CVS Drops Lilly's Zepbound from Preferred Coverage in Novo Win
Starting July 1, Zepbound will no longer be preferred on CVS Caremark's standard formulary, while Wegovy and other anti-obesity medicines will be, according to the company. The change means that Lilly's drug may cost more to insurers or employers that opt to pay for weight-loss drugs and who use CVS Caremark to manage their prescription drug plans.
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Business Insider
4 hours ago
- Business Insider
Hims Stock at $50: Here's What Truist Expects Next
Hims & Hers Health (NYSE:HIMS) stock has had a curious run in 2025. The first half of the year was marked by a massive 35% single-day plunge, sparked by Novo Nordisk's sudden decision to cut ties with the telehealth company. The Danish drugmaker accused Hims & Hers of engaging in misleading marketing and distributing unauthorized compounded versions of its blockbuster weight-loss drug, Wegovy. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. Despite the controversy, the stock has staged an impressive rebound, with shares up 108% year-to-date and now hovering around $50. The rally has been driven by strong quarterly results and growing momentum in the company's weight-loss offerings. Looking ahead, all eyes now turn to the company's upcoming Q2 earnings report, slated for August 4. Truist analyst Jailendra Singh expects results to land mostly in line with expectations, noting that current forecasts already reflect the high end of HIMS' guidance. He projects revenue of $549.4 million and adjusted EBITDA of $74.4 million, closely aligned with Street consensus and the company's provided range. However, Singh also flags some cautionary signals. The analyst anticipates a slight dip in online revenue per subscriber compared to Q1, attributing it to seasonal trends and reduced reliance on commercially available Semaglutide. Q1's outperformance, after all, benefited from one-off drivers like the Super Bowl ad and the initial buzz around HIMS-branded weight-loss offerings. That brings up the bigger question: where does HIMS go from here in the second half of the year? While some investors worry about a potential guidance cut following the Novo fallout, others are optimistic about a lift tied to the recent acquisition of European telemedicine provider Zava. Singh, for his part, remains cautious. The analyst believes a 2H ramp may be difficult unless Zava or other acquisitions begin to meaningfully contribute. Still, he doesn't expect management to revise guidance just yet, preferring to wait and assess the impact of new initiatives in Q3. As for upcoming developments to watch, Singh cites updates on a possible lawsuit from Novo Nordisk (which would be negative), new product launches in testosterone and menopause treatments (positive), and further M&A activity (also positive). 'From additional M&A point of view, a transaction giving the company entry into the employer/payor market will be transformational and has potential to change the narrative,' Singh further said. What to Do with HIMS Stock Now? Singh is sticking with a Hold (i.e., Neutral) rating, nudging his price target up from $45 to $48, which still suggests ~5% downside from where the stock is currently trading. (To watch Singh's track record, click here) And he's not alone in that cautious stance. The broader analyst community is mostly on the sidelines too, with 7 Holds, 2 Sells, and just 1 Buy – all coalescing to a Hold consensus rating. Based on the average price target of $41.78, the Street sees the stock pulling back by 17% over the next year. (See HIMS stock forecast) To find good ideas for stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights.
CNBC
19 hours ago
- CNBC
Weight loss drugs could be a gamechanger for women with a common hormonal disorder
For well over a decade, Grace Hamilton, 27, experienced hair loss, heavy periods, infrequent menstrual cycles, mental health issues and difficulty losing weight without knowing why. It wasn't until 2021 when she was diagnosed with polycystic ovary syndrome, or PCOS, a hormonal disorder common among women of reproductive age. After she saw limited improvements from birth control, diet and exercise, Hamilton joined a trial in 2024 examining a GLP-1 drug in PCOS patients. By October, she received her first weekly dose of semaglutide, the active ingredient in Novo Nordisk's obesity injection Wegovy and diabetes shot Ozempic. She said some results were almost immediate: after months without a cycle, her period resumed within two weeks of starting the drug. After 10 months on the treatment, Hamilton lost 50 pounds, saw hair regrowth and reported significant improvements in depression and anxiety "I'm so glad that I stuck with it because it was just clear as day that it was the missing link for me," said Hamilton, who works at a nonprofit in Arvada, Colorado, adding that she maintained diet and exercise while on the drug. She is just one of several women who have reported improvements in symptoms of PCOS after using GLP-1s, a growing class of obesity and diabetes treatments that have drawn massive patient demand and investor buzz over the last few years. Treating PCOS is among several new but unapproved potential uses of the blockbuster drugs beyond promoting weight loss and regulating blood sugar. PCOS, which is frequently underdiagnosed, affects an estimated 5 million to 6 million women of