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PTCT

PTC Therapeutics

$17.46

0.65 (3.87%)

15:40
09/28/17
09/28
15:40
09/28/17
15:40

FDA panel says data inconclusive on efficacy of PTC Therapeutics' ataluren

According to multiple media reports of the FDA Advisory Committee meeting to review the NDA for PTC Therapeutics' ataluren, the committee members voted 10-1 that the data are inconclusive on the effectiveness of the drug and more work is needed to establish if ataluren is effective. One vote was cast that the data are sufficient to conclude that ataluren is effective.

  • 28

    Sep

  • 24

    Oct

PTCT PTC Therapeutics
$17.46

0.65 (3.87%)

09/26/17
JPMS
09/26/17
NO CHANGE
JPMS
JPMorgan sees 'multiple negative points' in PTC briefing documents
09/26/17
JPMS
09/26/17
NO CHANGE
JPMS
Neutral
PTC briefing documents have 'very negative' tone, says JPMorgan
JPMorgan analyst Anupam Rama says the FDA briefing documents this morning for PTC Therapeutics' panel meeting Thursday have a "very negative" tone. The FDA's conclusion is that the data submitted by PTC is not "persuasive" for approval, Rama tells investors in a research note titled "Multiple Negative Points in Translarna FDA Briefing Docs Make Approval a Low Probability." He also believes management credibility "could be an overhang" based on some of the commentary in the documents. The analyst remains cautious on a positive Translarna panel outcome and approval going into Thursday's panel vote. He would not be surprised to see continued pressure on PTCT shares into the meeting. Rama reiterates a Neutral rating on the shares. PTC in morning trading is down 24%, or $4.72, to $14.79.
09/27/17
SBSH
09/27/17
NO CHANGE
Target $28
SBSH
Buy
Citi sees $22 of upside on positive vote, says buy PTC after selloff
Citi analyst Joel Beatty recommends using yesterday's weakness in shares of PTC Therapeutics as a buying opportunity. The stock closed down 14% to $16.81 after the FDA posted briefing documents ahead of Thursday's panel vote. At current levels, there is almost no value in PTC shares for U.S. Translarna sales, Beatty tells investors in a research note. He sees downside of less than $1 per share if the panel votes against approval, and upside of $22 per share if the panel votes that Translarna is effective. Beatty disagrees that the briefing documents raise concern about management credibility and he believes Translarna will stay on the market in Europe. The analyst keeps a Buy rating on PTC Therapeutics with a $28 price target.
09/27/17
LEER
09/27/17
NO CHANGE
LEER
Outperform
Sarepta doesn't see read through from PTC AdComm, says Leerink
After hosting Sarepta (SRPT) executives, Leerink analyst Joseph Schwartz noted management stated they do not anticipate any read through to Sarepta's exon skipping drugs from the advisory committee meeting to discuss PTC Therapeutics' (PTCT) ataluren as the therapies have different mechanisms and address different disease states. Additionally, the company said Exondys 51's U.S. launch has exceeded expectations, sales outside the U.S. are expected to be slower than U.S. sales, that they see a potential FDA filing for golodirsen in Q1 of 2018 and that they will update guidance in 2018. Schwartz keeps an Outperform rating on Sarepta shares.

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