Track market-moving stories before they get noisy

Investors await next Thursday's results as strong prescription volumes face lower realized prices. -

Summary

Full-year revenue guidance stands at $85 billion–$87 billion.

Diabetes and obesity-drug maker Eli Lilly LLY traded at $1,284.51, down approximately 1.70% at 10.09am EST, on October 23. With earnings due next Thursday, according to Reuters' earnings preview, the key question is whether surging demand can keep overpowering weaker pricing.

Lilly's second-quarter results put that tension in numbers: revenue climbed 48% to $23 billion as volume increased 60%, while realized prices declined 13%. Mounjaro and Zepbound generated roughly $14.9 billion combined. Management raised its full-year revenue outlook to $85 billion–$87 billion, setting a demanding benchmark for the next report.

The valuation picture shows shares 19.01% below the GF Value estimate of roughly $1,590, suggesting potential upside against that model rather than a guaranteed bargain. Demand is powerful. Turning it into profitable growth remains the test. Investors should watch realized pricing, gross margin and manufacturing progress to judge whether higher prescription volumes are delivering enough earnings power.

Disclosures
I/we have no positions in any stocks mentioned, and have no plans to buy any new positions in the stocks mentioned within the next 72 hours.

Click for the complete disclosure

In the latest trading session, Eli Lilly (LLY - Free Report) closed at $1,240.34, marking a -1.33% move from the previous day. The stock fell short of the S&P 500, which registered a gain of 0.41% for the day. Elsewhere, the Dow lost 0.07%, while the tech-heavy Nasdaq added 1.11%.

The stock of drugmaker has risen by 9.03% in the past month, leading the Medical sector's gain of 1.97% and the S&P 500's gain of 1.46%.

The upcoming earnings release of Eli Lilly will be of great interest to investors. The company's earnings report is expected on October 29, 2026. It is anticipated that the company will report an EPS of $5.38, marking a 23.36% fall compared to the same quarter of the previous year. In the meantime, our current consensus estimate forecasts the revenue to be $22.11 billion, indicating a 25.59% growth compared to the corresponding quarter of the prior year.

For the annual period, the Zacks Consensus Estimates anticipate earnings of $33.56 per share and a revenue of $88.94 billion, signifying shifts of +38.62% and +36.45%, respectively, from the last year.

Investors should also note any recent changes to analyst estimates for Eli Lilly. These revisions help to show the ever-changing nature of near-term business trends. As such, positive estimate revisions reflect analyst optimism about the business and profitability.

Our research demonstrates that these adjustments in estimates directly associate with imminent stock price performance. To exploit this, we've formed the Zacks Rank, a quantitative model that includes these estimate changes and presents a viable rating system.

The Zacks Rank system, running from #1 (Strong Buy) to #5 (Strong Sell), holds an admirable track record of superior performance, independently audited, with #1 stocks contributing an average annual return of +25% since 1988. The Zacks Consensus EPS estimate has moved 8.14% lower within the past month. Eli Lilly is currently sporting a Zacks Rank of #3 (Hold).

From a valuation perspective, Eli Lilly is currently exchanging hands at a Forward P/E ratio of 37.46. This signifies a premium in comparison to the average Forward P/E of 16.91 for its industry.

Also, we should mention that LLY has a PEG ratio of 1.67. The PEG ratio is similar to the widely-used P/E ratio, but this metric also takes the company's expected earnings growth rate into account. The Large Cap Pharmaceuticals was holding an average PEG ratio of 2.01 at yesterday's closing price.

The Large Cap Pharmaceuticals industry is part of the Medical sector. Currently, this industry holds a Zacks Industry Rank of 210, positioning it in the bottom 15% of all 250+ industries.

The Zacks Industry Rank assesses the strength of our separate industry groups by calculating the average Zacks Rank of the individual stocks contained within the groups. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.

You can find more information on all of these metrics, and much more, on Zacks.com.

Hong Kong-listed Metis TechBio (7666.HK) said on Monday it has entered ​into a collaboration agreement with Eli ‌Lilly (LLY.N) worth up to $1.1 billion to research and develop tissue-specific drug delivery technologies.

The Chinese biotech will ​use its proprietary AI-driven drug-delivery platform ​to develop next-generation technologies aimed at ⁠improving how LNP-based drugs reach target tissues.

Metis ​will be eligible to receive an upfront ​payment in the low double-digit millions US dollars and up to about $1.1 billion in development, regulatory ​and commercial milestone payments.

It will also ​be eligible for tiered royalties at a single-digit percentage ‌of ⁠annual net sales of products that are developed due to the collaboration.

The Chinese biotech will use its proprietary AI-driven ionizable ​lipid discovery and ​optimisation ⁠platform to develop delivery technologies aimed at improving the targeting and ​biodistribution of LNP-based therapies.

Metis and ​Lilly ⁠aim to discover and optimise novel LNP architectures that could improve tissue specificity and ⁠therapeutic ​performance, with potential applications ​across multiple disease areas.

First Phase 1 data for sofetabart mipitecan, Lilly's investigational FRα-targeting ADC, in platinum-sensitive ovarian cancer to be featured in a rapid oral presentation

Updated first-line data for olomorasib, an investigational therapy targeting KRAS G12C-mutant NSCLC, to be featured in a rapid oral presentation

Updated Phase 3 data for selpercatinib versus cabozantinib or vandetanib in advanced, kinase inhibitor-naïve, RET-mutant MTC to be shared in a proffered paper

, /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that new data from across its oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 23–27 in Madrid, Spain. Highlights include new Phase 1 data in platinum-sensitive ovarian cancer (PSOC) for sofetabart mipitecan (Sofe-M), Lilly's investigational FRα-targeting antibody-drug conjugate (ADC), in combination with bevacizumab, along with updated findings for olomorasib, Retevmo (selpercatinib), and Verzenio (abemaciclib) in lung, thyroid, and breast cancers, respectively. 

Key Presentation Highlights:

Sofetabart mipitecan (Sofe-M; FRα-targeting ADC): A rapid oral presentation on first Phase 1 data for sofetabart mipitecan plus bevacizumab in patients with PSOC. These data support the ongoing Phase 3 clinical trial of Sofe-M in PSOC.

Olomorasib (investigational KRAS G12C inhibitor):
A rapid oral presentation on an updated integrated analysis from the Phase 1/2 LOXO-RAS-20001 trial and the safety lead-in portion of the Phase 3 SUNRAY-01 trial, assessing olomorasib in combination with chemoimmunotherapy (pembrolizumab, pemetrexed, and platinum) as potential first-line treatments for patients with advanced/metastatic KRAS G12C-mutant non-small cell lung cancer (NSCLC). These data support the ongoing Phase 3 clinical trial of olomorasib in first-line KRAS G12C-mutant lung cancer.

Retevmo (selpercatinib; RET kinase inhibitor): A proffered paper presentation on updated results from the Phase 3 LIBRETTO-531 study of selpercatinib versus cabozantinib or vandetanib (C/V) in advanced, kinase inhibitor-naïve, RET-mutant medullary thyroid cancer (MTC). These data have supported global approvals of Retevmo in this treatment setting.

Verzenio (abemaciclib; CDK4/6 inhibitor): A rapid oral presentation on overall survival data from the Phase 3 postMONARCH trial of abemaciclib plus fulvestrant in HR-positive, HER2-negative advanced breast cancer following progression on a prior CDK4/6 inhibitor and endocrine therapy. These data support the abemaciclib plus imlunestrant results in the EMBER-3 trial and add to the evidence-based practice of switching endocrine therapy and CDK4/6 inhibitor at progression in metastatic breast cancer.

"Lilly's presentations at ESMO reflect both the breadth of our oncology portfolio and the focus behind it: following compelling science wherever it has the potential to change care," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "We're especially encouraged by the data we're sharing for sofetabart mipitecan in platinum-sensitive ovarian cancer, which build on what we've seen with this medicine in platinum-resistant disease and mark a critical step forward as we advance the ongoing Phase 3 FRAmework-01 study across both settings. Our updated first-line data for olomorasib in KRAS G12C-mutant lung cancer are very promising, with clinical activity and a safety profile consistent with earlier findings, which reinforce the importance of targeted therapy for patients from the outset of their treatment journey. Alongside new data in thyroid and breast cancers, these presentations represent meaningful momentum toward improving care for people with cancer."

A full list of abstract titles and viewing details are listed below:

Abstract Title

Author

Presentation
Type/#

Session Title

Session Date/Time

(CET)

Sofe-M (sofetabart mipitecan; investigational ADC targeting FRα):

Model-informed Phase 3 dose
selection for antibody-drug conjugate
(ADC) sofetabart mipitecan (Sofe-M):
First prospective application of a
clinical utility index (CUI) 

Jean-
Sebastien
Frenel

Poster
#1016P

Poster display
session

Friday, October 23

15:15-16:00

Efficacy and safety
of sofetabart mipitecan (Sofe-M), a
folate receptor alpha (FRα) targeting
antibody drug conjugate (ADC), plus
bevacizumab in recurrent platinum
sensitive ovarian cancer (PSOC) 

Chrisann Kyi

Rapid oral
#1246RO

Rapid oral 2:
Gynecological
cancers

Saturday, October 24

8:30-10:00

Sofetabart mipitecan (Sofe-M) in
patients ≥65 y with platinum-resistant
and -sensitive ovarian cancer
(PROC/PSOC) from the first-in-human
phase 1 study 

Ana Oaknin

Poster
#1288P

Poster display
session

Monday, October 26

12:00-12:45

Olomorasib (investigational KRAS G12C inhibitor)

First-line (1L) olomorasib +
chemoimmunotherapy (Chemo-IO) in
KRAS G12C-mutant NSCLC: Updated
results from the LOXO-RAS-20001 and
SUNRAY-01 trials 

Marcelo V.
Negrao

Rapid oral
#2652RO

Rapid oral 2:
NSCLC, metastatic

Sunday,

October 25

8:30-10:00

First-line (1L) olomorasib +
pembrolizumab in KRAS G12C-mutant
NSCLC: Updated results from LOXO-
RAS-20001 and SUNRAY-01 

Melissa L.
Johnson

Poster
#2683P

Poster display
session

Monday, October 26

12:00-12:45

Retevmo (selpercatinib; RET kinase inhibitor)

Updated results of randomized Phase
3 study of selpercatinib vs
cabozantinib or vandetanib (C/V) in
advanced, kinase inhibitor-naïve, RET-
mutant medullary thyroid cancer
(MTC) 

Jaume
Capdevila

Proffered paper
#4208O

Proffered paper:
NETs and
endocrine tumors

Monday, October 26

10:15-11:45

Verzenio (abemaciclib; CDK4/6 inhibitor)

Association of p27 V109G SNP zygosity
with outcomes
and abemaciclib treatment effect in
HR+, HER2– high-risk early breast
cancer: results from monarchE 

Miguel
Quintela-
Fandino

Poster
#4498P

Poster display
session

Friday, October 23

15:15-16:00

Overall survival from the Phase
3 postMONARCH trial of abemaciclib +
fulvestrant vs placebo + fulvestrant for
HR+, HER2– advanced breast cancer
following progression on a prior
CDK4/6 inhibitor + endocrine therapy 

Kevin Kalinsky

Rapid oral
#1RO

Rapid oral 1:
Breast cancer,
advanced stage

Saturday, October 24

10:15-11:45

Three-month persistence and
adherence to adjuvant abemaciclib in
high-risk HR+, HER2– early breast
cancer: real world data from ABSIDE-S 

Isabel Blancas
López-Barajas

ePoster
#1933eP

ePoster session

Friday, October 23

8:00

Treatment persistence and clinical
characteristics in patients with HR+,
HER2–, high-risk early breast cancer
(EBC) treated with abemaciclib: A
multi-country real-world study  

Hitomi Sakai

ePoster
#615eP

ePoster session

Friday, October 23

8:00

For more information on Lilly's oncology pipeline, click here.

About Sofetabart Mipitecan
Sofetabart mipitecan (Sofe-M; LY4170156) is composed of an Fc-silent, folate receptor alpha (FRα) specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker (PSARlink). Sofe-M was designed to target FRα across all expression levels with an improved therapeutic index. FRα is a cell-surface glycoprotein encoded by the gene FOLR1 that binds to the essential nutrients folic acid and reduced folates, bringing them into cells to facilitate cell division and growth.1,2 FRα is overexpressed in many solid tumors such as ovarian and endometrial cancers.1,3,4 Sofe-M has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for platinum-resistant ovarian cancer (PROC) and is currently being evaluated in the Phase 3 FRAmework-01 trial. The study is being conducted in partnership with the European Network for Gynaecological Oncological Trial groups (ENGOT – lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT).

About Olomorasib
Olomorasib (LY3537982) is an investigational, oral, potent, and highly selective second-generation inhibitor of the KRAS G12C protein. KRAS is the most common oncogene across all tumor types, and KRAS G12C mutations occur in 13% of patients with non-small cell lung cancer (NSCLC), and 1–3% of patients with other solid tumors.5 Olomorasib is a highly potent covalent inhibitor with potential for greater than 90% target occupancy, which may allow for safer combinations with less toxicity.6

Olomorasib is currently being studied in KRAS G12C-mutant cancers in combination with pembrolizumab with or without chemotherapy for first-line treatment of advanced NSCLC, in combination with immunotherapy for the treatment of resected and unresectable NSCLC, and as monotherapy and in combinations in other advanced solid tumors (NCT06119581, NCT06890598, and NCT04956640).

About Retevmo
Retevmo (selpercatinib, formerly known as LOXO-292) (pronounced reh-TEHV-moh) is a highly selective and potent RET kinase inhibitor with central nervous system (CNS) activity. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. RET-driver alterations are predominantly mutually exclusive from other oncogenic drivers. Retevmo is a U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ≥50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity.7

INDICATIONS FOR RETEVMO (selpercatinib)
RETEVMO is a kinase inhibitor indicated for the treatment of:

Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy IMPORTANT SAFETY INFORMATION FOR RETEVMO (selpercatinib)

Hepatotoxicity: Serious hepatic adverse reactions occurred in 4.6% of patients treated with Retevmo. Increased aspartate aminotransferase (AST) occurred in 62% of patients, including Grade 3 or 4 events in 11% and increased alanine aminotransferase (ALT) occurred in 58% of patients, including Grade 3 or 4 events in 13%. Monitor ALT and AST prior to initiating Retevmo, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose, or permanently discontinue Retevmo based on severity.

Severe, life-threatening, and fatal interstitial lung disease (ILD)/pneumonitis can occur in patients treated with Retevmo. ILD/pneumonitis occurred in 3% of patients who received Retevmo, including 0.3% with Grade 3 or 4 events, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold Retevmo and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Withhold, reduce dose, or permanently discontinue Retevmo based on severity of confirmed ILD.

Hypertension occurred in 43% of patients, including Grade 3 hypertension in 20% and Grade 4 in one (0.1%) patient. Overall, 6.4% had their dose interrupted, 1.5% had their dose reduced, and 0.2% discontinued Retevmo for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate Retevmo in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating Retevmo. Monitor blood pressure after 1 week, at least monthly thereafter, and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue Retevmo based on severity.

Retevmo can cause concentration-dependent QT interval prolongation. An increase in QTcF interval to >500 ms was measured in 8% of patients and an increase in the QTcF interval of at least 60 ms over baseline was measured in 22% of patients. Retevmo has not been studied in patients with clinically significant active cardiovascular disease or recent myocardial infarction. Monitor patients who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, and severe or uncontrolled heart failure. Assess QT interval, electrolytes, and thyroid-stimulating hormone (TSH) at baseline and periodically during treatment, adjusting frequency based upon risk factors including diarrhea.

Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating Retevmo and during treatment. Monitor the QT interval more frequently when Retevmo is concomitantly administered with strong and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Withhold and dose reduce or permanently discontinue Retevmo based on the severity.

Serious, including fatal, hemorrhagic events can occur with Retevmo. Grade ≥3 hemorrhagic events occurred in 4.3% of patients treated with Retevmo including 4 (0.5%) patients with fatal hemorrhagic events, including cerebral hemorrhage (n=2), tracheostomy site hemorrhage and hemoptysis (1 each). Permanently discontinue Retevmo in patients with severe or life-threatening hemorrhage.

Retevmo can cause hypersensitivity, including severe skin reactions such as Stevens-Johnson Syndrome. All grade hypersensitivity occurred in 6% of patients receiving Retevmo, including Grade 3 in 2%. The median time to onset was 1.9 weeks (range: 5 days to 6.5 years). Signs and symptoms of hypersensitivity included fever, rash and arthralgias or myalgias with concurrent decreased platelets or transaminitis. Stevens-Johnson Syndrome has been observed in the post-marketing setting. Discontinue Retevmo in patients with Stevens-Johnson Syndrome. If hypersensitivity occurs, withhold Retevmo and begin corticosteroids at a dose of 1 mg/kg prednisone (or equivalent). Upon resolution of the event, resume Retevmo at a reduced dose and increase the dose of Retevmo by 1 dose level each week as tolerated until reaching the dose taken prior to onset of hypersensitivity. Continue steroids until patient reaches target dose and then taper. Permanently discontinue Retevmo for recurrent hypersensitivity.

Tumor lysis syndrome (TLS) occurred in 0.9% of patients with medullary thyroid carcinoma and 0.3% of patients with non-small cell lung cancer receiving Retevmo. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.

Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, Retevmo has the potential to adversely affect wound healing. Withhold Retevmo for at least 7 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of Retevmo after resolution of wound healing complications has not been established.

Retevmo can cause hypothyroidism. Hypothyroidism occurred in 15% of patients treated with Retevmo; all reactions were Grade 1 or 2. Hypothyroidism occurred in 15% of patients (59/390) with thyroid cancer and 14% of patients (65/467) with other solid tumors including NSCLC. Monitor thyroid function before treatment with Retevmo and periodically during treatment. Treat with thyroid hormone replacement as clinically indicated. Withhold Retevmo until clinically stable or permanently discontinue Retevmo based on severity.

Based on data from animal reproduction studies and its mechanism of action, Retevmo can cause fetal harm when administered to a pregnant woman. Administration of selpercatinib to pregnant rats during organogenesis at maternal exposures that were approximately equal to those observed at the recommended human dose of 160 mg twice daily resulted in embryolethality and malformations. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Retevmo and for 1 week after the last dose. There are no data on the presence of selpercatinib or its metabolites in human milk or on their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Retevmo and for 1 week after the last dose.

Slipped capital femoral epiphysis/slipped upper femoral epiphysis in pediatric patients (SCFE/SUFE) occurred in 1 adolescent (2.8% of 36 patients) receiving Retevmo in LIBRETTO-121 and 1 adolescent patient (0.5% of 193 patients) receiving Retevmo in LIBRETTO-531. Monitor patients for symptoms indicative of SCFE/SUFE and treat as medically and surgically appropriate.

