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FDA approval of ICOTYDE (icotrokinra) for moderate-to-severe plaque psoriasis expands J&J's immunology pipeline.
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Eledon Rises on Updated Phase 2 Data and FDA Fast Track for Tegoprubart
Eledon Pharmaceuticals traded higher on Tuesday after updating long-term data from a mid-stage trial of its lead candidate tegoprubart and announcing that the FDA granted the drug Fast Track designation. Citing data from its Phase 2 BESTOW trial, the California-based biotech said the antibody therapy maintained a higher kidney function with a statistically significant effect based on the average estimated glomerular filtration rate, a measure of kidney graft function. The latest readout, presented at the International Congress of the Transplantation Society in Australia, set tegoprubart's eGFR advantage at approximately 13 mL/min/1.73 m² through 24 months, compared with an average eGFR of about 69 mL/min/1.73 m² in a 12-month analysis in November. On safety, the company said there were no rejections in the tegoprubart arm beyond six months post-transplant, compared with seven in the tacrolimus arm. Eledon added that it remains on track to begin its Phase 3 LEGACY trial for tegoprubart in kidney transplantation in Q4 2026.
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AbbVie's Rinvoq Wins EU Approval for Juvenile Idiopathic Arthritis
AbbVie announced that the European Commission has approved its immunology drug Rinvoq, also known as upadacitinib, for the treatment of active polyarticular juvenile idiopathic arthritis in patients aged two years and older who have had an inadequate response or intolerance to disease-modifying antirheumatic drugs. The approval marks the 11th indication for Rinvoq in the European Union, where it can be used either as monotherapy or in combination with methotrexate, and follows the drug's existing United States approval for the same condition. The decision was supported by the open-label phase I SELECT-YOUTH study, in which 66.4% of patients achieved an ACR Pediatric 70 response at week 12, rising to 79.5% by week 48, while clinical remission increased from 23% to 43.4% over the same period. Rinvoq is a key growth driver for AbbVie, with sales up 22.2% year over year to $4.64 billion in the first half of 2026 and expected revenues of around $10.2 billion for the full year. Separately, AbbVie announced a multi-year collaboration with Iambic to accelerate discovery of small-molecule therapies in immunology, neuroscience and oncology, using Iambic's AI-powered platform including its next-generation Enchant v3 model, with Iambic receiving an upfront payment plus milestone payments and tiered royalties on net sales.
Kodiak, Celldex, Rapport and Vaxcyte Face Key Fall Clinical Readouts
Four clinical-stage biotech companies are approaching potentially important mid- to late-stage data readouts this fall, with outcomes that could reshape their pipelines and valuations. Kodiak Sciences is on track to report top-line data this month from the phase III DAYBREAK study evaluating Zenkuda (tarcocimab tedromer) and KSI-501 for treatment-naïve wet age-related macular degeneration against Regeneron's Eylea, targeting a roughly $15-billion anti-VEGF market. Celldex Therapeutics expects a September/October 2026 top-line readout from its phase III EMBARQ-CSU1 and EMBARQ-CSU2 studies of barzolvolimab in chronic spontaneous urticaria, with 1,939 patients enrolled and a planned regulatory submission in 2027. Rapport Therapeutics is targeting October 2026 for phase II results on RAP-219 in bipolar mania, while Vaxcyte expects top-line safety, tolerability and immunogenicity data from the phase III OPUS-1 study of its 31-valent pneumococcal conjugate vaccine VAX-31 by the end of October 2026. Among the four, Kodiak carries a Zacks Rank #4 (Sell), while Celldex, Rapport and Vaxcyte each hold a Zacks Rank #3 (Hold).