Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
The company said on Monday it would resume shipments of Elevidys — approved in the U.S. to treat a rare condition called Duchenne muscular dystrophy — to patients who can walk. U.S. shipments to patients who cannot walk independently are still halted, following the death of two teenage boys earlier this year.
These incidents brought heightened regulatory scrutiny to Sarepta in recent weeks, while the pause of shipments raised concerns about the future of Elevidys — the company's largest revenue generator.
Sarepta's announcement followed the U.S. Food and Drug Administration's recommendation that the voluntary hold on shipments be removed after a probe showed the death of an 8-year-old boy in Brazil was not related to Elevidys.
Wall Street analysts said the resumption of shipments would allow Sarepta to fulfill its near-term payments to partner Arrowhead (ARWR.O), opens new tab and maintain access to its debt facilities.
"The FDA's recommendation and the resumption of commercial treatment in the U.S. virtually eliminate the risk of Elevidys being formally withdrawn from the market," said William Blair analyst Sami Corwin.
While the decision allows some patients to regain access to the treatment, analysts warned that patients and doctors could show hesitancy in light of the recent hit to reputation.
"It remains to be seen how the news headlines regarding the patient deaths will affect commercial interest in the near term," Corwin said.
Sarepta's partner Roche (ROG.S), opens new tab had also stopped Elevidys shipments in certain countries outside the U.S.
Shares of Sarepta surged 36% to $18.85 in premarket trading. They have fallen more than 80% since the first Elevidys-related death was reported in March.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Independent
14 minutes ago
- The Independent
FTSE 100 ends flat ahead of likely US rate hold
The FTSE 100 struggled for direction on Wednesday, despite progress elsewhere, as investors digested another earnings deluge and looked ahead to the US rate call and earnings from technology titans Meta Platforms and Microsoft. The FTSE 100 index closed up just 0.62 of a point at 9,136.94. The FTSE 250 closed 16.49 points lower, 0.1%, at 21,776.58, and the AIM All-Share closed down 3.03 points, 0.4%, at 762.72. In Europe on Wednesday, the CAC 40 in Paris rose 0.2%, as did the DAX 40 in Frankfurt. In New York on Wednesday, the Dow Jones Industrial Average was down 0.1%, the S&P 500 was 0.1% higher, and the Nasdaq Composite rose 0.3%. The US Federal Reserve will announce its interest rate decision at 7pm BST. According to the CME FedWatch Tool, it is near-certain that the Fed maintains rates at the 4.25% – 4.50% range this week. The Fed held in each of the first four meetings this year. Its last cut was in December, a 25 basis points trim to the federal funds rate range. A fifth successive hold is in the offing during the final meeting before a summer break. The US rate call will be swiftly followed by earnings from two of the Magnificent 7 after the closing bell on Wall Street – Microsoft and Meta Platforms. 'Coming hot off the heels of strong TSMC and Alphabet earnings, traders will be watching closely for capex spending habits and chip demand figures to highlight the continuation of the AI story. Nonetheless, for Meta and Microsoft, their performance will once again come down to the hum drum areas of advertising and cloud revenues,' said Joshua Mahoney, analyst at Rostro. Ahead of this investors weighed data showed the US economy registered stronger than expected growth in the second quarter of the year. According to the Bureau of Labour Statistics, the US economy expanded 3.0% quarter-on-quarter on an annualised basis in the three months to June. The reading topped an FXStreet cited forecast of a 2.4% rise and follows a first quarter which saw the US economy shrink 0.5%. 'The increase in real GDP in the second quarter primarily reflected a decrease in imports, which are a subtraction in the calculation of GDP, and an increase in consumer spending. These movements were partly offset by decreases in investment and exports,' the BEA said. But TD Economics said the figures 'overstated' the degree of strength in the US economy. 