Severe adverse reactions (Grade 3-4) occurring in ≥20% of patients who received Retevmo in LIBRETTO-001 were hypertension (20%), diarrhea (6.2%), prolonged QT interval (5%), fatigue (4.7%), musculoskeletal pain (4.1%), dyspnea (4.1%), hemorrhage (3.9%), abdominal pain (3.5%), vomiting (2.9%), urinary tract infection (2.2%), nausea (1.9%), headache (1.8%), edema (1.3%), decreased appetite (0.9%), constipation (0.8%), rash (0.8%), and dizziness (0.5%).

Severe adverse reactions (Grade 3-4) occurring in ≥15% of patients who received Retevmo in LIBRETTO-121 were increased weight (11%), vomiting (8%), constipation (6%), diarrhea (2.8%), nausea (2.8%), upper respiratory tract infection (2.8%), and urinary tract infection (2.8%).

Severe adverse reactions (Grade 3-4) occurring in ≥15% of patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were hypertension (20% vs 3.1%), electrocardiogram QT prolonged (9% vs 0%), fatigue (3.2% vs 5%), edema (2.5% vs 0%), rash (1.9% vs 1.0%), diarrhea (1.3% vs 2.0%), abdominal pain (0.6% vs 2.0%), pyrexia (0.6% vs 0%), COVID19 infection (0.6% vs 0%), constipation (0% vs 1.0%), nausea (0% vs 1.0%), vomiting (0% vs 1.0%), and decreased appetite (0% vs 2.0%).

Severe adverse reactions (Grade 3-4) occurring in ≥10% of patients who received Retevmo in LIBRETTO-531 were (Retevmo vs cabozantinib / vandetanib) hypertension (19% vs 18%), electrocardiogram QT prolonged (4.7% vs 2.1%), fatigue (4.1% vs 9%), diarrhea (3.1% vs 8%), rash (1.6% vs 4.1%), pyrexia (1.0% vs 0%), nausea (1.0% vs 5%), dry mouth (0.5% vs 1.0%), abdominal pain (0.5% vs 2.1%), stomatitis (0.5% vs 13%), headache (0.5% vs 0%), and decreased appetite (0.5% vs 5%).

Serious adverse reactions occurred in 58% of patients who received Retevmo in LIBRETTO-001. The most frequently reported serious adverse reactions (in ≥2% of patients) were pneumonia, hemorrhage, abdominal pain, dyspnea, pleural effusion, sepsis, musculoskeletal pain, hyponatremia, vomiting, diarrhea, and increased blood creatinine. Fatal adverse reactions occurred in 3% of patients in LIBRETTO-001; fatal adverse reactions included sepsis (n=6), respiratory failure (n=5), hemorrhage (n=4), pneumonia (n=4), cardiac arrest (n=3), pneumonitis (n=2), cardiac failure (n=2), sudden death (n=1), cerebral infarction (n=1), and dyspnea (n=1).

Serious adverse reactions occurred in 42% of patients who received Retevmo in LIBRETTO-121. Serious adverse reactions occurring in more than 1 patient were vomiting and fracture (2 patients each).

Serious adverse reactions occurred in 35% of patients who received Retevmo in LIBRETTO-431. The most frequently reported serious adverse reactions (≥2% of patients) were pleural effusion and abnormal hepatic function. Fatal adverse reactions occurred in 4.4% of patients who received Retevmo in LIBRETTO-431; fatal adverse reactions included myocardial infarction (n=2), respiratory failure (n=2), cardiac arrest, malnutrition, and sudden death (n=1 each).

Serious adverse reactions occurred in 22% of patients who received Retevmo in LIBRETTO-531. The most frequent serious adverse reactions were pneumonia and pyrexia (n=3 each), and hypertension and urinary tract infection (n=2 each). Fatal adverse reactions occurred in 2.1% of patients who received Retevmo in LIBRETTO-531; fatal adverse reactions included COVID19, diabetic ketoacidosis, multiple organ dysfunction syndrome, and sudden death (n=1 each).

Common adverse reactions (all grades) occurring in ≥20% of patients who received Retevmo in LIBRETTO-001 were musculoskeletal pain (59%), edema (53%), diarrhea (52%), fatigue (49%), dry mouth (44%), hypertension (43%), abdominal pain (39%), rash (38%), nausea (36%), constipation (35%), cough (30%), headache (30%), vomiting (29%), dyspnea (28%), hemorrhage (26%), decreased appetite (23%), dizziness (22%), prolonged QT interval (21%), and urinary tract infection (20%).

Common adverse reactions (all grades) occurring in ≥15% of patients who received Retevmo in LIBRETTO-121 were musculoskeletal pain (58%), diarrhea (47%), nausea (42%), hemorrhage (39%), pyrexia (39%), abdominal pain (36%), headache (33%), vomiting (31%), fatigue (31%), cough (31%), rash (28%), coronavirus infection (28%), upper respiratory tract infection (28%), edema (25%), constipation (22%), oropharyngeal pain (22%), hypothyroidism (22%), urinary tract infection (19%), and increased weight (19%).

Common adverse reactions (all grades) occurring in ≥15% of patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were hypertension (48% vs 7%), diarrhea (44% vs 24%), edema (41% vs 28%), dry mouth (39% vs 6%), rash (33% vs 30%), fatigue (32% vs 50%), abdominal pain (25% vs 19%), musculoskeletal pain (25% vs 28%), constipation (22% vs 40%), electrocardiogram QT prolonged (20% vs 1.0%), COVID19 infection (19% vs 18%), stomatitis (18% vs 16%), decreased appetite (17% vs 34%), nausea (13% vs 44%), vomiting (13% vs 23%), and pyrexia (13% vs 23%).

Common adverse reactions (all grades) occurring in ≥10% of patients who received Retevmo in LIBRETTO-531 (Retevmo vs cabozantinib / vandetanib) were hypertension (43% vs 41%), edema (33% vs 5%), dry mouth (32% vs 10%), fatigue (28% vs 47%), diarrhea (26% vs 61%), headache (23% vs 21%), rash (19% vs 27%), abdominal pain (18% vs 21%), constipation (16% vs 12%), erectile dysfunction (16% vs 0%), stomatitis (14% vs 42%), electrocardiogram QT prolonged (14% vs 13%), pyrexia (12% vs 2.1%), decreased appetite (12% vs 28%), hypothyroidism (11% vs 21%), and nausea (10% vs 32%).

Laboratory abnormalities (all grades ≥20%; Grade 3-4) worsening from baseline in patients who received Retevmo in LIBRETTO-001, were increased AST (62%; 11%), decreased calcium (61%; 7%), decreased albumin (61%; 3.6%), increased ALT (58%; 13%), increased glucose (56%; 4.0%), decreased lymphocytes (56%; 22%), increased creatinine (51%; 3.6%), decreased sodium (49%; 13%), increased alkaline phosphatase (43%; 4.4%), decreased platelets (41%; 4.0%), increased potassium (39%; 3.5%), decreased glucose (39%; 1.5%), increased total cholesterol (37%; 1.7%), decreased magnesium (37%; 0.7%), decreased hemoglobin (36%; 4.1%), increased bilirubin (32%; 2.9%), decreased neutrophils (27%; 3.8%), and decreased phosphate (25%; 5%).

Laboratory abnormalities (all grades ≥15%; Grade 3-4) worsening from baseline in patients who received Retevmo in LIBRETTO-121 were decreased calcium (61%; 11%), increased ALT (58%; 8%), decreased albumin (53%; 0%), increased alkaline phosphatase (50%; 0%), increased AST (50%; 2.8%), increased bilirubin (31%; 2.8%), increased cholesterol (28%, 0%), decreased magnesium (28%; 6%), increased potassium (28%; 2.8%), increased creatinine (19%, 2.8%), decreased potassium (19%, 6%), decreased sodium (17%, 0%), decreased neutrophils (40%; 8%), decreased hemoglobin (36%; 11%), increased hemoglobin (33%, 2.8%), decreased platelets (28%; 2.8%), and decreased lymphocytes (28%; 14%).

Laboratory abnormalities (all grades ≥20%; Grade 3-4) worsening from baseline in patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were increased ALT (81%; 21% vs 63%; 4.1%), increased AST (77%; 10% vs 46%; 0%), decreased calcium (53%; 1.9% vs 24%; 1.0%), decreased platelets (53%; 3.2% vs 39%; 5%), decreased lymphocytes (53%; 8% vs 64%; 15%), decreased neutrophils (53%; 2.0% vs 58%; 11%), increased bilirubin (52%; 1.3% vs 9%; 0%), increased alkaline phosphatase (35%; 1.3% vs 22%; 0%), decreased sodium (31%; 3.2% vs 41%; 2.1%), decreased albumin (25%; 0% vs 5%; 0%), increased blood creatinine (23%; 0% vs 21%; 0%), decreased hemoglobin (21%; 0% vs 91%; 5%), decreased potassium (17%; 1.3% vs 15%; 1.0%), and decreased magnesium (16%; 0.6% vs 8%; 0%).

Laboratory abnormalities (all grades ≥5%; Grade 3-4) worsening from baseline in patients who received Retevmo in LIBRETTO-531 (Retevmo vs cabozantinib / vandetanib) were decreased calcium (55%; 5% vs 62%; 11%), increased ALT (53%; 16% vs 72%; 7%), increased AST (47%; 5% vs 68%; 3.2%), decreased lymphocytes (41%; 18% vs 36%; 13%), increased alkaline phosphatase (37%; 6% vs 28%, 5%), increased bilirubin (32%; 1.1% vs 30%; 3.2%), decreased neutrophils (33%; 14% vs 42%; 19%), decreased platelets (28%; 1.1% vs 34%; 1.1%), increased creatinine (27%; 6% vs 16%; 8%), decreased sodium (20%; 3.2% vs 16%; 0%), decreased hemoglobin (18%; 2.1% vs 23%; 2.1%), decreased albumin (11%; 1.1% vs 7%; 0%), decreased magnesium (9%; 3.3% vs 26%; 9%), and decreased potassium (8%; 0% vs 22%; 4.4%).

Concomitant use of acid-reducing agents decreases selpercatinib plasma concentrations which may reduce Retevmo anti-tumor activity. Avoid concomitant use of proton-pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists, and locally acting antacids with Retevmo. If coadministration cannot be avoided, take Retevmo with food (with a PPI) or modify its administration time (with a H2 receptor antagonist or a locally acting antacid).

Concomitant use of strong and moderate CYP3A inhibitors increases selpercatinib plasma concentrations which may increase the risk of Retevmo adverse reactions including QTc interval prolongation. Avoid concomitant use of strong and moderate CYP3A inhibitors with Retevmo. If concomitant use of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the Retevmo dosage as recommended and monitor the QT interval with ECGs more frequently.

Concomitant use of strong and moderate CYP3A inducers decreases selpercatinib plasma concentrations which may reduce Retevmo anti-tumor activity. Avoid coadministration of Retevmo with strong and moderate CYP3A inducers.

Concomitant use of Retevmo with CYP2C8 and CYP3A substrates increases their plasma concentrations which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of Retevmo with CYP2C8 and CYP3A substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for CYP2C8 and CYP3A substrates provided in their approved product labeling.

Retevmo is a P-glycoprotein (P-gp) and BCRP inhibitor. Concomitant use of Retevmo with P-gp or BCRP substrates increases their plasma concentrations, which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of Retevmo with P-gp or BCRP substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for P-gp and BCRP substrates provided in their approved product labeling.

The safety and effectiveness of Retevmo have not been established in pediatric patients less than 2 years of age. The safety and effectiveness of Retevmo have been established in pediatric patients aged 2 years and older for the treatment of advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy, advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate), and locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Monitor open growth plates in pediatric patients. Consider interrupting or discontinuing Retevmo if abnormalities occur.

No dosage modification is recommended for patients with mild to severe renal impairment (estimated Glomerular Filtration Rate [eGFR] ≥15 to 89 mL/min, estimated by Modification of Diet in Renal Disease [MDRD] equation). A recommended dosage has not been established for patients with end-stage renal disease.

Reduce the dose when administering Retevmo to patients with severe hepatic impairment (total bilirubin greater than 3 to 10 times upper limit of normal [ULN] and any AST). No dosage modification is recommended for patients with mild or moderate hepatic impairment. Monitor for Retevmo-related adverse reactions in patients with hepatic impairment.

Retevmo (selpercatinib) is available as 40 mg and 80 mg capsules, and 40 mg, 80 mg, 120 mg, and 160 mg tablets.

SE HCP ISI All_JUL2026

Please see full Prescribing Information and Instructions for Use for Retevmo.

About Verzenio (abemaciclib)
Verzenio (abemaciclib) is approved to treat people with certain HR+, HER2– breast cancers in the adjuvant and advanced or metastatic settings. Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is authorized for use in more than 90 countries around the world. For full details on indicated uses of Verzenio in HR+, HER2– breast cancer, please see full Prescribing Information, available at www.Verzenio.com.

INDICATIONS FOR VERZENIO 

Verzenio (abemaciclib) is a kinase inhibitor indicated8,9:

in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer. in combination with fulvestrant for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. in combination with Inluriyo for the treatment of adults with estrogen receptor (ER)-positive, HER2-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. as monotherapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)
Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across five clinical trials in 3899 patients, diarrhea occurred in 81% to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8% to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of the first diarrhea event ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19% to 26% of patients with diarrhea required a Verzenio dose interruption and 13% to 23% required a dose reduction.

Instruct patients to start antidiarrheal therapy such as loperamide at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, withhold Verzenio until resolution to ≤Grade 1, and then resume Verzenio at the next lower dose.

Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across five clinical trials in 3899 patients, neutropenia occurred in 37% to 51% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19% to 32% of patients receiving Verzenio.

Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 days to 34 days, and the median duration of Grade ≥3 neutropenia ranged from 10 days to 16 days.

Febrile neutropenia has been reported in <1% of patients exposed to Verzenio across trials. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their healthcare provider.

Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In Verzenio-treated patients in early breast cancer (monarchE, N=2791), 3% of patients experienced ILD or pneumonitis of any grade: 0.4% were Grade 3 or 4 and there was one fatality (0.1%). In Verzenio-treated patients in advanced or metastatic breast cancer (N=1108) (MONARCH 1, MONARCH 2, MONARCH 3, EMBER-3), 3.2% of Verzenio-treated patients had ILD or pneumonitis of any grade: 0.5% had Grade 3 or 4, and 0.5% had fatal outcomes. Additional cases of ILD or pneumonitis have been observed in the postmarketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD or pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations.

Withhold or reduce dose for patients who develop persistent or recurrent Grade 2 ILD or pneumonitis. Permanently discontinue VERZENIO in all patients with Grade 3 or 4 ILD or pneumonitis.

Grade ≥3 increases in alanine aminotransferase (ALT) (2% to 6%) and aspartate aminotransferase (AST) (2% to 3%) were reported in patients receiving Verzenio.

Across four clinical trials in 3767 patients (monarchE, MONARCH 2, MONARCH 3, EMBER-3), the median time to onset of Grade ≥3 ALT increases ranged from 57 to 87 days and the median time to resolution to Grade <3 was 13 to 14 days. The median time to onset of Grade ≥3 AST increases ranged from 71 to 185 days and the median time to resolution to Grade <3 ranged from 11 to 15 days.

Monitor liver function tests (LFTs) prior to the start of VERZENIO therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or any Grade 3 or Grade 4 hepatic transaminase elevation.

Venous thromboembolic events (VTE) were reported in 2% to 5% of patients treated with Verzenio across four clinical trials in 3767 patients (monarchE, MONARCH 2, MONARCH 3, EMBER-3). VTE events included deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, inferior vena cava thrombosis, jugular vein thrombosis, peripheral vein thrombosis and superficial vein thrombosis. In clinical trials, deaths due to VTE occurred in patients treated with Verzenio.

Verzenio has not been studied in patients with early breast cancer who had a history of VTE. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Dose interruption is recommended for early breast cancer patients with any grade VTE event and for advanced or metastatic breast cancer patients with a Grade 3 or 4 VTE event.

Verzenio can cause fetal harm when administered to a pregnant woman, based on findings from animal studies and the mechanism of action. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for 3 weeks after the last dose.

Verzenio can increase serum creatinine without affecting renal function. These increases were not associated with changes in glomerular function. In EMBER-3, creatinine increase occurred in 36% for all grades (Grade 3 or 4: 1.1%) of patients who received Inluriyo in combination with Verzenio. During Verzenio treatment, use alternative measures that are not based on serum creatinine to assess renal function such as BUN, cystatin C, or calculated GFR.

The most common adverse reactions (all grades, ≥10%) observed in monarchE for Verzenio plus tamoxifen or an aromatase inhibitor vs tamoxifen or an aromatase inhibitor, with a difference between arms of ≥2%, were diarrhea (84% vs 9%), infections (51% vs 39%), neutropenia (46% vs 6%), fatigue (41% vs 18%), leukopenia (38% vs 7%), nausea (30% vs 9%), anemia (24% vs 4%), headache (20% vs 15%), vomiting (18% vs 4.6%), stomatitis (14% vs 5%), lymphopenia (14% vs 3%), thrombocytopenia (13% vs 2%), decreased appetite (12% vs 2.4%), ALT increased (12% vs 6%), AST increased (12% vs 5%), dizziness (11% vs 7%), rash (11% vs 4.5%), and alopecia (11% vs 2.7%).

The most frequently reported ≥5% Grade 3 or 4 adverse reaction that occurred in the Verzenio arm vs the tamoxifen or an aromatase inhibitor arm of monarchE were neutropenia (19.6% vs 1%), leukopenia (11% vs <1%), diarrhea (8% vs 0.2%), and lymphopenia (5% vs <1%).

Lab abnormalities (all grades; Grade 3 or 4) for monarchE in ≥10% for Verzenio plus tamoxifen or an aromatase inhibitor with a difference between arms of ≥2% were increased serum creatinine (99% vs 91%; 0.5% vs <0.1%), decreased white blood cells (89% vs 28%; 19.1% vs 1.1%), decreased neutrophil count (84% vs 23%; 18.7% vs 1.9%), anemia (68% vs 17%; 1% vs .1%), decreased lymphocyte count (59% vs 24%; 13.2% vs 2.5%), decreased platelet count (37% vs 10%; .9% vs .2%), increased ALT (37% vs 24%; 2.6% vs 1.2%), increased AST (31% vs 18%; 1.6% vs .9%), and hypokalemia (11% vs 3.8%; 1.3% vs 0.2%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 3 for Verzenio plus anastrozole or letrozole vs anastrozole or letrozole, with a difference between arms of ≥2%, were diarrhea (81% vs 30%), fatigue (40% vs 32%), neutropenia (41% vs 2%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3.1%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 3 were neutropenia (22% vs 1%), diarrhea (9% vs 1.2%), leukopenia (7% vs <1%)), increased ALT (6% vs 2%), and anemia (6% vs 1%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in ≥10% for Verzenio plus anastrozole or letrozole with a difference between arms of ≥2% were increased serum creatinine (98% vs 84%; 2.2% vs 0%), decreased white blood cells (82% vs 27%; 13% vs 0.6%), anemia (82% vs 28%; 1.6% vs 0%), decreased neutrophil count (80% vs 21%; 21.9% vs 2.6%), decreased lymphocyte count (53% vs 26%; 7.6% vs 1.9%), decreased platelet count (36% vs 12%; 1.9% vs 0.6%), increased ALT (48% vs 25%; 6.6% vs 1.9%), and increased AST (37% vs 23%; 3.8% vs 0.6%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 2 for Verzenio plus fulvestrant vs fulvestrant, with a difference between arms of ≥2%, were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 2.7%), thrombocytopenia (16% vs 3%), alopecia (16% vs 1.8%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4.5%), pyrexia (11% vs 6%), and weight decreased (10% vs 2.2%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 2 were neutropenia (25% vs 1%), diarrhea (13% vs 0.4%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (5.7% vs 3.5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for Verzenio plus fulvestrant with a difference between arms of ≥2% were increased serum creatinine (98% vs 74%; 1.2% vs 0%), decreased white blood cells (90% vs 33%; 23.7% vs .9%), decreased neutrophil count (87% vs 30%; 32.5% vs 4.2%), anemia (84% vs 34%; 2.6% vs .5%), decreased lymphocyte count (63% vs 32%; 12.2% vs 1.8%), decreased platelet count (53% vs 15%; 2.1% vs 0%), increased ALT (41% vs 32%; 4.6% vs 1.4%), and increased AST (37% vs 25%; 3.9% vs 4.2%).

