Lilly Eli & Co - LLY STOCK NEWS

Eli Lilly (NYSE: LLY) announced positive Phase 3 results for orforglipron, the first oral small molecule GLP-1 receptor agonist to complete Phase 3 trials. The ACHIEVE-1 study demonstrated significant efficacy in treating type 2 diabetes, with A1C reductions of 1.3% to 1.6% from a baseline of 8.0% across doses.

Key findings include:

• At the highest dose (36mg), participants lost an average of 16.0 lbs (7.9%) in weight
• Over 65% of participants on the highest dose achieved A1C ≤6.5%
• Common side effects were gastrointestinal, including diarrhea (19-26%) and nausea (13-18%)

Lilly plans to submit orforglipron for weight management regulatory approval by end of 2025, with type 2 diabetes submission expected in 2026. The company confirms readiness for worldwide launch without supply constraints.

Kanvas Biosciences has published new research demonstrating the capabilities of its High-Phylogenetic-Resolution Spatial Mapping (HiPR-Map) Platform, a spectral imaging technology for microbiome analysis. The platform outperforms conventional sequencing methods with:

- Detection sensitivity of 0.01%
- Species-level microbial identification
- Single-nucleotide resolution of ribosomal RNA

The research revealed three key findings:

• Superior technical performance compared to traditional sequencing
• Detailed engraftment profiles of Live Biotherapeutic Products (LBPs) in mouse GI tract
• Comprehensive mapping of spatial microbial interactions at microscale and mesoscale levels

The technology aims to enhance LBP development for treating conditions ranging from colitis to various cancers, offering advantages over traditional fecal microbiota transplants (FMTs).

Eli Lilly (NYSE: LLY) announced positive Phase 2 results for lepodisiran, an investigational siRNA therapy targeting lipoprotein(a) [Lp(a)]. The ALPACA study demonstrated that lepodisiran reduced Lp(a) levels by 93.9% at the highest tested dose (400 mg) over 60-180 days, meeting its primary endpoint.

Key findings include:

• 16 mg dose achieved 40.8% reduction
• 96 mg dose achieved 75.2% reduction
• 400 mg dose maintained 91% reduction at 1 year
• 74.2% reduction persisted at 1.5 years

The treatment showed a favorable safety profile with minimal adverse events. About 20% of Americans have high Lp(a) levels, which can double or triple heart attack risk. The company is currently conducting the ACCLAIM-Lp(a) Phase 3 trial to evaluate cardiovascular outcomes in adults with elevated Lp(a).

Eli Lilly (LLY) has expanded its LillyDirect digital healthcare platform to improve access to Alzheimer's disease care in the U.S. through independent in-person and telehealth options. The expansion aims to address significant healthcare challenges, as the majority of the nearly 7 million Americans with Alzheimer's remain undiagnosed.

The platform now includes Healthgrades, a doctor locator tool for finding local clinicians experienced in Alzheimer's care, and Synapticure, an independent telehealth provider specializing in neurodegenerative care. Synapticure commits to connecting patients with care navigators within two days and neurologist appointments within two weeks.

This initiative addresses critical issues in Alzheimer's care, including:

• Wait times expected to exceed 1 year by 2025
• Nearly 1 in 5 Medicare beneficiaries traveling over 50 miles to see neurologists
• Approximately 3,000 Americans progressing daily from mild to moderate/severe stages

Eli Lilly (NYSE: LLY) has announced upcoming presentations of preclinical data at the 2025 American Association for Cancer Research (AACR) Annual Meeting in Chicago from April 25-30. The company will showcase two key developments:

1. LY4050784: A selective SMARCA2 inhibitor, developed in collaboration with Foghorn Therapeutics, showing synergistic activity when combined with chemotherapy, pembrolizumab, and KRAS inhibitors in SMARCA4 mutant cancers.

2. LY4066434: A pan-KRAS inhibitor demonstrating high selectivity over HRAS and NRAS, with robust anti-tumor activity in KRAS-mutant models, including in the CNS.

Both programs are currently in Phase 1 clinical trials.

Eli Lilly (NYSE: LLY) reported promising Phase 3 BRAVE-AA-PEDS study results for baricitinib in treating adolescents with severe alopecia areata (AA). The study involved 257 patients aged 12-18 years.

Key findings at Week 36 showed that 42.4% of patients receiving 4mg baricitinib achieved 80% or more scalp hair coverage, compared to 4.5% on placebo. The 4mg dose group also demonstrated significant improvements with 50% achieving eyebrow regrowth and 42.9% showing eyelash regrowth.

Results suggest faster hair regrowth in adolescents compared to adults, with comparable efficacy achieved at 36 weeks versus 52 weeks in adult studies. The most common side effects included acne, influenza, and upper respiratory tract infection, with no major adverse events reported.

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.