Sign In
Time puterTime puter
Aa
  • Home
  • Social Media
  • Softwares
  • Gadgets
  • Mobiles
  • Solution
  • Apple
  • News
  • Contact Us!
Reading: Sarepta shares leap on FDA’s eteplirsen overview delay
Share
Time puterTime puter
Aa
Search
  • Home
  • Social Media
  • Softwares
  • Gadgets
  • Mobiles
  • Solution
  • Apple
  • News
  • Contact Us!
Have an existing account? Sign In
Follow US
© 2022 Foxiz News Network. Ruby Design Company. All Rights Reserved.
Time puter > Solution > Sarepta shares leap on FDA’s eteplirsen overview delay
Solution

Sarepta shares leap on FDA’s eteplirsen overview delay

Deep
Last updated: 2016/06/18 at 10:35 AM
Deep Published June 18, 2016
Share
2 Min Read

biotech pharmaceuticals

stocks of Sarepta Therapeutics rose nearly 27 percent Wednesday after announcing the meals and Drugadministration is delaying its evaluate of a key drug made through the company.

The FDA notified Sarepta that “they are persevering with their evaluation and internal discussions related to our pending NDA for eteplirsen and will now not have the ability to complete their work by the Prescription Drug person price Act (PDUFA) purpose date of may additionally 26, 2016,” Sarepta said, in a announcement. “The FDA has communicated that they’ll keep to paintings past the PDUFA purposedate and attempt to complete their work in as well timed a way as feasible.”

In a statement, the FDA said:

“As cited inside the organisation‘s assertion, the FDA contacted Sarepta Therapeutics to let themunderstand we’re continuing necessary paintings on their New Drug software for eteplirsen and couldno longer take action via the purpose date. We can not comment further at the drug review, howeveryou can contact the business enterprise for extra information. The FDA is prohibited by way of lawfrom commenting on pending packages due to the fact such statistics is taken into consideration privateand proprietary to the applicant.”
Eteplirsen is a drug designed by means of Sarepta to treat Duchenne Muscular Dystrophy.

Finish
TAGGED: delay, eteplirsen, FDA's, leap, on, overview:, Sarepta, shares
Deep June 18, 2016
Share
Previous Article college students easy lecture rooms in place of giving re-examination
Next Article IIHM eCHAT exam 2016: check out the results now

Recent Post

  • Exploring Pregnancy Test Line Progression: A Comprehensive Guide
  • Milk Bath Pregnancy Photos: Capturing Maternity Beauty
  • Magnesium Lotion for Pregnancy: A Soothing Solution for Expecting Moms
  • Understanding the Lump in Throat Sensation During Pregnancy
  • Late Ovulation Pregnancy Success Stories: Hope Beyond Timing
  • Is Lion’s Mane Safe During Pregnancy
  • Understanding Hyperkeratosis Areola During Pregnancy
  • Hazumi and Pregnancy: Navigating the Journey to Motherhood

Removed from reading list

Undo
Welcome Back!

Sign in to your account

Lost your password?