The most common adverse reactions (all grades, ≥10%) observed in MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), constipation (17%), leukopenia (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%).

The most frequently reported ≥5% Grade 3 or 4 adverse reactions from MONARCH 1 with Verzenio were diarrhea (20%), neutropenia (24%), fatigue (13%), and leukopenia (5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with Verzenio were increased serum creatinine (99%; .8%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 26.6%), anemia (69%; 0%), decreased lymphocyte count (42%; 13.8%), decreased platelet count (41%; 2.3%), increased ALT (31%; 3.1%), and increased AST (30%; 3.8%).

Serious and Fatal Adverse Reactions for Inluriyo in combination with Verzenio: Serious adverse reactions occurred in 21% of patients who received Inluriyo in combination with Verzenio. Serious adverse reactions in >1% of patients who received Inluriyo in combination with Verzenio included pneumonia (2.4%), abdominal pain, and renal failure (each 1.4%). Fatal adverse reactions occurred in 3.8% of patients who received Inluriyo in combination with Verzenio, including pneumonia (1.4%), myocardial infarction, interstitial lung disease, and sepsis (0.5% each).

Most Common Adverse Reactions for Inluriyo in combination with Verzenio: The most common (≥10%) adverse reactions with Inluriyo in combination with Verzenio, including laboratory abnormalities, were decreased neutrophils, diarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased platelets, fatigue, increased triglycerides, infections, increased AST, increased creatinine, increased ALT, vomiting, musculoskeletal pain, abdominal pain, decreased appetite, increased cholesterol, rash, cough, headache, and decreased weight.

Strong and moderate CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily with concomitant use of strong CYP3A inhibitors other than ketoconazole. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3-5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor. Patients should avoid grapefruit products. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements.

Avoid concomitant use of strong or moderate CYP3A inducers and consider alternative agents. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity.

With severe hepatic impairment (Child-Pugh C), reduce the Verzenio dosing frequency to once daily. No dosage adjustments are necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B).

Please see full Prescribing Information and Patient Information for Verzenio.

VZ IN HCP ISI ALL APPR

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about sofetabart mipitecan as a potential treatment for ovarian cancer as well as other FRα-expressing solid tumors, olomorasib as a potential treatment for certain KRAS G12C-mutant advanced solid tumors, Retevmo (selpercatinib) as a treatment for advanced RET-mutant medullary thyroid cancer (MTC), and Verzenio (abemaciclib) as a treatment for certain HR+, HER2– breast cancers in the adjuvant and advanced or metastatic setting, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that any of these therapies will prove to be a safe and effective treatment or receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Endnotes & References

Bax, Heather J et al. "Folate receptor alpha in ovarian cancer tissue and patient serum is associated with disease burden and treatment outcomes." British journal of cancer vol. 128,2 (2023): 342-353. doi:10.1038/s41416-022-02031-x  Scaranti, Mariana et al. "Exploiting the folate receptor α in oncology." Nature reviews. Clinical oncology vol. 17,6 (2020): 349-359. doi:10.1038/s41571-020-0339-5.  Kalli, Kimberly R et al. "Folate receptor alpha as a tumor target in epithelial ovarian cancer." Gynecologic oncology vol. 108,3 (2008): 619-26. doi:10.1016/j.ygyno.2007.11.020.  Viricel W, et al. Cancer Res. 2023;83(suppl 7):1544.  Ji J, Wang C, Fakih M. Targeting KRAS G12C-mutated advanced colorectal cancer: Research and clinical developments. OncoTargets and Therapy. 2022;Volume 15:747-756. doi:10.2147/ott.s340392 Peng S-B, Si C, Zhang Y, et al. Abstract 1259: Preclinical characterization of LY3537982, a novel, highly selective and potent KRAS-G12C inhibitor. Cancer Research. 2021;81(13_Supplement):1259-1259. doi:10.1158/1538-7445.am2021-1259 Retevmo. Prescribing information. Lilly USA, LLC. Verzenio. Prescribing information. Lilly USA, LLC. Inluriyo. Prescribing information. Lilly USA, LLC. Refer to:  Megan Talon; [email protected] (Media)
                 Michael Czapar; [email protected] (Investors)

SOURCE Eli Lilly and Company

Eli Lilly's (LLY +0.43%) Zepbound, an anti-obesity medicine, was first approved in the U.S. in 2023. It has become one of the company's main growth drivers ever since and is now the top-selling drug in the chronic weight management landscape. Zepbound could remain one of the most important therapies in Eli Lilly's arsenal, given that the weight-loss market is growing rapidly. However, the drugmaker has several other medicines that could help power its next era of growth. Let's consider three of them.

Image source: The Motley Fool.

1. Foundayo
Foundayo is an oral GLP-1 medicine approved for weight loss. It first earned approval in the U.S. in April and has been fairly successful since. What's important about Foundayo is that it isn't just cannibalizing Zepbound's sales. Earlier this year, Eli Lilly noted that 80% of prescriptions for Foundayo were for patients who had never taken GLP-1 medicines before.

That makes sense. Zepbound is administered once weekly via subcutaneous injection. Some patients simply dislike needles. It also has storage requirements that, while not overly stringent, can be inconvenient for some patients, especially those who travel regularly. These factors likely helped Eli Lilly attract a new audience with Foundayo.

True, the medicine is trailing the Wegovy pill in the oral weight loss market. But Foundayo could gain significant traction over the medium term. Here are two reasons why. First, it can be taken at any time of day without food or water restrictions. By contrast, oral Wegovy is taken first thing in the morning on an empty stomach.

Second, and perhaps more importantly, Foundayo will likely earn important label expansions, including in diabetes, obstructive sleep apnea, and several other indications. These could help boost the medicine's sales over the next few years.

2. Onswik
Eli Lilly earned approval for Onswik, a diabetes medicine, in September. Onswik is a once-weekly basal insulin injection which, in clinical trials, showed efficacy comparable to that of daily insulin medicines. Of course, Onswik is much more convenient since it significantly reduces the number of doses per year. So, it could attract a decent number of patients.

Onswik isn't the first once-weekly insulin medicine to earn approval. That was Novo Nordisk's (NVO -0.99%) Awiqli, which earned approval in the U.S. in March. Still, the launch of Onswik should strengthen Eli Lilly's already strong diabetes portfolio.

$1,257.03+$5.42 (+0.43%)

NYSE · As of 4:00 PM ET 10/16/26

3. Retatrutide
Retatrutide is the only one of Eli Lilly's next-gen drugs discussed here that has yet to earn approval. However, it could be the most promising. Retatrutide is an investigational weight-loss medicine that mimics the actions of three gut hormones: GLP-1, GIP, and glucagon. Here's why that's significant. Zepbound's market-leading efficacy is partly attributed to its ability to mimic two gut hormones, GLP-1 and GIP, whereas its main competitor, Wegovy, mimics only GLP-1.

But retatrutide goes one step further than Zepbound, which could, in theory, lead to even stronger efficacy. The data so far appear to support that theory. In one Phase 3 study, retatrutide led to an average weight loss of up to 28.3% over 80 weeks.

It has also shown tremendous promise in helping patients with diabetes lose weight (which is typically harder for them), as well as in other indications, such as obstructive sleep apnea. Retatrutide shouldn't simply cannibalize Zepbound's sales either -- it could attract newer patients, including those with very high BMIs (body mass indexes) who have had trouble losing weight even with the currently available options. Retatrutide could become one of Eli Lilly's key growth drivers. The pharmaceutical company plans to submit regulatory applications for the drug in the first quarter of 2027.

Buy and forget
This is not an exhaustive list of Eli Lilly's promising drugs and pipeline candidates. Others, such as eloralintide, an investigational drug for weight loss, Kisunla, a medicine approved for Alzheimer's disease (AD), and remternetug, which is being developed for AD, look promising as well. Eli Lilly will face more competition in the weight loss market in the coming years, but the company's pipeline across weight loss, diabetes, and other areas could allow it to remain one of the leaders in its core market while making significant progress in others. That's why, even though it has crushed broader equities in recent years, Eli Lilly remains one of the top healthcare stocks to buy.

Eli Lilly trades at a premium multiple, yet its revenue growth dwarfs every major pharma peer by a wide margin. Whether that gap justifies buying shares near all-time highs depends on one critical assumption about Lilly's pipeline.

Our 24/7 Wall St. price target for Eli Lilly (NYSE:LLY | LLY Price Prediction) is $1,378.50. That points to 17.83% upside from the current $1,169.93. Our model rates the stock a buy, with high confidence.

24/7 Wall St. Price Target Summary Metric Value Current Price $1,169.93 Price Target from 24/7 Wall St. $1,378.50 Upside/Downside 17.83% Recommendation BUY Confidence Level 90% Lilly trades at 24x forward earnings while revenue grew 47.7% year over year last quarter. For a stock with a trillion-dollar market cap, that multiple looks modest against the growth. Management has raised 2026 revenue guidance twice, to $85B-$87B, and plans to submit retatrutide in Q1 2027.

Lilly Climbs Back Toward Its Highs After Another Guidance Raise Shares are up 1.81% over the past week, 4.16% over the past month, 9.46% year to date and 39.3% over the past year. The stock sits about 9.5% below its 52-week high of $1,292.65 and 50.2% off its low of $778.94.

Q2 revenue reached $22.97B, ahead of the $20.69B estimate. EPS of $8.38 beat the $6.58 consensus. Mounjaro brought in $9.94B (+91%) and Zepbound $4.93B (+46%).

Since the report, the FDA has approved the once-weekly insulin Onswik and expanded Jaypirca’s label into previously untreated CLL. Lilly has also broken ground on a Houston plant, one of ten U.S. manufacturing sites announced since 2020.

Why Bulls See $1,437 and Beyond Lilly’s pipeline goes well past Mounjaro and Zepbound. In Q2, Foundayo prescribers grew from about 8,000 to 36,000. Medicare’s GLP-1 Bridge Program now covers 20 million eligible Americans at $50 per month.

Analysts expect 2027 EPS of $47.5925, and the high estimate reaches $54.94. The consensus target is $1,330.25, supported by 6 Strong Buy ratings plus 19 Buy ratings. In our bull scenario, the stock reaches $1,437.

Pricing Pressure Is the Risk Worth Watching Lilly’s U.S. price fell 9% in Q2 when rebate estimate adjustments are excluded. Management says rising volume will more than offset lower prices, calling the decline “very much embedded in our guide.” Acquired IPR&D charges of $3.03 per share also cut into Q2 EPS.

Those charges came from one-time deals that added to the pipeline. Retatrutide’s filing pathway still faces litigation over how the drug is classified. Analysts include 1 Sell and 1 Strong Sell rating. The bear case is $1,175.26.

How Lilly Compares to Novo Nordisk and AbbVie Novo Nordisk (NYSE:NVO) is Lilly’s direct GLP-1 rival. The stock trades at 12x forward earnings, but its revenue grew just 2.1% last quarter, and earnings declined 20.6%.

AbbVie (NYSE:ABBV) is a large pharma name with a strong immunology franchise. The shares trade at 16x forward earnings on 10.2% revenue growth.

Company Forward P/E Quarterly Revenue Growth YoY Eli Lilly 24x 47.7% Novo Nordisk 12x 2.1% AbbVie 16x 10.2% Lilly’s premium multiple comes with several times the revenue growth of either peer. Against that background, the 24/7 Wall St. price target looks reasonable.

Growth Outruns the Multiple, So Lilly Rates a Buy Our 24/7 Wall St. price target of $1,378.50 carries a buy rating with 90% confidence. What tips the scale for me is earnings momentum.

The case gets stronger if Foundayo keeps gaining share and retatrutide is filed on schedule. It weakens if price cuts start to outpace volume growth. On the current data, I think Lilly’s valuation understates its growth.

Here is where our model projects Lilly could trade at each year-end if current growth trends and market conditions hold.

Year Price Target from 24/7 Wall St. 2026 $1,221.61 2027 $1,417.01 2028 $1,596.31 2029 $1,747.66 2030 $1,853.50 The projections rest on Lilly continuing to execute its current strategy. Retatrutide’s approval, or deeper GLP-1 price cuts, could move the stock well above or below these figures.

Contact [email protected] for any questions or corrections.

Eli Lilly (LLY +0.28%) stock has soared 400% over the past five years, and though the momentum slowed in the early months of this year, it's now on the rise again. The stock has advanced 25% over the past six months, buoyed by optimism about Lilly's weight loss drug portfolio. Lilly is the maker of tirzepatide, sold under the names Mounjaro for type 2 diabetes and Zepbound for weight loss, and these blockbuster products have been driving explosive revenue growth.

Demand for this type of drug has been high worldwide, and Lilly has established itself as the leader, surpassing Novo Nordisk. In fact, the performance of its weight loss drugs has been so strong that Lilly now expects up to $87 billion in revenue this year. That compares to $65 billion in revenue last year.

Though Lilly stock has climbed, it makes a reasonable buy today. Let's check out why this stock still looks undervalued.

Image source: Getty Images.

How GLP-1 drugs work
So first, let's start with a few words about the GLP-1 market. This class of drugs interacts with hormonal pathways involved in the control of appetite and blood sugar levels -- and as such, is the key to weight loss. These drugs are easy to self-administer weekly by injection, and just this year, both Lilly and Novo have also launched GLP-1 drugs in oral formulations. GLP-1 drugs have proven their safety and efficacy in clinical trials and in the real world, and individuals seeking to lose weight have rushed to get in on them.

A couple of years ago, regulators even announced a GLP-1 shortage, but Lilly and Novo ramped up production, and the products are now back on the shelves. Novo was earliest to market with its GLP-1 drugs, Ozempic for type 2 diabetes and Wegovy for weight loss, but as mentioned, Lilly has slipped ahead. Novo's oral Wegovy, however, still has won more prescriptions than Lilly's pill, Foundayo, but it's important to keep in mind that oral Wegovy launched a few months earlier. So, it's too early to draw conclusions about which company may dominate in the oral GLP-1 space.

Premium Feature

Moneyball Superscore

96/100

Today's Change

(

0.28

%) $

3.35

Current Price

$

1,182.62

Demand for weight loss drugs has helped power Lilly's revenue higher; in the recent quarter, for example, Mounjaro and Zepbound drove a 48% increase in total revenue to $23 billion. Together, they accounted for more than $14 billion of that revenue.

Eli Lilly's valuation today
Now, let's consider why Lilly still looks undervalued even after its big gains. Right now, Lilly trades for about 32x forward earnings estimates, which is below its levels of a few years ago, when revenue was considerably lower.

LLY PE Ratio (Forward) data by YCharts

Meanwhile, analysts are optimistic about revenue to come. As mentioned, Lilly forecasts as much as $87 billion for the current full year, and the average analyst estimate calls for revenue of more than $100 billion in the following year.

At the same time, Lilly's weight loss portfolio isn't restricted to only a couple of products. The company has a solid weight loss drug pipeline, with exciting late-stage products that could be the revenue drivers of the future. For example, the pharma giant recently reported positive results from a phase 2 study of EloraTZP, a combination of eloralintide and tirzepatide -- in the trial, it delivered greater weight loss than tirzepatide alone. Lilly aims to initiate a phase 3 trial before the end of the year. The company is also studying retatrutide, another candidate with potential for greater weight loss, in phase 3 studies.

This is positive because, in the future, if Lilly sells several weight loss drugs, it can suit the needs of a variety of individuals. Some may like the convenience of a weight loss pill, while others may go for a drug that offers the potential for more or less weight loss, according to their particular needs.

The ongoing demand in today's weight loss drug market and the strength of Lilly's weight loss pipeline, which may produce additional drugs in the future, are reasons to believe that revenue could continue to march significantly higher. This is why today, even after its gains, Eli Lilly stock still looks undervalued.

Eli Lilly (LLY - Free Report) has recently been on Zacks.com's list of the most searched stocks. Therefore, you might want to consider some of the key factors that could influence the stock's performance in the near future.

Over the past month, shares of this drugmaker have returned +4.2%, compared to the Zacks S&P 500 composite's +1.3% change. During this period, the Zacks Large Cap Pharmaceuticals industry, which Lilly falls in, has gained 0.3%. The key question now is: What could be the stock's future direction?

While media releases or rumors about a substantial change in a company's business prospects usually make its stock 'trending' and lead to an immediate price change, there are always some fundamental facts that eventually dominate the buy-and-hold decision-making.

Earnings Estimate RevisionsRather than focusing on anything else, we at Zacks prioritize evaluating the change in a company's earnings projection. This is because we believe the fair value for its stock is determined by the present value of its future stream of earnings.

Our analysis is essentially based on how sell-side analysts covering the stock are revising their earnings estimates to take the latest business trends into account. When earnings estimates for a company go up, the fair value for its stock goes up as well. And when a stock's fair value is higher than its current market price, investors tend to buy the stock, resulting in its price moving upward. Because of this, empirical studies indicate a strong correlation between trends in earnings estimate revisions and short-term stock price movements.

Lilly is expected to post earnings of $9.83 per share for the current quarter, representing a year-over-year change of +40%. Over the last 30 days, the Zacks Consensus Estimate has changed +0.1%.

For the current fiscal year, the consensus earnings estimate of $36.64 points to a change of +51.3% from the prior year. Over the last 30 days, this estimate has changed +0.3%.

For the next fiscal year, the consensus earnings estimate of $46.8 indicates a change of +27.7% from what Lilly is expected to report a year ago. Over the past month, the estimate has changed +1.4%.

With an impressive externally audited track record, our proprietary stock rating tool -- the Zacks Rank -- is a more conclusive indicator of a stock's near-term price performance, as it effectively harnesses the power of earnings estimate revisions. The size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, has resulted in a Zacks Rank #3 (Hold) for Lilly.

The chart below shows the evolution of the company's forward 12-month consensus EPS estimate:

12 Month EPS

Projected Revenue GrowthEven though a company's earnings growth is arguably the best indicator of its financial health, nothing much happens if it cannot raise its revenues. It's almost impossible for a company to grow its earnings without growing its revenue for long periods. Therefore, knowing a company's potential revenue growth is crucial.

