Lilly Eli & Co Stock Price, News & Analysis

Boehringer Ingelheim and Eli Lilly have launched Hear Your Heart, an initiative aimed at empowering women, particularly Black and Latina women, who are living with heart failure. Heart disease is the leading cause of death in the U.S., affecting over six million people, with women often facing worse outcomes compared to men. The program provides tailored resources and education to help women prioritize their care, address health disparities, and optimize heart failure management. This initiative underscores the importance of equitable healthcare for this underserved population.

Eli Lilly and Company (NYSE: LLY) will announce its first-quarter 2022 financial results on April 28, 2022. Following this, the company will hold a conference call at 9 a.m. Eastern time to discuss the financial performance with investors and media. A live webcast will be available on Lilly's official website, along with a replay post-call. Lilly has a significant history of impacting global health with its innovative medicines, which help over 47 million people worldwide.

Lilly's lebrikizumab, an investigational IL-13 inhibitor, showed significant promise in treating moderate-to-severe atopic dermatitis (AD) in the ADhere trial. At 16 weeks, 70% of patients treated with lebrikizumab and topical corticosteroids (TCS) achieved EASI-75, compared to 42% with placebo. Improvements were noted in skin clearance, itch, sleep, and quality of life. Safety profiles were consistent with previous studies, with mild adverse events reported. Lilly seeks to advance lebrikizumab globally after receiving Fast Track designation from the FDA.

Eli Lilly and Company (NYSE: LLY) reported updated data from the Phase 1/2 LIBRETTO-001 trial for Retevmo® (selpercatinib) in treating RET fusion-positive non-small cell lung cancer (NSCLC). The study involved 355 patients, revealing a confirmed objective response rate of 61.1% for previously treated patients and 84.1% for treatment-naïve patients. Notably, the CNS objective response rate was 84.6%. The safety profile was consistent with prior knowledge, with common adverse effects including dry mouth and hypertension. A Phase 3 trial is underway, with results expected in 2023.

Innovent Biologics and Eli Lilly expand their strategic partnership to enhance cancer treatment options in China. Innovent will acquire sole commercialization rights for Cyramza® and Retsevmo® upon approval, and a right of first negotiation for Pirtobrutinib. Cyramza® is crucial for gastric and liver cancer, filling a significant treatment gap in China. The deal involves a total payment of US$45 million upon regulatory approvals. This agreement aims to increase Innovent's oncology portfolio to seven products, benefiting cancer patients.

On March 26, 2022, Eli Lilly released data from pivotal Phase 3 studies on OLUMIANT (baricitinib) for adults with severe alopecia areata, showing nearly 40% of patients on 4-mg achieved at least 80% scalp coverage at 52 weeks. Results indicate significant eyelash and eyebrow regrowth in those treated. The FDA granted priority review for OLUMIANT in February 2022, marking it as a potential first-in-disease treatment. Safety profiles were consistent over 52 weeks, with no new safety signals reported, reinforcing its promise as a key therapeutic option.

Eli Lilly and Company (NYSE: LLY) announced significant results from its ADvocate program, revealing that over 50% of patients with moderate-to-severe atopic dermatitis treated with the investigational drug lebrikizumab experienced a 75% reduction in disease severity (EASI-75) after 16 weeks. The treatment also provided substantial improvements in itch and skin clearance. Safety evaluations indicated a lower frequency of adverse events compared to placebo. Lilly plans to submit regulatory filings for lebrikizumab by the end of 2022.

Eli Lilly and Company (NYSE: LLY) received a complete response letter (CRL) from the FDA for its Biologics License Application (BLA) for sintilimab injection, a PD-1 inhibitor for treating nonsquamous non-small cell lung cancer (NSCLC). The FDA's letter indicates the application cannot be approved in its current form, recommending an additional clinical trial comparing sintilimab to standard care. Sintilimab is already approved in China for various cancer indications and is undergoing multiple clinical studies. Lilly is now evaluating next steps for the sintilimab program in the U.S.

The EMPA-KIDNEY trial, assessing Jardiance (empagliflozin) for chronic kidney disease (CKD), is set to stop early due to positive efficacy results from the Independent Data Monitoring Committee. This trial, the largest of its kind in CKD, involves over 6,600 participants with various kidney function levels. The primary goal is to evaluate kidney disease progression and cardiovascular death. The trial's findings aim to address significant unmet medical needs in CKD, a global health crisis affecting millions. Detailed results will be presented later this year.