'An unwinding of Q1's tariff front-running resulted in imports contracting by the largest amount (outside of the pandemic) since the height of the global financial crisis, resulting in a massive positive contribution to GDP. Once the effects of net trade, inventories and government were removed, sales to private domestic purchasers, expanded by just 1.2% or its slowest rate of growth in 2.5 years,' it noted. Nonetheless, US President Donald Trump stepped up pressure for an interest rate cut, citing the rosier economic growth figures. ''Too Late' MUST NOW LOWER THE RATE,' Mr Trump said on his Truth Social platform, using his critical nickname for Fed Chair Jerome Powell. The pound eased to 1.3285 dollars late on Wednesday afternoon in London, compared to 1.3337 dollars at the equities close on Tuesday. The euro traded at 1.1479 dollars, lower against 1.1537 dollars. Against the yen, the dollar was trading higher at 148.94 yen compared to 148.38 yen. The yield on the US 10-year treasury was at 4.37%, stretched from 4.35%. The yield on the US 30-year Treasury was at 4.91%, widened from 4.88%. In London, the results season continued in full swing with results from more FTSE heavyweights hitting the wires. GSK climbed 4.8% as it forecast annual sales growth at the top end of its outlook range, after 'another quarter of excellent performance' saw revenue and profit beat forecasts. The London-based pharmaceutical firm said its portfolio of Specialty Medicines led the way, and the group added that it is 'positioned to respond to the potential financial impact of tariffs'. Revenue in the second quarter of 2025 rose 1.3% to £7.99 billion from £7.88 billion, helping to push pretax profit up 26% to £1.89 billion from £1.50 billion. Core operating profit rose 12% at constant currency to £2.63 billion from £2.51 billion. Company-compiled consensus looked for revenue of £7.80 billion and operating profit of £2.47 billion. But HSBC slumped 5.0% as it said pretax profit fell 27% to 15.81 billion dollars in the six months ended June 30 from 21.56 billion dollars a year earlier. Diluted earnings per share fell to 0.65 dollars from 0.88 dollars. HSBC maintained its interim dividend at 0.10 dollars per share, but announced plans to initiate and complete a three billion dollar share buyback before its third quarter results are released. Housebuilder Taylor Wimpey shed 6.0% after revealing a £222 million increase in its cladding fire safety provision, a move RBC Capital Markets said caused several investors 'we spoke to this morning to choke on their cornflakes'. Elsewhere, International Personal Finance said it would be minded to accept a takeover bid from a suitor of around £500 million, should an offer come. The provider of credit products and insurance services confirmed it was in 'advanced' talks with asset-based financing provider BasePoint Capital. A price per share of 223.8 pence has been mooted, a sum IPF would recommend to shareholders should an official bid materialise, IPF said in a statement. Shares in IPF closed 19% to the good on the news. Brent oil was quoted higher at 72.99 dollars a barrel in London on Wednesday, up from 70.74 dollars late Tuesday. Gold fell to 3,292.75 dollars an ounce against 3,327.45 dollars. The biggest risers on the FTSE 100 were GSK, up 65.50 pence at 1,462.5p, Pershing Square Holding, up 130.0p at 4,194.0p, AstraZeneca, up 340.0p at 11,498.0p, Intercontinental Hotels Group, up 172.0p at 8,848.0p and Spirax Group, up 120.0p at 6,315.0p. The biggest fallers on the FTSE 100 were Taylor Wimpey, down 6.7p at 100.45p, ConvaTec, down 13.40p at 231.0p, HSBC, down 44.0p at 926.0p, Sage Group, down 57.0p at 1,200.5p, and JD Sports Fashion, down 3.16p at 85.9p. Thursday's local corporate calendar has half-year results from miner Anglo American, tobacco manufacturer BAT, gold miner Endeavour Mining, consumer products firm Haleon, stock exchange operator and data provider London Stock Exchange, aerospace company Rolls-Royce and oil major Shell. Retailer Next is set to update on trading. The global economic calendar on Thursday sees an interest rate decision in Japan overnight, plus retail sales, industrial production and consumer confidence figures in Japan, and US weekly initial jobless claims and the Chicago PMI.
