Eli Lilly (LLY) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approving its IL-23p19 antibody Omvoh (mirikizumab) for expanded use in Crohn’s disease (CD).The CHMP has recommended Omvoh to treat adults with moderately to severely active CD, who have had an inadequate response with, lost response to, or are intolerant to conventional or biologic therapies. A final decision from the European Commission is now expected in the next one or two months.This positive r ...

SAN FRANCISCO and SUZHOU, China, Dec. 15, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, and Eli Lilly and Company (NYSE: LLY) today jointly announced a Distribution and Promotion Agreement in Mainland China regarding Lilly's non-covalent (reversible) Bruton's t ...

As a major pharmaceutical company that is constantly innovating and developing new treatments, Eli Lilly (LLY 0.86%) is always providing investors with additional reasons to consider buying its stock.On the other hand, the nature of its industry means that there will often be solid new reasons to be a bit more cautious about making an investment in it. Here are two new reasons to be in favor of making a purchase, and two yellow flags to consider before doing so.New data and new capital investments are going ...

Eli Lilly (LLY 0.86%) and Novo Nordisk (NVO -1.53%) have competed for decades. They're both leaders in the areas of insulin and broader diabetes drugs, where they've made significant breakthroughs and fought for market share.In recent years, these two healthcare leaders have also been butting heads in the GLP-1 weight loss space. Eli Lilly's Zepbound and Novo Nordisk's Wegovy are the two most prominent brands in this area, which is projected to grow by leaps and bounds in the coming years. Which of these co ...

With drugs like Novo Nordisk's Wegovy becoming household names over the last couple of years, it's no surprise that there are quite a few opportunities to invest in the burgeoning market for weight-loss medicines.There are a pair of businesses that are particularly appealing on the basis of their proven or potential ability to compete in that market. Both of these companies have outperformed the market for at least the last 12 months, and there's ample reason to believe that the outperformance could continu ...

I am a full-time analyst interested in a wide range of stocks. With my unique insights and knowledge, I hope to provide other investors with a contrasting view of my portfolio, given my particular background.If you have any questions, feel free to reach out to me via a direct message on Seeking Alpha or leave a comment on one of my articles.Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the ...

The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without prior biologic failure and was the basis for the positive opinion  VIVID-1 was the first pivotal Crohn's disease trial to show benefits in hard-to-treat symptom of bowel urgency using a patient-centric scale Omvoh will be the first treatment for Crohn's disease with results demonstrating improvements of histologic measures of inflammation included in its label, if approved by the European CommissionLilly has als ...

Eli Lilly (LLY) announced results from the phase III EMBER-3 study, which showed that treatment with its orally administered investigational drug imlunestrant significantly reduced the risk of disease progression or death in certain patients with advanced breast cancer (ABC).The EMBER-3 study enrolled patients with estrogen receptor (ER)-positive, HER2-negative ABC whose disease progressed during or following an aromatase inhibitor (AI) therapy, with or without a CDK 4/6 inhibitor. These patients were then ...

Eli Lilly (LLY -0.44%) may seem like an expensive stock to invest in right now. It's trading at close to 90 times its trailing earnings. Its $720 billion market capitalization also means it's the most valuable healthcare stock in the world.Although it may seem like it has hit a peak given the stock's slowdown in recent weeks, there could be a huge catalyst upcoming for the business next year. It's one that investors should keep a close eye on because it could send the stock to record highs in 2025.Data from ...

Clinical Trial Results - Imlunestrant as monotherapy significantly reduced the risk of progression or death by 38% compared to standard endocrine therapy (ET) in patients with ESR1 mutations [1] - Imlunestrant in combination with Verzenio reduced the risk of progression or death by 43% compared to imlunestrant alone, regardless of ESR1 mutation status [1] - Median progression-free survival (PFS) was 5.5 months with imlunestrant versus 3.8 months with standard of care ET in patients with ESR1 mutations [4] - Median PFS for imlunestrant-abemaciclib combination was 9.4 months versus 5.5 months for imlunestrant alone in all patients [6] - Overall response rate (ORR) was 27% for imlunestrant-abemaciclib versus 12% for imlunestrant alone [7] Study Design and Patient Population - EMBER-3 is a Phase 3, randomized, open-label study of imlunestrant, investigator's choice of endocrine therapy, and imlunestrant in combination with abemaciclib [11] - The trial enrolled 874 adult patients with ER+, HER2- locally advanced or metastatic breast cancer [11] - 32% of patients enrolled as first-line treatment for advanced breast cancer (ABC), and 64% as second-line treatment following progression on initial therapy [11] - Randomization was stratified by prior CDK4/6 inhibitor use, presence of visceral metastases, and geographic region [3] Safety and Tolerability - Safety profile of imlunestrant-abemaciclib was consistent with known safety profile of fulvestrant in combination with abemaciclib [8] - Most common adverse events included diarrhea (86%), nausea (49%), neutropenia (48%), and anemia (44%) [8] - Discontinuation rate due to adverse events was low at 6.3% [8] Market and Industry Context - Imlunestrant is an orally administered, brain penetrant, pure ER antagonist that delivers continuous ER target inhibition [9] - Current standard treatment for ER+ breast cancer after progression on initial endocrine therapy is fulvestrant, which is administered via intramuscular injection [9] - 72% of patients receiving fulvestrant reported injection site pain, swelling, or redness, highlighting the need for oral alternatives [9] - Imlunestrant is also being investigated in the adjuvant setting for ER+, HER2- early breast cancer (EBC) with an increased risk of recurrence [10] Breast Cancer Epidemiology - Breast cancer is the second most commonly diagnosed cancer worldwide, with an estimated 2.3 million new cases in 2022 [13] - In the US, it is estimated that there will be more than 310,000 new cases of breast cancer diagnosed in 2024 [13] - Approximately 30% of high-risk early-stage breast cancer cases in the US will become metastatic [12] - Five-year relative survival rates are 99% for localized disease, 86% for regional/locally advanced disease, and 30% for metastatic/advanced disease [12]