In the case of Lilly, the consensus sales estimate of $22.14 billion for the current quarter points to a year-over-year change of +25.8%. The $88.88 billion and $102.02 billion estimates for the current and next fiscal years indicate changes of +36.4% and +14.8%, respectively.

Last Reported Results and Surprise HistoryLilly reported revenues of $22.97 billion in the last reported quarter, representing a year-over-year change of +47.7%. EPS of $8.38 for the same period compares with $6.31 a year ago.

Compared to the Zacks Consensus Estimate of $20.26 billion, the reported revenues represent a surprise of +13.38%. The EPS surprise was +39.43%.

The company beat consensus EPS estimates in each of the trailing four quarters. The company topped consensus revenue estimates each time over this period.

ValuationNo investment decision can be efficient without considering a stock's valuation. Whether a stock's current price rightly reflects the intrinsic value of the underlying business and the company's growth prospects is an essential determinant of its future price performance.

Comparing the current value of a company's valuation multiples, such as its price-to-earnings (P/E), price-to-sales (P/S), and price-to-cash flow (P/CF), to its own historical values helps ascertain whether its stock is fairly valued, overvalued, or undervalued, whereas comparing the company relative to its peers on these parameters gives a good sense of how reasonable its stock price is.

The Zacks Value Style Score (part of the Zacks Style Scores system), which pays close attention to both traditional and unconventional valuation metrics to grade stocks from A to F (an A is better than a B; a B is better than a C; and so on), is pretty helpful in identifying whether a stock is overvalued, rightly valued, or temporarily undervalued.

Lilly is graded D on this front, indicating that it is trading at a premium to its peers. Click here to see the values of some of the valuation metrics that have driven this grade.

ConclusionThe facts discussed here and much other information on Zacks.com might help determine whether or not it's worthwhile paying attention to the market buzz about Lilly. However, its Zacks Rank #3 does suggest that it may perform in line with the broader market in the near term.

Exploratory data presented at Fall Clinical 2026 showed broader biomarker changes with Taltz and Zepbound vs. Taltz alone as early as Week 12 in first-of-its-kind TOGETHER-PsO study

, /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new exploratory data from the TOGETHER-PsO Phase 3b clinical trial evaluating the concomitant use of Taltz (ixekizumab) and Zepbound (tirzepatide) compared with Taltz alone in adults with moderate-to-severe plaque psoriasis and obesity or overweight with at least one additional weight-related comorbid condition. The prespecified analysis, presented at the 2026 Fall Clinical Dermatology Conference in Las Vegas, provides new insights suggesting an immunometabolic relationship between psoriasis and obesity. These data showed that when Taltz and Zepbound were used together, changes were observed in more psoriasis disease-associated and metabolic biomarkers compared to Taltz monotherapy. In the U.S., approximately 61% of people with psoriasis also have obesity or overweight with at least one weight-related comorbidity.1 

"People living with psoriasis and obesity carry a compounded burden that extends beyond what is visible, yet these conditions are too often viewed through separate treatment lenses," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "The broader biomarker changes observed with Taltz and Zepbound, including those associated with skin clearance, may point to a meaningful relationship between immune and metabolic biology. Along with previously reported clinical outcomes, these findings support a more comprehensive approach to psoriasis care that also addresses obesity for people managing both conditions."

This analysis examined circulating proteins and gene expression in the blood to better understand the biological change observed when patients were treated concomitantly with Taltz and Zepbound vs. Taltz alone. At Week 36, observed changes in psoriasis-specific, immune and metabolic biomarkers in both the Taltz and Zepbound and Taltz monotherapy treatment arms were consistent with the known biological effects of each medicine when used for their approved indications. Notably, Taltz and Zepbound used together were associated with broader biomarker responses compared to Taltz alone as early as Week 12. This included changes in more proteins (482 vs. 140 differentially expressed proteins) and genes (467 vs. 16 differentially expressed genes) by Week 36.

Further, the analysis showed greater reductions in inflammatory immune activity with Taltz and Zepbound compared with Taltz alone, including changes related to neutrophils, a type of immune cell involved in inflammation. Changes in a subset of neutrophil-associated markers mediated a portion of the additional Psoriasis Area and Severity Index (PASI) response seen with Taltz and Zepbound vs. Taltz alone.

"This analysis provides new insights into the potential connected immune and metabolic biology in people with psoriasis and obesity," said James G. Krueger, M.D., Ph.D., Professor and Laboratory Head, The Rockefeller University. "What is most compelling is these findings identified differences in inflammatory pathways when patients received concomitant treatment with Taltz plus Zepbound for both conditions. These data at the intersection of psoriasis and obesity highlight immunometabolic health as an important area for continued scientific research."

These data follow previously reported results from TOGETHER-PsO, which showed that Taltz and Zepbound used together delivered superior skin clearance and clinically meaningful weight reduction compared with Taltz alone at the Week 36 primary endpoint. Improvements were maintained or further improved through Week 52, with safety consistent with the known profile of each respective medicine.

About the TOGETHER-PsO trial
TOGETHER-PsO (NCT06588283) is a 52-week Phase 3b, randomized, multicenter, assessor-blinded, open-label study assessing the efficacy and safety of concomitant administration of Taltz and Zepbound compared with Taltz alone in adults with moderate-to-severe plaque psoriasis and obesity or overweight (BMI ≥30 kg/m², or ≥27 to <30 kg/m²) with at least one additional weight-related comorbid condition. A total of 274 participants were randomized 1:1 to receive either Taltz alone or concomitantly with Zepbound, both administered subcutaneously. Patients in both arms received counseling on a reduced-calorie diet and increased physical activity. The primary endpoint is to assess the proportion of participants achieving both Psoriasis Area and Severity Index (PASI) 100 and ≥10% weight reduction at Week 36.

About Taltz (ixekizumab)
Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines. Taltz is approved to treat adults with active psoriatic arthritis and adults and children 6 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Additionally, Taltz is approved for adults with active ankylosing spondylitis, and adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

About Zepbound (tirzepatide) injection
Zepbound (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Zepbound should be used with a reduced calorie diet and increased physical activity. 

TALTZ INDICATIONS AND SAFETY SUMMARY
Taltz® (tȯl-ts) is an injectable medicine used to treat:

People 6 years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). Adults with active psoriatic arthritis. Adults with active ankylosing spondylitis. Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. It is not known if Taltz is safe and effective in children for conditions other than plaque psoriasis or in children under 6 years of age.

Warnings - Taltz affects the immune system. It may increase your risk of infections, some people have had serious infections, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized from these infections. Do not use Taltz if you have any symptoms of infection, unless your doctor tells you to. If you have a symptom after starting Taltz, call your doctor right away.

Your doctor should check you for TB before you start Taltz, and watch you closely for signs of TB during and after treatment with Taltz. If you have TB, or had it in the past, your doctor may treat you for it before you start Taltz.

Do not use Taltz if you have had a serious allergic reaction to ixekizumab or any other ingredient in Taltz, such as: swelling of your eyelids, lips, mouth, tongue or throat, trouble breathing, feeling faint, throat or chest tightness, or skin rash. Get emergency help right away if you have any of these reactions. See the Medication Guide that comes with Taltz for a list of ingredients.

Severe skin reactions that look like eczema can happen during treatment with Taltz from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with Taltz if you develop severe skin reactions. Tell your doctor if you have any of the following: redness or rash, itching, patches, your skin is dry or feels like leather, blisters or abrasions that ooze or become crusty, small bumps or plaques with scale or crusting.

Crohn's disease or ulcerative colitis (inflammatory bowel disease) can start or get worse with Taltz use. Tell your doctor if you have any of these symptoms or if they get worse: stomach pain, diarrhea, and weight loss.

You should not get live vaccines while taking Taltz. You should get the vaccines you need before you start Taltz.

Common side effects
The most common side effects of Taltz include:

Injection site reactions Nausea Upper respiratory infections Fungal skin infections Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using
Before you use Taltz, review these questions with your doctor:

Are you being treated for an infection? Do you have an infection that does not go away or keeps coming back? Do you have TB or have you been in close contact with someone with TB? Do you have possible symptoms of an infection such as fever, cough, sores, diarrhea, or other symptoms? Ask your doctor about other possible symptoms. Do you have Crohn's disease or ulcerative colitis? Tell your doctor if:

You need any vaccines or have had one recently. You take prescription or over-the-counter medicines, vitamins, or herbal supplements. You are pregnant or planning to become pregnant. It is not known if Taltz can harm an unborn baby. Pregnancy Exposure Registry: There is a pregnancy registry to collect information about women who are exposed to Taltz during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become pregnant while taking Taltz, you are encouraged to enroll in the pregnancy registry by calling 1-800-284-1695 or by visiting online at http://www.pregnancyregistry.lilly.com. You are breastfeeding or planning to breastfeed. It is not known if Taltz passes into breastmilk. How to take
See the instructions for use that come with Taltz. There you will find information about how to store, prepare, and inject Taltz. Adults may self-inject after receiving training from a healthcare provider.

For children 6 to 17 years of age:

If your child's healthcare provider decides that you may give Taltz injections at home, you should receive training on the right way to prepare and inject Taltz. Do not try to give Taltz to your child until you have been shown how to inject Taltz. Children should not inject themselves with Taltz. You or an adult caregiver should prepare and give Taltz injections to your child. Learn more
Taltz is a prescription medicine available as a 80 mg/mL, 40 mg/0.5mL, 20 mg/0.25mL injection. For more information, call 1-800-545-5979 or go to taltz.lilly.com.

This summary provides basic information about Taltz but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Taltz and how to take it. Your doctor is the best person to help you decide if Taltz is right for you.

IX CON BS 20AUG2024

U.S. ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:

obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.

Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. KwikPen®: Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them.

Zepbound may cause serious side effects, including:

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. 

Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.

Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Zepbound

Your healthcare provider should show you how to use Zepbound before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound. Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may call 1-844-524-0039 or email at [email protected] or visit https://pregnancyregistry.lilly.com/zepbound. How to take

Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or
have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously). Use Zepbound 1 time each week, at any time of the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.

Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.

This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.

ZP CON BS 01SEP2026

Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn.  P-LLY

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) as a treatment for psoriasis and Zepbound (tirzepatide) as a treatment for adults with obesity or overweight, and potential comprehensive treatment strategies for patients with psoriasis and obesity, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there is no guarantee that future study results will be consistent with the results to date, or that Lilly will execute its strategies as planned. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

References and endnotes

Armstrong et al, Addressing the Obesity-Psoriasis Connection: Prevalence, Incidence, and Comorbidity Insights from a Large US Population of 19.9 Million (2018-2024). Presented at Maui Derm, 2026. SOURCE Eli Lilly and Company

Only part of the headline value is committed; most payments require research, clinical or commercial milestones. Summary

Lilly added discovery options without assuming an immediate $870 million expense.

Eli Lilly LLY, the medicines and metabolic-disease company, expanded its drug-discovery partnership with Gate Bioscience, with shares up approximately 3.6% at 11.44am EST to $1,200.23 on October 7, 2026. The target: proteins that have proved tough for conventional medicines to tackle. The valuation picture shows shares sitting 23.49% below the roughly $1,570 GF Value estimate, suggesting potential upside if the assumptions behind that estimate hold.

The expanded agreement adds one target and gives Lilly an option to pursue a second. Potential payments could exceed $870 million if the specified milestones are met. Gate gets an undisclosed upfront payment plus research funding. Lilly gets worldwide development and commercialization rights for selected programs. That headline number is a conditional payout ceiling, not cash already spent.

For Lilly, the appeal is a wider hunting ground for new medicines. But more targets do not automatically mean more successful drugs. The programs still need to clear candidate selection, preclinical testing and eventually human trials. Investors should watch what emerges from the lab: a promising candidate would say far more about the partnership's value than its maximum deal size.

Disclosures I/we have no positions in any stocks mentioned, and have no plans to buy any new positions in the stocks mentioned within the next 72 hours.

Click for the complete disclosure

The 24/7 Wall St. price target for Eli Lilly (NYSE:LLY | LLY Price Prediction) is $1,359.12 over the next 12 months. With the stock at $1,142.85, that implies 18.92% upside. Lilly wins a buy rating from the model, with high…

This post may contain links from our sponsors and affiliates, and Flywheel Publishing may receive compensation for actions taken through them.

The 24/7 Wall St. price target for Eli Lilly (NYSE:LLY | LLY Price Prediction) is $1,359.12 over the next 12 months. With the stock at $1,142.85, that implies 18.92% upside. Lilly wins a buy rating from the model, with high confidence.

Metric Value Current Price $1,142.85 Price Target from 24/7 Wall St. $1,359.12 Upside/Downside 18.92% Model Rating BUY Confidence Level 90% Mounjaro and Zepbound built the story. The next leg comes from an oral GLP-1, a next-generation incretin, and a non-obesity portfolio that is growing quickly. Lilly’s oncology, immunology, and neuroscience medicines grew 121% year over year last quarter.

Record Growth Meets a Pullback From the Highs Shares sit 11.6% below the 52-week high of $1,292.65 and 46.7% above the low of $778.94. LLY is down 2.3% since mid-July, up 10.1% since mid-January, and up 39.5% from mid-October 2025.

Q2 revenue reached $22.97B, up 47.67% and ahead of the $20.69B estimate. EPS of $8.38 beat the $6.58 consensus even after taking on $3.03 of acquired IPR&D charges. Management raised full-year revenue guidance to $85B-$87B and set non-GAAP EPS guidance at $35.50-$36.50.

Why Bulls See $1,416 as Lilly Moves Beyond Obesity Foundayo, the oral GLP-1, brought in $98M last quarter. Prescribers rose from about 8,000 to 36,000, and the pill is under review in over 40 additional countries.

A U.S. type 2 diabetes decision is expected later this year. Retatrutide has Phase 3 data in obesity, sleep apnea, and knee osteoarthritis, where pain fell by 75%, and a U.S. filing is planned for Q1 2027.

Outside cardiometabolic drugs, Ebglyss grew 131%, Jaypirca rose 56%, and Inluriyo holds more than 50% of new U.S. oral SERD prescriptions.

In early testing, Verve’s VERVE-102 gene editor cut LDL cholesterol by up to 62% with one dose. Analyst ratings stand at 6 Strong Buy and 19 Buy, with a consensus target of $1,328.83. The bull case reaches $1,416.26.

Pricing Pressure Is the Risk to Watch Volume rose 60% last quarter while prices fell 13%. Mounjaro and Zepbound still make up most of revenue, and tariffs and competition from Novo Nordisk (NYSE:NVO) remain live risks.

Q2 also carried $2.78B in IPR&D charges. Those were one-time costs of buying pipeline assets, though, and point to future growth. The bear case of $1,161.70 still sits above today’s price.

Lilly’s Premium Over Novo Nordisk and AbbVie Is Earned Novo Nordisk is Lilly’s direct GLP-1 rival. The stock changes hands at about 12x forward earnings, but quarterly revenue grew just 2.1% and earnings fell 20.6%. The discount shows lost share.

AbbVie (NYSE:ABBV) is the benchmark for a diversified immunology franchise, trading at 16x forward earnings on 10.2% revenue growth.

Company Forward P/E Quarterly Revenue Growth (YoY) Eli Lilly 26x 47.67% Novo Nordisk 12x 2.1% AbbVie 16x 10.2% Lilly is growing several times faster than either peer, so I think a 26x multiple supports the 24/7 Wall St. price target as reasonable.

Growth Beyond Weight Loss Justifies the Upside The 24/7 Wall St. price target is $1,359.12, the model rates LLY a buy, and confidence is 90%. The deciding factor is a non-obesity portfolio compounding on top of the incretin franchise.

A Foundayo diabetes approval and on-schedule retatrutide filing would strengthen the case. It gets weaker if price cuts start to exceed volume growth. Right now, volume growth is exceeding price declines.

Eli Lilly Price Prediction 2026-2030 Year Price Target from 24/7 Wall St. 2026 $1,190.88 2027 $1,410.20 2028 $1,590.91 2029 $1,714.65 2030 $1,879.00 Lilly needs to keep executing on its current strategy for these projections to hold. Retatrutide’s regulatory path and U.S. drug pricing policy could move them sharply in either direction.

Contact [email protected] for any questions or corrections.

Tompkins Financial Corp decreased its position in shares of Eli Lilly and Company (NYSE:LLY – Free Report) by 2.3% during the 3rd quarter, according to the company in its most recent filing with the SEC. The institutional investor owned 26,968 shares of the company’s stock after selling 629 shares during the quarter. Eli Lilly and Company makes up approximately 2.2% of Tompkins Financial Corp’s holdings, making the stock its 13th largest holding. Tompkins Financial Corp’s holdings in Eli Lilly and Company were worth $31,204,000 as of its most recent filing with the SEC.

Several other hedge funds and other institutional investors also recently made changes to their positions in the company. Neville Rodie & Shaw Inc. raised its position in shares of Eli Lilly and Company by 0.5% during the third quarter. Neville Rodie & Shaw Inc. now owns 17,312 shares of the company’s stock worth $20,031,000 after acquiring an additional 86 shares during the last quarter. Baker Tilly Wealth Management LLC increased its position in Eli Lilly and Company by 46.0% in the third quarter. Baker Tilly Wealth Management LLC now owns 2,388 shares of the company’s stock worth $2,764,000 after purchasing an additional 752 shares during the period. CapWealth Advisors LLC raised its holdings in Eli Lilly and Company by 10.4% during the 3rd quarter. CapWealth Advisors LLC now owns 10,188 shares of the company’s stock worth $11,788,000 after purchasing an additional 962 shares during the last quarter. Heartwood Wealth Advisors LLC lifted its position in Eli Lilly and Company by 9.7% during the 3rd quarter. Heartwood Wealth Advisors LLC now owns 430 shares of the company’s stock valued at $498,000 after purchasing an additional 38 shares during the period. Finally, Violich Capital Management Inc. lifted its position in Eli Lilly and Company by 151.0% during the 3rd quarter. Violich Capital Management Inc. now owns 3,241 shares of the company’s stock valued at $3,750,000 after purchasing an additional 1,950 shares during the period. 82.53% of the stock is owned by institutional investors and hedge funds.

Insider Buying and Selling In other news, EVP Patrik Jonsson sold 6,500 shares of the company’s stock in a transaction dated Monday, August 17th. The stock was sold at an average price of $1,175.10, for a total transaction of $7,638,150.00. Following the completion of the transaction, the executive vice president directly owned 54,147 shares of the company’s stock, valued at $63,628,139.70. This represents a 10.72% decrease in their ownership of the stock. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available at this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, EVP Anat Hakim sold 5,000 shares of Eli Lilly and Company stock in a transaction that occurred on Friday, August 7th. The shares were sold at an average price of $1,190.00, for a total value of $5,950,000.00. Following the completion of the sale, the executive vice president directly owned 11,875 shares in the company, valued at approximately $14,131,250. This represents a 29.63% decrease in their position. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last ninety days, insiders sold 13,500 shares of company stock valued at $15,958,170. Company insiders own 0.14% of the company’s stock.

