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PTCT

PTC Therapeutics

$13.27

-0.3 (-2.21%)

08:08
10/17/16
10/17
08:08
10/17/16
08:08

PTC Therapeutics denied appeal for Translarna by FDA

PTC Therapeutics announced that at the end of last week, the Office of Drug Evaluation I, or ODE-I, of the FDA, denied the company's first appeal of the refuse to file letter issued by the FDA's Division of Neurological Products, or DNP, on February 22 regarding PTC's New Drug Application, or NDA, for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy, nmDMD. The company intends to escalate its appeal to the next supervisory level of the FDA. This is an iterative process and the company anticipates that multiple cycles of appeals to progressively higher levels of the FDA may be required.

  • 06

    Nov

PTCT PTC Therapeutics
$13.27

-0.3 (-2.21%)

07/20/16
WEDB
07/20/16
NO CHANGE
Target $12
WEDB
Neutral
Wedbush staying on sidelines on PTC Therapeutics after NICE issues guidance
Noting that NICE has finalized access for England for PTC Therapeutics' Translarna, Wedbush analyst Heather Behanna said she remains on the sidelines on PTC shares, citing the drug's continued regulatory and pricing risks in Europe. While keeping a Neutral rating and $12 price target on PTC shares, Behanna said she believes it is unlikely that the EMA will pull the drug from the market and sees "meaningful upside" in early 2017 if Translarna can demonstrate a statistically significant positive result in cystic fibrosis.
07/26/16
FBCO
07/26/16
DOWNGRADE
Target $6
FBCO
Neutral
PTC Therapeutics downgraded to Neutral from Outperform at Credit Suisse
Credit Suisse analyst Alethia Young downgraded PTC Therapeutics to Neutral and lowered its price target to $6 from $12 citing further uncertainty around the Eurozone DMD approval case. Following the company's release, Young believes that the approval timelines in EU at the best case are now longer than his original expectations though the drug does remain on the market and lowered his probability of success in EMA to 75% from $100.
09/20/16
JEFF
09/20/16
NO CHANGE
Target $7
JEFF
Hold
Jefferies thinks eteplirsen approval will have limited impact on PTC
Jefferies analyst Gena Wang believes yesterday's FDA approval of Sarepta Therapeutics' (SRPT) eteplirsen will have a limited impact on PTC Therapeutics (PTCT). While PTC's potential treatment for Duchenne muscular dystrophy ataluren is considered safe, the FDA approval of eteplirsen is mainly based on the marginal increase of dystrophin level and PTC does not have any dystrophin data from Phase 3, Wang tells investors in a research note. Eteplirsen's approval could pressure the FDA to reconsider the review progress of ataluren, but the final outcome would likely remain the same, the analyst contends. She keeps a Hold rating on PTC with a $7 price target. The stock closed yesterday up 21%, or $1.88, to $10.99.
10/03/16
BOFA
10/03/16
NO CHANGE
Target $15
BOFA
Buy
PTC Therapeutics price target raised to $15 from $9 at BofA/Merrill
BofA/Merrill analyst Tazeen Ahmad raised PTC Therapeutics' price target to $15 from $9 following partner Roche's recruitment for a trial it is conducting to investigate a potential treatment for Spinal Muscular Atrophy, or SMA, patients. Given this advancement, the analyst is raising his probability of approval to 30% from 20% in SMA and maintains his Neutral rating.

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