Regeneron announces analyses from Phase 3 C-Post trial
Regeneron (REGN) Pharmaceuticals announced detailed analyses from the Phase 3 C-POST trial, which evaluated PD-1 inhibitor Libtayo in patients with high-risk cutaneous squamous cell carcinoma, CSCC, after surgery. The results, shared during an oral session at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting and simultaneously published in the New England Journal of Medicine, NEJM, include additional data for the primary endpoint of disease-free survival, DFS, and the first presentation of key secondary endpoint outcomes. With a median duration of follow-up of 24 months, efficacy results for Libtayo compared to placebo, were as follows: 68% reduction in the risk of disease recurrence or death, with median DFS not reached for Libtayo-treated patients; At two years, DFS was 87% with Libtayo versus 64% with placebo; 80% reduction in the risk of locoregional recurrence; 65% reduction in the risk of distant recurrence
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New York Post
an hour ago
- New York Post
Weight loss drugs like Ozempic can mess with your fertility, dietitian warns — how it can impact both men and women
GLP-1 drugs like Ozempic and Wegovy might help you ditch the food baby, but they could also affect your ability to make a real one. Ayla Barmmer, a registered dietitian and reproductive health expert, told The Post that about 15% of her patients using the medications have struggled to conceive. Within that group, she said roughly 40% have reported problems such as irregular periods, delayed ovulation and even declining sperm quality linked to their rapid weight loss. 7 Surveys suggest one in eight US adults have used a GLP-1 at some point. alones – But in a surprising twist, some women have experienced the opposite effect on their fertility, giving rise to the so-called 'Ozempic baby.' Barmmer explained what's behind these conflicting outcomes — and shared her top recommendations for anyone taking a GLP-1 who is thinking of starting a family. How GLP-1s might be wrecking your fertility GLP-1 drugs help people slim down by curbing their appetite — but that can lead to serious nutrient deficiencies if you aren't careful. 'Clinical dietitians and endocrinologists have already documented shortfalls in protein, vitamin B12, vitamin D, iron, calcium and folate among GLP‑1 users, especially once weight loss exceeds 10% of baseline,' Barmmer said. Those missing nutrients are key players in egg and sperm development, hormone production and embryo health. 7 The decision to discontinue GLP-1s should be made with your doctor. Getty Images/iStockphoto To make matters worse, sudden weight loss or under-eating triggers the brain's alarm system. As a result, the hypothalamus pumps the brakes on reproductive hormone production to save energy. 'Women tend to experience cycle changes first, whereas men more often present with falling testosterone, lower semen volume and reduced motility after significant weight loss,' Barmmer said. For women, this can also cause luteal-phase defects, where the uterine lining doesn't thicken enough to support pregnancy. How GLP-1s can supercharge fertility But it's not all bad news for baby-making. GLP-1s have sparked a flood of social media posts from women stunned to find themselves pregnant just months after starting the drugs — including those who were once told they couldn't conceive. 7 GLP-1s can harm fertility if you aren't careful — but they can also give it an unexpected boost. Getty Images/iStockphoto Barmmer said the fertility boost likely comes from the drugs' ability to improve insulin sensitivity and reduce systemic inflammation. Take polycystic ovary syndrome (PCOS), a top cause of infertility in women that often leads to irregular or missing periods. 'For those with PCOS, which is the No. 1 endocrine disorder worldwide, GLP-1's have been shown to restore ovulation due primarily to the positive impact on insulin sensitivity,' she explained. Barmmer also noted GLP-1 receptors have been found in the lining of the uterus, ovaries and testes — where they may fight inflammation and the buildup of fibrous tissue that harms fertility. That could help ovarian follicles thrive and embryos implant. It might even boost sperm quality, improving concentration and motility. 7 Nutritional deficiencies can negatively affect sperm quality. Getty Images 'There is this delicate line where there are benefits for fertility as long as nutritional needs are met,' Barmmer said. Trying to conceive? Here's what you need to know If you're on a GLP-1 and hope to grow your family one day, you probably don't need to quit the drugs cold turkey. 'Much of the risk is attributed to not paying careful attention to meeting nutrient needs while losing weight, which can be mitigated,' Barmmer said. Some of her patients have continued using the medication while her team adjusts their diet and monitors nutrient levels through regular lab work. Others have chosen to taper off eight to 10 weeks before trying to conceive, giving the drug time to clear their system. 7 Registered dietitians can help prevent nutrient deficiencies that could make conceiving more difficult. Getty Images/iStockphoto 'The worst case scenario is to start trying to conceive with depleted in key nutrients that impact conception, the health of the pregnancy and even the baby's long-term health,' Barmmer warned. 