Latest news with #SriparnaRoy
Yahoo
7 days ago
- Business
- Yahoo
Regeneron shares slide on mixed trial data for smoker's lung drug
By Sriparna Roy (Reuters) -Regeneron shares fell nearly 18% on Friday after its experimental drug for patients with a type of lung condition commonly called "smoker's lung" failed a late-stage trial, although it succeeded in another. Regeneron and partner Sanofi were studying the drug, which some analysts expect could bring in peak sales of as much as $5 billion, for treating chronic obstructive pulmonary disease (COPD). Investors had pinned their hopes on the drug, itepekimab, which targets a broader population, to potentially drive growth beyond Regeneron and Sanofi's blockbuster Dupixent, which is also approved for the condition, as its patent expiry looms. "Today's update likely represents a 2-3 year delay to market," said J.P. Morgan analyst Chris Schott for Regeneron's itepekimab. The drug showed a significant reduction in exacerbations or flare-ups in the condition by 27% compared to placebo at 52 weeks in a 1,127-patient study. But the second study - which had enrolled fewer former smokers compared to the first - did not meet its goal, although a benefit was seen earlier in the trial. "Given the mixed results, the regulatory path is murky," said HSBC analyst Rajesh Kumar. At least four analysts said the companies may need to conduct additional studies for a potential approval for the drug. Shares of Regeneron, which have already fallen 15% this year, were down at $497.01, while U.S.-listed shares of French drugmaker Sanofi fell more than 7% to $48.65 in morning trading. Regeneron's price-to-earnings ratio, a common benchmark for valuing stocks, was 16.15, compared with 13.62 for Gilead and 7.29 for Bristol Myers Squibb. Itepekimab binds to and inhibits interleukin-33, a type of protein that causes inflammation in COPD. The common lung disease causes restricted airflow and breathing problems. It typically affects smokers, but can also be caused by pollutants. 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
Yahoo
23-05-2025
- Health
- Yahoo
Americans scramble as weight-loss drug discounts fall short, copies face crackdown
By Sriparna Roy (Reuters) -After years of easily available, cheap copies of Eli Lilly's and Novo Nordisk's highly effective weight-loss drugs, some U.S. patients say they are unwilling to pay more and are pursuing alternatives to get around the regulatory deadline for compounding pharmacies to stop making them. The U.S. Food and Drug Administration has cracked down on compounded drugs, which were readily available while the patented ones were in shortage, and many are worried they will lose access to the treatments that have given them hope and changed their lives, according to interviews with 10 patients. "I do not have the money to be spending $350, and that's the entry-level dose," said Amanda Bonello, a 36-year-old based in Iowa, referring to the price that Lilly charges for the 2.5 mg dose. "It would not be easy thinking about the Christmas presents that would be missed that year and other opportunities that my family could potentially have." The branded drugs cost more than $1,000 per month though both Lilly and Novo charge less for purchases on their websites - as low as $349 - and at some pharmacies. On Thursday, Novo introduced a one-month price of $199, coinciding with the deadline for halting sales of compounded versions. Health insurance can cover much of that cost, but most Americans are not covered for these drugs. The average price on telehealth sites for compounded drugs is about $200. For two years, patients have turned to compounded versions, in which pharmacies mix the drug ingredients, while Wegovy and Zepbound were hard to get. The FDA set a May 22 deadline for large compounding facilities to stop producing versions of Novo's drugs, having already done so for Lilly's. Patients told Reuters they have turned to stockpiling the compounded drugs or prescription hopping, a practice in which they go from one provider to another to collect these drugs, or source the drugs from countries like Canada. Patients are saving the stocked up drugs in their