The Independent
14 minutes ago
- The Independent
FDA looking to make vapes less addictive as agency head claims 85% of those sold are ‘illegal'
The Food and Drug Administration (FDA) says it is taking significant steps to make vaping less addictive, with its commissioner likening a synthetic byproduct found in some products to an opioid. Vapes or e-cigarettes are the most commonly used tobacco product among American youths, and there is growing concern about addiction. The agency has formally recommended that the Drug Enforcement Administration (DEA) classify certain 7-hydroxymitragynine (7-OH) products under the Controlled Substances Act. Speaking to Newsmax, FDA Commissioner Marty Makary said there is a widespread problem with illicit vaping products. 'First of all, 85 percent of vaping products sold at your local vape shop are illegal,' he told Rob Schmitt Tonight. 'These are products that are even banned in China, where they come from. They've got these cutesy, fruity flavours or even a video game [that is] part of the vape device designed to addict kids.' Makary went on to condemn these products as 'predatory' and warned of a growing 'epidemic,' noting that 'at some high schools, a quarter of the kids are using these vaping products regularly. So, we've got an epidemic we've got to address,' he said. The substance 7-OH, described by Makary as an opioid, is a derivative of kratom, a South Asian tree. While kratom leaves can produce stimulant effects at low doses and sedative effects at higher doses, the DEA warns they can also lead to psychotic symptoms and both psychological and physiological dependence. Makary issued a stark warning to parents: 'You can walk down to many of these vape stores or convenience stores or gas stations and buy an opioid today.' He added: 'Parents need to know about this. And we recommended the DEA starts to schedule this as a controlled substance. And that's something that's inside of these vapes.' Makary clarified the FDA's focus, explaining: ' Kratom has a trace amount of 7-OH. We're not focused on that. We're focused on the synthetic concentrated byproduct.' According to data from the Centers for Disease Control and Prevention, the use of e-cigarettes was the most commonly used tobacco product among middle and high school students in the United States in 2024. A total of 1.63 million (5.9 percent) students currently use them, including 410,000 (3.5 percent) middle school pupils and 1.21 million (7.8 percent) high school students. Of these, 87.6 percent reported using flavoured e-cigarettes, with disposable e-cigarettes the most popular choice at 55.6 percent, followed by prefilled or refillable pods (15.6 percent) and tank or mod systems (7 percent). According to Johns Hopkins Medicine, evidence shows that vaping is less harmful than smoking, as it exposes users to fewer toxins and at lower levels than smoking cigarettes. However, vapes are just as addictive as traditional cigarettes, as many users get even more nicotine than they would from a combustible tobacco product because users can buy extra-strength cartridges or increase the e-cigarette's voltage to get a greater hit of the substance.
