Vyvgart Hytrulo

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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 ...
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]
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 ...
HALO Stock Up on Q1 Earnings and Revenue Beat, Raised 2025 View
ZACKS· 2025-05-07 17:15
Halozyme Therapeutics (HALO) reported first-quarter 2025 adjusted earnings of $1.11 per share, which comprehensively beat the Zacks Consensus Estimate of 95 cents. Earnings rose 41% year over year.Total revenues in the first quarter increased 35% year over year to $264.9 million. Revenues too surpassed the Zacks Consensus Estimate of $239 million. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)The top-line growth was primarily driven by higher royalty payments from Roche (RHHBY) fo ...
HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG FIRST QUARTER 2025 RESULTS
Prnewswire· 2025-05-06 20:01
Announcing New $250M Share Repurchase Total Revenue Increased 35% YOY to $265 million and Royalty Revenue Increased 39% YOY to $168 million Net Income Increased 54% YOY to $118 million; Adjusted EBITDA Increased 40% YOY to $162 million; GAAP Diluted EPS Increased 55% YOY to $0.93; non-GAAP Diluted EPS Increased 41% YOY to $1.111 Raising 2025 Financial Guidance Ranges for Total Revenue to $1,200 - $1,280 million, Representing YOY Growth of 18% - 26%, Adjusted EBITDA to $790 - $840 million, Representing YOY G ...
FDA Approves Argenx's Vyvgart Hytrulo Prefilled Syringe For Self-Injection For At Home Use Setting
Benzinga· 2025-04-11 21:41
The U.S. Food and Drug Administration (FDA) on Thursday approved a new option for patients to self-inject Argenx SE’s ARGX Vyvgart Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).Vyvgart Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous inje ...
Halozyme(HALO) - 2024 Q4 - Earnings Call Transcript
2025-02-19 00:55
Halozyme Therapeutics, Inc. (NASDAQ:HALO) Q4 2024 Earnings Conference Call February 18, 2025 4:30 PM ET Company Participants Tram Bui - Vice President, Investor Relations & Corporate Communications Helen Torley - President & Chief Executive Officer Nicole LaBrosse - Chief Financial Officer Conference Call Participants Sean Laaman - Morgan Stanley Brendan Smith - TD Cowen Mohit Bansal - Wells Fargo Jessica Fye - JPMorgan Michael DiFiore - Evercore ISI Jason Butler - Citizens JMP Operator Good afternoon. My n ...