Amgen Hammered As 'Tough' Obesity Meeting Reminds It It's Not The Incumbent
Amgen stock dropped Monday after a "tough" American Diabetes Association discussion around its experimental weight-loss drug, MariTide. Dr. Julio Rosenstock, the director of the Dallas Diabetes Research Center at Medical City, reviewed MariTide at the ADA meeting in Chicago. If approved, MariTide would be a monthly shot to reduce weight, rivaling weekly injections from Eli Lilly and Novo Nordisk.
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5 hours ago
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Amgen Hammered As 'Tough' Obesity Meeting Reminds It It's Not The Incumbent
Amgen stock dropped Monday after a "tough" American Diabetes Association discussion around its experimental weight-loss drug, MariTide. Dr. Julio Rosenstock, the director of the Dallas Diabetes Research Center at Medical City, reviewed MariTide at the ADA meeting in Chicago. If approved, MariTide would be a monthly shot to reduce weight, rivaling weekly injections from Eli Lilly and Novo Nordisk.
Yahoo
6 hours ago
- Yahoo
Corcept Presents Data from Treatment Phase of CATALYST Trial at American Diabetes Association's 85th Scientific Sessions with Simultaneous Publication in Diabetes Care
Treatment with a cortisol modulator significantly improves glucose control in patients with hypercortisolism and difficult-to-control diabetes, accompanied by reductions in body weight, waist circumference and glucose-lowering medications CATALYST's prevalence phase identified hypercortisolism in 24 percent of patients with difficult-to-control type 2 diabetes REDWOOD CITY, Calif., June 23, 2025--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today presented data from the randomized, double-blind, placebo-controlled treatment phase of its CATALYST trial of Korlym® in patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes at the American Diabetes Association's 85th Scientific Sessions. CATALYST met its primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c (HbA1c), which decreased 1.47 percent from baseline, compared to a 0.15 percent decrease in patients who received placebo (p-value: < 0.001). Of the 91 patients in the treatment group, 65 (71%) received at least 600mg of Korlym and 28 (31%) received 900mg. Patients who received 900mg of Korlym had an improvement in HbA1c of 2.01 percent, compared to a 0.16 percent decrease in patients who received placebo (p-value: < 0.001). The trial also met its secondary endpoints, as patients who received Korlym exhibited significantly reduced body weight (5.1 kg; p-value: 0.001) and waist circumference (5.1 cm; p-value: 0.002), compared to patients who received placebo. Patients receiving Korlym achieved these improvements despite reducing or discontinuing their glucose-lowering medications. Adverse events in CATALYST were manageable and consistent with Korlym's known safety profile. The most common adverse events (> 20% of participants receiving Korlym) were hypokalemia, fatigue and nausea. The conference presentations can be found here. Results were published simultaneously in Diabetes Care, in an article titled "Inadequately Controlled Type 2 Diabetes and Hypercortisolism: Improved Glycemia With Mifepristone Treatment." CATALYST is the largest and most rigorous trial ever conducted to determine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes and assess the effect of treating patients found to have hypercortisolism with a cortisol modulator. The initial prevalence phase of the trial screened 1,057 patients with difficult-to-control type 2 diabetes (i.e., patients with HbA1c greater than 7.5 percent despite receiving multiple glucose-lowering medications, including best-in-class therapies such as GLP-1 agonists) at 36 sites in the United States. Based on results from a standard 1-mg dexamethasone suppression test, 24 percent of the patients screened were found to have hypercortisolism and were eligible to enter the trial's treatment phase, where they were randomized, 2:1, to receive either Korlym or placebo for 24 weeks. One hundred thirty-six patients enrolled in the treatment phase. "Many people with type 2 diabetes do not respond adequately to conventional glucose-lowering therapies," said John Buse, M.D., Ph.D., director of the University of North Carolina's Diabetes Center. "CATALYST shows that these patients should be screened for hypercortisolism and that treatment with a cortisol-directed therapy can confer significant clinical benefits, including meaningful reductions in HbA1c, body weight and waist circumference. These powerful findings provide important guidance for physicians treating patients with