Eli Lilly & Co. - LLY STOCK NEWS

Eli Lilly and Incyte announced that the FDA has approved OLUMIANT (baricitinib) as the first systemic treatment for adults with severe alopecia areata. Available in 1 mg, 2 mg, and 4 mg doses, OLUMIANT has shown promising results in clinical trials, with 32-35% of patients achieving over 80% scalp coverage. The approval follows the BRAVE-AA1 and BRAVE-AA2 trials, involving 1,200 patients. While the treatment offers hope for patients, it comes with serious risks, including infections and cardiovascular events. Manufacturers are also working on patient access programs to help with costs.

Eli Lilly and Company (NYSE: LLY) announced positive one-year results from Phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. Eighty percent of responders maintained skin clearance (EASI-75) over the year, with effective dosing every two to four weeks. The treatment also provided lasting itch relief. Safety profiles remained consistent with earlier studies, and no new safety signals were reported. Lilly plans to submit a Biologics License Application (BLA) to the FDA in H2 2022, supporting lebrikizumab's potential as a first-line biologic.

Eli Lilly's Mounjaro (tirzepatide) has demonstrated superior efficacy in reducing fat mass and achieving glycemic targets in adults with type 2 diabetes compared to injectable semaglutide and placebo, as presented at the ADA's 82nd Scientific Sessions. In a 28-week study, Mounjaro participants lost an average of 11.2 kg in weight and 9.7 kg in fat mass, significantly more than those on semaglutide. Mounjaro also helped participants reach A1C targets quicker, achieving A1C <7% in 8 weeks. The drug is FDA-approved and utilizes a dual-action mechanism of GIP and GLP-1 receptor agonism.

The latest analyses from the EMPRISE study indicate that Jardiance (empagliflozin) significantly reduces the risk of hospitalization for heart failure by 50% compared to DPP-4 inhibitors and by 30% against GLP-1 receptor agonists among adults with type 2 diabetes. Furthermore, for those with Medicare, Jardiance shows a 40% reduction in all-cause mortality. The study involved nearly 500,000 adults, confirming Jardiance's effectiveness and safety profile. These findings complement the EMPA-REG OUTCOME trial results, reinforcing Jardiance's role in cardiovascular risk management for diabetic patients.

Eli Lilly's phase 3 AWARD-PEDS trial demonstrated that Trulicity (dulaglutide) significantly reduces A1C levels in youth with type 2 diabetes, achieving a reduction of up to 1.5% compared to placebo. Conducted on 154 adolescents, the trial met all primary and secondary glycemic control objectives. Notably, 51.5% of participants on Trulicity achieved an A1C of <7%. However, gastrointestinal side effects were reported more frequently than in the placebo group. Lilly plans to seek regulatory approval based on these promising results presented at the ADA's 82nd Scientific Sessions.

Eli Lilly's phase 3 SURMOUNT-1 trial results for tirzepatide, presented at the ADA's 82nd Scientific Sessions and published in NEJM, show significant weight loss in adults with obesity. Participants lost an average of 16.0% to 22.5% of body weight over 72 weeks, with 89%-96% achieving at least 5% reduction compared to 28% on placebo. Secondary endpoints also met, reinforcing tirzepatide's efficacy. Adverse events were primarily mild to moderate gastrointestinal issues, with treatment discontinuation rates lower than placebo. Lilly anticipates further results from additional SURMOUNT trials in 2023.

Eli Lilly and Company (NYSE: LLY) will participate in the Goldman Sachs 43rd Annual Global Healthcare Conference on June 14, 2022. Key executives, Anne White and Mark Mintun, will engage in a fireside chat at 1:40 p.m. ET. Investors can listen to the event via a live audio webcast on Lilly's Investor website, with a replay available for 90 days. Founded nearly 150 years ago, Lilly is committed to advancing health solutions that positively impact over 47 million people globally. For more information, visit Lilly.com.

Eli Lilly and Company (NYSE: LLY) has announced that data from its oncology portfolio will be showcased at the 2022 ASCO Annual Meeting from June 3-7, 2022. Key presentations include analyses from the Phase 3 monarchE study of Verzenio (abemaciclib) focusing on treatment discontinuation in high-risk HR+, HER2- early breast cancer. Updates on Retevmo (selpercatinib) will highlight its efficacy in RET fusion-positive solid tumors, while results from the Phase 1 EMBER trial on the investigational drug imlunestrant will also be presented. The event promises significant insights into cancer treatment advancements.

Bigfoot Biomedical has appointed Matt Rainville as Chief Commercial Officer, aiming to enhance the Bigfoot Unity® Diabetes Management Program. With over 20 years in healthcare commercialization, including roles at Insulet and Eli Lilly, Rainville will focus on expanding access to diabetes management solutions. CEO Jeffrey Brewer emphasized that this hiring is crucial as they seek to grow their presence in the market for insulin management. Rainville's leadership is expected to drive adoption of their innovative solutions for diabetes care.