Eli Lilly & Co. - LLY STOCK NEWS

The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) tablets, which aims to reduce kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD). The application is based on data from the EMPA-KIDNEY phase III trial, which demonstrated a 28% reduction in the risk of kidney disease progression or cardiovascular death compared to placebo. Nearly 37 million U.S. adults are affected by CKD. Jardiance could potentially fill a significant gap in treatment options for CKD, which is associated with high hospitalization rates and healthcare costs.

Eli Lilly and Company (NYSE: LLY) has received a complete response letter from the FDA regarding the accelerated approval submission for donanemab, intended for treating early symptomatic Alzheimer's disease. The FDA’s concerns centered on the insufficient number of patients—less than 100 with at least 12 months of drug exposure—provided in the application. No additional deficiencies were noted. The ongoing Phase 3 TRAILBLAZER-ALZ trial, which is expected to yield topline data in Q2 2023, will support future traditional approval. Lilly confirmed that this regulatory setback does not alter its 2023 financial guidance.

Eli Lilly and Company (NYSE: LLY) has scheduled its fourth-quarter 2022 financial results announcement for February 2, 2023. The event will feature a conference call commencing at 10 a.m. Eastern time, where executives will discuss the company's financial performance with investors and media. A live webcast will be accessible via Lilly's investor relations website, and a replay will be provided afterward. With a legacy of nearly 150 years, Lilly is committed to advancing innovative medicines for conditions such as diabetes, obesity, Alzheimer’s, immune disorders, and severe cancers.

Eli Lilly and Company (NYSE: LLY) will participate in the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023. CEO David A. Ricks will engage in a fireside chat at 6:45 p.m. Eastern time. The session will be available via live audio webcast on Lilly's Investor website, with a replay accessible for 90 days afterwards. Lilly has a long history of innovation, helping over 47 million people globally through advanced medicines. The company focuses on addressing significant health challenges, including diabetes and Alzheimer's.

Eli Lilly and ProQR Therapeutics announced an expanded collaboration on December 22, 2022, focusing on genetic medicines utilizing ProQR's Axiomer RNA editing technology. The partnership, originally established in September 2021, will now target additional disorders affecting the central and peripheral nervous systems. ProQR will receive $75 million upfront and an option for an additional $50 million. The total potential value of the collaboration is approximately $3.75 billion in milestones and royalties. This collaboration aims to develop innovative treatments for diseases with significant unmet needs.

Eli Lilly has announced a collaboration with EVA Pharma to provide affordable insulin to over one million people in low- to middle-income countries, primarily in Africa. As part of this initiative, Lilly will supply active pharmaceutical ingredients at reduced costs and offer pro-bono technical support for manufacturing. The partnership aims to increase insulin accessibility by empowering local production, with plans to distribute products within 18 months and reach annual targets by 2030. This aligns with Lilly's broader goal to improve healthcare access for 30 million individuals by 2030.

Eli Lilly announced its 2023 financial guidance, projecting revenue between $30.3 billion and $30.8 billion, driven by volume growth from key products. Expected EPS is $7.65 to $7.85 (reported) and $8.10 to $8.30 (non-GAAP). Highlights include potential product launches and ongoing clinical trials for treatments targeting obesity and Alzheimer's. The company anticipates a fifth consecutive annual dividend increase of 15%. Lilly reaffirmed its 2022 guidance, emphasizing an optimistic outlook bolstered by new product launches and pipeline advancements.

Eli Lilly (NYSE: LLY) announced promising results from the BRUIN Phase 1/2 trial for pirtobrutinib, a reversible Bruton's tyrosine kinase inhibitor, at the 2022 ASH Annual Meeting. In chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients, it achieved an overall response rate (ORR) of 82% with a median progression-free survival (PFS) of 19.6 months. For mantle cell lymphoma (MCL), the ORR was 58%. Notably, pirtobrutinib showcases activity in patients previously treated with covalent BTK inhibitors, addressing key unmet needs.

The board of directors of Eli Lilly and Company (NYSE: LLY) has announced a 15% increase in its quarterly dividend, setting the first quarter 2023 dividend at $1.13 per share. This dividend is scheduled for payment on March 10, 2023, to shareholders on record as of February 15, 2023.

This decision highlights Lilly's commitment to returning value to shareholders while continuing to advance its innovative healthcare solutions for various diseases.