'This goes for both women and men because men's preconception nutrition status has a profound impact on the risk for pregnancy complications,' she added. To support fertility while on a GLP-1, Barmmer recommends consuming at least 1.4 grams of protein per kilogram of your target body weight each day. You should also include a source of healthy fat in every meal and keep your calorie intake above 30 kilocalories per kilogram to prevent your reproductive system from slowing down. 7 Ozempic aids in weight loss, which can improve fertility in women with conditions like PCOS or obesity. Christopher Sadowski Barmmer encourages her patients to focus on foods rich in protein, iron, choline, omega‑3 fatty acids, zinc, selenium and antioxidants. She recommends getting lab work every three months to make sure nutritional needs are being met. 'This is a vital time to work with a registered dietitian, particularly one who is also a fertility expert,' she said. And no, standard prenatal vitamins aren't enough on their own. While helpful, Barmmer said they don't deliver the extra protein, omega‑3 fats or calories needed for reproductive cell development and early embryo growth. They also can't fix common gastrointestinal side effects associated with GLP-1s — like nausea, early satiety or malabsorption — that can limit nutrient uptake. 7 The gastrointestinal side effects associated with GLP-1s could increase the risk of nutrient gaps. Dragana Gordic – Even still, 'a very nutrient-dense, comprehensive and thoroughly tested prenatal multivitamin and omega-3 fatty acid supplement are absolutely necessary,' Barmmer said. If pregnancy is on your immediate to-do list, she recommends stopping GLP-1s at least eight weeks before trying to conceive to allow your ovulation or semen quality to return to normal. If your period has been missing or your nutrition is off track, it might take longer. Bottom line: You don't necessarily have to break up with your weight-loss medications to start a family — but you do need a game plan. 'When GLP‑1 therapy is combined with intentional, nutrient‑dense eating, the right supplement protocol and careful monitoring,' Barmmer said, 'many clients move from 'weight‑management mode' to 'family‑building mode' with healthy, predictable cycles and robust semen quality.' 'The key is giving the body both the biochemical signals and the raw materials it needs to support optimal reproductive health,' she added.
Yahoo
2 hours ago
- Yahoo
Alto Neuroscience Adds 'Intriguing' Depression Asset Via Over $100 Million Deal
On Tuesday, Alto Neuroscience, Inc. (NASDAQ:ANRO) announced an asset purchase agreement with Chase Therapeutics Corporation for a portfolio of dopamine agonist drug combinations for treatment-resistant depression (TRD), generally defined as a failure on two or more antidepressants. Alto paid Chase Therapeutics an upfront payment of $1.75 million. Chase Therapeutics will be eligible for up to $71.5 million in milestone payments, $41 million of the potential future milestone payments are tied to the product candidates' commercial success. Alto expects its current cash balance to support planned operations into 2028 through five clinical trial readouts across its pipeline most advanced program, ALTO-207 (formerly known as CTC-501), is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for Parkinson's disease with demonstrated antidepressant effect, and ondansetron, an antiemetic, selective 5-HT3 receptor antagonist. As a fixed-dose combination, ALTO-207 enables rapid titration and higher dosing by mitigating the dose-limiting adverse events typically experienced with pramipexole. Phase 2a trial of CTC-501 Chase Therapeutics completed a Phase 2a trial evaluating CTC-501 in 32 patients with depression. The primary endpoint was achieved in the study. Patients randomized to receive CTC-501 reached a mean dose of 4.1mg per day, with 67% achieving the highest allowable dose of 5mg/day. CTC-501 was generally well tolerated in the maintenance period of the study. CTC-501 demonstrated statistically significant and clinically meaningful improvements from baseline compared to placebo on depression symptoms as measured by the Montgomery Åsberg Depression Rating Scale or MADRS. CTC-501 also demonstrated significantly greater improvement on the Clinician Global Impression Scale of Severity (CGI-S) compared to placebo. Alto expects to initiate a Phase 2b trial, designed to be a potentially pivotal study, with ALTO-207 in patients with TRD by mid-2026 and report topline data in 2027. Phase 2a Trial For CTC-413 ALTO-208 (or CTC-413) is a fixed-dose combination of pramipexole and aprepitant, an antiemetic, neurokinin-1 (NK-1) receptor antagonist. ALTO-208 is being developed for patients with Parkinson's disease (PD). Chase Therapeutics completed a blinded Phase 2a trial evaluating CTC-413 in 13 patients with PD. The mean tolerated dose of CTC-413 significantly exceeded pramipexole. Six subjects (67%) tolerated CTC-413 at the maximum dose of 9.0mg/day, and all but one remained on that dose throughout the final three-month treatment period. CTC-413 demonstrated favorable safety and tolerability with no unexpected, serious or persistent issues. William Blair reiterated an Outperform rating on Alto Neuroscience, viewing the acquisition of ALTO-207 as an 'intriguing asset.' The firm noted the impressive efficacy of pramipexole in the PAX-D study but also highlighted the possibility of functional unblinding in that study, which may have contributed to the perceived efficacy. Price Action: ANRO stock is trading higher by 2.31% to $2.66 at last check Tuesday Read Next:Photo by fizkes via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Alto Neuroscience Adds 'Intriguing' Depression Asset Via Over $100 Million Deal originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. 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
