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]

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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 ...

Shares of Halozyme Therapeutics (HALO) have gained 5.2% over the past four weeks to close the last trading session at $48, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $61 indicates a potential upside of 27.1%.The mean estimate comprises 10 short-term price targets with a standard deviation of $7.94. While the lowest estimate of $49 indicates a 2.1% increase from the current ...

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Halozyme Therapeutics, Inc. (HALO) announced that it has withdrawn its non-binding proposal to acquire Evotec SE (EVO) for €11.00 per share in cash. The acquisition offer implied a fully diluted equity value of €2.0 billion.Halozyme decided to withdraw the acquisition bid following the unwillingness of Evotec’s management to discuss the potential buyout offer. EVO maintained its desire to remain an independent company.Besides withdrawing the buyout offer, HALO also reaffirmed its 2024 revenue guidance that ...

Halozyme Therapeutics (HALO) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of ...

Core Viewpoint - Halozyme Therapeutics has withdrawn its non-binding proposal to acquire Evotec SE for €11.00 per share, which would have implied a fully diluted equity value of €2.0 billion, due to Evotec's unwillingness to engage in discussions about a potential combination [1][2]. Group 1: Acquisition Proposal - Halozyme's CEO stated that a combination with Evotec would create a leading global pharma services company, benefiting shareholders, patients, and employees [2]. - Despite extensive external diligence and attempts to engage with Evotec's management, Halozyme faced repeated refusals to discuss the potential transaction [3]. - The formal proposal was made to convey strong interest in exploring a transaction, but it became clear that Evotec's boards were not interested in constructive engagement [3]. Group 2: Company Outlook - Halozyme remains focused on improving patient treatment experiences and is confident in its future, with a strategy aimed at achieving 10 approved products with ENHANZE® by 2025 and $1 billion in royalty revenue by 2027 [4]. - The company has reiterated its 2024 revenue guidance of $970-$1,020 million and adjusted EBITDA of $595-$625 million, indicating significant double-digit growth [4]. Group 3: Company Profile - Halozyme is a biopharmaceutical company known for its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of drugs, improving patient experience [5]. - The company has impacted over 800,000 patients through its commercialized products and has partnered with major pharmaceutical companies like Roche, Takeda, and Pfizer [5]. - Halozyme also develops drug-device combination products aimed at enhancing patient comfort and adherence [6].