Core Insights - Regeneron Pharmaceuticals, Inc. (REGN) received FDA approval for linvoseltamab-gcpt, branded as Lynozyfic, for treating relapsed or refractory multiple myeloma (MM) after at least four prior therapies [1][6][7] - Lynozyfic is a bispecific antibody that connects B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells, leading to T-cell activation and cancer cell destruction [2][5] - The approval was based on the LINKER-MM1 trial, which showed a 70% objective response rate and a 45% complete response rate, marking it as one of the most effective bispecific antibodies for this patient group [4][7] Regulatory Approval - Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody with a dosing schedule of every two weeks starting at week 14, and every four weeks if a very good partial response is achieved after 24 weeks of therapy [5][7] - The approval addresses a significant unmet need for patients with late-stage MM, who have limited treatment options [6] Market Context - MM is the second most common blood cancer, with over 36,000 new cases expected in the US by 2025 [5] - REGN's shares have declined by 22.9% year-to-date, contrasting with a 0.6% decline in the industry [2] Oncology Portfolio Development - The approval of Lynozyfic enhances REGN's oncology portfolio, which includes Libtayo for various cancers [9] - REGN is also pursuing the approval of odronextamab for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma, with a target action date for resubmission set for July 30, 2025 [10][11] Competitive Landscape - REGN faces challenges with its lead drug Eylea, which is experiencing declining sales due to competition from Roche's Vabysmo, impacting its market share [11][12]

思宇年度活动回顾： 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 | 首届全球医美科技大会 即将召开： 2025年7月17日，第二届全球医疗科技大会 2025年9月3-5日，第三届全球手术机器人大会 近日， EyePoint公司 宣布其 湿性年龄相关性黄斑变性（nAMD） 候选产品 Duravyu的三期 LUGANO 研究 提 前完成患者招募。 短短 7 个月内，超过400名受试者完成入组并随机分组，这标志着该 药械合一控释植入剂 在 nAMD治疗中的临床推进进入关键阶段。 Duravyu 通过 EyePoint 专有的缓释技术 Durasert ETM，将伏罗尼布制为固体可生物降解的植入剂进行药物递 送。 根据公司规划， LUGANO 试验的初步数据将在2026年中期公布，后续LUCIA研究结果预计于 2026年下半年发布 。 LUCIA试验目前已随机分组60%的患者，预计2025年第三季度完成招募。 本轮进展不仅推动Duravyu临近商业化节点，也使其成为 "半年一针" 持续释放 治疗方案中最受瞩目的候选之 一。这一发展，正嵌入眼科控释治疗从基础探索走向结构重塑的背景逻辑中。 # 频繁注 ...

Regeneron Pharmaceuticals, Inc. (REGN) and partner Sanofi (SNY) announced mixed results from two late-stage studies, AERIFY-1 and AERIFY-2, on itepekimab for the treatment of chronic obstructive pulmonary disease (COPD).The candidate is being jointly developed by Regeneron and Sanofi. It is currently in clinical development programs for chronic rhinosinusitis with nasal polyps (phase III), non-cystic fibrosis bronchiectasis (phase II) and chronic rhinosinusitis without nasal polyps (phase II).Year to date, ...

Core Insights - Regeneron Pharmaceuticals, Inc. announced promising initial results from the early-stage study of oncology drug linvoseltamab, particularly in patients with relapsed/refractory multiple myeloma [1][2] Group 1: Study Results - The LINKER-MM2 trial showed linvoseltamab combined with carfilzomib or bortezomib yielded high response rates in earlier treatment lines for relapsed/refractory multiple myeloma [2] - Efficacy results indicated a 90% objective response rate (ORR) and a 76% complete response (CR) at a median follow-up of 15 months [6] - Among patients treated with linvoseltamab and bortezomib, an 85% ORR was observed with 50% achieving CR [7] Group 2: Patient Demographics - The study included patients who had progressed after at least two lines of therapy, with many being double-class refractory or triple-class exposed [4] - 48% of enrolled patients had baseline soft tissue plasmacytomas, and 39% were over 75 years old, indicating a high-risk patient population [5] Group 3: Regulatory Developments - The European Commission granted conditional marketing approval for linvoseltamab under the brand name Lynozyfic for adults with relapsed/refractory multiple myeloma [8] - The FDA has accepted the resubmission of the Biologics License Application (BLA) for linvoseltamab, with a target action date of July 10, 2025 [9] Group 4: Oncology Portfolio Expansion - Regeneron is focused on strengthening its oncology portfolio, which includes Libtayo for various cancers [10] - The approval of odronextamab for treating relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma has also contributed to the oncology franchise [11] Group 5: Market Competition - The decline in sales of Regeneron's lead drug Eylea is a concern, attributed to competition from Roche's Vabysmo, which has significantly impacted Eylea's market share [12][13]

