AbbVie Inc.（ABBV）のニュースとイベントABBVAbbVie Inc.

AbbVie Announces New Findings on Skyrizi Treatment for Crohn's Disease

AbbVie announced new findings from the Phase 3 AFFIRM study evaluating a new option for induction treatment with Skyrizi in adults with moderately to severely active Crohn's disease, or CD. Presented at the American College of Gastroenterology annual scientific meeting, the findings build on the previously reported efficacy results of subcutaneous, or SC, Skyrizi treatment, showing new endoscopic remission and ulcer-free endoscopy outcomes for patients receiving Skyrizi subcutaneously. After treatment with Skyrizi, 35.8% of patients achieved endoscopic remission, or the healing of the intestinal lining with little to no visible inflammation. Across subgroups, 36.6% of patients who had ulcers at the start of the study achieved the complete absence of ulcers, known as ulcer-free endoscopy, after induction and maintenance treatment. Among advanced therapy-naive patients, rates were higher, with 45.1% achieving endoscopic remission and 49% achieving ulcer-free endoscopy, representing the highest rates observed across the evaluated subgroups. Evaluating subcutaneous Skyrizi against endoscopic outcomes demonstrates its potential to help CD patients achieve deeper control of underlying inflammation with a fully patient-administered regimen. Subcutaneous induction with Skyrizi for adults with moderately to severely active CD is currently under regulatory review with the FDA and European Medicines Agency. AFFIRM included patients with longstanding, difficult-to-treat CD; 65% had previously experienced an inadequate response to advanced therapies. Patients had lived with the disease for an average of more than seven years and had substantial intestinal inflammation at study entry. Safety findings through week 24 were consistent with the known safety profile of risankizumab, with lower rates of treatment-emergent adverse events observed in the risankizumab treatment groups versus placebo during both induction and maintenance. Rates of adverse events of special interest remained low, and no new safety signals were identified.

AbbVie Receives Two Breakthrough Therapy Designations from FDA

AbbVie announced that the U.S. FDA has granted two Breakthrough Therapy Designations for telisotuzumab adizutecan in colorectal cancer and non-small cell lung cancer. Temab-A has received two BTDs: one in combination with bevacizumab for adults with refractory, metastatic CRC who have been previously treated with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody, and if indicated, anti-EGFR mAb therapy. The second designation is for Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC who have previously received treatment with platinum-based chemotherapy and an anti-PD-1 antibody therapy. These designations were primarily based on results from the first-in-human study M21-404.

AbbVie Lowers Q3 2026 EPS Guidance to $3.73-$3.77

The company states: "Reported GAAP earnings and adjusted non-GAAP earnings for the third quarter of 2026 are expected to include acquired IPR&D and milestones expense of $216 million on a pre-tax basis, representing an unfavorable impact of $0.11 to both GAAP diluted earnings per share and adjusted non-GAAP diluted earnings per share. Results for the quarter ended September 30, 2026 have not been finalized and are subject to our financial statement closing procedures. While acquired IPR&D and milestones expense may be incurred upon execution of collaborations, licensing agreements, and other asset acquisitions, AbbVie does not forecast acquired IPR&D and milestones expense due to uncertainty of the future occurrence and timing of these transactions. Adjusted diluted earnings per share guidance for 2026 previously announced on July 31, 2026 excluded the impact of acquired IPR&D and milestones expense that may be incurred beyond the second quarter of 2026. AbbVie's full-year 2026 adjusted diluted earnings per share guidance range, including the impact of third-quarter 2026 acquired IPR&D and milestones expense, is $13.76 - $13.96. AbbVie's third-quarter 2026 adjusted diluted earnings per share guidance range, including the impact of third-quarter 2026 acquired IPR&D and milestones expense, is $3.73 - $3.77."