CNBC
3 hours ago
- CNBC
Here's what is driving Tuesday's stock rally — plus, an analyst comes to Eli Lilly's defense
Every weekday, the CNBC Investing Club with Jim Cramer releases the Homestretch — an actionable afternoon update, just in time for the last hour of trading on Wall Street. Markets: Stocks are rallying on Tuesday, overcoming yet another premarket decline like we saw Monday. The data center and AI infrastructure trade — ranging from semiconductor stocks like Nvidia and Broadcom to industrials like GE Vernova and Eaton — is powering the market higher in reaction to Meta Platform's 20-year agreement to buy nuclear power from Constellation Energy . The Club owns all these stocks, except for Constellation Energy. Meanwhile, there was no real news on the trade negotiation front. A big thing to watch on trade in the coming days is whether President Donald Trump and Chinese leader Xi Jinping do, in fact, hold a call. The White House has indicated such a conversation is likely to happen this week. Eli Lilly: JPMorgan reiterated its overweight rating and $1,100 price target on Club name Eli Lilly in a research note on Tuesday. The main takeaway from the note was that volume trends for Lilly's GLP-1 drug portfolio — Zepbound for obesity and Mounjaro for type 2 diabetes — were running ahead of JPMorgan's expectations, resulting in the analysts raising their already above-consensus revenue forecast for the second quarter. JPMorgan cited two factors behind the increased estimates: strong growth in the obesity market, with prescriptions up approximately 25% quarter over quarter, and Eli Lilly capturing nearly three-quarters of all new patient starts. Importantly, JPMorgan thinks this strong category and share growth will help Lilly's prescriptions continue to grow despite the CVS formulary change to make rival Novo Nordisk's Wegovy the preferred GLP-1 for weight loss. This goes into effect on July 1. However, according to Lilly, it is only expected to impact roughly a couple hundred thousand patients. JPMorgan also doesn't think the Novo Nordisk and CVS deal will lead to a GLP-1 price war. The script trends and JPMorgan's belief that Lilly can offset any CVS headwind is very encouraging — especially on the CVS angle because that bit of news has been a huge overhang on Lilly shares ever since it was announced May 1. The broader pharmaceutical group has also been under pressure due to uncertainty tied to possible sectoral tariffs and drug pricing regulation. Lilly stock had fallen more than 20% in the month of May before mounting a modest rally in recent days. We added to our Lilly position a few weeks ago at around $715 per share. Before Eli Lilly reports second-quarter earnings in August, the next major event is the 2025 American Diabetes Conference, taking place between June 20 to June 23. There are expected to be several high-profile data readouts and presentations at the conference. In a separate note by JPMorgan, the analysts said investors should watch out for the full late-stage trial results from Eli Lilly's oral GLP-1 orforglipron. Eli Lily shares surged in April after GLP-1 pill was successful in a late-stage trial for type 2 diabetes, potentially paving the way for Food and Drug Administration approval in early 2026. Similarly, another readout to watch is more complete trial data for Novo Nordisk's CagriSema, which is a combination of an amylin analog called cagrilintide along with semaglutide, the active ingredient behind Wegovy and Ozempic. It targets fat loss and was thought to be Novo's next-generation product to follow up Wegovy. However, its preliminary trial results disappointed earlier this year. Amgen is also expected to release its mid-stage trial data on MarTide, which is a once-monthly GLP-1 injection. Finally, JPMorgan said we could see some data on one of Elil Lilly's next-gen weight loss drugs, bimagrumab. That was one of the assets that Lilly acquired as part of its acquisition spree in 2023 , and muscle mass preservation is one of its distinguishing features. Up next: Club name CrowdStrike reports after the closing bell on Tuesday. The LSEG consensus estimate is for revenue of $1.10 billion and EPS of 65 cents. We expect management will reaffirm its outlook that net new annual recurring revenue growth will reaccelerate in the second half the fiscal year, driven by strong adoption of the Falcon Flex platform and the expiration of the Customer Commitment Package incentive program. Other companies report are Hewlett Packard Enterprise and Asana . Thor Industries and Dollar Tree report before the opening bell on Wednesday. On the economic data side, there's weekly mortgage applications, the ADP private employment report, and ISM's look at the services industry. (See here for a full list of the stocks in Jim Cramer's Charitable Trust.) As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio. If Jim has talked about a stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB. NO SPECIFIC OUTCOME OR PROFIT IS GUARANTEED.
