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Sarepta fails obtain support eu new: Furthermore,
Sarepta fails obtain support eu:
((Translation automated by Reuters using automatic learning. Therefore, generative AI, please refer to the following warning: https://bit.ly/rtrsauto)))))
(Updating of actions. However, adding analyst comments to paragraphs 7-8, Sarepta declaration to paragraphs 5,11) by Christy Santhosh and Mrinalika Roy
SAREPTA THERAPEUTICS SRPT.O failed to obtain the support of the European Medicines regulator for its gene therapy of muscle disorders on Friday. For example, while the company faces intense regulatory monitoring after two recent deaths of patients related to treatment. However,
The actions of the company based in Cambridge, in the Massachusetts, fell by 11 %. In addition, They have lost 88.8 % since the start of the year. In addition,
The EUvidys Committee’s negative opinion on EUVIDYS is a new major setback for the company. Similarly, sarepta fails obtain support eu new to which the American health regulatory authority asked at sarepta fails obtain support eu the beginning of the month. In addition, to stop all the expeditions of gene therapy – the only approved by the United States for the treatment of Duchenne muscular dystrophy (DMD).
Sarepta had already interrupted the dosage in non-ambulatory patients. that is to say incapable of walking independently. and then complied with the demand of the American Food and Drug Administration to interrupt all deliveries, as well as Roche Rog.S-its partner outside the United States.
“Although we are disappointed with the negative opinion of the CHMP (Committee for Medicinal Products for Human Use). we understand the urgent need to continue dialogue. collaboration in order to provide transformative therapies to people with Duchenne disease,” said Louise Rodino-Klapac, responsible for research and development at Sarepta.
The DMD is mainly observed in men, sarepta fails obtain support eu new affecting 1 in 5,000 boy born in the world. The average life expectancy of a sarepta fails obtain support eu person with this disease is 22 years.
Sami Corwin. analyst at William Blair. said that the fall in Sarepta’s actions reflected the reduction of income from future potential steps and rock fees.
“Even if we think that it is possible that the break on Elevidys’ deliveries to the United. States is raised before the end of the year. especially for young patients and ambulatory patients, uncertainty will continue to weigh on action.”
Roche said on Friday that she would continue her dialogue with the European Medicines Agency to explore. a potential path to make Elevidys available in the EU.
The benefit-risk profile remains positive in ambulatory patients, said Swiss drug manufacturer.
Sarepta said he was continuing to work with the sarepta fails obtain support eu new FDA in the United States to respond to. recent security problems related to Elevidys.
Sarepta fails obtain support eu new
Sarepta fails obtain support eu
sarepta fails obtain support eu
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