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A Timeline Of PTC Therapeutics' Translarna Journey

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A Timeline Of PTC Therapeutics' Translarna Journey

Shares of PTC Therapeutics, Inc. (NASDAQ: PTCT) soared more than 80 percent higher on Friday.

The company confirmed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the renewal of the company's therapy called Translarna (ataluren) for the treatment of Duchenne Muscular Dystrophy.

Here is a brief timeline of the lead-up to Friday's announcement:

  • February 23: PTC's stock tumbled 50 percent after the company announced receipt of a Refuse to File letter from the FDA for Translarna.
  • February 25: PTC was reportedly targeted for an acquisition.
  • February 26: PTC confirms it hasn't been able to reach an agreement with Germany's reimbursement authorities on price and may have to withdraw Translarna from the market.
  • March 14: PTC says that Health Canada will not be reviewing its New Drug submission for Translarna in the first half of 2016.
  • April 15: PTC's stock soared after the company announced that the England-based National Institute for Health and Care Excellence recommended the company's Translarna therapy.
  • July 25: PTC initiates a pediatric clinical study of Translarna in patients two to five years old.
  • July 25: PTC confirms that a renewal assessment procedure with the CHMP won't be completed by mid-year 2016.
  • September 20: PTC's therapy gained investor intention after the FDA approved Sarepta Therapeutics Inc (NASDAQ: SRPT)'s Eteplirsen for the treatment of DMD.
  • October 17: PTC plunged more than 25 percent after the U.S. Food and Drug Administration (FDA) sent a denial letter for its Translarna.
  • October 17: PTC said it will escalate an appeal to the next supervisory level of the FDA.
  • November 2: PTC reported its third-quarter results in which the company lost $1.03 per share on revenue of $22.98 million.

At last check, PTC Therapeutics shares were up 73.27 percent at $10.40.

Posted-In: DMD Duchenne Muscular Dystrophy PTC TherapeuticsBiotech Health Care Movers Trading Ideas General Best of Benzinga

 

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