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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of argenx SE - ARGX
Prnewswire· 2025-07-07 19:58
NEW YORK, July 7, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of argenx SE ("argenx" or the "Company") (NASDAQ: ARGX). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether argenx and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action]On June 30, 2025, the U.S. Food and ...
高盛:全球医疗保-2025 年第三季度值得关注的生物制药催化因素
Goldman Sachs· 2025-07-03 02:41
Global Healthcare Biopharma catalysts to watch in 3Q25 With macroeconomic volatility and healthcare policy uncertainty persisting likely into the back half of the year, we continue to advocate for and highlight idiosyncratic catalysts with attractive risk/reward setups to drive alpha generation. Herein, we highlight and preview key catalysts in 3Q25 across the GS biotechnology coverage universe from pivotal studies: BMY's Cobenfy ADEPT-2 in Alzheimer's disease psychosis; LLY's orforglipron ATTAIN-1 in obesi ...
FDA Flags Major Safety Concerns For Argenx's Nerve Disorder Drug, Stock Falls
Benzinga· 2025-06-30 17:13
Core Viewpoint - Argenx SE's stock is experiencing a decline due to serious safety concerns raised by the FDA regarding its drug Vyvgart Hytrulo, particularly related to chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) [1][2] Group 1: FDA Concerns - The FDA has identified severe risks associated with Vyvgart Hytrulo, specifically the worsening of CIDP, which is characterized by inflammation of nerve roots and peripheral nerves [1] - The FDA is currently evaluating the need for potential regulatory action regarding Vyvgart [2] Group 2: Drug Approval and Usage - The European Commission has recently approved Vyvgart 1000mg for subcutaneous injection as a monotherapy for adult patients with progressive or relapsing active CIDP after prior treatments [2] - In April, the FDA approved a self-injection option for Vyvgart Hytrulo for adult patients with generalized myasthenia gravis (gMG) and CIDP [3] Group 3: Stock Performance and Analyst Ratings - Argenx's stock has an average 1-year price target of $753.23, indicating an expected upside of 43.52% [4][6] - There are no bearish recommendations for Argenx, with 13 analysts providing bullish ratings; the highest price target is $1065.0 from Guggenheim, while the lowest is $680.0 from Baird [5][7] - As of the latest check, Argenx's stock is down 6.56% at $523.37 [7]
Halozyme Announces argenx Received European Commission Approval for VYVGART® Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Prnewswire· 2025-06-20 17:15
Core Insights - The European Commission has approved VYVGART® (efgartigimod alfa) for subcutaneous injection as a monotherapy for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins [1][4] - VYVGART is the first targeted IgG Fc-antibody fragment for CIDP and introduces a novel mechanism of action for CIDP treatment in over 30 years [2] - The approval is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date, and is valid across all 27 EU Member States, as well as Iceland, Norway, and Liechtenstein [4] Company Overview - Halozyme Therapeutics, Inc. specializes in biopharmaceutical solutions aimed at improving patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [5] - The company has impacted over one million patients through its commercialized products and has licensed its ENHANZE® technology to major pharmaceutical companies including Roche, Takeda, and Pfizer [5] - Halozyme also develops drug-device combination products using advanced auto-injector technologies to enhance patient comfort and adherence [6] Strategic Partnerships - The approval of VYVGART represents a significant milestone in Halozyme's partnership with argenx, expanding access to CIDP treatment in Europe [3] - The company continues to collaborate with various pharmaceutical and biotechnology firms to leverage its ENHANZE® technology for improved drug delivery [5][6]
argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy
Globenewswire· 2025-06-20 17:00
VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDPApproval based on ADHERE clinical trial, the largest study of CIDP patients to dateFirst novel mechanism of action for CIDP treatment in more than 30 years June 20, 2025, 7:00 PM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseas ...
argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Positive Phase 2 Proof-of-Concept Results in Myositis and Sjogren’s Disease
Globenewswire· 2025-06-10 22:01
ALKIVIA data demonstrate significant improvement in muscle strength and physical function in myositis patients treated with efgartigimodRHO data show efgartigimod achieved sustained reduction in autoantibodies and improved functional outcomes in patients with Sjogren’s disease; program granted U.S. FDA Fast Track designationargenx committed to new therapeutic areas in rheumatology with ongoing Phase 3 studies in myositis (ALKIVIA) and Sjogren’s disease (UNITY) June 11, 2025, 12:01 AM CET Amsterdam, the Net ...
摩根士丹利:动态追踪_ 美国中小型生物技术股表现
摩根· 2025-05-14 03:09
May 11, 2025 10:00 PM GMT New Slide Refreshed Slide Key MORGAN STANLEY & CO LLC. Vikram Purohit Equity Analyst vikram.purohit@ms.com +1 212 761-3804 Judah Frommer Equity Analyst judah.frommer@ms.com +1 212 761-1270 Michael Ulz Equity Analyst michael.ulz@ms.com +1 212 761-4650 Maxwell Skor Equity Analyst maxwell.skor@ms.com +1 212 761-4804 Sean Laaman Equity Analyst sean.laaman@ms.com +1 212 761-4947 Terence Flynn Equity Analyst terence.flynn@ms.com +1 212 761-2230 Finger On The Pulse US SMID Cap Biotech Bea ...
Argenx Q1 Earnings: Less Than Perfect Report Gets Punished
Seeking Alpha· 2025-05-09 12:02
Group 1 - Argenx's shares declined after missing revenue estimates for the first time since the launch of Vyvgart 13 quarters ago [2] - There are inconsistencies in revenue reporting, with Seeking Alpha reporting a figure of $23.8 million [2] Group 2 - The Growth Stock Forum focuses on attractive risk/reward situations and tracks portfolio and watchlist stocks closely [1]
Zai Lab Limited (ZLAB) Reports Q1 Earnings: What Key Metrics Have to Say
ZACKS· 2025-05-08 15:01
Financial Performance - Zai Lab Limited reported revenue of $106.49 million for the quarter ended March 2025, reflecting a year-over-year increase of 22.2% [1] - The earnings per share (EPS) for the quarter was -$0.45, an improvement from -$0.55 in the same quarter last year [1] - The reported revenue was below the Zacks Consensus Estimate of $117.09 million by 9.06% [1] - The EPS exceeded the consensus estimate of -$0.50 by 10.00% [1] Key Metrics - Product revenue for ZEJULA was $49.53 million, surpassing the average estimate of $48.32 million from three analysts [4] - Product revenue for OPTUNE reached $11.36 million, exceeding the average estimate of $8.35 million [4] - Product revenue for VYVGART was $18.11 million, falling short of the average estimate of $31.75 million [4] - Product revenue for NUZYRA was $15.12 million, slightly above the average estimate of $14.39 million [4] - Product revenue for QINLOCK was $8.51 million, exceeding the average estimate of $8.21 million [4] Stock Performance - Shares of Zai Lab Limited have returned +4.8% over the past month, compared to the Zacks S&P 500 composite's +11.3% change [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]
ZAI LAB(ZLAB) - 2025 Q1 - Earnings Call Presentation
2025-05-08 12:38
NASDAQ:ZLAB | HKEX:9688 © 2025. Zai Lab. All Rights Reserved. Forward-Looking Statements This presentation contains forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth / CAGR, profitabil ...