EU regulator does not recommend approval of Sarepta's muscle disorder gene therapy
Shares of the company were down nearly 17% at $10.70 in premarket trading.
The EU committee's negative opinion comes as yet another setback for the company that is facing increasing regulatory scrutiny after two recent deaths of patients who received Elevidys.
Sarepta and its partner outside the U.S., Roche (ROG.S), opens new tab, did not immediately respond to Reuters' requests for comment.
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Reuters
19 minutes ago
- Reuters
Legal cannabis blooms in Morocco but black market still beckons
BAB BERRED, Morocco, July 29 (Reuters) - Beneath the blazing summer sun, Abderrahman Talbi surveyed the neat rows of flourishing cannabis blooms in compact fields, reflecting on how his life has changed since he joined Morocco's burgeoning legal cannabis industry two years ago. Like many farmers in the northern Rif mountains who have long grown the crop illegally, Talbi is relieved that raids and seizures by the authorities are no longer a worry. "I can now say I am a cannabis farmer without fear," Talbi told Reuters. "Peace of mind has no price." Talbi's pivot to legal farming is an example of what Morocco, one of the world's biggest cannabis producers, hoped to achieve when it legalised cultivation for medical and industrial use, but not for recreational purposes, in 2022. Regulating cannabis farming brought with it hopes for fresh revenue and economic revitalisation in the impoverished Rif region. The step made Morocco a forerunner among major producing countries and the first in the Middle East and North Africa to join a global trend that has seen countries like Canada, Germany and Uruguay legalise production and use. It also hoped to lure farmers away from the illegal economy in the restive Rif mountains, where cannabis production has long been tolerated to facilitate social peace. Al Hoceima, a major city in Rif, saw the largest protests in Morocco in 2016-17 over economic and social conditions. Legalisation efforts have gained traction, with about 5,000 farmers joining the industry this year, from just 430 in 2023, says Morocco's cannabis regulator, or ANRAC. And legal production surged to nearly 4,200 tonnes last year, a 14-fold increase over the first harvest in 2023. Still, the black market remains dominant and lucrative due to demand for recreational use from Europe and regionally in Africa, potentially undermining efforts to fully regulate the sector. Morocco has 5,800 hectares (14,300 acres) of legally planted land, according to ANRAC. That's dwarfed by illegal cultivation spanning over 27,100 hectares, Interior Ministry data shows. While many farmers still choose illicit cultivation, they face the risk of increased crackdowns by authorities, which led to the seizure of 249 tonnes of cannabis resin by September last year, up 48% from all of 2023, according to the Interior Ministry. Mohammed Azzouzi, 52, spent three years in hiding for cannabis-related charges before receiving a royal pardon along with over 4,800 others last year. Now, he is preparing for his first legal harvest and hopes to earn more than the 10,000 dirhams ($1,100) he used to make in the illegal economy each year. The country's prohibition on growing cannabis for leisure use, along with bureaucratic red tape, limit legal farming, with every stage of the supply chain requiring a specific license from ANRAC, discouraging many a farmer from making the switch. A grower who wants to cultivate legally needs to join a licensed cooperative, which buys the farmer's product and processes it into derivatives or sells the resin to other licensed manufacturers. Talbi's cooperative, Biocannat, near the town of Bab Berred, 300 km (186 miles) north of Rabat, bought about 200 tonnes of cannabis last year from some 200 farmers, processing it into resin, supplements, capsules, oils and powders for medical and cosmetic purposes. About 60 km east of Biocannat, in the main producing area of Issaguen, farmer Mohamed El Mourabit was initially hopeful about the legalisation plan in 2021, but is less so now. "The process is too complicated," he said. And money talks, as well, for many farmers, who are lured by the higher rewards of the black market, despite its risks. While cooperatives take months to pay farmers about 50 dirhams per kilogram for the raw plant, on the illicit market, processed cannabis resin can fetch up to 2,500 dirhams per kilogram, farmers and activists say. To close that gap, legalisation advocates say growing for recreational use should be allowed, too. But it's not clear whether that will happen soon. Mohamed Guerrouj, head of ANRAC, said legalising recreational use would only be considered within a medical framework. "The goal is to develop Morocco's pharmaceutical industry ... not coffee shops," he said.
