecasts adjusted earnings per share between $3.55 and $3.90, reflecting an improvement of 28% to 41% year over year [8] Market Sentiment - Estimates for Halozyme have been trending upward over the past month, indicating positive market sentiment [9] - The company holds a Zacks Rank 3 (Hold), suggesting an expectation of in-line returns in the coming months [11] Industry Comparison - Halozyme operates within the Zacks Medical - Biomedical and Genetics industry, where competitor Moderna has seen a 27% gain over the past month despite reporting a significant revenue decline [12]

Based on this new patent grant, management believes that it will be able to maintain the original royalty rate for J&J's Darzalex SC, in the EU through March 2029. In the past 30 days, the Zacks Consensus Estimate for ALX Oncology's 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73. Year to date, shares of ALXO have plunged 40.9%. Halozyme Therapeutics (HALO) announced that it has been granted a new p ...

Core Viewpoint - Halozyme Therapeutics, Inc. is raising its full year 2024 financial guidance and updating its 5-year financial outlook due to the grant of a new European patent covering its ENHANZE® rHuPH20 product, which is expected to enhance its revenue streams and protect royalty rates until March 6, 2029 [1][8][16]. Financial Guidance - Total revenue is projected to be between $935 million and $1,015 million, indicating a growth of 13% to 22% compared to 2023 [4][18]. - Royalty revenue is expected to range from $520 million to $555 million, reflecting a growth of 16% to 24% over 2023 [4][18]. - Adjusted EBITDA is forecasted to be between $555 million and $615 million, representing a growth of 30% to 44% compared to 2023 [4][18]. - Non-GAAP diluted earnings per share are anticipated to be between $3.65 and $4.05, showing a growth of 32% to 46% over 2023 [4][18]. Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences through its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of drugs [3][12]. - The company has impacted over 800,000 patients globally and has licensed its technology to major pharmaceutical companies including Roche, Takeda, and Pfizer [3][12]. - Halozyme's headquarters is located in San Diego, CA, with additional offices in Ewing, NJ, and Minnetonka, MN [5].

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 ...

Core Insights - Nexalin Technology, Inc. has received FDA consensus on the design for clinical studies targeting anxiety and insomnia using its Gen-3 HALO Clarity™ device, a non-invasive Deep Intracranial Frequency Stimulation (DIFS™) headset [1][3] - The initial pilot and pivotal studies are set to begin in Q3 2024, involving 150 patients per study to assess HALO's effectiveness in reducing symptoms of anxiety and insomnia [2] - The company plans to submit a De Novo request to the FDA for HALO after the studies, which will provide a marketing pathway for novel medical devices [1] Clinical Studies - The pivotal studies will consist of 75 patients receiving active treatment and 75 receiving sham treatment, aimed at evaluating HALO's efficacy [2] - These studies will build on previous positive clinical results from Nexalin's Gen-3 HALO using the advanced DIFS™ waveform [2] Company Statements - Dr. David Owens, Chief Medical Officer, highlighted the consensus with the FDA as a significant milestone for Nexalin, emphasizing the safety and efficacy evaluation of HALO [3] - CEO Mark White stated that HALO has the potential to revolutionize mental health treatment, offering an alternative to pharmacological options that may have limited efficacy and side effects [3] - Nexalin is initiating a large production run of over 500 units to support the FDA protocols for the upcoming studies [3] Company Overview - Nexalin Technology, Inc. focuses on developing innovative neurostimulation products to address the global mental health crisis, utilizing bioelectronic medical technology [4] - The company's devices are designed to be non-invasive and aim to provide relief for mental health issues by penetrating deep brain structures associated with these disorders [4] - The Nexalin Gen-2 neurostimulation device has recently received approval in Oman and China, indicating the company's expanding market presence [4]

Updated Prescription Drug User Fee Act goal date of December 29, 2024 SAN 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 ...