difficult-to-control type 2 diabetes." "We urgently need all physicians, not just endocrinologists, to develop a greater understanding of Cushing's syndrome," said Leslie Edwin, President of the Cushing's Support & Research Foundation. "As a person who has lived with the complex and far-reaching effects of Cushing's syndrome for almost two decades, it is difficult to see that some things have been slow to change. Patients are still spending years on average searching for the cause of deceptively common symptoms, like elevated blood sugar, weight gain, depression and anxiety treated as individual diagnoses instead of parts of a bigger, more burdensome problem that carries tremendous health risk. The CATALYST data will help physicians identify and treat patients more quickly and accurately through earlier screening, and that is such an exciting prospect for all of us in the Cushing's community." "The CATALYST results will help physicians more accurately diagnose and treat people with hypercortisolism, a serious and deadly disease that too often goes undetected," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "One in four patients with difficult-to-control type 2 diabetes have hypercortisolism and treatment with a cortisol modulator can be highly effective in improving many of their signs and symptoms. Corcept is thankful to the patients who participated in CATALYST. We hope these data can help all patients with this disease." About Hypercortisolism (Cushing's Syndrome) Hypercortisolism is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. IMPORTANT LIMITATIONS OF USE Do not use for the treatment of type 2 diabetes mellitus unrelated to endogenous Cushing's syndrome. BOXED WARNING: TERMINATION OF PREGNANCY Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym and prevented during treatment and for one month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential. DOSAGE AND ADMINISTRATION Obtain a negative pregnancy test prior to initiating treatment with Korlym in females of reproductive potential, or if treatment is interrupted for more than 14 days. Administer once daily orally with a meal. The recommended starting dose is 300 mg once daily. Renal impairment: Do not exceed 600 mg once daily. Mild-to-moderate hepatic impairment: Do not exceed 600 mg once daily. Do not use in severe hepatic impairment. Based on clinical response and tolerability, the dose may be increased in 300-mg increments to a maximum of 1200 mg once daily. Do not exceed 20 mg/kg per day. Concomitant use of Korlym with a strong CYP3A inhibitor resulted in a 38% increase in mean plasma concentration of mifepristone. For patients already being treated with a strong CYP3A inhibitor, start with a Korlym dose of 300 mg per day and titrate to a maximum of 900 mg per day if clinically indicated. When a strong CYP3A inhibitor is administered to patients already receiving Korlym, adjust the dose as follows: for patients receiving a daily dose of 600 mg, reduce dose to 300 mg. For patients receiving a daily dose of 900 mg, reduce dose to 600 mg. For patients receiving a daily dose of 1200 mg, reduce dose to 900 mg. Titrate if clinically indicated and do not exceed a Korlym dose of 900 mg in combination with a strong CYP3A inhibitor. CONTRAINDICATIONS Pregnancy; patients taking simvastatin or lovastatin and CYP3A substrates with narrow therapeutic ranges; patients receiving systemic corticosteroids for lifesaving purposes; women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma; patients with known hypersensitivity to mifepristone or to any of the product components. WARNINGS AND PRECAUTIONS Adrenal insufficiency: Patients should be closely monitored for signs and symptoms of adrenal insufficiency. Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment. Vaginal bleeding and endometrial changes: Women may experience endometrial thickening or unexpected vaginal bleeding. Use with caution if the patient also has a hemorrhagic disorder or is on anticoagulant therapy. QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval. Use of strong CYP3A inhibitors: Concomitant use increases mifepristone plasma levels. Adjust Korlym dose as described in Dosage and Administration. Use only when necessary and do not exceed a Korlym dose of 900 mg. ADVERSE REACTIONS Most common adverse reactions in Cushing's syndrome (≥20%): nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, endometrial hypertrophy. DRUG INTERACTIONS Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Adjust Korlym dose as described in Dosage and Administration. Use only when necessary, and do not exceed a Korlym dose of 900 mg. CYP3A inducers: Do not use Korlym with CYP3A inducers. Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym. Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion and efavirenz. Hormonal contraceptives: Do not use with Korlym. USE IN SPECIFIC POPULATIONS Lactation: Mifepristone is present in human milk, however, there are no data on the amount of mifepristone in human milk, the effects on the breastfed infant, or the effects on milk production during long term use of mifepristone. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym®, relacorilant, miricorilant, dazucorilant and our other product candidates; those molecules' clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include: the impact of CATALYST on the medical field's practices regarding the screening for and treatment of hypercortisolism. We disclaim any intention or duty to update forward-looking statements made in this press release. View source version on Contacts Investor inquiries:ir@ Media inquiries:communications@ Sign in to access your portfolio
Yahoo
8 hours ago
- Yahoo
Amgen stock slips, weight-loss drug moves to phase 3 trial
Shares of Amgen (AMGN) fell on Monday after announcing that its weight-loss drug will move into a phase 3 trial, with participants getting to the highest dose level through a three-step dose escalation. Yahoo Finance Senior Healthcare Reporter Anjalee Khemlani reports the details. To watch more expert insights and analysis on the latest market action, check out more Market Domination here. at Amgen revealing plans for phase three of its highly anticipated GLP1 maratide from over. Bringing in here, Yahoo! Finance senior health reporter, Anjalee Khemlani. Anj. That's right. So we got news from Amgen today, which is at the American Diabetes Association conference. That's why you're getting a flood of GLP1 news today. And their latest is that they've started enrolling for their phase three of maratide. Now remember, this drug is their weight loss drug that was is going to enter a market that is competing with Eli Lilly and Novo Nordisk. Currently the drug has about 20% weight loss for those without diabetes and 17%, and as you already can tell with those numbers, that's a little bit lower than what the com the com the competition on the market is, really being the lead with 24%. And so that's the market that's going to enter in. We do know that they have changed how they're doing the dosing for phase three, looking at a step up or three step up, and they did this in a phase one trial to kind of figure out because they were having some issues with tolerability, not abnormal for these kinds of drugs, but of course, trying to figure out how to make it more appealing for patients, and this is why. So looking at that, they are going to start off at 21 milligrams and then move all the way up, potentially to 350 milligrams. And that's sort of what we got from the from the company today, and we'll just have to wait and see how that phase three trial pans out, and then eventually when they do get to market. And Anj, what what exactly are investors looking for from Amgen? I mean, we know like GLP1s, ones are the hot thing. Weight loss drugs are such an area of interest for investors, and so you would think there would be all this enthusiasm here, but what specifically do they expect and do they want from Amgen to try to meet some of those other competitors? Yeah, so the tolerability was one part of it, but they're they've also kind of just been sort of mixed bag on the stock itself, wondering where Amgen gets to play. It's important to remember that this is a differentiated drug because it is going to be a one once a month injectable rather than the current weekly, and so that really reduces the burden on patients and it's a reason why a Jefferies analyst was saying earlier that it looks like really this could be the play. Amgen uh means uh, sorry, Amgen remains debated by investors, right? But they still get pretty good feedback from the doctors, and that's the part that they have to look at, is that what will what are the doctors going to be prescribing? Because at the end of the day, that's where the pickup is for the medication. And so if doctors like it, then they're going to be really more likely to prescribe it. And in addition to that, Amgen is also studying the drug for quarterly maintenance. They've noted that the drug has sort of a lack of plateauing at the end of the current study, and they're going to look and see whether or not more weight loss is possible, so it could still end up being competitive is what they think. So there's a lot to really wait and see on this drug right now. All right. Thank you, Anj. Appreciate it. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
