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].

SAN FRANCISCO and SUZHOU, China, May 6, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces the completion of first patient dosing in the Phase 2 clinical study of efdamrofusp alfa (R&D code: IBI302), a recombinant human vascular endothelial growth factor r ...

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 ...