PTC Therapeutics (NASDAQ:PTCT) changed -4.83% to recent value of $42.79. The stock transacted 782346 shares during most recent day however it has an average volume of 999.53K shares. It spotted trading -28.55% off 52-week high price. On the other end, the stock has been noted 38.96% away from the low price over the last 52-weeks.
On April 7, 2020, PTC Therapeutics (NASDAQ:PTCT) reported that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam to August 24, 2020. Roche recently submitted additional data including comprehensive data from SUNFISH part 2 to help provide access to risdiplam for a broad range of people living with spinal muscular atrophy (SMA), triggering this extension. The FDA has informed Roche that the review team is working expeditiously to complete their review of the application as quickly as possible. The FDA has also indicated to Roche that no substantive review issues have been identified to date.
We are encouraged that the FDA has no substantive review issues. Their interest in the additional results from the clinical studies demonstrating risdiplam’s activity supports our goal of enabling access to this important therapy for all SMA patients, stated Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. Enabling access to a home-administered oral therapy for a broad patient population is critically important and we look forward to the FDA living up to its commitment to review the application as quickly as possible.
In order to further support broad, global access to risdiplam for people living with SMA, Roche has submitted applications for approval in Indonesia, Taiwan, Chile, Brazil, South Korea and Russia and the submission of the filing in China is imminent. The submission of a Marketing Authorization Application (MAA) to the EMA and filings in other international markets remain on track for mid-2020.
PTCT has a gross margin of 96.00% and an operating margin of -78.60% while its profit margin remained -82.00% for the last 12 months. Its earnings per share (EPS) expected to touch remained -55.40% for this year while earning per share for the next 5-years is expected to reach at -9.51%.
The company has 66.17M of outstanding shares and 60.65M shares were floated in the market. According to the most recent quarter its current ratio was 3.3 that represents company’s ability to meet its current financial obligations. The price moved ahead of 1.70% from the mean of 20 days, -13.64% from mean of 50 days SMA and performed -5.55% from mean of 200 days price. Company’s performance for the week was -4.08%, -16.08% for month and YTD performance remained -10.91%.