Key Headlines Impacting Eli Lilly and Company Here are the key news stories impacting Eli Lilly and Company this week: Positive Sentiment: The FDA expanded approval of Jaypirca (pirtobrutinib) for previously untreated adults with chronic lymphocytic leukemia or small lymphocytic lymphoma without a 17p deletion. The decision, supported by Phase 3 results, expands Jaypirca’s addressable market and could accelerate sales growth. FDA Expands Approval for Eli Lilly Therapy in Untreated Leukemia Patients Positive Sentiment: Lilly’s experimental cancer drug olomorasib received FDA orphan-drug designation for pancreatic cancer. The designation may provide development incentives and highlights Lilly’s effort to broaden its oncology pipeline, though it is not an approval or proof of commercial success. Lilly Expands Oncology Footprint With FDA Win for Pancreatic Cancer Drug Positive Sentiment: Lilly expanded its collaboration and licensing agreement with Gate Bioscience to discover medicines aimed at difficult-to-drug proteins. It also partnered with Ginkgo Bioworks on drug discovery, strengthening external innovation efforts and potentially adding to its long-term pipeline. Gate Bioscience Expands Collaboration and License Agreement With Lilly Positive Sentiment: Early results for a next-generation obesity treatment targeting the amylin pathway renewed enthusiasm about Lilly’s ability to extend its leadership in the rapidly growing weight-loss market. Reports also point to strong patient growth and market-share gains versus Novo Nordisk. Eli Lilly Targets Amylin Pathway to Unlock Next Generation Obesity Drug Combinations Neutral Sentiment: Lilly will present 21 dermatology studies at the Fall Clinical Dermatology Conference, including data on Ebglyss, Taltz and Zepbound. The presentations could support future adoption, but they are not immediate revenue catalysts. Lilly Dermatology Portfolio Data Negative Sentiment: At roughly $1.09 trillion in market value and a forward earnings multiple near 39, Lilly’s valuation already reflects substantial obesity-drug growth. Any clinical, regulatory or competitive setback could therefore produce outsized downside. Analyst Upgrades and Downgrades Several brokerages have recently commented on LLY. Cantor Fitzgerald lifted their price target on shares of Eli Lilly and Company from $1,350.00 to $1,410.00 and gave the stock an “overweight” rating in a research report on Thursday, August 6th. Morgan Stanley reaffirmed an “overweight” rating and issued a $1,419.00 price objective on shares of Eli Lilly and Company in a research note on Thursday, August 6th. Truist Financial lifted their target price on shares of Eli Lilly and Company from $1,370.00 to $1,376.00 and gave the stock a “buy” rating in a report on Friday, August 7th. JPMorgan Chase & Co. increased their price target on Eli Lilly and Company from $1,400.00 to $1,500.00 and gave the company an “overweight” rating in a research note on Monday, September 28th. Finally, HSBC raised their price target on Eli Lilly and Company from $850.00 to $940.00 and gave the stock a “reduce” rating in a research report on Thursday, September 10th. One equities research analyst has rated the stock with a Strong Buy rating, twenty-five have issued a Buy rating, three have assigned a Hold rating and one has issued a Sell rating to the company. According to data from MarketBeat.com, the stock presently has an average rating of “Moderate Buy” and a consensus price target of $1,311.96.

Read Our Latest Stock Analysis on Eli Lilly and Company

Eli Lilly and Company Trading Up 1.0% Eli Lilly and Company stock traded up $11.17 during mid-day trading on Monday, hitting $1,154.02. 835,852 shares of the company’s stock were exchanged, compared to its average volume of 2,976,150. The company’s 50 day simple moving average is $1,176.33 and its 200-day simple moving average is $1,089.48. The company has a quick ratio of 1.00, a current ratio of 1.35 and a debt-to-equity ratio of 1.41. The firm has a market capitalization of $1.09 trillion, a P/E ratio of 38.77, a PEG ratio of 1.40 and a beta of 0.46. Eli Lilly and Company has a fifty-two week low of $783.85 and a fifty-two week high of $1,292.65.

Eli Lilly and Company (NYSE:LLY – Get Free Report) last released its quarterly earnings data on Wednesday, August 5th. The company reported $8.38 earnings per share for the quarter, beating the consensus estimate of $6.40 by $1.98. Eli Lilly and Company had a return on equity of 97.83% and a net margin of 33.53%.The business had revenue of $22.97 billion for the quarter, compared to analysts’ expectations of $20.82 billion. During the same quarter in the previous year, the business posted $6.31 EPS. Eli Lilly and Company’s revenue for the quarter was up 47.7% on a year-over-year basis. Eli Lilly and Company has set its FY 2026 guidance at 35.500-36.500 EPS. On average, equities analysts anticipate that Eli Lilly and Company will post 36.66 earnings per share for the current year.

(Free Report)

Eli Lilly and Company is a global pharmaceutical company headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company researches, develops, manufactures and markets medicines for a range of conditions, including diabetes, obesity, cancer, immunological disorders, neurological diseases and pain.

Its products include Mounjaro and Zepbound, which contain tirzepatide and are used for type 2 diabetes and chronic weight management, respectively. Other key medicines include Trulicity for diabetes, Verzenio for certain breast cancers, Taltz for inflammatory and autoimmune conditions, Humalog insulin, and Kisunla for early symptomatic Alzheimer’s disease.

Featured Stories Five stocks we like better than Eli Lilly and Company A Manufacturing Surprise Could Be a Big Win for These 2 Companies What a $1 Billion Chip Deal Says About Amazon’s AI Ambitions 3 Stocks Benefiting From AI Demand Just Announced Major Buybacks Insiders Are Selling These 3 Stocks, Should You? Want to see what other hedge funds are holding LLY? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Eli Lilly and Company (NYSE:LLY – Free Report).

Receive News & Ratings for Eli Lilly and Company Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Eli Lilly and Company and related companies with MarketBeat.com's FREE daily email newsletter.

Violich Capital Management Inc. raised its position in Eli Lilly and Company (NYSE:LLY – Free Report) by 151.0% during the third quarter, according to its most recent disclosure with the Securities and Exchange Commission. The firm owned 3,241 shares of the company’s stock after acquiring an additional 1,950 shares during the quarter. Violich Capital Management Inc.’s holdings in Eli Lilly and Company were worth $3,750,000 at the end of the most recent quarter.

A number of other institutional investors also recently modified their holdings of LLY. Miller Global Investments LLC grew its holdings in Eli Lilly and Company by 17.5% in the third quarter. Miller Global Investments LLC now owns 322 shares of the company’s stock worth $373,000 after purchasing an additional 48 shares during the period. Polaris Financial Partners bought a new stake in shares of Eli Lilly and Company in the 3rd quarter worth approximately $551,000. GoalVest Advisory LLC grew its stake in shares of Eli Lilly and Company by 8.2% in the 3rd quarter. GoalVest Advisory LLC now owns 2,355 shares of the company’s stock worth $2,725,000 after buying an additional 178 shares during the last quarter. Planning Strategies Inc. increased its position in Eli Lilly and Company by 128.6% during the 3rd quarter. Planning Strategies Inc. now owns 96 shares of the company’s stock valued at $111,000 after buying an additional 54 shares in the last quarter. Finally, Private Client Services LLC raised its stake in Eli Lilly and Company by 3.4% during the third quarter. Private Client Services LLC now owns 911 shares of the company’s stock valued at $1,055,000 after buying an additional 30 shares during the last quarter. 82.53% of the stock is currently owned by hedge funds and other institutional investors.

More Eli Lilly and Company News Here are the key news stories impacting Eli Lilly and Company this week:

Positive Sentiment: Eli Lilly’s next-generation obesity treatment produced encouraging clinical-trial results, potentially adding another major growth product alongside Zepbound. The company also has multiple additional weight-loss candidates in development. Eli Lilly’s Next Weight-Loss Drug Could Be Its Biggest Blockbuster Yet Positive Sentiment: The company said Foundayo was associated with a 57% reduction in the risk of developing type 2 diabetes, a result that could strengthen the potential market opportunity for Lilly’s metabolic-disease portfolio. Eli Lilly says Foundayo is associated with 57% reduction in type 2 diabetes risk Positive Sentiment: Lilly’s current weight-loss medicines generated approximately $14 billion in recent-quarter sales, highlighting strong demand in a market that could approach $100 billion within several years. Eli Lilly Just Announced Something Big Neutral Sentiment: Analysts emphasize Lilly’s competitive moat—drug innovation, patents, manufacturing capacity, brand strength, and its pipeline—but the stock’s elevated valuation means continued rapid growth may already be reflected in the shares. Eli Lilly’s Valuation Has Changed Insider Transactions at Eli Lilly and Company In other Eli Lilly and Company news, EVP Patrik Jonsson sold 6,500 shares of the firm’s stock in a transaction dated Monday, August 17th. The stock was sold at an average price of $1,175.10, for a total value of $7,638,150.00. Following the transaction, the executive vice president directly owned 54,147 shares of the company’s stock, valued at approximately $63,628,139.70. This trade represents a 10.72% decrease in their ownership of the stock. The sale was disclosed in a document filed with the SEC, which is accessible through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, EVP Anat Hakim sold 5,000 shares of the business’s stock in a transaction dated Friday, August 7th. The shares were sold at an average price of $1,190.00, for a total value of $5,950,000.00. Following the sale, the executive vice president owned 11,875 shares of the company’s stock, valued at approximately $14,131,250. This represents a 29.63% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders have sold a total of 13,500 shares of company stock worth $15,958,170 in the last ninety days. Insiders own 0.14% of the company’s stock. Eli Lilly and Company Stock Up 0.1% LLY opened at $1,144.20 on Monday. The stock has a market capitalization of $1.08 trillion, a price-to-earnings ratio of 38.40, a PEG ratio of 1.40 and a beta of 0.46. The firm has a 50 day moving average price of $1,176.33 and a 200-day moving average price of $1,089.48. Eli Lilly and Company has a twelve month low of $783.85 and a twelve month high of $1,292.65. The company has a quick ratio of 1.00, a current ratio of 1.35 and a debt-to-equity ratio of 1.41.

Eli Lilly and Company (NYSE:LLY – Get Free Report) last issued its earnings results on Wednesday, August 5th. The company reported $8.38 earnings per share (EPS) for the quarter, topping the consensus estimate of $6.40 by $1.98. The company had revenue of $22.97 billion for the quarter, compared to analysts’ expectations of $20.82 billion. Eli Lilly and Company had a net margin of 33.53% and a return on equity of 97.83%. The firm’s quarterly revenue was up 47.7% on a year-over-year basis. During the same quarter last year, the company posted $6.31 earnings per share. Eli Lilly and Company has set its FY 2026 guidance at 35.500-36.500 EPS. Equities research analysts forecast that Eli Lilly and Company will post 36.66 earnings per share for the current year.

Wall Street Analysts Forecast Growth Several equities analysts have recently issued reports on LLY shares. HSBC lifted their price target on Eli Lilly and Company from $850.00 to $940.00 and gave the stock a “reduce” rating in a research report on Thursday, September 10th. Royal Bank Of Canada lifted their target price on shares of Eli Lilly and Company from $1,250.00 to $1,500.00 and gave the stock an “outperform” rating in a report on Wednesday, July 8th. Wells Fargo & Company increased their price target on shares of Eli Lilly and Company from $1,280.00 to $1,330.00 and gave the company an “overweight” rating in a report on Thursday, August 6th. Wall Street Zen lowered shares of Eli Lilly and Company from a “strong-buy” rating to a “buy” rating in a report on Sunday, August 23rd. Finally, TD Cowen reaffirmed a “buy” rating and issued a $1,250.00 price objective on shares of Eli Lilly and Company in a research report on Tuesday, September 22nd. One investment analyst has rated the stock with a Strong Buy rating, twenty-five have issued a Buy rating, three have assigned a Hold rating and one has given a Sell rating to the stock. Based on data from MarketBeat.com, Eli Lilly and Company has an average rating of “Moderate Buy” and an average price target of $1,311.96.

Get Our Latest Stock Analysis on LLY

(Free Report)

Eli Lilly and Company is a global pharmaceutical company headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company researches, develops, manufactures and markets medicines for a range of conditions, including diabetes, obesity, cancer, immunological disorders, neurological diseases and pain.

Its products include Mounjaro and Zepbound, which contain tirzepatide and are used for type 2 diabetes and chronic weight management, respectively. Other key medicines include Trulicity for diabetes, Verzenio for certain breast cancers, Taltz for inflammatory and autoimmune conditions, Humalog insulin, and Kisunla for early symptomatic Alzheimer’s disease.

Featured Articles Five stocks we like better than Eli Lilly and Company Could Nike’s Brutal Sell-Off Finally Be Running Out of Steam? The AI Buildout Needs Power It Cannot Get: 4 Energy Stocks Already Have It McDonald’s Is Undergoing a Massive New Growth Strategy. Can It Win Back Consumers? MGM Resorts Stock Sinks After Diller Deal Collapse: Overreaction or Warning?

Receive News & Ratings for Eli Lilly and Company Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Eli Lilly and Company and related companies with MarketBeat.com's FREE daily email newsletter.

Healthcare stocks have lagged broader equities over the past few years, but the company that is now the largest in that sector, Eli Lilly (LLY -0.61%), has delivered outstanding returns. One of the most important reasons for the drugmaker's run is that it has emerged as the leader in the anti-obesity market. Eli Lilly's Zepbound is currently the best-selling medicine in this niche, and it is posting outstanding sales growth. However, Eli Lilly has several pipeline candidates, and one of them could be even better than Zepbound.

Image source: The Motley Fool.

Triple G for the winZepbound was a breakthrough. It became the first medicine to mimic the GLP-1 and GIP gut hormones and be approved for weight loss. Its main competitor, Wegovy, only mimics GLP-1. The dual hormonal pathway approach has proved highly effective. Zepbound has produced greater weight loss than Wegovy in head-to-head trials.

Eli Lilly is going one step further with its next-gen medicine, retatrutide. This investigational therapy mimics the actions of GLP-1, GIP, and glucagon.

Eli Lilly dubbed it "Triple G." Does the fact that retatrutide mimics the action of three gut hormones result in greater weight loss than Zepbound?

So far, the data suggest an affirmative answer to that question. Phase 3 study results for retatrutide are out, and they are excellent. For instance, in one Phase 3 study, patients who had type 2 diabetes and were either overweight or obese lost an average of up to 20.8% of their body weight over 80 weeks.

This is significant because people with diabetes typically have a much harder time dropping pounds. It's always hard to compare across clinical trials, but note that Zepbound helped a similar population of patients lose up to 15.7% of their weight.

These weren't head-to-head studies, and retatrutide's trial was longer. Still, the medicine's results have been excellent. We could also point to retatrutide's up to 28.3% average weight loss in patients who were overweight or obese, compared to Zepbound's 20.2% average in a similar population.

Retatrutide has also shown strong clinical trial results in other conditions, including obstructive sleep apnea, reducing severity by up to 60.6% in a Phase 3 study. The medicine is undergoing several additional studies and could be used to treat many indications. Eli Lilly plans on formally requesting approval for the medicine in the first quarter of 2027.

Premium Feature

Moneyball Superscore

94/100

Today's Change

(

-0.61

%) $

-7.00

Current Price

$

1,142.85

An embarrassment of richesMany companies are looking to enter the weight loss market and challenge Eli Lilly. On the one hand, that poses a problem for the pharmaceutical company. More weight loss drug launches will lead to more competition and, potentially, less pricing power for the healthcare giant. But there are at least two reasons why investors should be cautiously optimistic about the company's prospects.

First, the anti-obesity market is growing fast and should continue to do so for at least the next five years. Estimates vary, but according to some research, the weight-loss market will grow at a compound annual rate of 27% through 2036. So, there should be more than enough space for multiple winners.

Second, Eli Lilly's pipeline suggests the company could remain the undisputed leader in this market for a while.

It's not just retatrutide either. Consider another one of the company's promising candidates: eloralintide. This medicine mimics the action of the amylin hormone. Eli Lilly recently posted Phase 2 study results for the combination of eloralintide and tirzepatide (the active ingredient in Zepbound) for patients who were either overweight or obese and had type 2 diabetes.

The combo treatment led to a mean weight loss of 23.3% in a mere 48 weeks, beating tirzepatide's mean weight loss of up to 14.8% in the same study. Lilly plans to start Phase 3 clinical trials for this combination treatment in the fourth quarter. In another mid-stage clinical trial, eloralintide demonstrated GLP-1-like efficacy and strong tolerability, which could particularly appeal to patients who avoid weight-loss medicines due to side effects.

Eli Lilly has additional pipeline candidates, including many outside its core therapeutic area, as the company has sought to diversify in recent years. Investors should expect significant clinical and regulatory progress over the medium term. In the meantime, Eli Lilly could continue to post excellent financial results and deliver above-average market returns.

It's still time to invest in the stock.

Eli Lilly just posted a 47.7% revenue surge while rivals like Novo Nordisk are watching earnings fall, and a fresh pipeline catalyst could push Lilly toward a valuation Wall Street has only seen from two companies in history.

This post may contain links from our sponsors and affiliates, and Flywheel Publishing may receive compensation for actions taken through them.

Eli Lilly (NYSE:LLY | LLY Price Prediction) trades at $1,184.92, which gives it a market value of about $1.057 trillion. The 24/7 Wall St. price target for Eli Lilly is $1,401.42 over the next 12 months. That means 18.27% upside and earns a high-confidence buy rating from our model.

24/7 Wall St. Price Target Summary Metric Value Current Price $1,184.92 Price Target from 24/7 Wall St. $1,401.42 Upside/Downside 18.27% Recommendation BUY Confidence Level 90% If shares hit our target, Lilly would be worth about $1.25 trillion. A $2 trillion valuation would take a share price near $2,243 on today’s share count. It sits above our base-case 2031 milestone of $2,000.56, so the headline goal depends on the pipeline outperforming.

A Blowout Q2 and Fresh Retatrutide Data Keep Lilly Near Its Highs Shares have gained 1.21% over the past week, 10.74% year to date and 64.04% over the past year. The stock sits 8.3% below its 52-week high of $1,292.65.

Second-quarter revenue of $22.97 billion rose 47.7% and beat the $20.69 billion consensus. EPS of $8.38 exceeded the $6.58 estimate even after $3.03 of acquired IPR&D charges. Management also raised full-year revenue guidance to $85 billion to $87 billion.

September added to the momentum. The FDA approved Onswik, a once-weekly insulin, on September 24. At the EASD meeting, Lilly presented new retatrutide results and a comparison in which Foundayo beat oral semaglutide.

Why Bulls See $1,460 and Beyond Lilly plans to file retatrutide in Q1 2027, after trial patients lost up to 71.2 lbs. Foundayo prescribers rose to about 36,000, and a global rollout is planned for 2027.

Medicare’s GLP-1 Bridge Program opened coverage to 20 million eligible Americans. Analysts expect 2027 EPS of $47.5425, up from $44.4568 90 days ago. The consensus target is $1,328.83. Our bull case hits $1,460.67, or 23.27% upside.

