Lilly Eli & Co - LLY STOCK NEWS

Eli Lilly and Incyte presented data for baricitinib at the virtual Fall Clinical Dermatology meeting from Oct 29 to Nov 1, 2020. The Phase 2 study (BRAVE-AA1) evaluated its efficacy in adult patients with alopecia areata (AA). Results showed significant improvement in patients achieving a SALT score ≤20 at 36 weeks, with the 4-mg dose showing 51.9% improvement versus 3.6% for placebo (p=0.001). Following positive Phase 2 results, Phase 3 trials (BRAVE-AA1 and BRAVE-AA2) have been initiated. The FDA has granted Breakthrough Therapy designation for baricitinib for AA due to unmet medical needs.

Eli Lilly and Company (NYSE: LLY) announced new data on Taltz (ixekizumab) at the European Academy of Dermatology and Venereology Congress. The findings from the long-term UNCOVER-3 study show five-year sustained efficacy of Taltz for psoriasis, with 83%, 73%, and 89% of patients achieving complete clearance in challenging areas like the scalp, nails, and palms. No new safety concerns were reported. Additional results highlighted Taltz's effectiveness in treating psoriatic arthritis, showcasing a significant patient response rate compared to adalimumab.

Eli Lilly announced the publication of Phase 2 BLAZE-1 study data for bamlanivimab (LY-CoV555) in the New England Journal of Medicine. The study assessed the efficacy of bamlanivimab in outpatient COVID-19 patients with mild to moderate symptoms. Results indicated that bamlanivimab may effectively reduce viral load and hospitalization risks. The company is pursuing emergency use authorization from the FDA for this treatment. The trial enrolled over 800 participants and reported no serious drug-related adverse events, supporting its potential role in early-stage COVID-19 treatment.

Eli Lilly announced an agreement with the U.S. government to supply 300,000 vials of bamlanivimab, an investigational antibody, for $375 million, pending Emergency Use Authorization (EUA) from the FDA. The initial agreement includes provisions for an additional 650,000 vials. Lilly aims to manufacture up to one million doses by the end of 2020, with significant production capacity expected in Q1 2021. The company has completed Phase 1 studies showing potential benefits of bamlanivimab in treating COVID-19. The government program ensures no out-of-pocket cost for patients receiving the treatment.

Eli Lilly announced Q3 2020 results, reporting revenue of $5.741 billion, a 5% increase from Q3 2019. Net income was $1.208 billion (-4%), with EPS of $1.33 (-3%). Non-GAAP net income grew by 3% to $1.407 billion, with EPS at $1.54 (+4%). Key growth products contributed significantly, with notable increases in Trulicity (+9%) and Taltz (+34%). Total operating expenses rose 9% to $3.035 billion, impacted by COVID-19 expenses of $125 million. Lilly also made strides in COVID-19 treatment development, submitting a request for Emergency Use Authorization for bamlanivimab.

New findings from the EMPEROR-Reduced phase III trial reveal that Jardiance (empagliflozin) significantly reduces the risk of adverse cardiovascular and kidney events in adults with heart failure and reduced ejection fraction, regardless of diabetes or chronic kidney disease status. The study reported a 25% reduction in cardiovascular death or heart failure hospitalization and a 50% decrease in composite kidney endpoints. With a safety profile consistent with prior studies, these results underscore Jardiance's potential in addressing the growing needs of patients suffering from both heart failure and chronic kidney disease.

Eli Lilly and Company (NYSE: LLY) has declared a $0.74 dividend for the fourth quarter of 2020, set to be paid on December 10, 2020. Shareholders must be on record by the close of business on November 13, 2020 to receive this dividend. This announcement underscores Lilly's commitment to providing value to its shareholders while continuing its mission to develop life-changing medicines.

Eli Lilly and Company (NYSE: LLY) has entered into a definitive agreement to acquire Disarm Therapeutics for an upfront payment of $135 million, with potential future payments totaling $1.225 billion tied to development milestones. Disarm specializes in developing SARM1 inhibitors aimed at treating axonal degeneration linked to neurological diseases such as ALS and multiple sclerosis. This acquisition aligns with Lilly's commitment to advancing therapies for nerve damage. The transaction is not expected to alter Lilly's 2020 non-GAAP earnings per share guidance.

Eli Lilly announced promising results from the Phase 2 SERENITY study of mirikizumab for treating moderate to severe Crohn's disease. The trial reported that nearly 60% of patients achieved significant endoscopic response, while over 45% attained patient-reported outcome remission at 52 weeks. These findings were shared during the UEG Week 2020. The study highlights the potential of mirikizumab as a treatment option, addressing a critical need for new therapies in this challenging condition. Safety profiles were consistent, with common adverse events being manageable.