reproductive age in the U.S., according to some estimates. The condition is typically characterized by higher levels of testosterone and other hormones usually associated with men called androgens, which can leads to symptoms such as irregular and painful periods, excess hair growth and acne. PCOS is the most common cause of infertility. The condition is strongly linked to metabolic issues, as an estimated 35% to 80% of patients experience insulin resistance. That means the pancreas pumps out more insulin to keep blood sugar in check, and high insulin levels can promote weight gain and disrupt hormone balance. A significant share of women with PCOS have obesity or Type 2 diabetes. Yet there's no standard PCOS treatment. Current options like birth control, lifestyle changes and the diabetes drug Metformin may only help with certain symptoms, which could differ depending on the patient. But some health experts see promise in GLP-1s, particularly given their effect on improving weight loss and insulin sensitivity. "The unmet need is massive," said Dr. Melanie Cree, a pediatric endocrinologist at Children's Hospital Colorado. "Primary therapies used for PCOS symptoms haven't changed in nearly 50 years." Cree has been studying the effect of GLP-1s in adolescents with PCOS for more than 10 years. She previously studied the oral form of semaglutide and has an ongoing clinical trial on the injectable version, which is what Hamilton participated in for 10 months. But her studies are still small in comparison to drugmakers' previous clinical trials on GLP-1s with thousands of patients. Not all of the women who have so far completed Cree's ongoing study lost significant weight, demonstrating that not everyone may respond to GLP-1s. Novo Nordisk and rival Eli Lilly have been studying their GLP-1s as potential treatments for other chronic conditions like fatty liver disease, but not PCOS. Cree said that's because the Food and Drug Administration has not established specific "endpoints" or goals drugs must meet in clinical trials to demonstrate how effective they are for PCOS. In a statement, a Novo Nordisk spokesperson said the company welcomes "independent research investigating the safety, efficacy and clinical utility of our products, including semaglutide." Eli Lilly did not immediately respond to a request for comment. Conducting longer and larger trials to better understand the effect of GLP-1s on PCOS symptoms is crucial, said Sasha Ottey, executive director of the advocacy group PCOS Challenge. It is still unclear if GLP-1s can help address or resolve all PCOS symptoms, or whether the effect differs depending on a patient's age or the specific drug, Ottey said. She added that certain patients may not lose weight on GLP-1s, and others may not need to shed pounds. Meanwhile, insurance coverage for GLP-1s is a barrier for some PCOS patients, who are often eligible for approved uses of the drugs. Most plans cover GLP-1s for diabetes, but not for obesity or unapproved uses. The drugs can cost roughly $1,000 per month before insurance. Still, Eli Lilly and Novo Nordisk offer significant discounts on their drugs to some patients who pay for it out-of-pocket. More research is needed to fully understand why GLP-1s may help some PCOS patients, but Cree said their effect on symptoms appears to be largely indirect. She said a key finding in several previous studies motivated her to start studying GLP-1s: In adults with PCOS, losing as little as 5% of body weight can improve insulin sensitivity. That makes the body respond better to insulin, so it doesn't need to produce as much of it to manage blood sugar. That lowers insulin levels, which Cree and some researchers believe causes the ovaries to produce less testosterone and, as a result, can help reduce symptoms such as irregular periods, acne and excess hair growth. "One of the questions was, what other methods do we have to improve insulin sensitivity?" Cree said. She noted that other recommended treatments for PCOS symptoms, such as food changes, increasing exercise and the diabetes drug Metformin, are based on that goal. GLP-1s such as semaglutide improve insulin sensitivity and reduce appetite through several mechanisms. That includes slowing how quickly food leaves the stomach, prompting the pancreas to release insulin when blood sugar is high and suppressing the release of a hormone that raises blood sugar. The weight loss caused by GLP-1s further helps improve insulin sensitivity. Early results from Cree's ongoing study support the idea that GLP-1s may lower testosterone. The trial, which began in 2023, follows girls and women ages 12 to 35 with obesity and PCOS who are on or off Metformin. The study is designed to administer semaglutide to patients for 10 months, and examine their weight loss, metabolic changes and improvements in reproductive function. Cree hopes the trial will answer whether GLP-1s can improve ovulation in women with PCOS. Many women with PCOS don't ovulate regularly, which can lead to irregular periods and difficulty getting pregnant. Cree has initial data on 11 women who completed the 10 months on semaglutide and were not on Metformin. She said eight of them lost more than 10% of their body weight and saw a reduction in their testosterone levels. Five out of the eight patients had their testosterone levels reach "normal ranges," Cree said. Meanwhile, six out of the eight patients reported