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SAN DIEGO, Dec. 30, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Takeda received regulatory approval for HYQVIA® [Immune Globulin Infusion 10% (Human) with Halozyme's Recombinant Human Hyaluronidase] by the Japanese Ministry of Health, Labour and Welfare (MHLW) for patients with agammaglobulinemia or hypogammaglobulinemia, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primar ...

SAN DIEGO, Dec. 30, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx's VYVDURA (efgartigimod alfa and hyaluronidase-qvfc), which is co-formulated with Halozyme's ENHANZE® drug delivery technology, was granted regulatory approval by Japan's Ministry of Health, Labour and Welfare (MHLW) for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVDURA was approved for CIDP as a once weekly 30-to-90 second subcutaneous injection, which can b ...

Core Insights - Halozyme Therapeutics announced FDA approval for Opdivo Qvantig, the first subcutaneously administered PD-1 inhibitor, co-formulated with Halozyme's ENHANZE drug delivery technology [1][3][13] Group 1: Product Efficacy and Approval - Opdivo Qvantig demonstrated consistent efficacy and a comparable safety profile to IV Opdivo in the Phase 3 CheckMate-67T trial [1][3] - The trial showed noninferiority for co-primary endpoints: time-averaged concentration over 28 days (Cavgd28) with a geometric mean ratio (GMR) of 2.10 (90% CI: 2.00-2.20) and minimum concentration at steady state (Cminss) with a GMR of 1.77 (90% CI: 1.63-1.93) [3] - The overall response rate (ORR) for Opdivo Qvantig was 24% (95% CI: 19-30) compared to 18% (95% CI: 14-24) for IV Opdivo [3] Group 2: Administration and Patient Experience - Subcutaneous administration of Opdivo Qvantig is faster, taking three to five minutes compared to 30 minutes for IV Opdivo, potentially offering greater flexibility for patients [2][5] - The approval represents Halozyme's ninth co-formulated product, showcasing the effectiveness of the ENHANZE technology in improving patient experiences [3][6] Group 3: Safety Profile - Serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig, with the most frequent being pleural effusion and pneumonitis, each at 1.6% [4] - Common adverse reactions reported in ≥10% of patients included fatigue (20%), musculoskeletal pain (31%), and rash (15%) [4] - Fatal adverse reactions occurred in 1.2% of patients, including myocarditis and colitis complications, with 10% of patients discontinuing therapy due to adverse reactions [4]

Growth stocks are attractive to many investors, as above-average financial growth helps these stocks easily grab the market's attention and produce exceptional returns. However, it isn't easy to find a great growth stock.In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end.However, it's pretty easy to find cutting-edge growth stocks with the help of the Zacks Growth Style Score ...

Investors interested in stocks from the Medical - Biomedical and Genetics sector have probably already heard of Halozyme Therapeutics (HALO) and Amicus Therapeutics (FOLD) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look.Everyone has their own methods for finding great value opportunities, but our model includes pairing an impressive grade in the Value category of our Style Scores system with a strong Zacks Rank. The Zacks Rank favors s ...

Core Viewpoint - Halozyme Therapeutics (HALO) shares have increased by 5.2% recently, with analysts suggesting a potential upside of 27.1% based on a mean price target of $61 [1][9]. Price Targets and Analyst Estimates - The mean estimate for HALO comprises 10 short-term price targets, with a standard deviation of $7.94, indicating variability among analysts [2]. - The lowest price target is $49, suggesting a 2.1% increase, while the highest target is $73, indicating a potential surge of 52.1% [2]. - A low standard deviation among price targets suggests strong agreement among analysts regarding the stock's price movement [7]. Earnings Estimates and Analyst Sentiment - Analysts have shown growing optimism regarding HALO's earnings prospects, as indicated by upward revisions in EPS estimates [9]. - The Zacks Consensus Estimate for the current year has increased by 1.2% over the past month, with one estimate rising and no negative revisions [10]. - HALO currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [11]. Reliability of Price Targets - While price targets are commonly referenced by investors, their reliability as indicators of stock price direction is often questioned [5][6]. - Analysts may set overly optimistic price targets due to business incentives, which can lead to inflated estimates [6]. - Despite skepticism towards price targets, the direction they imply can serve as a useful guide for further research [12].

Core Viewpoint - Investors are increasingly seeking growth stocks that demonstrate above-average growth potential, with Halozyme Therapeutics (HALO) currently highlighted as a strong candidate due to its favorable growth metrics and Zacks Rank [1][2]. Earnings Growth - Halozyme Therapeutics has a historical EPS growth rate of 49.5%, with projected EPS growth of 46.3% for the current year, significantly outperforming the industry average of 23.4% [4]. Cash Flow Growth - The company exhibits a year-over-year cash flow growth of 19.7%, which is notably higher than the industry average of -2.5%. Additionally, its annualized cash flow growth rate over the past 3-5 years stands at 48.7%, compared to the industry average of 3.3% [5][6]. Earnings Estimate Revisions - There has been a positive trend in earnings estimate revisions for Halozyme Therapeutics, with the current-year earnings estimates increasing by 1.2% over the past month, indicating strong near-term stock price movement potential [7][9]. Overall Positioning - Halozyme Therapeutics holds a Zacks Rank of 2 (Buy) and a Growth Score of B, positioning it well for potential outperformance in the growth stock category [9][10].

Core Viewpoint - Halozyme Therapeutics, Inc. has withdrawn its non-binding proposal to acquire Evotec SE due to Evotec's management's unwillingness to discuss the offer, which was valued at €2.0 billion [1][5]. Group 1: Acquisition Proposal - Halozyme's acquisition offer was €11.00 per share in cash, representing a 109% premium over Evotec's undisturbed share price on October 15, 2024 [3]. - The acquisition was expected to create a global services company with complementary technologies and an innovative pipeline, potentially diversifying Halozyme's operations and extending revenues and EBITDA into the next decade [4]. Group 2: Financial Guidance - Halozyme reaffirmed its 2024 revenue guidance, expecting total revenues between $970 million and $1.02 billion, indicating a year-over-year growth of 13-22% [7]. - Royalty revenues are anticipated to be in the range of $550-$565 million, with adjusted EBITDA expected between $595 million and $625 million, reflecting a growth of 40% to 47% year over year [8]. - The company projects adjusted earnings per share between $4.00 and $4.20, indicating an improvement of 44-52% year over year [8]. Group 3: Stock Performance - Following the announcement of the acquisition withdrawal, shares of Halozyme increased by 7.2% on November 22, and the stock has rallied 32.6% year-to-date, contrasting with an industry decline of 8.5% [2].

Core Viewpoint - Halozyme Therapeutics (HALO) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Company Performance and Outlook - For the fiscal year ending December 2024, Halozyme Therapeutics is projected to earn $4 per share, reflecting a 44.4% increase from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Halozyme has risen by 2.5%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating, suggesting superior potential for market-beating returns [9][10]. - Halozyme's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong likelihood of stock price appreciation in the near term [11].