Eli Lilly and Co. (NYSE:LLY) stock is trading lower on Tuesday after its weight loss drug rival, Novo Nordisk A/S (NYSE:NVO), trimmed its 2025 financial outlook.
The cut marks the second time this year Novo Nordisk has lowered its guidance.
Novo Nordisk now projects 2025 sales growth to be 8-14% at constant exchange rates, a notable reduction from its earlier forecast of 13-21%.
Similarly, the outlook for operating profit growth has been lowered to 10-16% from the previously anticipated 16-24%.
This revised guidance largely stems from a slower-than-expected penetration of its branded GLP-1 treatments, particularly in the United States, a market increasingly impacted by the persistent use of compounded GLP-1 alternatives.
GLP-1 Drugs
In a letter to the U.S. Food and Drug Administration (FDA) Commissioner Marty Makary on Friday, over 80 bipartisan members asked the agency to stop counterfeit and copycat versions of GLP-1 drugs like Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly’s Zepbound from flooding the market.
The group wrote the letter urging immediate action against the rising threat of illegal, counterfeit anti-obesity medications entering the U.S.
The group urged the FDA to issue warning letters, pursue civil enforcement, and monitor non-compliant online retailers and compounding pharmacies selling unapproved weight-loss drugs.
In April, after media reports on Hims & Hers Inc. (NYSE:HIMS) partnering with the company, Eli Lilly said in a statement that it has no affiliation with Hims & Hers.
Zepbound (tirzepatide) can be prescribed by any licensed healthcare professional. People who are commercially insured with coverage for Zepbound may be eligible to pay as little as $25.
Trial Data
On Tuesday, Eli Lilly also released topline results from the Phase 3 BRUIN CLL-314 trial of Jaypirca (pirtobrutinib) versus Imbruvica (ibrutinib) in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
Johnson & Johnson’s (NYSE:JNJ) Imbruvica is a covalent BTK inhibitor.
The study enrolled patients with treatment-naïve CLL/SLL and those previously treated but were BTK inhibitor-naïve.
The study met its primary endpoint of non-inferiority on overall response rate (ORR) as assessed by an independent review committee (IRC) in both the pre-treated and intent-to-treat populations.
ORR favored pirtobrutinib with a nominal P-value for superiority (p <0.05). Progression-free survival (PFS), a key secondary endpoint, was not yet mature at this analysis, but was trending toward pirtobrutinib.
BRUIN CLL-314 is the first ever head-to-head trial versus ibrutinib in CLL to include treatment-naïve patients.
The overall safety profile of pirtobrutinib in BRUIN CLL-314 was similar to previously reported trials. Detailed results will be presented at a medical congress later in 2025.
These data build on the previously reported positive results from the BRUIN Phase 1/2 trial and the Phase 3 BRUIN CLL-321 trial, the first randomized, controlled study ever conducted in an exclusively post-covalent BTK inhibitor population.
The BRUIN CLL-313 Phase 3 study of pirtobrutinib versus chemoimmunotherapy in treatment naïve CLL/SLL is expected to read out later in 2025 and combined with the results of BRUIN CLL-314, will form the basis of regulatory submissions globally.
Price Action: LLY stock is down 4.93% at $768.27 at the last check on Tuesday.
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