Eli Lilly & Co. - LLY STOCK NEWS

Eli Lilly and Company (NYSE: LLY) announced updates on its research and development programs at an investment community meeting. The company is on track to launch 20 new medicines by 2023, with 16 launched since 2014 and five expected soon, including tirzepatide. Lilly updated its 2021 and 2022 financial guidance, projecting earnings per share (EPS) of $6.18 to $6.23 for 2021 and $8.00 to $8.15 for 2022. Revenue for 2021 is estimated at $28.0 to $28.3 billion, driven by strong product uptake, despite expected declines in Alimta and COVID-19 antibody revenue.

Eli Lilly and Company (NYSE: LLY) announced successful results from the Phase 3 maintenance study of mirikizumab for ulcerative colitis (UC). In the LUCENT-2 trial, patients receiving mirikizumab showed a statistically significant higher rate of clinical remission at one year compared to placebo (p<0.001). All key secondary endpoints were also met, demonstrating improvements in endoscopic and histologic measures. The drug's safety profile was consistent with previous studies. Lilly plans to file a Biologics License Application with the FDA in early 2022, marking a potential significant advancement in UC treatment.

Eli Lilly has announced a 15% increase in its quarterly dividend, declaring a payment of $0.98 per share for Q1 2022. This dividend will be payable on March 10, 2022, to shareholders recorded by the close of business on February 15, 2022. The increase reflects Lilly's commitment to return value to shareholders amidst its ongoing commitment to healthcare innovation.

Loxo Oncology at Lilly and Foghorn Therapeutics announced a strategic collaboration aimed at developing novel oncology drugs using Foghorn's Gene Traffic Control platform. The agreement entails a $300 million upfront payment and an $80 million equity investment from Lilly. Foghorn will lead early research for their BRM-selective program, while Lilly will manage development and commercialization. They will share U.S. economics 50/50 and Foghorn stands to earn up to $1.3 billion in potential milestones. This collaboration addresses BRG1 mutations in various cancers, impacting a significant patient population.

Loxo Oncology at Lilly presented updated clinical data from the Phase 1/2 BRUIN trial of pirtobrutinib, a non-covalent Bruton's tyrosine kinase inhibitor, at the ASH Annual Meeting. The trial enrolled 618 patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). Key findings include an overall response rate (ORR) of 68% in CLL/SLL patients, and a durable median progression-free survival (PFS) not reached. The safety profile was favorable, with most adverse events being mild. Lilly aims to advance pirtobrutinib through additional Phase 3 studies.

Eli Lilly and Regor Therapeutics have formed a multi-year collaboration to develop new therapies for metabolic disorders. Lilly will license specific Regor intellectual property and handle clinical development globally, except in China, Macau, Hong Kong, and Taiwan. Regor will receive an upfront payment of up to $50 million and could earn up to $1.5 billion based on development milestones. This collaboration aims to enhance treatment options for patients with obesity and diabetes without altering Lilly's 2021 earnings guidance.

Eli Lilly and Company (NYSE: LLY) released findings from the CONFIDE Study, revealing that bowel urgency is the second most reported symptom among individuals with moderately-to-severely active ulcerative colitis (UC), affecting 47% in the past month. Notably, only 38.2% of those experiencing bowel urgency felt comfortable discussing it with healthcare providers, highlighting a significant communication gap. Despite 76.5% of respondents receiving advanced therapies, bowel urgency persisted in 46.4% of cases. The study emphasizes the need for improved patient-provider communication regarding this disruptive symptom.

The FDA has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab for high-risk pediatric patients under 12 years. This allows treatment of mild to moderate COVID-19 and post-exposure prophylaxis. The decision was supported by findings from the BLAZE-1 clinical trial, showing a median symptom resolution time of 5 to 7 days. Over 700,000 patients have been treated, potentially preventing over 35,000 hospitalizations. No deaths or hospitalizations were recorded among pediatric subjects during the trial.

Eli Lilly and Company (NYSE: LLY) will hold an investment community meeting on Dec. 15, 2021, from 9 a.m. to 4 p.m. Eastern time. The meeting will include the company's initial financial guidance for 2022 and an in-depth discussion on its research and development opportunities in diabetes, immunology, neuroscience, and oncology. The event will be accessible via a live video webcast, with a replay available after the meeting.