Lilly Eli & Co - LLY STOCK NEWS

Eli Lilly's EBGLYSS® (lebrikizumab-lbkz) demonstrated significant long-term efficacy in treating moderate-to-severe atopic dermatitis, according to new three-year data presented at the American Academy of Dermatology Annual Meeting.

Key findings from the ADjoin extension study show that among Week 16 responders receiving monthly maintenance doses:

• 50% achieved complete skin clearance (EASI 100 or IGA 0)
• 87% achieved almost-clear skin (EASI 90)
• 83% did not require additional topical therapies

Additional studies revealed EBGLYSS's effectiveness across diverse patient groups: The ADmirable study showed ~60% of patients with skin of color experienced significant improvement in itch and skin pain at Week 16. In the ADapt study of previous dupilumab users, 75% achieved significant skin pain improvement and 62% showed itch improvement at Week 24.

EBGLYSS, approved in September 2024 as a first-line monotherapy biologic treatment, works by selectively blocking IL-13 signaling. The safety profile remained consistent with previous studies, with mild to moderate adverse effects primarily including conjunctivitis and injection-site reactions.

Laekna (2105.HK) has received FDA IND approval for LAE120, a novel USP1 inhibitor for treating advanced solid tumors. LAE120 is characterized as an allosteric and highly potent inhibitor showing strong tumor inhibitory activity across various xenograft models and demonstrating synergistic effects with PARP inhibitors.

The company is also advancing LAE118, a mutant-selective PI3Kα inhibitor currently in IND-enabling studies, with IND filing expected in Q4 2025. LAE118 shows promise as a potential best-in-class treatment for various cancers including breast, colorectal, lung, and endometrial cancers.

Additionally, Laekna has established a clinical collaboration with Lilly (LLY) in November 2024 to accelerate the global clinical development of LAE102 for obesity treatment. The company is actively seeking strategic partnerships to expedite clinical development and commercialization of its drug candidates.

Eli Lilly (NYSE: LLY) has announced its participation in the upcoming Leerink Partners Global Healthcare Conference scheduled for March 10, 2025. The company's executive vice president and CFO, Lucas Montarce, will engage in a fireside chat at 9:20 a.m. Eastern time.

Investors and interested parties can access a live audio webcast of the presentation through Lilly's investor website in the 'Webcasts & Presentations' section. The recording will remain available for approximately 90 days following the event.

Eli Lilly's (LLY) Jaypirca (pirtobrutinib) received a positive recommendation from EMA's CHMP for treating adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who were previously treated with a BTK inhibitor.

The recommendation is based on the Phase 3 BRUIN CLL-321 trial results, which demonstrated that Jaypirca reduced disease progression or death risk by 46% compared to standard treatments (median PFS: 14.0 vs. 8.7 months). The median time to next treatment improved by 63% (24 months vs. 11 months).

The trial showed consistent results across key subgroups, including patients with poor prognosis factors. Common adverse reactions included neutropenia, fatigue, diarrhea, anemia, rash, and contusion. The European Commission's final decision is expected within 1-2 months.

Eli Lilly (NYSE: LLY) has announced plans to build four new pharmaceutical manufacturing sites in the United States, bringing its total U.S. capital expansion commitments to over $50 billion since 2020. Three sites will focus on active pharmaceutical ingredients (API) manufacturing and chemical synthesis, while the fourth will expand injectable therapy production.

The expansion will create 3,000 high-skilled jobs including engineers, scientists, and technicians, plus approximately 10,000 construction jobs. The new facilities will manufacture medicines across therapeutic areas including cardiometabolic health, oncology, immunology, and neuroscience.

This investment builds upon Lilly's previous domestic expansion commitments of $23 billion from 2020-2024, which included facilities in North Carolina, Indiana, and Wisconsin. The company is currently negotiating with several states and welcomes additional interest by March 12, 2025. Production at the new facilities is expected to begin within five years.

Eli Lilly and Company (NYSE: LLY) has announced the launch of new 7.5 mg and 10 mg Zepbound (tirzepatide) single-dose vials for $499 per month through the new Zepbound Self Pay Journey Program. The company has also reduced prices of existing 2.5 mg vials to $349 and 5 mg vials to $499 per month.

These offerings are available exclusively through LillyDirect Self Pay Pharmacy Solutions, which provides transparent pricing by eliminating third-party supply chain entities and allowing patients to access savings directly outside of insurance.

The Zepbound Self Pay Journey Program reduces the regular prices of 7.5 mg ($599) and 10 mg ($699) doses to $499 per month at first fill and refills occurring within 45 days of prior delivery.

Zepbound is also available in various dosages in single-dose pen autoinjectors, with recommended maintenance dosages of 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly.

Eli Lilly (NYSE: LLY) has announced its participation in TD Cowen's 45th Annual Health Care Conference scheduled for March 4, 2025. Jake Van Naarden, executive vice president and president of Lilly Oncology, will participate in a fireside chat at 1:50 p.m. Eastern time.

The event will be accessible through a live audio webcast on Lilly's investor website under the 'Webcasts & Presentations' section. Investors and interested parties can access the replay of the presentation on the same platform for approximately 90 days following the event.

Eli Lilly (NYSE: LLY) announced positive two-year results from the VIVID-2 study for Omvoh® (mirikizumab-mrkz) in treating Crohn's disease. The study showed remarkable sustained efficacy, with 92.9% of patients maintaining clinical remission and 87.6% maintaining endoscopic response after two years of continuous treatment.

Among patients not in remission at year one, 60.8% achieved clinical remission and 35.4% gained endoscopic remission during the second year. The safety profile remained consistent, with only 6.8% reporting serious adverse events and 0.8% discontinuing treatment due to adverse events.

Omvoh, which targets IL-23p19 protein to reduce gastrointestinal inflammation, received FDA approval for Crohn's disease in January 2025 and is already approved in 44 countries for ulcerative colitis treatment. It's the first IL-23p19 antagonist demonstrating long-term efficacy for both conditions.

Eli Lilly (LLY) reported strong Q4 2024 financial results with revenue increasing 45% to $13.53 billion, primarily driven by Mounjaro and Zepbound sales. Q4 EPS grew 102% to $4.88 on a reported basis and 114% to $5.32 on a non-GAAP basis.

The company received FDA approval for Zepbound for moderate-to-severe obstructive sleep apnea in adults with obesity and Omvoh for Crohn's disease. Notable developments include a pending acquisition of Scorpion Therapeutics' PI3Kα inhibitor program and a $15 billion share repurchase program.

For 2025, Lilly provided guidance with revenue expected between $58.0-61.0 billion, representing approximately 32% growth compared to 2024. EPS guidance for 2025 is set at $22.05-23.55 on a reported basis and $22.50-24.00 on a non-GAAP basis.