Falling GLP-1 Prices Could Stall the Rally Excluding rebate adjustments, U.S. prices fell 9% last quarter. Mounjaro and Zepbound brought in $14.9 billion, most of Lilly’s revenue. Generic semaglutide is now on sale in India and Brazil, and the retatrutide filing pathway faces litigation. One analyst rates the stock Sell and another Strong Sell.

The bear case of $1,191.31 suggests little gain from here. On the other side, the IPR&D charges come from acquisitions and do not repeat. Volume growth also more than made up for lower prices.

Lilly Earns Its Premium Over Novo Nordisk, Merck and AbbVie Novo Nordisk (NYSE:NVO) is Lilly’s direct GLP-1 rival. It trades at 12x forward earnings, but quarterly earnings fell 20.6%. Merck (NYSE:MRK) shows what a mature pharma multiple looks like. AbbVie (NYSE:ABBV) competes with Lilly in immunology.

Company Forward P/E Quarterly Revenue Growth Eli Lilly 24x 47.7% Novo Nordisk 12x 2.1% Merck 15x 5.1% AbbVie 16x 10.2% Lilly is growing revenue several times faster than any of these peers. That growth supports its higher multiple and makes the 24/7 Wall St. price target look reasonable.

Lilly Still Has Room to Run The 24/7 Wall St. price target of $1,401.42 carries a buy rating and high confidence. What tips the scale is rising earnings estimates.

Bulls stay in control if volume continues outpacing price cuts and retatrutide files on schedule. Bears take over if U.S. price declines grow faster than prescriptions. Right now, the growth numbers favor the bulls.

Here is where our model projects Lilly trading if current growth trends and market conditions hold.

Year Price Target from 24/7 Wall St. 2026 $1,233.89 2027 $1,406.11 2028 $1,583.87 2029 $1,748.51 2030 $1,889.79 These projections assume Lilly continues executing its current strategy. Retatrutide’s approval or faster GLP-1 price erosion could drive results well above or below this path.

Contact [email protected] for any questions or corrections.

Eli Lilly (LLY -0.63%) has emerged as the leader in the weight-loss market and is posting excellent financial results, partly thanks to its position in this area. And although the company will face more competition in the next few years, it will also benefit from a rapidly expanding anti-obesity market. In fact, Eli Lilly recently announced an initiative that could broaden its reach in the global weight-loss space and help it capitalize on it for years to come.

Image source: The Motley Fool.

Making weight loss drugs more accessibleOn Sept. 28, Eli Lilly announced an initiative dubbed the Lilly Change the Course Commitment. The goal is simple: Eli Lilly wants to treat as many patients with diabetes and obesity in resource-limited settings -- including low- and middle-income countries (LMICs) -- as it does in more affluent places like the U.S. before 2040. There is a massive addressable market here.

As Eli Lilly points out, roughly 70% of adults with obesity and 80% of adults with diabetes live in LMICs. Yet, there is just one adult in these countries with access to Eli Lilly's relevant medicines (which are among the world leaders) for every four adults who have access to these drugs in richer countries. Increasing access to its groundbreaking therapies could help Eli Lilly significantly expand its addressable market worldwide.

A closer look at the market opportunity One reason pharmaceutical companies tend to target richer countries is that revenue per patient in these countries is much higher than in LMICs. However, in this case, the sheer number of potential patients in other countries could more than offset that. According to the World Health Organization, as of 2022, 2.5 billion people worldwide were overweight, and 890 million of them were obese. That's several times the entire population of the U.S., never mind the number of Americans who are overweight or obese.

In addition, about 830 million people worldwide have diabetes, although there is a significant overlap between the diabetic and obese populations. Still, that's a massive worldwide addressable opportunity. Provided Eli Lilly can manufacture some of its weight-loss medicines at scale and at relatively low cost, it could tap into this large worldwide opportunity.

Premium Feature

Moneyball Superscore

92/100

Today's Change

(

-0.63

%) $

-7.23

Current Price

$

1,149.85

That's why the company's Foundayo -- its oral GLP-1 anti-obesity drug -- may become an important part of this plan. Foundayo, a small-molecule pill, could offer manufacturing and distribution advantages over Zepbound, an injectable peptide-based medication that is currently the best-selling product in this area. Even with substantially lower prices in low-income countries, Foundayo could generate meaningful sales for Eli Lilly if it achieves significant penetration in LMICs over the next decade.

What this means for Eli Lilly's prospectsAs part of its Lilly Change the Course Commitment, Eli Lilly plans to work with regulators and local health systems in LMICs, as well as with global health organizations, to train community health workers. In other words, the drugmaker could help strengthen healthcare infrastructure and build a network of connections in these countries that could outlast 2040, the year it plans to achieve its ambitious goal.

That is an important facet of this plan that investors shouldn't neglect. Eli Lilly's initiative could establish it as a more global healthcare powerhouse with a significant footprint across many LMICs, potentially giving it a competitive edge in these markets that could allow it to access more patients (perhaps including in areas outside of diabetes and weight loss) than most of its pharmaceutical peers in these countries long after 2040.

Now, it's essential to highlight that most of the company's revenue and earnings should still come from countries like the U.S. That is unlikely to change. But this initiative could materially impact the company's financial results for many years to come. There are already plenty of reasons to invest in the stock.

Eli Lilly is a leader in the weight-loss market, has a deep pipeline, has significantly diversified its portfolio in recent years, and has invested in artificial intelligence to discover and develop drugs more quickly and cheaply. This new plan is the icing on the cake.

Eli Lilly (LLY.N) said on Wednesday its experimental combination weight-loss drug outperformed its ​blockbuster Zepbound in a head-to-head trial, intensifying the competition with Danish rival Novo Nordisk (NOVOb.CO) for new, more effective obesity therapies.

The Indianapolis-based drugmaker said patients ‌with diabetes on the highest tested dose of EloraTZP, which combines tirzepatide and experimental drug eloralintide, lost an average of 23.3% of body weight over 48 weeks. That compared with 14.8% for patients on the highest dose of Zepbound in the mid-stage trial.

Tirzepatide is the active ingredient in Zepbound as well as Lilly's diabetes drug Mounjaro.

Kenneth Custer, president of Lilly's cardiometabolic health division, said in an interview that ​he expected the combo drug would offer "the best balance of efficacy, safety, and tolerability" within Lilly's obesity portfolio and among competitors.

He noted that the treatment produced ​significant weight loss in patients with diabetes, a group that historically faces greater challenges with weight management.

Custer said it was possible the ⁠combination could produce even greater weight loss in later trials than retatrutide, another promising Lilly experimental obesity medication. In a late-stage trial, the highest dose of retatrutide drove an average ​weight reduction of up to 28.3% over 80 weeks in patients without diabetes.

EloraTZP also cut blood sugar levels, lowering A1C by up to 2.9% versus 2.4% for tirzepatide alone, according ​to data presented at the European Association for the Study of Diabetes meeting in Milan.

Patients stopped taking EloraTZP in the trial at a rate of 10.8% to 27% depending on the severity of their side effects as multiple doses were tested. That compared with a dropout rate of 0% to 10.8% with eloralintide alone, 2.9% for tirzepatide and 16.7% for those who received a placebo.

The most common side ​effects were mild to moderate gastrointestinal issues that occurred mainly during dose escalation and were more frequent in the combination arms than with either drug alone, the company said.

Lilly, ​in a press conference to discuss the results, said the higher discontinuation rate was due to patients ramping up doses of two drugs at once. It said the company will improve escalation ‌schedules in longer, ⁠late-stage trials.

COMPETITIVE LANDSCAPE
The results raise the stakes in a fight between Lilly and Novo for share of the global weight-loss market forecast by some analysts to reach $100 billion to $150 billion annually by the end of the decade.

Novo is on track to launch the first combination obesity drug, CagriSema, early next year. Expectations for that medication took a hit in February when it fell short of Lilly's high-dose tirzepatide in a head-to-head trial, despite achieving a 23% average weight reduction over 84 weeks.

Novo's fortunes have reversed sharply from its days of ​dominating the market with the 2021 arrival ​of powerful obesity drug Wegovy that ⁠propelled its valuation above $600 billion. The Danish drugmaker's shares have tumbled more than 70% from their record highs in the face of stiff competition from US rival Lilly.

Eli Lilly executives said it was too early to determine the ideal patient profile for its combination therapy, ​but noted it could serve individuals needing 20% to 30% weight loss, or those who fail to achieve their goals on ​Zepbound, by targeting a ⁠hormone pathway linked to hunger and thoughts about food.

Eloralintide belongs to a class of drugs known as selective amylin receptor agonists, which target a different hormone than GLP-1 Zepbound.

In the multi-arm EloraTZP trial of 367 obese or overweight adults with type 2 diabetes in the US and Argentina, eloralintide alone led to an average weight loss of 12.3% on the second highest dose ⁠tested, and ​11.1% on the highest, while those taking a placebo lost just 3%.

The company said it plans to ​start late-stage trials for EloraTZP in the fourth quarter of 2026, while late-stage trials of eloralintide in obese and overweight patients with and without diabetes were ongoing.

"Obesity and type 2 diabetes are interconnected, and we are seeing ​the potential benefit of targeting multiple hormonal pathways to address both," said Liana Billings, the study's lead researcher.

In this new analysis, Zepbound 15 mg showed 4.5% greater weight loss than Wegovy HD in adults with obesity

Participants receiving Zepbound 15 mg had more than three times the odds of achieving at least 20% body-weight reduction compared with Wegovy HD

, /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Foundayo (orforglipron), today announced results from a new analysis showing that Zepbound (tirzepatide) 10 mg and 15 mg, a dual GIP and GLP-1 receptor agonist, delivered greater weight loss than Wegovy HD (semaglutide injection 7.2 mg) in adults with obesity. The findings come from an indirect treatment comparison of Zepbound and Wegovy HD, drawing on data from the SURMOUNT-1 and STEP UP trials.1,2,3 These results, presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan, Italy, add to the growing body of evidence comparing Zepbound and Wegovy, including SURMOUNT-5, a randomized controlled Phase 3b trial in which Zepbound 10 mg and 15 mg demonstrated superior weight loss compared with Wegovy 1.7 mg and 2.4 mg.

"For people living with obesity, the choice of treatment matters, and clinicians increasingly want evidence on how the available options compare," said John Wilding, DM, professor of medicine at the University of Liverpool. "Tirzepatide 10 mg and 15 mg and semaglutide 1.7 mg and 2.4 mg were compared directly in SURMOUNT-5, where tirzepatide helped people with obesity lose more weight. In the absence of a head-to-head trial comparing tirzepatide 15 mg against semaglutide 7.2 mg, this indirect comparison offers useful evidence for physicians as they make treatment decisions."

In the indirect treatment comparison, which was covariate-adjusted for gender, age, baseline weight and baseline A1C, Zepbound 10 mg and 15 mg were associated with greater reductions in body weight than Wegovy HD at 72 weeks using the treatment-regimen estimand.4,5 Participants taking Zepbound 15 mg lost 4.5% more of their body weight (95.0% CrI: -6.3, -2.8) on average, and those taking 10 mg lost 3.2% more of their body weight (95.0% CrI: -5.0, -1.4).  Using the efficacy estimand, Zepbound 15 mg and 10 mg were associated with 1.8% (95.0% CrI: -3.8, 0.1) and 0.7% (95.0% CrI: -2.6, 1.3) greater mean weight reduction than Wegovy HD, respectively, though these differences did not reach statistical significance.6

"People with obesity have more treatment options than ever before, and their healthcare providers deserve as much information as possible to help guide their decisions," said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. "In a head-to-head Phase 3 clinical trial, Zepbound 10 mg and 15 mg delivered greater weight loss than Wegovy 1.7 mg and 2.4 mg, and a new indirect treatment comparison suggests the same doses of Zepbound may outperform Wegovy HD, as well. Together, these results offer physicians more information as they choose a treatment path."

In addition to achieving greater weight loss, participants taking Zepbound 15 mg were four times more likely to achieve 20% or greater body weight reduction compared with Wegovy HD using the efficacy estimand (odds ratio 4.15; 95.0% CrI: 1.02, 15.64), and more than three times more likely using the treatment-regimen estimand (odds ratio 3.54; 95.0% CrI: 1.05, 11.05). While not statistically significant, participants taking Zepbound 10 mg had more than two times the odds of achieving at least 20% body-weight reduction compared with Wegovy HD using the efficacy (odds ratio 2.8; 95.0% CrI: 0.7, 10.8) and treatment-regimen estimands (odds ratio 2.46; 95.0% CrI: 0.7, 7.8).

Zepbound 10 mg and 15 mg showed comparable rates of treatment discontinuation due to adverse events versus Wegovy HD across both estimands.

About SURMOUNT-1 and the SURMOUNT clinical trial program  
SURMOUNT-1 (NCT04184622) is a multi-center, randomized, double-blind, parallel, placebo-controlled trial comparing the efficacy and safety of tirzepatide 5 mg, 10 mg and 15 mg to placebo as an adjunct to a reduced-calorie diet and increased physical activity in adults without type 2 diabetes who have obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease. The trial randomized 2,539 participants across the U.S., Argentina, Brazil, China, India, Japan, Mexico, Russia and Taiwan in a 1:1:1:1 ratio to receive either tirzepatide 5 mg, 10 mg or 15 mg or placebo. The co-primary objectives of the study were to demonstrate that tirzepatide 10 mg and/or 15 mg is superior in percentage of body weight reductions from baseline and percentage of participants achieving ≥5% body weight reduction at 72 weeks compared to placebo.

The SURMOUNT phase 3 global clinical development program for tirzepatide in chronic weight management began in late 2019 and has enrolled more than 5,000 people with obesity or overweight across six registration studies, four of which are global studies.

About SURMOUNT-5
SURMOUNT-5 (NCT05822830) was a 72-week, multi-center, randomized, open-label, Phase 3b trial evaluating the efficacy and safety of Zepbound (tirzepatide) compared with Wegovy (semaglutide) in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea (OSA) or cardiovascular disease, who did not have diabetes. Participants in both treatment groups received counseling on a reduced-calorie diet and increased physical activity. The trial randomized 751 participants across the U.S. and Puerto Rico in a 1:1 ratio to receive maximum tolerated dose of Zepbound (10 mg or 15 mg) or Wegovy (1.7 mg or 2.4 mg). With tirzepatide, 89.3% received at least one dose of the 15 mg dose and with semaglutide 92.8% received at least one dose of the 2.4 mg dose. The primary objective of the study was to demonstrate Zepbound's superiority in percent change from baseline in body weight at 72 weeks compared to Wegovy.

For the primary endpoint, participants treated with Zepbound achieved an average weight reduction of 20.2% compared to 13.7% with Wegovy at 72 weeks using the treatment-regimen estimand, a 47% greater relative weight loss. Participants using Zepbound lost an average of 50.3 lbs (22.8 kg) and participants on Wegovy lost an average of 33.1 lbs (15.0 kg). 

About Zepbound (tirzepatide) injection
Zepbound (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Zepbound should be used with a reduced calorie diet and increased physical activity.

Endnotes and References

Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. New England Journal of Medicine. 2022;387(3):205-216. doi:10.1056/NEJMoa2206038. Wharton S, Freitas P, Hjelmesæth J, et al. Once-weekly semaglutide 7.2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial. The Lancet Diabetes & Endocrinology, 2025; 13, 949-963. https://doi.org/10.1016/S2213-8587(25)00226-8 Wilding J, Postma MJ, Jacobi D, et al. Tirzepatide 10 and 15 mg (SURMOUNT-1) vs semaglutide 7.2 mg (STEP UP) in adults with obesity without type 2 diabetes: an indirect treatment comparison. Presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD). Weight loss data represent an ML-NMR analysis. Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation. Efficacy estimand represents efficacy prior to discontinuation of study drug. U.S. ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:

obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children. Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. KwikPen®: Do not share your KwikPen with other people, even if the pen needle has been changed.  You may give other people a serious infection or get a serious infection from them.

Zepbound may cause serious side effects, including:

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.

Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Zepbound

 Your healthcare provider should show you how to use Zepbound before you use it for the first time.  Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.  If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound. Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may call 1-844-524-0039 or email at [email protected] or visit https://pregnancyregistry.lilly.com/zepbound. How to take

Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or
have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously). Use Zepbound 1 time each week, at any time of the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.

Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.

This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.

ZP CON BS 01SEP2026
Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. 

U.S. FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo™ (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.

Foundayo should not be used with other GLP-1 receptor agonist medicines. It is not known if Foundayo is safe and effective for use in children. Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo. Foundayo may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.

Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.

Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.

Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking Foundayo

Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. Review these questions with your healthcare provider:

❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?

How to take

Take Foundayo exactly as your healthcare provider tells you to. Use Foundayo with a reduced-calorie diet and increased physical activity. Take Foundayo by mouth 1 time each day, with or without food. Swallow tablets whole. Do not break, crush, or chew the tablet. If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day. Do not take more than 1 tablet per day. If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment. If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.

This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.

OG CON BS APR2026

Foundayo™ is a trademark of Eli Lilly and Company.

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements 
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Zepbound (tirzepatide) as a treatment for adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, or that Zepbound will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

SOURCE Eli Lilly and Company

Foundayo 17.2 mg was associated with 1.5% greater weight loss and 0.3% greater A1C reduction than oral semaglutide 25 mg at 52 weeks

These additional analyses build on findings of the ACHIEVE-3 head-to-head study, where Foundayo 9 mg and 17.2 mg delivered greater A1C and weight reductions than oral semaglutide 14 mg

, /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide), today announced results from a new analysis showing that Foundayo (orforglipron) 17.2 mg was associated with significantly greater weight loss and better blood sugar control than oral semaglutide 25 mg in adults with type 2 diabetes. The findings are based on an indirect treatment comparison of Foundayo 17.2 mg against oral semaglutide 25 mg, drawing on data from ACHIEVE-3 and PIONEER PLUS.1,2,3,4 Presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan, Italy, these results add to a growing body of evidence supporting Foundayo's efficacy.

"For someone managing type 2 diabetes, the choice between treatments is a decision that impacts their life every day," said Deborah Horn, D.O., director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston. "Having data to help us compare available medications provides clinicians the opportunity to make informed treatment choices that fit each patient's needs."

In an indirect treatment comparison using data from ACHIEVE-3 and PIONEER PLUS, Foundayo 17.2 mg showed significantly greater weight loss and A1C reduction compared to oral semaglutide 25 mg at 52 weeks.5 On average, participants taking Foundayo 17.2 mg lost 1.5% more of their body weight compared to oral semaglutide 25 mg (95% CI -2.7%, -0.2%). Additionally, Foundayo lowered A1C by 0.3% more than oral semaglutide 25 mg (95% CI -0.6%, -0.1%). This analysis was covariate-adjusted for gender, age, baseline A1C and baseline weight. Analyses using different statistical methods produced consistent results, with Foundayo 17.2 mg showing 1.5% to 2.4% greater weight loss and 0.3% to 0.6% greater A1C reduction compared to oral semaglutide 25 mg. 

