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What happened
<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Rare Disease Specialist Actions Therapeutic Sarepta (NASDAQ: SRPT) down to 20% in pre-trading today. The drug manufacturer's actions are being transformed into a response to a full response letter issued yesterday by the Food and Drug Administration (FDA) for the drug candidate golodirsen (Duchenne Muscular Dystrophy) (proposed brand name: Vyondys 53). "Data-reactid =" 12 "> Rare Disease Specialist Actions Therapeutic Sarepta (NASDAQ: SRPT) down to 20% in pre-trading today. The drug manufacturer's actions are being transformed into a response to a full response letter issued yesterday by the Food and Drug Administration (FDA) for the drug candidate golodirsen (Duchenne Muscular Dystrophy) (proposed brand name: Vyondys 53).
Sarepta said the FDA had rejected the expedited regulatory filing of the drug for potential safety reasons, such as the risk of infection and kidney toxicity. Biotech CEO, Doug Ingram, said in a following press release that the FDA had raised none of these outstanding issues during the official review of the drug, leaving the company "surprised" by this regulatory decision.
A young woman pretending to be surprised while looking at an open laptop.
Source of the image: Getty Images.
So what
Wall Street was expecting golodirsen to end up banking on healthy annual sales of $ 400 million on the drug maker's first line early in the next decade. With the approval of the drug now in doubt, these projected sales may never materialize. Given this context, investors' decision to take out this morning is easy to understand.
Now what
<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "The bad news is that the FDA has not not seemed Sarepta would intend to sit down as soon as possible with the regulators to determine the way forward, but the main benefit is that there might not be a quick fix in In short, the FDA seems to be taking a much more critical stance towards golodirsen than its other drug, DMD, & nbsp;Exondys 51. This means investors may want to avoid this falling knife today. & Nbsp; & nbsp; "Data-reactid =" 29 "> The bad news is that the FDA did not seem to give society enough leeway to respond quickly to these safety concerns. As a matter of fact, the FDA seems to be taking a much more critical stance towards golodirsen than its other DMD drug, Exondys 51. This means that investors will want to maybe avoid this knife falling today.
<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "George Budwell has no position in any of the actions mentioned. The Motley Fool has no position in the mentioned actions. The Motley Fool has a disclosure policy."data-reactid =" 31 ">George Budwell has no position in the mentioned actions. The Motley Fool has no position in the mentioned actions. Motley Fool has a disclosure policy.
<p class = "canvas-atom-text-canvas Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "This article was originally published on Fool.com"data-reactid =" 32 "> This article was originally published on Fool.com
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