refrigerators, and some are tailoring the dose to make them last longer, even beyond their expiration date. "It's been a roller coaster, and it's been so stressful that so many people have just stuck their heads in the sand while others have been stockpiling to prepare," said Bonello, who started building up a one-year stockpile in October 2024. A Novo Nordisk spokesperson said the company would continue to develop solutions to make Wegovy more accessible, pointing to its direct-to-consumer website as an example. "Unfortunately, today people living with obesity continue to fight stigma and bias within a complex healthcare system that still denies coverage to medically-prescribed and effective treatments," the spokesperson said. "We recognize that affordability challenges are real for many patients and not all situations are the same," the spokesperson said in an emailed statement. A Lilly spokesperson said the company was committed to expanding access to adults, with and without insurance, for its weight-loss drug Zepbound. Many compounders charge prices similar to those of its LillyDirect online pharmacy for "risky knockoff" products, the spokesperson added. LIMITED OPTIONS Three patients told Reuters they would consider buying the brand-name drugs from the manufacturer's websites, if they were more affordable, but without insurance coverage it meant they still had to sacrifice elsewhere. "They are still kind of leaps and bounds from where the price of compound is, and they just still don't quite fit into my budget at this time," said 32-year-old Zach Niemiec, who is based in Colorado, and works in the nutrition industry. Telehealth companies that sell compounded weight-loss drugs are still trying to figure out how to stay in the market. Noom, for instance, is pushing a new regimen it says would fall under a personalized dosage exception. Veronica Johnson, a Chicago-based obesity medicine physician at Northwestern Medicine, advised against the at-home adjustments patients are making. "The stockpiling and trying to do your own dosing if you're not under, and even if you are under, the medical expertise of someone, puts a lot more harm to potential issues going forward," said Johnson.
Yahoo
22-05-2025
- Health
- Yahoo
GSK's asthma drug wins FDA approval to treat 'smoker's lung'
By Siddhi Mahatole and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration has approved British drugmaker GSK's asthma drug to treat some patients with a chronic lung disease commonly known as "smoker's lung", the company said on Thursday. The approval expands the use of the drug, Nucala, as an add-on treatment for patients with a type of chronic obstructive pulmonary disease. Sanofi and Regeneron's blockbuster drug Dupixent and Verona Pharma's inhaled therapy Ohtuvayre are also approved for the condition, which affects the lungs, causing restricted airflow and breathing problems. GSK's Nucala is a monoclonal antibody that inhibits interleukin-5, which helps regulate eosinophils, a type of white blood cell that causes inflammation in the lungs when overproduced. The regulator had set a target action date of May 7 for its decision on the drug. The approval, however, came two weeks later. This is the latest instance where the drug regulator has missed its deadline after mass layoffs as part of a major overhaul of federal health agencies under Secretary of Health and Human Services Robert F. Kennedy Jr. The approval was based on a late-stage trial, in which patients treated with Nucala and an inhaled maintenance therapy for up to 104 weeks had significantly reduced exacerbations by 21% compared to placebo. "There's a very high burden when you have severe exacerbations and end up being hospitalized. The aim is to keep patients out of the hospital, keep them stable, and keep them at home," GSK's Chief Commercial Officer Luke Miels said ahead of the approval. Nucala recorded 1.78 billion pounds ($2.38 billion) in total sales last year. The disease commonly affects cigarette smokers but can also be caused by air pollution and related occupational hazards. It is the fourth leading cause of death worldwide, according to the World Health Organization.
