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PTCT

PTC Therapeutics

$13.27

-0.3 (-2.21%)

11:11
10/17/16
10/17
11:11
10/17/16
11:11

Citi says time running out for PTC Therapeutics in Europe

Citi analyst Joel Beatty says that while the FDA's denial of PTC Therapeutics' first appeal was widely expected, the major objection relating to the efficacy of Translarna by Europe's Committee for Medicinal Products for Human Use is more concerning. The move highlights that the CHMP is still not comfortable with the overall risk-benefit profile of Translarna ahead of an expected decision by year-end, Beatty tells investors in a research note. He sees heightened risk of Translarna's marketing authorization not being renewed in Europe and feels PTC's time is running out to alleviate CHMP's concerns. The analyst has a Neutral rating on the shares with a $9 price target. PTC is trading down 30%, or $3.94, to $9.34 in morning trading.

  • 06

    Nov

PTCT PTC Therapeutics
$13.27

-0.3 (-2.21%)

10/17/16
JANY
10/17/16
NO CHANGE
JANY
PTC's denial has negative read-through for BioMarin, says Janney Capital
Janney Capital noted that PTC Therapeutics' (PTCT) Translarna and Sarepta's (SRPT) Exondys 51 address non-overlapping DMD populations and there was an expectation of flexibility from the FDA following the conditional approval of Exondys 51. However, the FDA has denied the first appeal of the refuse to file letter regarding PTC's NDA for Translarna for the treatment of nonsense mutation DMD, which the firm said has potential negative read-through for BioMarin's (BMRN) attempt to rekindle Kyndrisa, which is a direct competitor to Sarepta's Exondys 51. The firm added that the news might positively impact reimbursement decisions for Exondys 51.
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.
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.
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.

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MGA

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HON

Honeywell

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MSFT

Microsoft

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RCL

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RCL

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XOM

Exxon Mobil

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MXWL

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RCL

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