"Head-to-head trials ultimately provide the best comparison of two medicines, but when we don't yet have those data, then other approaches can provide informative data points," said Rachel Batterham, OBE, MBBS, Ph.D., FRCP, senior vice president of medical innovation and external engagement, Lilly Cardiometabolic Health. "Results from this indirect treatment comparison suggest that Foundayo may deliver A1C and weight lowering that is similar to the 25 mg dose of oral semaglutide. These results, paired with simple administration free of fasting or water restrictions, are what make Foundayo a potentially foundational therapy for adults managing type 2 diabetes around the world."

About Foundayo (orforglipron)
Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence. 

About ACHIEVE-3 and ACHIEVE clinical trial program
ACHIEVE-3 (NCT06045221) is a Phase 3, 52-week, randomized, open-label trial evaluating the efficacy and safety of orforglipron compared with oral semaglutide (Rybelsus) in adults with type 2 diabetes inadequately controlled with metformin. The trial randomized 1,698 participants across the U.S., Argentina, China, Japan, Mexico and Puerto Rico to receive either 9 mg or 17.2 mg orforglipron or 7 mg or 14 mg oral semaglutide in a 1:1:1:1 ratio. The primary objective of the study was to demonstrate that orforglipron is non-inferior in A1C reduction from baseline after 52 weeks compared with oral semaglutide when comparing the lower and higher doses.

In ACHIEVE-3, Foundayo lowered A1C by an average of 1.9% (9 mg) and 2.2% (17.2 mg) compared to 1.1% (7 mg) and 1.4% (14 mg) with oral semaglutide at 52 weeks. Foundayo also delivered greater weight loss, with participants losing an average of 14.6 lbs (6.7%; 9 mg) and 19.7 lbs (9.2%; 17.2 mg) compared to 7.9 lbs (3.7%; 7 mg) and 11.0 lbs (5.3%; 14 mg) with oral semaglutide.

The ACHIEVE Phase 3 global clinical development program for orforglipron enrolled more than 6,000 people with type 2 diabetes across five global registration trials.

Endnotes and References

Rosenstock J, Yabe D, Cox D, et al. Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (ACHIEVE-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial. Lancet. 2026 Mar 21;407(10534):1147-1160. https://doi.org/10.1016/S0140-6736(26)00202-3. Epub 2026 Feb 26. PMID: 41765029. Aroda V, Aberle J, Bardtrum L, et al. Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial. The Lancet, 2023; 402, 693-704. https://doi.org/10.1016/s0140-6736(23)01127-3 Cheng A, Jacobi D, Mojdami D, Li J, Li J, Zhao Y, Terrell K, Liu-Seifert H. Oral orforglipron 17.2 mg versus oral semaglutide 25 mg in adults with type 2 diabetes and BMI ≥25kg/m2: an indirect treatment comparison. A 25 mg once-daily dose of oral semaglutide is not approved in the United States for the treatment of type 2 diabetes. Novo Nordisk has submitted an application to the FDA seeking approval of that dose. All data referenced in this press release are based on the efficacy estimand. In ACHIEVE-3, the efficacy estimand represents treatment efficacy had all randomized participants remained on study intervention (with possible dose interruptions and/or dose modifications) for 52 weeks without initiating additional antihyperglycemic medications (>14 days of use). In PIONEER PLUS, the corresponding estimand is termed as the trial product estimand in the manuscript. U.S. FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS 
Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. 

Foundayo should not be used with other GLP-1 receptor agonist medicines.  It is not known if Foundayo is safe and effective for use in children.  Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. 

Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).  Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).  Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.  Foundayo may cause serious side effects, including: 

Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. 

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away. 

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. 

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery. 

Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. 

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo. 

Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. 

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures. 

Common side effects 
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. 

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. 

Before taking Foundayo 

Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.  Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).  If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.  Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.  Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?  

How to take 

Take Foundayo exactly as your healthcare provider tells you to.  Use Foundayo with a reduced-calorie diet and increased physical activity.  Take Foundayo by mouth 1 time each day, with or without food.  Swallow tablets whole. Do not break, crush, or chew the tablet.  If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.  Do not take more than 1 tablet per day.  If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.  If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.  Learn more 
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com. 

This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.

OG CON BS APR2026

Foundayo™ is a trademark of Eli Lilly and Company.

U.S. ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:

obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.

Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. KwikPen®: Do not share your KwikPen with other people, even if the pen needle has been changed.  You may give other people a serious infection or get a serious infection from them.

Zepbound may cause serious side effects, including:

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.

Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Zepbound

Your healthcare provider should show you how to use Zepbound before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound. Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may call 1-844-524-0039 or email at [email protected] or visit https://pregnancyregistry.lilly.com/zepbound. How to take

Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or
have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously). Use Zepbound 1 time each week, at any time of the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.

Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.

This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.

ZP CON BS 01SEP2026
Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. 

About Lilly   
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY 

Cautionary Statement Regarding Forward-Looking Statements 
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Foundayo (orforglipron) as a potential treatment for adults with type 2 diabetes and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned or that future study results will be consistent with study results to date, that Foundayo will prove to be a safe and effective treatment for adults with type 2 diabetes or other potential indications, that Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Trademarks and Trade Names 
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. 

SOURCE Eli Lilly and Company

Through this commitment, Lilly aims to expand access to its innovative diabetes and obesity medicines to as many people in resource-limited settings, including low- and middle-income countries (LMICs), as in high-income countries, before 2040

Key highlights:

Lilly today launched the Lilly Change the Course Commitment, a new global health initiative with a simple, yet ambitious goal: parity in the number of patients treated. This means treating as many people in resource-limited settings, including LMICs1, as in high-income countries. As a medicine company and a leader in diabetes care for over a century, Lilly is stepping up to help close a long-standing access gap in prevention, detection, treatment and care of diabetes and obesity. As part of the commitment, Lilly will register its innovative diabetes and obesity medicines in LMICs and work with health systems, regulators, global health organizations, NGOs and other collaborators to help more people in resource-limited settings access the medicines and care they need. The commitment follows the completion of the Lilly 30x30 global health initiative, which helped expand access to quality healthcare for 40 million people in resource-limited settings in 2025, surpassing its original goal of helping 30 million people annually by 2030 — five years ahead of schedule.
  , /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) is launching today the Lilly Change the Course Commitment, a new global health initiative that aims to achieve parity in patients treated with Lilly's innovative diabetes and obesity medicines. This means treating as many people with diabetes and obesity in resource-limited settings, including low- and middle-income countries (LMICs), as in high-income countries before 2040. Today, for every 4 people in high-income countries who have access to Lilly's diabetes and obesity medicines, only 1 person in low- and middle-income countries can reach them. To close this gap, Lilly will focus on three pillars: starting from clinical development of medicines, their registration and access pathways and health systems strengthening.    

The announcement follows the completion of the Lilly 30x30 global health initiative five years ahead of schedule, which expanded access to quality healthcare for 40 million people in resource-limited settings in 2025 – exceeding its original goal of reaching 30 million people annually by 2030.

Why is Lilly launching a new commitment now?
4 in 5 adults with diabetes and 7 in 10 adults with obesity live in LMICs, 2-4 and prevalence continues to rise. Historically, people in resource-limited settings have waited decades to access innovative medicines, long after their availability in high-income countries. As a result, the therapies capable of changing the trajectory of diabetes and obesity are still not reaching the people who need them. 

For more than a century, Lilly has been developing innovative medicines for people living with diabetes and obesity. As a leader in this field, Lilly aims to ensure that access to medicines keeps pace with scientific innovation.

David A. Ricks, Lilly chair and CEO: "For 150 years, Lilly has addressed some of humanity's most pressing health challenges by turning science into medicines that improve lives. That same commitment to scientific progress has transformed how we understand and treat diabetes and obesity, conditions that affect more than a billion people worldwide. But innovation only matters when it reaches the people who need it. That is why, as a medicine company that puts health above all, we are now going further. With the Lilly Change the Course Commitment, we aim to treat as many people in resource-limited settings as we do in high-income countries with our diabetes and obesity medicines. Innovative medicines like Foundayo (orforglipron), an oral treatment that can be stored at room temperature, will help us distribute and scale access across more LMICs."

How will Lilly close the gap?
Barriers in resource-limited settings extend beyond the availability of treatment and include fragmented health systems, limited healthcare infrastructure and persistent access gaps. To address them, the Lilly Change the Course Commitment is organized around three focus areas:

Developing medicines for people who need them: Lilly is working to ensure its diabetes and obesity medicines are suitable for people living in resource-limited settings from the earliest stages of clinical development, focusing on clinical trials, medical presentations and cold chain storage. Registering and expanding access to medicines to reach people sooner: Lilly intends to register its innovative diabetes and obesity medicines, including GLP-1s, in more low- and middle- income countries, working with regulatory agencies and local health systems to expand access sooner, with a focus on Africa, Latin America and Asia.  Helping strengthen health systems: Lilly aims to collaborate with global health organizations to help strengthen primary health systems by training community health workers, leveraging technology and digital tools, and improving disease awareness, prevention, diagnosis, and care in resource-limited settings. Together, these efforts aim to help more people extend their lifespan and enhance their quality of life by managing their diabetes and obesity earlier, reducing long-term complications, and, over time, preventing new cases of diabetes and obesity.

How will Lilly measure and report progress?
Lilly will report progress in treatment reach against the Lilly Change the Course Commitment through its annual Sustainability Report and at key global health forums.

About Foundayo™ (orforglipron) 
Foundayo™ (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day with no planning around food or drink.2 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orfoglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.   

INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo™ (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.  

Foundayo should not be used with other GLP-1 receptor agonist medicines.  It is not known if Foundayo is safe and effective for use in children.   Warnings — Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. 

Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).  Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).  Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.   Foundayo may cause serious side effects, including: 

Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.  

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away. 

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. 

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.  

Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. 

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo. 

Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. 

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.  

Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. 

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. 

Before taking Foundayo 

Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.  Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).  If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.  Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.  Review these questions with your healthcare provider: 

Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?  Do you have a history of diabetic retinopathy?  Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?  Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.  Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.  Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?  How to take 

Take Foundayo exactly as your healthcare provider tells you to.  Use Foundayo with a reduced-calorie diet and increased physical activity.  Take Foundayo by mouth 1 time each day, with or without food.  Swallow tablets whole. Do not break, crush, or chew the tablet.   If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.  Do not take more than 1 tablet per day.  If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.  If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.   Learn more 

Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.  

This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.

OG CON BS APR2026
Foundayo™ is a trademark of Eli Lilly and Company.

Endnotes
Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. https://doi.org/10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152.  

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. I-LLY

Trademarks and trade names
Trademarks and trade names in this release are the property of Lilly or their respective owners. The ® and ™ symbols are omitted for convenience only and do not waive any party's rights. Use of other companies' marks does not imply their endorsement, sponsorship, or affiliation.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the Lilly Change the Course Commitment and reflects Lilly's current beliefs and expectations. However, there can be no assurance that the Lilly Change the Course Commitment will achieve Lilly's objectives or that Lilly will execute its strategy as planned. For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Endnotes and references
1. Low- and middle-income countries (LMICs) are defined by the World Bank based on gross national income (GNI) per capita. For the current fiscal year, low-income economies are those with 2025 GNI per capita of $1,175 or less; lower-middle-income, $1,176–$4,635; upper-middle-income, $4,636–$14,375; high-income, above $14,375.
World Bank Country and Lending Groups. Accessed Sept. 2026. https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups

2. International Diabetes Federation. Global Diabetes Report 2000–2050. IDF Diabetes Atlas. Accessed Sept. 1, 2026. https://diabetesatlas.org/data-by-location/global/ 

3. Ahmed SK, Mohammed RA. Obesity: prevalence, causes, consequences, management, preventive strategies and future research directions. Metabol Open. 2025;27:100375. doi:10.1016/j.metop.2025.100375

4. Phelps NH, Singleton RK, Zhou B, et al. Worldwide trends in underweight and obesity from 1990 to 2022: a pooled analysis of 3663 population-representative studies with 222 million children, adolescents, and adults. The Lancet. 2024;403(10431):1027-1050. doi:10.1016/S0140-6736(23)02750-2

Refer to:     
Karine Mendelek; [email protected] (Media)
Michael Czapar; [email protected] (Investors)

SOURCE Eli Lilly and Company

 FDA approval supported by data from BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe alopecia areata (AA)

Treatment with Olumiant resulted in substantial scalp hair regrowth, as well as improvements in eyebrows and eyelashes

Severe AA can result in extensive hair loss during adolescence, a formative stage of life

, /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Olumiant (baricitinib), a once-daily pill, for the treatment of pediatric patients 12 years of age and older with severe alopecia areata (AA).1 The approval expands Olumiant's U.S. label, building on its established use in adults with moderately to severely active rheumatoid arthritis and severe AA.

AA is a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2% of people develop AA at some point in their lives,2 and nearly 40% of cases occur before the age of 20.3 Early-onset AA can be more severe and lead to extensive hair loss.3

"Today's approval marks an important milestone for young people living with severe alopecia areata and their families, who have had limited treatment options to date," said Adrienne Brown, executive vice president and president, Lilly Immunology. "The visible and often extensive hair loss that comes with severe alopecia areata can have a profound impact on anyone, especially adolescents who are at a pivotal stage of life. Expanding Olumiant to patients as young as 12 provides them a much-needed treatment choice and reinforces our commitment to advancing care for people living with immune-mediated diseases."

The FDA approval is based on 36-week data from the adolescent cohort (ages 12 to under 18) of BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe AA.4 At baseline, the median Severity of Alopecia Tool (SALT) score was 100, indicating complete scalp hair loss, and patients had been living with AA for a mean of 6.4 years.1

At Week 36, treatment with once-daily Olumiant delivered:1

80% or more scalp hair coverage, as measured by a SALT score ≤20, in 42% of patients treated with Olumiant 4 mg and 27% treated with Olumiant 2 mg, compared with 5% receiving placebo. 90% or more scalp hair coverage, as measured by a SALT score ≤10, in 37% of patients treated with Olumiant 4 mg and 21% treated with Olumiant 2 mg, compared with 2% receiving placebo. Improved eyebrow and eyelash coverage among patients with substantial eyebrow and eyelash hair loss at baseline treated with Olumiant 4 mg. The overall safety profile observed in pediatric patients 12 years of age and older with severe AA is consistent with the safety profile in adults with severe AA.1 The U.S. FDA-approved labeling for Olumiant includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis.1 See below for full Safety Summary.

"Severe alopecia areata that starts early in life can be more extensive and harder to treat over time, making it important to consider all available treatment options early in the course of disease," said Brittany Craiglow, M.D., adjunct associate professor of dermatology, Yale School of Medicine. "The evidence supporting Olumiant's approval is particularly meaningful because it comes from a Phase 3 study specifically designed for pediatric patients, helping clinicians and families make more informed decisions when considering advanced therapies."

Olumiant is available as 4 mg, 2 mg and 1 mg tablets.1 The recommended dose is Olumiant 2 mg/day, with an increase to 4 mg/day if treatment response is inadequate.1 For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg/day. Once an adequate response is achieved on 4 mg/day, the dosage is to be decreased to 2 mg/day.1

"Alopecia areata can affect much more than hair, particularly during adolescence, when young people are navigating important personal and social milestones," said George Gondo, chief mission officer, National Alopecia Areata Foundation. "More treatment choices mean more families have the opportunity to find the option that's right for their child, together with their doctor."

Lilly is committed to ensuring patients have access to much-needed medicines. Today, Olumiant has coverage at three of the largest pharmacy benefit managers (PBMs) for adults with severe AA.5 Through Lilly Support Services™ for Olumiant, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients.

Learn more about Olumiant; view the 2 mg and 4 mg product photos and brand logo.

Since 2017, more than 33,000 patients have been prescribed Olumiant in the U.S.6 Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly and is available through specialty pharmacies nationwide. In 2022, the FDA approved Olumiant for adult patients with severe AA, making it the first systemic treatment approved in the U.S. for this condition. In April 2026, the European Commission also approved Olumiant for the treatment of adolescents (ages 12 to under 18) with severe AA.

About BRAVE-AA-PEDS
BRAVE-AA-PEDS (NCT05723198) is an ongoing, placebo-controlled, Phase 3 clinical trial involving pediatric patients ages 12 to under 18 years with severe AA, as measured by a SALT score of ≥50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years.

The first two cohorts of patients enrolled in BRAVE-AA-PEDS included adolescents (ages 12 to under 18 years, weighing ≥ 30 kg). The first cohort included 257 adolescent participants who were randomized in a 1:1:1 ratio to receive once-daily placebo, Olumiant 4 mg or Olumiant 2 mg. The primary endpoint of this study was a SALT score ≤20 (i.e., 80% or more scalp hair coverage) at Week 36. The second cohort of 166 adolescents was randomized 1:1 to Olumiant 4 mg or Olumiant 2 mg to further accumulate safety data.7

About Olumiant 
Olumiant, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Baricitinib is approved in the U.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Olumiant is also approved for adults and pediatric patients 12 years of age and older with severe AA in the US, European Union and Japan. Olumiant is also approved for the treatment of hospitalized adults with COVID-19 in the U.S.

The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events and Thrombosis. See the full Prescribing Information here.1

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of Olumiant and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Olumiant® (O-loo-me¯ -ant) is a Janus kinase (JAK) inhibitor used to treat:

adults and adolescents 12 years and older with severe alopecia areata. adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated. It is not known if Olumiant is safe and effective in children with juvenile idiopathic arthritis or with severe alopecia areata who are younger than 12 years old.

Warnings - Olumiant may cause serious side effects, including:

Serious infections, including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you get symptoms of an infection, such as: fever, sweating, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning with urination or urinating more often than normal feeling tired If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.

Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors. Cancer and immune system problems. Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor's advice about having your skin checked for skin cancer while taking Olumiant. Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker. Get emergency help right away if you get any symptoms of a heart attack or stroke while taking Olumiant, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or on one side of your body slurred speech Blood clots in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant. Allergic reactions. While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious. Tears in the stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits. Low blood sugar (hypoglycemia) in people with diabetes. Low blood sugar, including serious low blood sugar, has happened in people with diabetes after starting Olumiant and other JAK inhibitors. Your doctor may check your blood sugar more often. While taking Olumiant, tell your doctor if you have diabetes and you have signs or symptoms of low blood sugar. Changes in laboratory test results. Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed. Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:

upper respiratory tract infections (cold or sinus infections) headache acne increased cholesterol levels increased muscle enzyme levels urinary tract infection increased liver enzyme levels inflammation of hair follicles (folliculitis) tiredness lower respiratory tract infections nausea genital yeast infection low red blood cell count (anemia) low white blood cell count (neutropenia) stomach-area (abdominal) pain shingles (herpes zoster) increased weight The most common side effects of Olumiant in people treated for rheumatoid arthritis include:

upper respiratory tract infections (cold or sinus infections) nausea herpes simplex virus infections, including cold sores shingles (herpes zoster) These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects. You can report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using
Before you use Olumiant, tell your doctor if you:

❑ Are being treated for an infection, have an infection that won't go away or keeps coming back, or think you have symptoms of an infection. 
❑ Have TB or have been in close contact with someone with TB.
❑ Have or had shingles (herpes zoster).
❑ Have or had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
❑ Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
❑ Are a current or past smoker. 
❑ Have or had a heart attack, other heart problems or stroke.
❑ Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
❑ Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
❑ Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
❑ Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. There is a pregnancy exposure registry that monitors women exposed to Olumiant during pregnancy. If you become pregnant during treatment with Olumiant call 1‑800‑284-1695 or visit https://pregnancyregistry.lilly.com to report the pregnancy.
❑ Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
❑ Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:

a medicine called probenecid. medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection. ❑ Are under age 18. It is not known if Olumiant is safe and effective in children for conditions other than alopecia areata or in children under 12 years of age.