more regular periods. Cree said her trial will eventually have data from 40 women, but she is still enrolling patients in the group that takes Metformin. She said it will likely take two years before she publishes the first results from the study, which will focus on the differences in outcomes between kids and adults who only received semaglutide. She said comparing the groups is crucial because hormones that control growth are released during puberty, which could change how kids respond to GLP-1s. Not all women with PCOS will benefit from taking a GLP-1. Cree said in her trial, three patients who completed 10 months on semaglutide did not lose at least 10% of their body weight. One of those women did not lose weight at all, she said. Cree said that's consistent with previous studies on GLP-1s in adults with obesity. Despite the promise of GLP-1s in improving symptoms, more research is also needed on PCOS itself, said Dr. Karen Tang, an OB-GYN and founder of Thrive Gynecology. She said some people can experience hallmark symptoms of the condition, such as facial hair and acne, even though they have normal levels of testosterone. "There's still a lot that's very much unknown about PCOS and exactly how the disease kind of works," Tang told CNBC. Anecdotal evidence suggests GLP-1s may address more than just weight issues for people with PCOS. In a recent survey of 1,700 people by the birth control app Natural Cycles, 64% of women with PCOS who took a GLP-1 reported more predictable periods, and 20% said their bleeding days were shorter. Some patients with PCOS may also lose more weight on GLP-1s than those without the condition, said Dr. Kerry Krauss, an OB/GYN and medical director at Natural Cycles, who has PCOS herself. Research needs to confirm those benefits, but she said it gives hope to many PCOS patients who are frustrated with common treatments for the condition. Those options typically target just one aspect of PCOS, such as reducing androgen levels with certain types of birth control. Tang added that diet and exercise alone often fall short of addressing symptoms: "A lot of people can exercise very aggressively and regularly or watch what they eat and still struggle with hormone imbalances, weight, and blood sugar." That was the case for Haley Sipes, a 31-year-old mother of three based in Western Kentucky who experienced PCOS symptoms for years without a diagnosis. In 2022, before being diagnosed, she lost 75 pounds over 10 months through diet and exercise alone. Her progress stalled in late 2022 despite an intense diet and exercise regimen, and her weight began to fluctuate in 2023. By mid-2024, she had regained about 30 pounds. Sipes sought help from her primary care provider and underwent blood work, which revealed she had a hormonal imbalance. Initial efforts to regulate her hormones with progesterone and testosterone had a limited effect. Further bloodwork diagnosed Sipes with PCOS and insulin resistance, which she views as the root cause of her weight loss struggles. She recalled bloating, fatigue, low energy, and water retention during earlier efforts to lose weight. Despite her history of painful, irregular periods and ovarian cysts since age 10, her providers never mentioned PCOS as a possible diagnosis. In September 2024, her doctor prescribed Zepbound. Her insurance covered it due to her BMI and prediabetes status. Sipes said she noticed changes within the first month: her food cravings quieted, her inflammation decreased, she experienced less joint pain, and her period became less painful and occurred more regularly. Sipes added that she has not had ovarian cysts since starting Zepbound. After around eight months on the medication, she lost more than 60 pounds. Sipes said those results significantly improved her emotional health. "All the symptoms and being overweight might not seem like big things, but when you have 20 little things that are constantly nagging you, then you're going to be in a bad mood sometimes," Sipes said. "I'm just a better version of myself when I'm not controlled by food thoughts and hormonal issues that cause mood swings," she continued. "My life does feel so much more enjoyable." Sipes plans to continue taking Zepbound to maintain her results, possibly at lower doses. She noted that more research is needed on whether PCOS symptoms can fully resolve. Insurance coverage is currently the biggest hurdle preventing PCOS patients from accessing GLP-1s, said Dr. Alyssa Dominguez, an endocrinologist with Keck School of Medicine at the University of Southern California. She said many PCOS patients are eligible to use GLP-1s for their approved uses based on BMI or related conditions, but may not have coverage. More than one-third of employers now cover GLP-1s for both weight loss and diabetes, while 55% only cover them for diabetes, according to a recent survey from the International Foundation of Employee Benefit Plans. In April, President Donald Trump rejected a Biden administration plan that would have required Medicare and Medicaid to cover obesity drugs. Some patients, like 34-year-old California mom Nabeelah Karim, have turned to other options. Karim was diagnosed with PCOS at 19 and took birth control on and off until giving birth in 2021. She said she struggled with hair loss, irregular periods, debilitating cramps, facial hair growth, severe water retention and mood swings. Karim said her period symptoms