With a 42% placebo-adjusted reduction in proteinuria at week 36, Vera Therapeutics Inc. met its primary endpoint in the Origin phase III trial with BAFF and APRIL dual inhibitor atacicept in treating immunoglobulin A nephropathy (IgAN) in adults.
Mabwell (Shanghai) Bioscience Co. Ltd. on May 30 gained Chinese approval of Mailisheng (albipagrastim alfa; 8MW-0511) as a subcutaneous injection to treat febrile neutropenia induced by myelosuppressive anticancer treatment, such as radiotherapy and chemotherapy.
Only a few days out of the European Association for the Study of the Liver annual meeting, the metabolic dysfunction-associated steatohepatitis (MASH) space continues to grab headlines, with GSK plc shelling out $1.2 billion up front to acquire phase III-ready efimosfermin alfa in a deal with Boston Pharmaceuticals Inc. that could end up totaling about $2 billion.
Another complete response letter from the U.S. FDA for Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) therapy Eylea (aflibercept) – along with disappointing sales of the VEGF inhibitor – dented shares (NASDAQ:REGN) by $41.95. They closed April 29 at $568.91, having traded as low as $542.44 during the day.
The sparsity of mid-to-late stage prospects in atopic dermatitis (AD, or eczema) – which has proved an especially challenging indication – plus some newsmaking fizzles in the space have caused developers to probe new targets with particular intensity. Most popular approaches thus far involve IL-4, IL-13, thymic stromal lymphopoietin and JAK. Developers have stumbled for varying reasons such as high placebo response rates, safety or lack of clinical proof of concept. Among the potential AD rescuers is Nektar Therapeutics Inc. with rezpegaldesleukin (rezpeg), which takes aim at IL-2.
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
When an autoimmune disease disrupted the life of someone close to scientist Dario Gutierrez, an idea emerged for a new company called Merida Biosciences focused on removing misdirected antibodies and their negative effects using Fc biotherapeutics.
After announcing that lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD), Opthea has now decided to close the Coast trial as well as the Shore trial. As reported by BioWorld, Opthea announced last week that it was considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet AMD.
Losing nearly 60% of its value, Mural Oncology plc backed away from its lead interleukin-2 (IL-2) drug, nemvaleukin alfa, in platinum-resistant ovarian cancer based on interim results showing it failed to reach significance in the overall survival primary endpoint.
Opthea Ltd. is considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD). The global Coast phase III trial evaluated the efficacy and safety of intravitreally administered 2-mg sozinibercept every four or eight weeks in combination with 2-mg aflibercept every eight weeks after a loading phase for the treatment of wet AMD. The trial did not meet its primary endpoint of mean change in best corrected visual acuity from baseline to week 52.
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