How to take

Take Olumiant exactly as your doctor says. Take Olumiant once a day by mouth with or without food. Talk to your doctor if you cannot swallow tablets whole. If you take too much Olumiant, call your doctor or poison control center at 1‑800‑222‑1222, or go to the nearest hospital emergency room right away. Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979 or go to www.olumiant.com.

This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.

BA CON BS SEP2026

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

Trademarks and Trade Names 
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

Cautionary Statement Regarding Forward-Looking Statements 
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Olumiant (baricitinib) as a treatment for alopecia areata and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, and that Olumiant will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

References 
1 Olumiant. Prescribing Information. Lilly USA, LLC.
2 Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014;134(4):1141-1142. doi:10.1038/jid.2013.464
3 Villasante Fricke, A. C., & Miteva, M. (2015). Epidemiology and burden of alopecia areata: a systematic review. Clinical, cosmetic and investigational dermatology, 8, 397–403. https://doi.org/10.2147/CCID.S53985
4 Passeron T, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 36-week efficacy and safety results from a Phase 3 randomized, controlled trial. American Academy of Dermatology Annual Meeting. March 7-11, 2025.
5 Eli Lilly and Company. (2026, June 9). FDA approves Lilly's EBGLYSS® (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis [Press release]. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglyssr-lebrikizumab-lbkz-one-maintenance
6 Enterprise Longitudinal Access and Adjudication Dataset (ELAAD) - September 2026.
7Craiglow B, Piraccini BM, Ohyama M, et al. Impact of severity and disease course on baricitinib treatment response in adolescents with severe AA: updated data from the BRAVE-AA-PEDS trial. Presented at: Society for Pediatric Dermatology Annual Meeting; July 22-25, 2026; Minneapolis, MN.

Olumiant® and Lilly Support Services™ are trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
CMAT-51507 09/2026 © Lilly USA, LLC 2026. All rights reserved.

SOURCE Eli Lilly and Company

Eli Lilly (LLY -1.64%) is posting excellent financial results, with tirzepatide, a medicine that has earned indications for diabetes, weight management, and obstructive sleep apnea (OSA), currently the company's biggest growth driver. Tirzepatide was a breakthrough. It became the first approved therapy to mimic the actions of the GLP-1 and GIP gut hormones, a mechanism of action that likely contributes to its greater effectiveness than its biggest competitor, semaglutide.

However, Eli Lilly has several pipeline candidates in this area that could strengthen its position, and one of them is retatrutide. This compound isn't approved yet, but it is already generating plenty of buzz, with some analysts expecting it to generate up to $25 billion in peak annual sales. Let's find out why there is so much excitement surrounding retatrutide and what investors should do about it.

Image source: The Motley Fool.

Excellent clinical trial data Retatrutide goes one step further than tirzepatide by mimicking the action of three gut hormones: GLP-1, GIP, and glucagon. In theory, that makes retatrutide a differentiated asset that may push the boundaries of what approved weight loss medicines can do. This is no longer just a theory. Retatrutide has been successful in several Phase 3 clinical trials that enrolled patients with obesity or obesity and some obesity-related conditions.

For instance, in one study, the therapy led to an average weight loss of 28.3% in 80 weeks in obese patients. In another study, it helped overweight or obese patients with diabetes (for whom it is harder to lose weight) lose an average of 20.8% of their body weight over 80 weeks. It has also produced positive Phase 3 results in patients with obesity and OSA or knee osteoarthritis pain, as well as patients with severe obesity and cardiovascular disease. Retatrutide has been so impressive that there is already a black market for it, despite the medicine not yet being approved. Eli Lilly has had to seek legal action to stop the illegal sale of its next-gen weight-loss medicine.

Premium Feature

Moneyball Superscore

93/100

Today's Change

(

-1.64

%) $

-19.15

Current Price

$

1,150.99

Retatrutide's addressable marketRetatrutide could target a large pool of patients with obesity and other indications, given its Phase 3 results and ongoing clinical trials in areas such as chronic low back pain and metabolic dysfunction-associated steatotic liver disease. However, it could cannibalize tirzepatide's sales. Even so, there are several reasons retatrutide could be worth so much to Eli Lilly. Let's consider two.

First, it won't just compete with tirzepatide. There is unquestionably some overlap between the two. We should expect some patients currently on tirzepatide to switch to retatrutide, once it's approved. But retatrutide seems especially suitable for a specific subset of people with obesity, including those with severe, treatment-resistant cases. Eli Lilly has already made it available on a limited expanded-access basis to patients who meet certain criteria, including having refractory obesity. In other words, retatrutide should help expand the market. It will also target indications that tirzepatide won't.

Second, if tirzepatide loses $1 of sales to retatrutide, at least that stays within Eli Lilly's ecosystem. But if tirzepatide loses $1 of sales to a drug from one of the company's competitors, that's a worse outcome for the pharmaceutical giant. Retatrutide should help Eli Lilly retain some patients who might otherwise have switched to competing medicines as the weight-management landscape evolves and new drugs enter the market. That's another reason it is an important asset for Eli Lilly.

What is retatrutide worth?Eli Lilly plans to submit an application for regulatory approval for retatrutide in the first quarter of 2027. There is a high chance it will receive approval without a hitch, but it could later encounter clinical setbacks in ongoing studies. So, we have to estimate not only how much retatrutide could generate in sales in every indication, but also the probability that it will ace relevant clinical trials and eventually earn approval.

These complications partly explain why projections for retatrutide's sales vary wildly, but given the medicine's sales potential and the weight-loss market's incredible current pace of growth, the medicine is likely worth over $10 billion to Eli Lilly right now. It should help the company maintain its leadership in its core therapeutic area and expand its streak of excellent financial results. So, while the bears continue to expect the stock to decline significantly, investors should stay put: Eli Lilly stock is still a buy.

The U.S. Food and Drug Administration (FDA) on Friday granted full approval to Eli Lilly and Co.’s (NYSE:LLY) Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for pretreated breast cancer patients.

The approval covers estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated locally advanced or metastatic breast cancer (MBC), with disease progression following at least one line of endocrine therapy.

• Eli Lilly stock is trading at elevated levels. What’s ahead for LLY stock?

FDA Approval Backed by EMBER-3 TrialThe full FDA approval is based on the results of the Phase 3 EMBER-3 trial in patients with MBC whose tumors harbor an ESR1 mutation (n=159).

Among patients with ESR1-mutated MBC, Inluriyo in combination with Verzenio doubled median progression-free survival (PFS) versus Inluriyo alone, with a median PFS of 11.1 months versus 5.5 months.

Lilly continues to study Inluyiro in the ongoing Phase 3 EMBER-4 adjuvant trial, with initial results expected in 2027.

Financial Projections and Competitive EdgeIn an investor note on Tuesday, TD Securities wrote, “From a competitive standpoint, Inluriyo has the advantage of being approved and leverages the well-established Verzenio franchise.”

Analyst Steve Scala said physicians will likely weigh efficacy gains against chronic CDK4-related toxicities, particularly diarrhea and neutropenia, which were common in EMBER-3 despite low discontinuation rates.

Read Next

It remains uncertain whether physicians will use continuous ctDNA monitoring under AstraZeneca Plc’s (NYSE:AZN) Etcamah SERENA-6 protocol or wait for radiographic progression before initiating Inluriyo with or without Verzenio.

Lilly argues that switching both endocrine therapy and CDK4/6 inhibition at clinical progression could deliver better outcomes than earlier intervention.

However, direct comparisons between EMBER-3 and SERENA-6 are difficult because of differences in patient populations, treatment timing, and PFS measurement.

Future OpportunitiesScala sees the adjuvant breast cancer setting as the larger opportunity for oral SERDs, with giredestant awaiting approval and AstraZeneca and Eli Lilly awaiting readouts for their respective drugs.

TD Securities projects global Inluriyo sales of $290 million in 2026, rising to $1.05 billion by 2032.

LLY Price Action: Eli Lilly shares were up 0.32% at $1,168.60 at the time of publication on Tuesday, according to Benzinga Pro data.

Photo: Michael Vi / Shutterstock

Read Next

© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Eli Lilly just posted a quarter that crushed estimates on every major metric, yet the stock has spent the past month getting punished anyway. One of Wall Street's biggest banks thinks the selloff created the most compelling entry point in…

This post may contain links from our sponsors and affiliates, and Flywheel Publishing may receive compensation for actions taken through them.

Eli Lilly (NYSE:LLY | LLY Price Prediction) currently trades at $1,164.79, while Wall Street’s average analyst price target sits at $1,325.39. That leaves roughly 14% of implied upside between where the stock is and where the consensus says it belongs.

Lilly is the dominant force in the GLP-1 obesity and diabetes market, with Mounjaro and Zepbound now generating a combined $14.9 billion in a single quarter. Wall Street watches this stock closely because it is one of the largest healthcare companies in the world, with a market cap near $1.03 trillion, and because its pipeline may decide whether the entire obesity category becomes a multi-decade franchise.

Lilly just wrapped a rough stretch, and one major bank is arguing the selling is overdone.

A One-Month Slide That Peers Mostly Sidestepped Lilly shares have dropped 7.21% over the past month, sliding from about $1,255.40 to current levels even as the broader market pushed higher. Q2 revenue beat consensus by 11.06% and EPS came in 27.27% above estimates.

Pricing anxiety weighed on the stock. Realized U.S. prices fell 9% excluding rebate adjustments, and international pricing compressed after Mounjaro’s inclusion in China’s National Reimbursement Drug List. Investors also digested $2.78 billion in acquired IPR&D charges and fresh competitive noise from Novo Nordisk’s post-Wegovy strategy update on Monday.

Why Citi Still Sees a Path to $1,600 Citigroup’s Geoff Meacham carries a Street-high $1,600 price target with a reiterated Buy rating, implying roughly 37% upside from current levels. His model assumes Lilly holds a ~60% commanding global share of the obesity and type 2 diabetes markets, with next-generation assets like oral orforglipron and triple-agonist retatrutide extending the runway well into 2027 and beyond.

Of 30 analysts covering the name, 6 rate it Strong Buy, 18 Buy, 4 Hold, 1 Sell, and 1 Strong Sell. The 2027 EPS consensus climbed from $44.4551 ninety days ago to $47.3443, with 19 upward revisions in the trailing 30 days.

Near-term catalysts include a retatrutide BLA submission targeted for Q1 2027, continued ramp of oral Foundayo, and the Medicare GLP-1 Bridge Program that granted 20 million eligible Americans coverage at $50 per month.

Novo Nordisk (NYSE:NVO) closed at $39.81, down 7.93% in a single session after its post-Wegovy strategy update disappointed. With an average target of $46.80, implied upside is about 17.6%. Analysts skew Hold, with 11 Holds against 3 Buys and no Sells.

Viking Therapeutics (NASDAQ:VKTX) trades at $30.11 against a consensus target of $92.39, for an implied upside near 207%. That is a clinical-stage biotech skew: 5 Strong Buys, 13 Buys, and 2 Holds. Wall Street is pricing binary trial risk on a clinical-stage biotech.

Pfizer (NYSE:PFE) sits at $27.74 versus a $28.88 target, an underwhelming 4.1% of upside. Ratings lean Hold at 16 Holds, 10 Buys, and 2 Sells.

Among cash-generative large-caps, Lilly’s 14% consensus gap and Citi’s 37% bull case remain the most credible risk-adjusted setup.

Underperforming the Index Despite Trillion-Dollar Scale Year to date, Lilly is up 8.92%, trailing the S&P 500’s 13.43% gain. Over one year, Lilly has returned 55.89% against the SPDR S&P 500 ETF Trust (NYSEARCA:SPY) return of 16.54%.

Valuation reflects the growth premium. Lilly trades at a trailing P/E of 39 and a forward P/E of 24, on TTM revenue of $79.67 billion and TTM EPS of $29.75. Consensus sees 2026 EPS of $36.7319 rising to $47.3443 in 2027.

Bull Case Weighed Against Pricing and Pipeline Risk The bull case rests on retatrutide clearing the FDA on schedule, Foundayo maintaining its inflection (management says nearly one out of four new incretin starts are choosing it), and the Medicare Bridge Program expands U.S. access. In that scenario, 2027 EPS above $47 makes today’s forward multiple reasonable, and Citi’s $1,600 case becomes math rather than hope.

The bear case builds if pricing compresses faster than volume can offset, if retatrutide filing delays push growth into 2028, or if tariffs and payer pressure squeeze margins. Lilly is a premium multiple on premium execution; any crack reprices quickly.

Position sizing should account for volatility. Consensus at $1,325.39 is a reasonable base case; Citi’s $1,600 is the reward if the pipeline delivers.

Contact [email protected] for any questions or corrections.

New facility will manufacture active pharmaceutical ingredients for medicines like Foundayo (orforglipron), strengthening domestic supply chain

Site will employ more than 600 people in high-wage jobs

$12.5 million in support to build talent pipeline, workforce training center with San Jacinto College

, /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) broke ground today in Houston, Texas, one of ten U.S. manufacturing sites — and fifth location to produce domestic active pharmaceutical ingredients (API) — announced since 2020. As part of the company's $50 billion push to reshore medicine production to meet growing demand at home and export American-made medicines to people around the world, the $6.5 billion Houston site will manufacture Foundayo (orforglipron), Lilly's first synthetic oral GLP-1 medicine, along with other small-molecule medicines and advanced therapeutics.

Foundayo is a GLP-1 receptor agonist approved in the U.S. for weight management in adults with obesity, or adults with overweight and a weight-related condition. It is a small molecule rather than a peptide; small molecules are manufactured using more well-established technologies and therefore can be more readily scalable. Foundayo is currently under regulatory review in more than 40 countries, with a full global rollout targeted for 2027. Lilly is also studying Foundayo for other uses, including type 2 diabetes and obstructive sleep apnea, with data expected later this year.

David A. Ricks, Lilly Chair and CEO: "We are thrilled to break ground on our latest 'medicines made in America' site in the great state of Texas. This $6.5B investment will help change the game for tens of millions of people suffering from overweight, obesity and its consequences like diabetes. We will make and ship Lilly's latest products from Texas to people here at home and around the world."

Building a talent pipeline in Houston
Lilly is providing $12.5 million to support a relationship with San Jacinto College to give Houstonians a pathway into advanced chemical synthesis manufacturing careers, with no prior experience required. This relationship will focus on developing training pathways and expanding the equipment and facility capacity needed to produce technicians, operators, maintenance professionals, and other manufacturing talent, while also leveraging Lilly experts to support curriculum development and instructor readiness and preparation. Separately, Lilly is providing a $2.5 million charitable donation to the San Jacinto College Foundation to support scholarships for eligible students.

Lilly is currently hiring in Houston and expects the new facility to create more than 600 high-wage jobs like engineers, scientists, operations personnel, and lab technicians — along with 4,000 construction jobs as the site is being built and brought online. Visit the Lilly Houston career page for open positions or join Lilly's talent community for future opportunities.

Edgardo Hernandez, Executive Vice President and President of Lilly Manufacturing Operations: "When you invest in a place like Houston, you invest in its people first. This facility will run on the talent of this community, powered by our relationship with San Jacinto College. We're hiring across the greater Houston area to help residents build careers close to home. The facility itself is being built to the highest standards for safety, quality and responsible stewardship of the environment, and every one of these jobs helps bring innovative medicines to the patients counting on them."

In addition to Foundayo, the Houston site will focus on advanced therapeutics that were not within reach even a few years ago. This will include oligonucleotides, a class of medicines that can work at the genetic level to switch off the production of specific proteins to treat disease closer to its source.

Texas Governor Greg Abbott: "Texas is the global hub for life sciences. This $6.5 billion Lilly investment in Houston is the largest active pharmaceutical ingredient project in Texas history and will create more than 600 high-wage jobs, right here in Texas. Texas will produce these medicines at home so we can deliver life-changing treatments to millions of Americans."

Producing this pipeline of medicines at scale requires manufacturing capacity built to match the pace of innovation. Lilly has announced ten U.S. sites since 2020:

Five will produce API Richmond, Virginia; Huntsville, Alabama; Houston, Texas; and two sites in Lebanon, Indiana – Lebanon API and Lilly Medicine Foundry, which will also focus on new production methods and making medicines for clinical trials Four will make injectable medicines and manufacture devices Research Triangle Park and Concord, North Carolina; Kenosha, Wisconsin; and Lehigh Valley, Pennsylvania One will make genetic medicines, Lebanon Advanced Therapies The Houston site will use state-of-the-art technologies, including machine learning, AI, digitally integrated systems and advanced data analytics to drive right-first-time execution. Digital automation will be embedded throughout the site to streamline operations and ensure a reliable supply of safe, high-quality medicines.

Additional quotes for media use
Dr. Brenda Hellyer, Chancellor of San Jacinto College: "Eli Lilly's manufacturing investment in Generation Park is a tremendous opportunity for the Houston region. San Jacinto College is proud to work with Lilly to develop the skilled workforce needed to support the growth of biopharmaceutical manufacturing. Together, we will expand industry-informed education and hands-on training pathways that prepare students and incumbent workers with the technical skills these advanced manufacturing careers require. This relationship will build a strong, sustainable talent pipeline for Lilly while creating meaningful, high-demand career opportunities across our region."

For media use:

Foundayo™ (orforglipron) Digital Media Kit  About Foundayo™ (orforglipron)
Foundayo™ (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day with no planning around food or drink.2 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orfoglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.

INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo™ (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.

Foundayo should not be used with other GLP-1 receptor agonist medicines. It is not known if Foundayo is safe and effective for use in children. Warnings — Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo. Foundayo may cause serious side effects, including:
Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.

Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.

Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.

Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking Foundayo

Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. Review these questions with your healthcare provider:

Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? Do you have a history of diabetic retinopathy? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby. Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo. Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements? How to take

Take Foundayo exactly as your healthcare provider tells you to. Use Foundayo with a reduced-calorie diet and increased physical activity. Take Foundayo by mouth 1 time each day, with or without food. Swallow tablets whole. Do not break, crush, or chew the tablet. If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day. Do not take more than 1 tablet per day. If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment. If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.

This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.

OG CON BS APR2026

Foundayo™ is a trademark of Eli Lilly and Company.

Endnotes
Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. https://doi.org/10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152.

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, a nd today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. C-LLY

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including about planned capital investments in new manufacturing capacity, production and delivery of advanced therapies and medicines, including Foundayo, hiring and related initiatives and the economic impact thereof and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the manufacturing process, development and commercialization of pharmaceutical products any of which could impact the overall commercial success of our products, and as related to cost, completion timing, expected capacity, personnel, and other factors which could impact expected benefits of the capacity expansion and related initiatives. For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.   

SOURCE Eli Lilly and Company