Eledon Pharmaceuticals IncELDN
▲ PositiveRegulationTechnologyrelevance
FDA granted Fast Track designation to tegoprubart.
Impact on assets 1
Biotech & Genomic Medicine▲ · 1 stocks
Eledon Pharmaceuticals IncTheme Impact 1
Off-coverage companies
Related news
▲3
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).
▲
AbbVie Q2 Revenue Rises 10.2% to $16.99 Billion, Beating Estimates
AbbVie reported second-quarter revenues of $16.99 billion, up 10.2% year on year and 1.2% above analysts' consensus expectations, though the quarter was mixed with only a narrow beat of EPS estimates and a slight miss of full-year EPS guidance estimates. The results came as the 11 therapeutics stocks tracked by the report collectively beat consensus revenue estimates by 8% in Q2, with share prices up 24.8% on average since the latest earnings results. Biogen posted the group's best quarter, with revenues of $2.74 billion, up 3.4% year on year and 12.1% above expectations, while Myriad Genetics delivered the weakest performance, reporting revenues of $190.7 million, down 10.5% year on year and 8.2% below expectations, alongside full-year revenue guidance that missed and a significant EPS miss. Gilead Sciences reported revenues of $7.80 billion, up 10.2% year on year and 6.2% above expectations, and Moderna reported revenues of $145 million, up 2.1% year on year and 35.8% above expectations, the biggest analyst estimate beat of the group. AbbVie's stock is up 2.9% since reporting and currently trades at $264.79.