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Eli Lilly has successfully completed its acquisition of Akouos, enhancing its focus on genetic medicines. The acquisition, valued at $12.50 per share plus contingent value rights, aims to integrate Akouos's innovative gene therapies targeting inner ear conditions, including hearing loss. As of the acquisition date, 81.1% of Akouos's shares were tendered. Post-acquisition, Akouos will be a wholly owned subsidiary of Lilly, and its shares will be delisted. The deal includes potential milestone payments based on the progress of Akouos's clinical trials.
Eli Lilly (NYSE: LLY) announced positive results from the Phase 3 TRAILBLAZER-ALZ 4 study for its investigational Alzheimer’s treatment, donanemab. The study showed that after 6 months, 37.9% of donanemab-treated patients achieved brain amyloid clearance compared to only 1.6% for Aduhelm (aducanumab-avwa). Additionally, donanemab reduced amyloid levels by 65.2%, outpacing Aduhelm’s 17% reduction. The FDA has also accepted donanemab's application for accelerated approval. This trial marks a significant step in evaluating amyloid-targeting therapies for Alzheimer's disease.
Eli Lilly and Company (NYSE: LLY) and Akouos, Inc. (NASDAQ: AKUS) announced the expiration of a tender offer for Akouos's shares at $12.50 each, plus a contingent value right potentially worth $3.00. The offer expired on November 29, 2022, with 29,992,668 shares (81.1%) validly tendered. All conditions were satisfied, and the acquisition is expected to close on December 1, 2022. Lilly aims to enhance its portfolio in gene therapies for hearing loss through this strategic acquisition.
Eli Lilly and Company (NYSE: LLY) will announce its 2023 financial guidance on Dec. 13, 2022. A conference call with the investment community and media will take place at 9 a.m. Eastern time on the same day to detail the guidance. Investors and the public can access a live webcast through Lilly's website, with a replay available afterward. Lilly has a long history of creating innovative medicines that enhance lives globally, addressing critical health challenges like diabetes, obesity, and cancer.
Eli Lilly and Company (NYSE: LLY) will participate in the Evercore ISI HealthCONx Conference on November 30, 2022. Jacob Van Naarden, EVP and CEO of Loxo@Lilly, along with Dr. David Hyman, the Chief Medical Officer of Loxo@Lilly, will engage in a fireside chat at 12:10 p.m. Eastern Time. Investors and the public can access a live audio webcast via Lilly's Investor website, with a replay available for 90 days. Lilly continues to advance health care solutions impacting millions globally.
Eli Lilly and Company (NYSE: LLY) is launching the Tempo® Personalized Diabetes Management Platform in the U.S. later this year, designed to assist adults with type 1 or type 2 diabetes in managing their treatment with Lilly insulins. Key components include the Tempo Smart Button®, TempoSmart™ app, and Tempo Pen®. The platform integrates with devices like Dexcom® CGMs and fitness trackers. The phased rollout will target clinics initially, with national availability aimed for 2023. Lilly is also working with insurers to enhance patient access to the platform.
Bigfoot Biomedical has announced the compatibility of its Bigfoot Unity Diabetes Management System with four additional rapid-acting insulin products, including Eli Lilly’s Insulin Lispro and Novo Nordisk’s Insulin Aspart. These insulins are offered at prices at least 50% lower than their branded counterparts, addressing the urgent need for affordable diabetes care. The system, which features smart pen caps compatible with various insulin pens, also includes Lilly’s Lyumjev, available for $35 under the Lilly Insulin Value Program, enhancing access for diabetes patients.
On November 4, 2022, the EMPA-KIDNEY Phase III trial reported significant findings for Jardiance (empagliflozin), demonstrating a 28% reduction in the risk of kidney disease progression or cardiovascular death compared to placebo. The trial, featuring 6,609 participants, also revealed a 14% reduction in all-cause hospitalizations, enhancing treatment options for chronic kidney disease (CKD) patients. Jardiance's safety profile remained consistent with previous studies, prompting discussions for potential marketing authorization globally.
Loxo@Lilly, the oncology unit of Eli Lilly, will present new data on pirtobrutinib from the BRUIN Phase 1/2 trial at the ASH Annual Meeting in New Orleans from December 10-13, 2022. Pirtobrutinib is a novel, selective BTK inhibitor for treating various B-cell malignancies such as CLL and MCL. Key presentations will highlight its efficacy and safety in previously treated patients. The updated data cutoff is July 2022, reflecting ongoing research and development in targeted cancer therapies. This data aims to enhance understanding of pirtobrutinib's potential in patient care.
Lilly reported Q3 2022 revenue of $6.94 billion, up 2% year-over-year, with strong volume growth offset by lower prices and decreased Alimta revenue due to generics. Key growth products saw a 19% increase, contributing 70% of total revenue. Mounjaro launched successfully, generating $97.3 million in U.S. sales. Q3 EPS rose 32% to $1.61. The company updated its 2022 EPS guidance to $6.50-$6.65 (reported) and $7.70-$7.85 (non-GAAP), citing unfavorable foreign exchange impacts and asset impairment charges. Overall, Lilly continues to advance its pipeline with multiple regulatory approvals.