Zogenix (NASDAQ: ZGNX) changed 0.27% to recent value of $47.78. The stock transacted 1683009 shares during most recent day however it has an average volume of 813.49K shares. It spotted trading -23.86% off 52-week high price. On the other end, the stock has been noted 42.93% away from the low price over the last 52-weeks.
Zogenix (NASDAQ: ZGNX) a global pharmaceutical company developing rare disease therapies, announced that following receipt of final minutes from the U.S. Food and Drug Administration (FDA) from the Type A meeting held on May 30, 2019, the Company intends to resubmit its New Drug Application (NDA) for FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in the third quarter of this year.
The Type A meeting was conducted to review the two issues identified in the Refusal to File (RTF) letter issued by the FDA on April 5, 2019: first, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine; and, second, the application contained an incorrect version of a clinical dataset. Based on the final meeting minutes received, the FDA has agreed to Zogenix’s plan to resubmit the NDA for FINTEPLA without the inclusion of the new chronic toxicity studies requested in the RTF letter. With regards to the second issue, the Company conducted and discussed with the FDA a root cause analysis to explain the incorrect clinical dataset submitted in the original NDA, and the FDA is in agreement with the Company’s plan for resubmission of the datasets in the NDA.
We are very pleased with the outcome of our meeting with the FDA and appreciate their thoughtful approach in considering the totality of the data from our drug development program, along with additional clinical and non-clinical literature that will be referenced in our resubmission, said Stephen J. Farr, Ph.D., President and CEO of Zogenix. We now have the clarity required to successfully resubmit our FINTEPLA NDA, which we anticipate will occur in the third quarter. Its earnings per share (EPS) expected to touch remained 0.90% for this year while earning per share for the next 5-years is expected to reach at 2.80%.
The company has 42.75M of outstanding shares and 41.3M shares were floated in the market. According to the most recent quarter its current ratio was 9.1 that represents company’s ability to meet its current financial obligations. The price moved ahead of 19.56% from the mean of 20 days, 23.23% from mean of 50 days SMA and performed 10.39% from mean of 200 days price. Company’s performance for the week was 17.63%, 28.13% for month and YTD performance remained 31.05%.
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