NEW YORK (TheStreet) -- Shares of PTC Therapeutics (PTCT) - Get Report are declining by 3.69% to $10.44 on heavy trading volume on Wednesday morning, after the company received an FDA "Refuse to File" letter this week regarding its New Drug Application.
About 2.87 million of the company's shares were traded by this morning, well above its average volume of 1.77 million shares per day.
The letter to the South Plainfield, NJ-based biopharmaceutical company was regarding its drug ataluren, which is used to treat Duchenne muscular dystrophy, a muscle disorder.
The FDA said the application was not sufficiently complete, according to statement from the company.
PTC "is reviewing its content to determine the appropriate next steps."
Earlier this morning, Jefferiesupgraded the stock. The firm said the European Union's decision on the drug remains unclear.
PTC is focused the discovery, development and commercialization of orally administered, small molecule therapeutics for human diseases.
Separately, TheStreet Ratings Team has a "Sell" rating with a score of D on the stock.
This is driven by several weaknesses, which should have a greater impact than any strengths, and could make it more difficult for investors to achieve positive results compared to most of the stocks covered.
The company's weaknesses can be seen in multiple areas, such as its feeble growth in its earnings per share, deteriorating net income, disappointing return on equity, weak operating cash flow and generally disappointing historical performance in the stock itself.
Recently, TheStreet Ratings objectively rated this stock according to its "risk-adjusted" total return prospect over a 12-month investment horizon. Not based on the news in any given day, the rating may differ from Jim Cramer's view or that of this articles's author.
You can view the full analysis from the report here: PTCT