Lynozyfic (linvoseltamab)

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2 Biotech Stocks That Could Soar 29% and 165% According to Wall Street's Top Analysts
The Motley Fool· 2025-08-03 10:00
Core Insights - The healthcare industry remains a resilient sector for investors, particularly in biotech, which is known for innovation and life-saving products [1][2] Company Summaries Regeneron Pharmaceuticals - Regeneron Pharmaceuticals is projected to have a potential upside of 29% to 68% over the next 12 months, driven by its antibody-based therapies [4] - The company's top-selling product, Dupixent, achieved global net sales of $14.2 billion in 2024, a 22% increase from the previous year [5] - Eylea, another key product, generated $6 billion in U.S. net sales in 2024, maintaining its sales figures from 2023 [5] - Libtayo, an oncology drug, surpassed $1 billion in annual net sales in 2024, reflecting a 40% increase from the prior year [5] - Regeneron is advancing its pipeline with 45 product candidates in clinical development and expects several regulatory approvals in 2025 [8] - Recent approvals include Lynozyfic for multiple myeloma and several label expansions for Dupixent [8] - The company reported a first-quarter revenue of $3.03 billion, a 3.7% year-over-year decline, but net income increased by 12% to $809 million [7] Viking Therapeutics - Viking Therapeutics has a projected share price increase of 165% at the midpoint and up to 268% at the high end over the next year [11] - The lead candidate, VK2735, is a dual GLP-1 and GIP receptor agonist currently in phase 3 trials for obesity [11][12] - Viking is also developing an oral tablet formulation of VK2735 and plans to announce results from a phase 2 study in the second half of 2025 [12] - The company has other candidates targeting metabolic dysfunction and X-linked adrenoleukodystrophy (X-ALD) [13][14] - As a clinical-stage biopharmaceutical company, Viking is pre-revenue and has reported losses while preparing for commercialization [15] - The company had approximately $808 million in cash and equivalents at the end of Q2 [15]
Regeneron, SNY Report Mixed Results From Late-Stage COPD Studies
ZACKS· 2025-05-30 15:21
Core Viewpoint - Regeneron Pharmaceuticals and Sanofi reported mixed results from late-stage studies on itepekimab for chronic obstructive pulmonary disease (COPD), with one trial meeting its primary endpoint while the other did not [1][4][6]. Group 1: Clinical Trials and Results - AERIFY-1 and AERIFY-2 are phase III trials assessing the efficacy and safety of itepekimab in adults aged 40-85 years with moderate-to-severe COPD [4]. - AERIFY-1 achieved its primary endpoint, showing a 27% reduction in moderate or severe acute exacerbations compared to placebo at week 52 [5]. - AERIFY-2 did not meet the primary endpoint, although some benefits were observed earlier in the study [6]. Group 2: Product Pipeline and Market Position - Itepekimab is part of a broader clinical development program that includes trials for chronic rhinosinusitis with nasal polyps, non-cystic fibrosis bronchiectasis, and chronic rhinosinusitis without nasal polyps [1]. - The successful development of itepekimab could enhance Regeneron's portfolio, which is currently reliant on Eylea and Dupixent for revenue [9]. - Dupixent sales are strong, driven by prescription trends across multiple indications, including a recent label expansion for COPD [9]. Group 3: Competitive Landscape - Regeneron faces challenges with Eylea sales due to competition from Roche's Vabysmo, which has seen significant uptake [7]. - The company is also expanding its oncology portfolio, with recent conditional marketing approval for linvoseltamab to treat relapsed/refractory multiple myeloma [10].
Regeneron Pharma Margins Tighten As Competition Grows, Stock Slides
Benzinga· 2025-04-29 18:52
Core Insights - Regeneron Pharmaceuticals reported a decline in first-quarter adjusted earnings per share to $8.22, down 14% year-over-year, missing the consensus estimate of $8.82 [1] - The company's sales for the first quarter were $3.03 billion, a 4% decrease from the previous year, also falling short of the consensus of $3.29 billion [1] - U.S. net sales for Eylea HD and Eylea decreased by 26% year-over-year to $1.04 billion, which included $307 million from Eylea HD [1] Sales Performance - Net product sales of Eylea HD increased in the first quarter of 2025 compared to the first quarter of 2024, primarily due to higher sales volumes [2] - However, Eylea's net product sales were negatively impacted by increased competition from other anti-VEGF products and the transition of patients to Eylea HD [2][7] Collaboration Revenue - Sanofi collaboration revenue increased in the first quarter of 2025, driven by higher profits from the commercialization of antibodies, amounting to $1.018 billion compared to $804 million in the first quarter of 2024 [3] Manufacturing Expansion - Regeneron announced a significant expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotechnologies to produce bulk drug products at their North Carolina campus [4] - The company revised its 2025 GAAP gross margin guidance to 83%-84%, down from 84%-85%, and adjusted gross margin guidance to 86%-87%, down from 87%-88% [4] Regulatory Developments - The European Commission granted conditional marketing approval to Regeneron's Lynozyfic (linvoseltamab) for treating adults with relapsed and refractory multiple myeloma [5] - The FDA accepted the Biologics License Application for linvoseltamab in the U.S., with a target action date of July 10, 2025 [5] Stock Performance - Following the announcements, Regeneron stock experienced a decline of 6.38%, trading at $571.90 [5]