12.03.2019 13:52:30
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Ascendis Pharma - It's Been All About Growth...
(RTTNews) - Shares of Ascendis Pharma A/S (ASND) closed yesterday's trading at an all-time high of $125.29, and that represents a gain of nearly 100% year-to-date.
Ascendis Pharma is a biopharmaceutical company with a pipeline of three independent, rare disease endocrinology product candidates in clinical development, and oncology as its second therapeutic area of focus.
The Company's lead product candidate is TransCon hGH for the treatment of pediatric growth hormone deficiency or GHD, under phase III program.
Children with GHD are characterized by short stature, metabolic abnormalities, cognitive deficiencies and poor quality of life.
On March 4, the Company announced positive top-line results from a phase III trial that compared its once-weekly TransCon Growth Hormone to a daily growth hormone (Genotropin) in children with pediatric growth hormone deficiency, sending the stock up over 74% to $120 that day.
In the trial, dubbed height, TransCon hGH was observed to be non-inferior and, additionally, superior to the daily growth hormone on the primary endpoint of annualized height velocity (AHV) at 52 weeks.
In addition to the flight trial, there are two more phase III trials in the TransCon hGH program - fliGHt and enlighten.
The fliGHt Trial is evaluating TransCon hGH in subjects who switch from daily hGH, and top-line data from this study are expected in the second quarter of 2019.
The enliGHten Trial is a long-term extension that provides subjects from the heiGHt and fliGHt Trials with the opportunity to continue once-weekly TransCon hGH treatment.
Next up in the pipeline is TransCon PTH, a long-acting prodrug of parathyroid hormone (PTH), in subjects with hypoparathyroidism.
A phase II study of TransCon PTH in adults with hypoparathyroidism, dubbed PaTH Forward, was initiated last month. Top-line results from this study are anticipated in the fourth quarter of 2019.
Another product in clinical development is TransCon CNP, a long-acting prodrug of C-type natriuretic peptide for the treatment of achondroplasia.
Achondroplasia is the most common form of dwarfism, affecting approximately 250,000 people worldwide.
The Company expects to initiate a phase II trial of TransCon CNP in children with achondroplasia in the third quarter of this year.
Recent event:
On March 8, the Company completed the sale and issuance of an aggregate of 4.17 million American Depositary Shares ("ADSs"), each of which were sold to the public at a price of $120.00 per ADS. The net proceeds from the offering were approximately $469.3 million.
ASND was trading around $17 when we alerted our premium subscribers to this stock on March 30, 2015 (Report titled "It's All About Growth..."). The stock has been on an ascent all these years and it hit a peak of $127.33 yesterday before closing at $125.29.
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