The Guardian
15 minutes ago
- The Guardian
Why it's important to protect your hearing as you age – and what experts suggest
A recent study examined the potential link between hearing loss and dementia, suggesting that treating hearing loss can help the brain. Although the possible connection is still being untangled, study co-author and audiologist Nicholas Reed advises prioritizing hearing health regardless. 'There are already more than enough established benefits related to hearing care,' says Reed, a faculty member of the NYU Langone Health Optimal Aging Institute. What's especially important about supporting hearing health is the effect it has on keeping people engaged in the world, Reed explains. Here's what experts recommend in order to support your hearing as you age. Hearing loss can result from a wide range of genetic and environmental factors, such as chronic diseases and smoking. Some also experience age-related hearing loss, called presbycusis. Hearing loss is 'not about volume', Reed explains. Instead, it's a clarity issue. We lose our hearing at different frequencies at different rates, which can make sounds garbled. There is a tendency to 'normalize hearing loss as we age to some extent', says Reed. Other conditions can seem more pressing, and hearing loss becomes a low priority. There can be 'downstream effects' in a healthcare context because hearing loss can hinder patient-provider communication, says Reed. Early research suggests that hearing loss is associated with increased cognitive decline and an increased risk of new cases of dementia, although further studies are needed to understand this connection. Researchers have not, however, found a cause-and-effect relationship between hearing loss and dementia. Reed and his colleagues wanted to calculate the number of cases of dementia there could be in a population if a potential risk factor, in this case hearing loss, was eliminated. They used a sample of nearly 3,000 adults aged 66 to 90 and found 32% of the dementia risk in the sample group was potentially associated with audiometric hearing loss (hearing loss measured through testing). According to the authors, these results suggest that treating hearing loss may delay the onset of dementia in some older adults. However, this research cannot establish whether hearing loss causes dementia, explains co-author Jason Smith, a postdoctoral researcher at the University of North Carolina. One potential reason hearing loss is associated with cognitive changes is that it can lead to more social isolation, which may strain the brain and affect memory, says Reed. Another theory is that because auditory signals stimulate the brain, the lack of stimulation caused by hearing loss can lead to accelerated brain atrophy. If hearing problems are linked to an increased risk of dementia, are there ways to reduce that risk? An influential 2020 Lancet report recommended the use of hearing aids and protecting ears from excessive noise exposure. A 2023 analysis found a connection between the use of devices like hearing aids and a decreased risk of cognitive decline. However, further research is needed. Hearing loss is not an inevitable part of ageing. But certain factors, such as age-related changes to the inner ear and auditory nerve, as well as genetics, are beyond our control. We can still mitigate the likelihood of damage from other causes. For example, we can manage conditions associated with hearing loss, such as high blood pressure and diabetes. We can also limit exposure to sources of damaging noise, like construction equipment, lawn mowers, motorcycles and loud music. Small actions, like protecting your hearing at a loud concert with over-ear headphones, which Reed prefers to earplugs, can have a big impact. Sign up to Well Actually Practical advice, expert insights and answers to your questions about how to live a good life after newsletter promotion 'A healthy lifestyle and healthy listening habits can go a long way,' says Reed. Reed also recommends that people start getting their hearing tested in their late 30s or 40s. Establishing a baseline can help you identify changes over time, and indicate if and when new habits might be useful. The longer you live with impaired hearing, the harder it is to adjust to tools like hearing aids. Several treatments and devices can help alleviate hearing loss, but their effectiveness depends on the individual. If you suspect you have hearing issues, it's best to have your hearing checked and discuss options with your healthcare provider. Hearing aids can be purchased over-the-counter or with a prescription. Reed says learning how to wear them takes time and practice. There's a critical public health need to expand coverage for these tools, says Smith, because it's well-established that hearing aids can improve quality of life. While studies haven't proven that hearing aids will delay dementia, scientists are intrigued by their potential to support brain health. 'The idea is that, in theory, if a person uses hearing aids, communication becomes easier and you lower the burden of cognitive load,' says Reed. 'You're stimulating the brain with more auditory signals.' Staying engaged in social networks is key to maintaining mental and physical wellbeing, says Reed. In a 2025 study, Reed and colleagues found that, among people with hearing loss, participants who received hearing aids and were counseled on their use experienced less loneliness and social isolation. They also had more varied types of connections, such as friends, family and acquaintances. Similarly, assistive technologies may help. These range widely in function and design, but generally amplify sound, reduce background noise, and improve communication. For example, apps that convert speech to text can assist with phone calls, and personal amplifiers can enhance hearing in conversations. People with mild to moderate hearing loss may find some relief in settings like crowded restaurants through items like the Apple AirPods Pro 2, which feature a built-in hearing aid, says Reed. In some instances, what can help a person manage hearing loss best is how they are supported by their community. There's a need for more equitable environments that support people with sensory health needs, says Smith. 'Some communication tips can go really far,' says Reed. 'Good communication is looking someone in the face. It's speaking slowly. It's about rephrasing and adding context.'
