AbbVie (NYSE: ABBV) announced Friday September 11, 2026 positive topline results from the Phase 3 LUNA trial evaluating Qulipta (atogepant, an oral calcitonin gene-related peptide receptor antagonist small molecule) for the preventive treatment of menstrual migraine in adults. LUNA is a multicenter randomized double-blind placebo-controlled trial that enrolled 468 adult women with pure menstrual migraine or menstrually-related migraine across sites in Europe and Asia; participants took atogepant for 7 consecutive days starting 3 days before the onset of menses, repeated over 3 menstrual cycles. Atogepant reduced perimenstrual migraine days by a mean of 1.20 days versus 0.40 days with placebo (0.80 fewer migraine days versus placebo, p<0.0001) and met all 8 ranked secondary endpoints (p<0.0001). No treatment is currently FDA-approved specifically for menstrual migraine. AbbVie plans to submit the LUNA data to health authorities and present at future medical congresses. Qulipta is already approved in the U.S. for adults with episodic migraine and chronic migraine — the LUNA readout supports a distinct short-term perimenstrual dosing regimen and potentially a dedicated label expansion. CGRP is a neuropeptide involved in migraine pathophysiology; atogepant is a small-molecule CGRP receptor antagonist rather than a peptide itself.
AbbVie (NYSE: ABBV) announced Thursday September 3, 2026 positive topline results from the Phase 3 CERVINO trial of etentamig (an investigational monthly-dosed BCMA x CD3 bispecific T-cell engager) versus investigator's choice of standard available therapies in patients with triple-class-exposed relapsed/refractory multiple myeloma. The 393-patient trial met both dual primary endpoints: 74% objective response rate versus standard therapies plus a 60% reduction in the risk of disease progression or death (hazard ratio 0.40). Median follow-up was 11.4 months; safety was manageable with cytokine release syndrome and infection rates consistent with the BCMA bispecific class. Full CERVINO data will be presented in a plenary session at the 23rd International Myeloma Society Annual Meeting September 23-26, 2026 in Glasgow, Scotland. Etentamig would enter a competitive BCMA bispecific field led by Johnson & Johnson's Tecvayli (teclistamab) and Elrexfio (elranatamab, Pfizer), with the monthly dosing profile positioned as convenience-differentiated versus the weekly and biweekly regimens of the incumbents.
AbbVie (NYSE: ABBV) reported Q2 2026 earnings Friday July 31, 2026 before market open with total net revenues of $17 billion (+10.2% year-over-year), beating consensus by $300 million. Skyrizi (risankizumab, IL-23p19 monoclonal antibody for psoriasis, psoriatic arthritis, and inflammatory bowel disease) reached global Q2 net revenues of $5.505 billion (+24.4% YoY reported, +24.0% YoY operational). Rinvoq (upadacitinib, oral JAK1-selective inhibitor for rheumatoid arthritis, atopic dermatitis, and inflammatory bowel disease) reached global Q2 net revenues of $2.525 billion (+24.5% YoY reported, +23.7% YoY operational), with Rinvoq on pace for 30% growth in gastroenterology this year. AbbVie now expects the combined Skyrizi and Rinvoq franchise to generate approximately $32 billion in peak annual sales, with management anticipating combined peak sales for Rinvoq in vitiligo and alopecia areata to approach $2 billion. Humira (adalimumab, the anchor immunology franchise before biosimilar competition began in 2023) continued its expected decline at $756 million Q2 revenue, -35.9% YoY reported / -36.1% YoY operational. The neuroscience portfolio delivered approximately 20% Q2 growth with Vraylar, Botox Therapeutic, Ubrelvy, and Qulipta all achieving double-digit sales growth. Full-year 2026 guidance was reiterated at $14.08-14.28 adjusted EPS on approximately $67 billion in revenue.