Eli Lilly and (LLY) Stock News

Eli Lilly (NYSE: LLY) reported 52-week Phase 3b results from the TOGETHER-PsO and TOGETHER-PsA trials, which evaluated concomitant Taltz (ixekizumab) plus Zepbound (tirzepatide) versus Taltz alone in adults with moderate-to-severe plaque psoriasis or active psoriatic arthritis and obesity or overweight with a weight-related comorbidity.

At Week 52, the primary composite outcomes (maximal disease control plus ≥10% weight loss) favored combination therapy: in TOGETHER-PsO, 30.6% on Taltz+Zepbound versus 4.4% on Taltz alone achieved PASI 100 plus ≥10% weight loss; in TOGETHER-PsA, ACR50 plus ≥10% weight loss was achieved by 39.2% versus 1.7%, respectively. Complete skin clearance (PASI 100) in psoriasis was 40.5% with combination vs 29.1% with monotherapy, and ACR50 responses in psoriatic arthritis increased to 43.7% vs 15.7%.

According to Lilly, improvements in systemic inflammation (hsCRP), BMI and multiple metabolic measures were sustained or further improved through one year, with no new safety concerns; adverse events were generally mild to moderate and consistent with known profiles of each medicine.

Lilly (NYSE: LLY) has signed a definitive agreement to acquire Merida Biosciences, a biotechnology company developing precision biologics for serious autoimmune and allergic diseases. Merida’s antibody-engineering platform is designed to selectively and durably remove disease-causing antibodies while preserving normal immune function.

Merida’s lead asset, MER511, is in Phase 1 for Graves’ disease and thyroid eye disease, with initial data showing robust reductions in pathogenic thyroid-stimulating antibodies and a favorable initial safety profile. The pipeline also includes MER769, a preclinical program for food allergy, asthma, chronic spontaneous urticaria and other IgE‑driven diseases, plus earlier programs in kidney and other immune-mediated conditions.

According to Lilly, the deal is valued at up to $2.875 billion in cash, including an upfront payment and contingent milestone payments. The transaction is subject to customary closing conditions and regulatory approvals and is expected to close in the fourth quarter of 2026, after which it will be reflected in Lilly’s GAAP financial results and guidance.

Eli Lilly (NYSE: LLY) announced that the U.S. FDA has approved an expanded indication for Mounjaro (tirzepatide), a dual GIP and GLP‑1 receptor agonist, to lower the risk of major adverse cardiovascular events (cardiovascular death, non‑fatal heart attack or non‑fatal stroke) in adults with type 2 diabetes at high cardiovascular risk.

The decision is supported by the Phase 3 SURPASS‑CVOT trial, which enrolled 13,299 participants across 30 countries over roughly five years. Mounjaro was non‑inferior to Trulicity (dulaglutide), an established GLP‑1 therapy with cardiovascular benefit, for the composite MACE‑3 endpoint; superiority was not shown. Lilly reports that Mounjaro’s safety and tolerability profile in SURPASS‑CVOT was generally consistent with prior experience, with mostly mild‑to‑moderate gastrointestinal side effects during dose escalation and boxed warnings for thyroid C‑cell tumors and other serious risks highlighted in the prescribing information.

Eli Lilly (NYSE: LLY) reported results from a retrospective real‑world cohort study of 15,843 adults over 55 with overweight or obesity showing that sustained use of Zepbound (tirzepatide) for weight management was associated with lower non‑drug healthcare costs versus matched untreated controls.

Using pairwise and inverse probability of censoring weighting (IPCW) analyses that excluded Zepbound costs, estimated monthly healthcare costs were up to 15% lower (up to $181 per patient) at six months and up to $607 per patient per month at 12 months, corresponding to up to 38% lower costs. According to Lilly, cost savings from six months onward nearly offset, and from 12 months exceeded, the Medicare GLP‑1 Bridge program treatment cost of $195 per month, driven in part by lower hospital admissions and emergency department visits and higher routine outpatient visit rates. Results were published in Diabetes, Obesity and Metabolism.

Summary not available.

Lilly (NYSE: LLY) reported Q2 2026 revenue of $23.0 billion, up 48% year over year, driven mainly by surging volumes of Mounjaro and Zepbound. Reported EPS rose 26% to $7.94, while non-GAAP EPS increased 33% to $8.38, despite $3.03 per share of acquired IPR&D charges.

Gross margin reached 85.8% of revenue, and key products generated $15.7 billion, with strong growth in immunology, oncology, and neuroscience. Lilly raised 2026 revenue guidance to $85–$87 billion and increased non-GAAP performance margin guidance to 49.0%–50.5%, while updating non-GAAP EPS guidance to $35.50–$36.50.

Regulatory and pipeline progress included U.S. FDA approval of Ebglyss, European Commission approval of Jaypirca for CLL, positive Phase 3 data for retatrutide in obesity, and completion of a clinical package supporting global registrations starting with a planned U.S. BLA submission in Q1 2027. Business development featured completed acquisitions of Orna, Ajax, Centessa, and Kelonia, plus additional infectious disease deals and an agreement to acquire AtaiBeckley. Lilly also committed an extra $4.5 billion to expand Indiana manufacturing.

Eli Lilly (NYSE: LLY) announced that the U.S. FDA has granted Breakthrough Therapy designation to investigational KRAS G12C inhibitor olomorasib as monotherapy for adults with previously treated KRAS G12C‑mutant advanced pancreatic cancer, identified by an FDA‑approved test. This designation is based on preliminary data from the ongoing open‑label, multicenter Phase 1/2 LOXO‑RAS‑20001 trial in KRAS G12C‑mutant solid tumors, including pancreatic cancer after at least one prior systemic therapy.

According to Lilly, this is the second FDA Breakthrough Therapy designation for olomorasib, which previously received the status in combination with pembrolizumab (KEYTRUDA) for first‑line KRAS G12C‑mutant NSCLC with PD‑L1 ≥50%. Olomorasib is described as an oral, potent and highly selective next‑generation KRAS G12C inhibitor being studied across multiple global trials.

Eli Lilly (NYSE: LLY) reported positive topline Phase 3 results for its investigational triple agonist retatrutide in two 80‑week obesity trials, TRIUMPH‑2 and TRIUMPH‑3. In TRIUMPH‑2, adults with obesity or overweight and type 2 diabetes receiving 4 mg, 9 mg, and 12 mg weekly lost an average of 12.7%, 19.1%, and 20.8% of body weight (up to 49.6 lbs) and saw A1C reductions up to 1.6%, versus 4.0% weight loss and 0.2% A1C reduction on placebo.

In TRIUMPH‑3, adults with severe obesity and established cardiovascular disease lost 21.6% and 22.6% of body weight on 9 mg and 12 mg (up to 55.8 lbs) versus 3.2% on placebo, and showed reductions in triglycerides, non‑HDL cholesterol, systolic blood pressure, waist circumference, and hsCRP. MACE rates were numerically described with hazard ratios for MACE‑5 of 0.82 in‑study and 0.73 on‑treatment versus placebo. Gastrointestinal events were the most common adverse events, with higher discontinuation rates than placebo. Lilly plans to complete CMC work and submit a BLA for retatrutide to the U.S. FDA in Q1 2027; the molecule remains investigational and is not approved for sale.

Lilly (NYSE: LLY) plans to announce its second-quarter 2026 financial results on August 5, 2026, followed by a conference call with investors and media at 10 a.m. Eastern time. A live webcast and subsequent replay will be accessible via Lilly's investor relations website.