1d ago
AbbVie Q2'26: Etentamig nears regulatory test while Temab-A broadens oncology ambitions
AbbVie Inc. (NYSE: ABBV) held its Q2 2026 earnings call on July 31, 2026, during which the most consequential pipeline disclosures centered on four developments: a near-term regulatory binary for etentamig in multiple myeloma, expansion of the Temab-A oncology program, higher-dose development of emraclidine, and increased expectations for Rinvoq in dermatology.
Total net revenues were nearly USD 17 billion for the quarter, up 10.2% year-on-year, and AbbVie raised full-year revenue guidance by USD 300 million to approximately USD 67.6 billion.
Key Strategic Signals
- Etentamig — multiple myeloma regulatory submission possible in H2 2026: Chief Scientific Officer Roopal Thakkar said an interim progression-free survival analysis is planned in Q3 from the monotherapy third-line-plus trial; a positive result would support a regulatory submission later this year. A Phase III combination study with pomalidomide in second-line-plus patients — including those previously exposed to anti-CD38 antibodies or who lost response to anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell therapy or ADCs — is set to begin by year-end. Separately, 100% hematologic complete response with no cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome at the 40 mg dose in light chain amyloidosis, presented at the recent European Hematology Association Congress, is driving plans for a Phase III trial in newly diagnosed amyloidosis patients.
- Temab-A — breakthrough designation in colorectal cancer, Phase II data to shape broader strategy: The c-Met-targeting ADC Temab-A (telisotuzumab adizutecan or ABBV-400) received breakthrough therapy designation for use in combination with bevacizumab in refractory metastatic colorectal cancer (CRC), and the Phase III trial in the third-line-plus all-comer setting is actively recruiting. Phase II data in second-line CRC, expected later this year, will determine whether Temab-A can replace irinotecan in earlier lines — a substantially larger market. Thakkar said plans for Phase III in c-Met-selected ovarian cancer will be discussed with regulators in coming months, and a Phase II study in front-line head and neck cancer in combination with pembrolizumab is set to start soon. In ovarian cancer, management said a c-Met-directed approach would be "highly distinctive and differentiated" from the majority of competitors pursuing folate receptor alpha, noting little overlap between the two biomarker populations.
- Emraclidine dose escalation targets receptor occupancy gap: The 100 mg dose confirmed a safe and tolerable profile in the multi-ascending dose study, and 150 mg is now being evaluated. Thakkar attributed prior efficacy shortfalls in the Phase II EMPOWER studies to insufficient receptor occupancy and PK variability, and said higher dosing is expected to deliver more consistent pharmacokinetics and improved occupancy. Dose selection for both schizophrenia and psychosis programs is expected within months, with Phase II studies on track to initiate in Q4 2026. The M4 muscarinic agonist mechanism remains differentiated from current antipsychotics by the absence of gastrointestinal adverse events, management said.
- Rinvoq vitiligo and alopecia areata — peak sales guidance raised to nearly USD 2 billion combined: European approvals for Rinvoq (upadacitinib) in both non-segmental vitiligo and severe alopecia areata were received in the quarter. US regulatory decisions are anticipated later this year for vitiligo and in early 2027 for alopecia areata. Management said combined peak sales for these two indications alone are now expected to approach USD 2 billion, described as "meaningfully above" prior expectations. Rinvoq would be the first systemic therapy approved for vitiligo in the US.
Analyst Pressure Points
- HS trial design and lutikizumab differentiation: Wells Fargo's Mohit Bansal questioned whether lutikizumab, a dual IL-1 alpha/beta bispecific antibody, could break through the efficacy ceiling in hidradenitis suppurativa (HS) or represented an incremental mechanism. Thakkar cited Phase II data showing high deltas versus anti-tumor necrosis factor and anti-IL-17 agents, an absence of fungal infections, and no inflammatory bowel disease flares as supporting a favorable benefit-risk profile. Thakkar also noted the two HS trials — lutikizumab enrolling biologic-naive and anti-TNF-failed patients with a HiSCR 75 primary endpoint, and Rinvoq enrolling post-biologic patients with a HiSCR 50 endpoint — are designed to mirror the commercial positioning AbbVie has executed in IBD with Skyrizi (risankizumab) and Rinvoq. Sixteen-week data from both Phase III trials are expected later this year.
- Skyrizi subcutaneous induction — manufacturing and timeline confidence: Morgan Stanley's Terence Flynn asked whether manufacturing was aligned for the anticipated fall US approval of subcutaneous induction dosing for Skyrizi in Crohn's disease. Thakkar said the submission is complete, the review is proceeding as planned, and manufacturing is well established given the asset's existing commercial history.
Forward-Looking Catalysts
- Etentamig Q3 interim analysis: A positive progression-free survival readout from the third-line-plus monotherapy study would position AbbVie to file for accelerated approval later in 2026, making this the most time-sensitive binary in the near-term pipeline.
- Temab-A Phase II second-line CRC data (H2 2026): Results against irinotecan-based chemotherapy will determine whether Temab-A advances into first- and second-line CRC — indications substantially larger than the approved third-line setting. Thakkar said response rates and depth of response in earlier lines will also inform the biomarker strategy, with c-Met expression expected to be lower than in later-line patients.
- Tavapadon US approval (Q3 2026): FDA approval is expected in the current quarter for the selective D1/D5 dopamine agonist in Parkinson's disease, as both monotherapy and add-on to levodopa/carbidopa. Stewart said the launch ramp will be modest initially due to Medicare formulary timing, but framed the asset as a meaningful contributor to the company's stated Parkinson's portfolio peak sales target of more than USD 5 billion alongside Vyalev (foscarbidopa/foslevodopa) and Duopa.
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Summary
AbbVie Inc. (NYSE: ABBV) held its Q2 2026 earnings call on July 31, 2026, during which the most consequential pipeline disclosures centered on three areas:...