Reuters
21 minutes ago
- Reuters
Bank of Ireland shares fall on U.S. related impairment charge
DUBLIN, July 29 (Reuters) - Bank of Ireland (BIRG.I), opens new tab shares fell 3% on Tuesday after it set aside more money than expected to cover potential losses in its U.S. acquisition finance business in the first half of the year when lower interest rates cut its pre-tax profit by one-third. Ireland's biggest lender still maintained its guidance for a full year return on tangible equity of around 15% after upgrading its net interest income forecast to 2027. The bank set aside 137 million euros ($158 million) in the first half, reflecting a cost of risk of 33 basis points and increased its expectation for the year as a whole to 30 basis points from the low- to mid-20s previously forecast. It said just under a third of the first half charge reflected its view of the macroeconomic outlook, with most of the rest related to its 1.5 billion euro ($1.7 billion) U.S. finance business, equivalent to just under 2% of its total loan book. "I regard that very much as a preemptive measure. This is getting ahead of the potential problem and what you would expect us to do, particularly given the U.S. dynamics throughout quarter two," Bank of Ireland CEO Myles O'Grady told an analyst call. Bank of Ireland shares were 3.3% lower at 0840 GMT. First half pre-tax profits fell to 721 million euros ($832 million) from 1.1 billion euros ($1.3 billion) in 2024 following a run of European Central Bank rate cuts. The bank's Irish loans and deposits grew by 5% year-on-year in the first half, which contributed to it nudging up its net interest income expectations for the next three years. Those upgrades point to upside to 2026 and 2027 management and consensus expectations, analysts at Davy Stockbrokers wrote in a note. The bank added that its estimates in February for deposit and loan book growth of 3% and 4% respectively in both 2026 and 2027 were unaffected by the uncertainty associated with U.S. tariffs. Finance chief Mark Spain told Reuters its loan book showed there were no perceptible challenges emerging from the tariffs and that the caution larger business customers had shown at the height of trade tensions in April was beginning to dissipate. ($1 = 0.8652 euros) ($1 = 0.8645 euros)
Reuters
21 minutes ago
- Reuters
Turkey asks Iraq to ensure full use of oil pipeline in talks on new deal
ANKARA, July 29 (Reuters) - Turkish Energy Minister Alparslan Bayraktar said a proposed new energy agreement between Turkey and Iraq must include a mechanism to ensure the full use of the oil pipeline between the two countries. Last week, Ankara said the decades-old accord covering the Kirkuk-Ceyhan oil pipeline would end in July 2026 and an Iraqi official said Turkey had proposed expanding the deal to include cooperation in oil, gas, petrochemicals and electricity. Laying out Turkey's core demands, Bayraktar said the country was asking for a draft agreement to include "a mechanism to ensure full use of this pipeline". "The note we've sent is along these lines," he told reporters after a cabinet meeting on Monday. "This pipeline has a capacity of almost 1.5 million barrels per day. There's no flow at the moment. Even when it did flow, it was never at full capacity," he said further. The Kirkuk-Ceyhan pipeline has been offline since 2023, after an arbitration court ruled Ankara should pay $1.5 billion in damages for unauthorised Iraqi exports between 2014 and 2018. Turkey is appealing the ruling. Bayraktar said Turkey's proposal included options such as extending the pipeline to the south of Iraq. "It (the pipeline) doesn't have to be filled entirely with oil from Iraq. To reach those figures, the pipeline needs to reach the south anyway," he said, adding that the deadline to agree on a new deal was July 2026. The Turkish government has said the Development Road initiative - a high-speed road and rail link running from Iraq's port city of Basrah on the Gulf to the Turkish border and later to Europe - is an opportunity to extend the pipeline south. Baghdad allocated initial funding for the project in 2023.
