Eli Lilly and Company (LLY) Wins FDA Label Expansion for Jaypirca in Untreated CLL/SLL

Eli Lilly (LLY) announced FDA approval for Jaypirca (pirtobrutinib) as a first-line treatment for adults with CLL/SLL without 17p deletion. The drug is the first FDA-approved non-covalent BTK inhibitor. LLY continues Phase 3 studies for further expansion. LLY stock closed at $1,142.85, down 0.61%.

Eli Lilly's tirzepatide (Zepbound) showed greater weight loss than semaglutide (Wegovy HD) in an indirect comparison, according to data presented at a diabetes conference. The analysis used data from SURMOUNT-1 and STEP UP trials, showing tirzepatide 15 mg led to 4.5% more weight loss than semaglutide 7.2 mg at 72 weeks. Lilly also cited SURMOUNT-5, a direct comparison trial, where tirzepatide outperformed semaglutide in weight loss and other metrics.

Eli Lilly (LLY) reported positive clinical data for obesity drug Foundayo, diabetes candidate EloraTZP, and dermatitis therapy EBGLYSS, with plans for regulatory filings. The company ended a cancer-drug collaboration with Foghorn Therapeutics and faces legal setbacks after a jury verdict found it breached a collaboration agreement with Nektar Therapeutics, awarding damages to Nektar. Investors are advised to monitor upcoming regulatory submissions and legal outcomes.

Mercedes-Benz plans to invest $4 billion in Alabama by 2030, joining other companies like Eli Lilly, ArcelorMittal, and U.S. Steel in major investments. These projects are expected to create thousands of jobs. The article contrasts this investment wave with the previous administration's policies, which it claims were less effective in attracting manufacturing investments.

Novo Nordisk (NVO) invested $3.92B in two licensing deals to enhance its obesity pipeline, aiming to compete with Eli Lilly (LLY). The deals include a quarterly injection technology from Nanexa and a weekly oral pill from Hengrui Pharma. Novo's shares are down 70% from their 2-year high. The company's FY2025 revenue was $46.5B, with a net income of $15.4B. Analysts expect a 3% sales decline and 4% net income contraction in FY2026.

The FDA expanded Eli Lilly's pirtobrutinib (Jaypirca) approval to include initial treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma without 17p deletion. Clinical trial data showed an 80% reduction in risk for progression or death compared to chemoimmunotherapy. The drug is already approved for relapsed or refractory cases.