Core Viewpoint - Roche's Susvimo® has received FDA approval for the treatment of diabetic retinopathy, marking it as the first and only continuous delivery treatment that requires just one refill every nine months, potentially benefiting millions affected by this condition [1][2][7]. Group 1: Product Details - Susvimo is a refillable eye implant that delivers a customized formulation of ranibizumab, designed to maintain vision in diabetic retinopathy patients with only one treatment every nine months [3][9]. - The FDA's approval was based on positive results from the phase III Pavilion study, which demonstrated significant improvements in the Diabetic Retinopathy Severity Scale for patients using Susvimo compared to those receiving monthly anti-VEGF injections [2][6]. - The Port Delivery Platform allows for continuous delivery of medication directly into the eye, addressing retinal conditions that can lead to vision loss [3][9]. Group 2: Market Impact - The approval of Susvimo expands treatment options for diabetic retinopathy patients, providing a more durable solution compared to traditional monthly injections [2][7]. - Diabetic retinopathy affects nearly 10 million people in the US and over 100 million globally, highlighting a significant market opportunity for Roche [1][5]. - Susvimo is the third FDA-approved indication for the product, which is also approved for treating neovascular age-related macular degeneration and diabetic macular edema [7][13]. Group 3: Clinical Study Insights - The Pavilion study involved 174 participants with non-proliferative diabetic retinopathy, comparing the efficacy and safety of Susvimo with monthly clinical observation [6][8]. - Participants receiving Susvimo showed a reduction in the severity of eye damage without requiring supplemental treatment at one year [2][6]. - The primary endpoint of the study was a two-step improvement on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at week 52 [6][8].

Core Insights - XOMA Royalty Corporation reported a strong first quarter for 2025, with total income and revenues of $15.9 million, a significant increase from $1.5 million in the same period in 2024, driven by various milestone payments and royalties [7][21]. - The company received $18.0 million in cash receipts during the first quarter, including $13.4 million from royalties and commercial payments, and $4.6 million from milestones and fees [15][7]. - XOMA Royalty is focused on prudent cash deployment, strict expense control, and opportunistic share repurchases, indicating a commitment to generating shareholder value [2][6]. Pipeline Advancements - The Marketing Authorization Application (MAA) for tovorafenib by Day One Biopharmaceuticals and Ipsen was accepted for review by the European Marketing Authority (EMA) [1]. - Takeda initiated a Phase 3 trial for mezagitamab, targeting chronic primary immune thrombocytopenia [1]. Business Development - XOMA Royalty acquired a royalty interest in Castle Creek Biosciences' D-Fi (FCX-007), a Phase 3 asset for dystrophic epidermolysis bullosa, contributing $5 million to a $75 million syndicated royalty financing transaction [3][1]. - The company successfully sold all unpartnered Kinnate assets, with a portion of any upfront payments to be distributed to Kinnate CVR holders [1][3]. Financial Performance - The company recorded a net income of $2.4 million for the first quarter of 2025, compared to a net loss of $8.6 million in the first quarter of 2024 [14][22]. - Research and Development (R&D) expenses increased to $1.3 million in Q1 2025 from $33,000 in Q1 2024, primarily due to licensing fees and clinical trial costs [9][21]. - General and Administrative (G&A) expenses decreased to $8.1 million in Q1 2025 from $8.5 million in Q1 2024, mainly due to lower stock compensation costs [10][11]. Anticipated Events - Key upcoming events include the EMA's decision on the MAA for tovorafenib and the completion of enrollment in the sunRIZE Phase 3 clinical trial for ersodetug, with topline data expected in December 2025 [6][1].

XOMA Royalty sold the remaining Kinnate pipeline assets for a total of up to $270 million in upfront and milestone payments, plus royalties on commercial sales at rates ranging from low single digits to mid-teens Holders of Kinnate Contingent Value Rights (CVRs) will receive 85% of all related upfront, milestone, and royalty payments paid to XOMA Royalty prior to April 2, 2029 EMERYVILLE, Calif., April 14, 2025 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (NASDAQ:XOMA), the biotech royalty aggregator, annou ...