worsened after she gave birth, and in late 2023, she began what would be a painful five-month-long period. Doctors suggested that she lose weight, take painkillers or return to birth control. While Karim lost some weight through diet and exercise, she was eventually prescribed Eli Lilly's diabetes drug Mounjaro through the digital health startup Noom in April 2024. Her long period stopped and symptoms eased within days, and she began to lose more weight over time. "It had solved all the problems that I had experienced for years up until that point," Karim said. But her insurance plan never formally approved or denied coverage of Mounjaro, forcing her to pay its more than $1,000 per month out-of-pocket price. She eventually found a third-party compounding pharmacy that accepted her prescription, allowing her to buy a cheaper but unapproved version of the drug. Karim used that compounded version for six months and continued to experience weight loss and improvements to her PCOS symptoms. During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. They can also be produced on a case-by-case basis when it's medically necessary for a patient, such as when they can't swallow a pill or are allergic to a specific ingredient. But Novo Nordisk, Eli Lilly and some health experts have pushed back – and in some cases, taken legal action – against the practice, largely because the FDA does not approve compounded drugs. The FDA has declared U.S. shortages of both companies' drugs over. "When people ask about how safe compounded drugs are, the answer I typically give is I don't know," said Dominguez from USC's School of Medicine. She said that's unlike branded drugs, which have clearly defined risks and benefits proven in clinical trials. Hamilton, the 27-year-old patient who took a GLP-1 for PCOS symptoms, has never taken a compounded GLP-1. She is currently appealing her insurer's denial of semaglutide now that she has completed Cree's trial. "My whole life has been an inability to access care for my medical condition, and I'm tired of that," she said. "If somebody would have been able to provide 11-year-old Grace with this drug, that would have saved me."
Fox News
2 days ago
- Fox News
DR. MARC SIEGEL: More bad news about our kids' health. Is Ozempic the solution?
The disturbing news about our young children's health is coming at us fast and furious. First we find out that there is an obesity epidemic among our youth, that more than 20% (perhaps more) are now obese, and I can tell you as a practicing internist that today's obese child could be tomorrow's obese adult with type 2 diabetes, heart disease, high blood pressure or stroke. And now we find out that, according to the latest CDC data, a third of all children ages 12 to 17 have pre-diabetes. Please note: this is not connected to the kind of diabetes (type 1) that is autoimmune or tied to genetics and the most common form diagnosed it childhood, but the kind (type 2) where you don't make enough insulin to drive the glucose you have into the cells and where insulin resistance builds up. And it doesn't take actual type 2 diabetes to do that. Pre-diabetes is well on the road to actual diabetes, though it can often still be reversed by lifestyle changes. The inflammation and excess glucose associated with pre-diabetes can also damage kidneys, coronary arteries, retinas, and nerves, whether a child goes on to develop full type 2 diabetes or not. Considering that between 21 and 40% of obese patients have pre-diabetes, and considering that the GLP1 agonist drugs including Ozempic and Wegovy are highly effective at not just glucose control but also weight loss, and adding to that they appear to have cardioprotective effects and are also seemingly good for the brain, it is no surprise that there is a huge clamor for them all across America. So shouldn't all of our children with a weight or sugar problem be on them? The answer is a resounding no. Not only are there concerns about gastrointestinal side effects and intolerance, but optical side effects (headaches, macular degeneration, and even loss of vision have been reported) need to be further studied along with thyroid cancer concerns. Currently, there is no data on long-term side effects and a child who, once committed to them, could be on these drugs for life. It is easy to see that the benefits outweigh the risks much more for adults than for most children. Also, at a time when there is an epidemic of social media and excess screen-time addiction, where our children's diets are filled with ultra-processed high-sugar foods, when too many children are not exercising, I feel it would be a big mistake to rush to these semaglutide drugs as a quick fix to the problem. Don't get me wrong, I much prefer the drugs to the long-term side effects of obesity, which include all the diseases and more mentioned above. If I knew for sure that a child was in a group where they were destined for diabetes or heart disease because of their weight and I could do something about it, of course I would, but most of the time there are lifestyle changes to promote first. Clearly, we have a long way to go to improve our kids' diets, but now is the time to start. For those children with persistent obesity and/or prediabetes, a nutritionist along with an endocrinologist should be involved, but for most, it should be a very runway before the Ozempic or Wegovy plane is launched, at least for now.