Yahoo
13-05-2025
- Business
- Yahoo
Pharma stocks recover from initial shock of Trump's drug pricing order
By Sriparna Roy and Joel Jose (Reuters) -Shares of U.S. drugmakers rebounded on Monday after an initial selloff as analysts said that President Donald Trump's sweeping executive order to slash prescription drug prices would be difficult to implement and face legal challenges. Trump signed a wide-reaching executive order on Monday directing drugmakers to lower the prices of their medicines to align with what other countries pay. Shares of major U.S. drugmakers AbbVie, Eli Lilly, Amgen, Pfizer and Merck were trading 2.1% to 4.8% higher in morning trading on Monday after falling premarket. Leerink analyst Michael Cherny said the executive order would likely face heavy legal challenges, and its execution will be important to gauge the impact on the sector. "So the timing of any implication of the pieces of the executive order will remain in question." Shares of U.S. drugmakers have been under pressure in the past few weeks since initial reports that Trump would sign an order aimed at lowering drug prices in the United States. "A drug pricing announcement had been expected for a while now and had weighed on stocks in this sector, so the official executive order doesn't seem to be impacting sentiment too much," said James Harlow, senior vice president at Novare Capital Management, which owns shares of Merck and Pfizer. Trump had also tried in his first term to bring U.S. drug prices in line with other countries, but was blocked by the courts. The broader market moved higher on Monday following the news that the U.S. will cut extra tariffs it imposed on Chinese imports in April this year to 30% from 145% and Chinese duties on U.S. imports will fall to 10% from 125%. Trump's comments of "cutting out the middlemen" also weighed on shares of companies that own pharmacy benefit managers. Shares of Cigna slid 6.3%, CVS shares fell 4% and UnitedHealth was marginally down. The ripple effect of the proposed order, however, had weighed on global stocks throughout the day. In India, Biocon and Lupin also saw declines, as about a third of the country's pharma exports go to the U.S. Australian healthcare stocks closed 1.4% down to their lowest since late April, meanwhile Japan's pharmaceutical sector closed 6.5% lower and was the worst performer among the Tokyo Stock Exchange's 33 industry sub-indexes. Shares of Daiichi Sankyo sank over 8%. The U.S. is an important revenue generator for several UK, European and Japanese pharma companies. UBS analysis estimates the implementation of Most Favored Nation (MFN) pricing or international reference pricing, as proposed by Trump earlier, across the highest-spending drugs could cut 2028 net income of global pharma companies by 8%.
Yahoo
08-05-2025
- Business
- Yahoo
Novavax says talks with FDA on COVID vaccine approval ongoing calming investor fears
By Sriparna Roy (Reuters) -Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S. regulators saying that it sees a pathway to resolving issues with the FDA, sending shares up nearly 19% in early trading. The vaccine maker said it believes commitments to run new trials would be after it receives approval for the shot. "Based on what we've received to date, formally from FDA, they're asking for a post-marketing commitment. And by definition, it's our understanding that a post-marketing commitment comes after approval and you've begun to market that product," CEO John Jacobs said in a post-earnings conference call with analysts. The vaccine's prospects were thrown into doubt after the U.S. Food and Drug Administration missed its April 1 target to approve the shot. U.S. Health and Human Services secretary Robert F. Kennedy Jr. attributed the delay to the shot's composition in a CBS interview earlier that month. The company said talks with the agency on the proposed study design are ongoing. "We haven't commented publicly on the nature of the post-marketing commitment at this time, but we continue to work with the FDA diligently and urgently to try to bring this forward as soon as possible to a positive conclusion, and we do see a pathway forward to approval based on the formal comments and questions we've received from FDA," said Jacobs. The company wants to convert the vaccine's emergency authorization granted in 2022 into a full approval that would allow for expanded use and help it compete against shots from rivals. Novavax, whose protein-based shot uses an older technology, missed out on the pandemic vaccine windfall – enjoyed by rivals Moderna and Pfizer which make messenger RNA-based vaccines – due to manufacturing issues and regulatory hurdles. Novavax swung to profit in the first quarter, helped by reduced costs tied to the development and sale of its COVID-19 vaccine, its only product on the market. The Maryland-based biotech has been banking on revenue from its Sanofi deal and vaccines in development. It signed a licensing deal worth at least $1.2 billion with the French drugmaker last year to hand over the rights to sell its vaccines in several markets, including the United States and Europe. Novavax's quarterly revenue rose to $667 million in the reported quarter, from $94 million a year ago, and comfortably surpassed analysts' estimate of $343.85 million, according to data compiled by LSEG. The sales boost was mainly driven by revenue recognition of $603 million following the termination of two advance purchase agreements in Canada and New Zealand and related to cash received in prior years. The company sees adjusted total revenue for 2025 to be between $975 million and $1.03 billion, more than double its prior expectations of between $300 million and $350 million. This excludes Sanofi sales and royalties. Net income came in at $519 million for the quarter ended March 31, compared to a net loss of $148 million a year earlier. 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
