Ascendis Pharma A/S (ASND - Free Report) announced that it has submitted an Investigational New Drug (“IND”) application with the FDA related to progress of clinical development of its pipeline candidate, TransCon PTH. The IND seeks to initiate a phase II study – PaTH Forward – to evaluate safety, tolerability and efficacy of TransCon PTH in adult patients with hypoparathyroidism (“HP”).
The company is developing the candidate as a potential replacement therapy for HP, administered once-daily.
Shares of Ascendis Pharma increased 2.4% on Feb 12 following the news. The company’s shares have gained 3.3% in the past six months against the industry’s decline of 14.6%.
TransCon PTH works by restoring the parathyroid hormone to physiologic levels in the body for 24 hours, every day, which currently available therapies are unable to do.
The mid-stage PaTH Forward study will evaluate three fixed doses of TransCon PTH in patients with HP who are currently being treated with standard-of-care, comprising active vitamin D and calcium supplements. The study will also evaluate a titration regimen of the candidate as a complete replacement of the standard-of-care for patients.
The company will also assess a ready-to-use pre-filled pen device as part of the study.
Data from successfully completed phase I study on the candidate demonstrated its potential in replacing and restoring PTH to physiologic levels for 24 hours per day.
Top-line data from the phase II study is expected in the fourth quarter of 2019.
Ascendis Pharma has two other candidates built on the proprietary TransCon platform, which are in different stages of development. The most advanced candidate in its pipeline – TransCon hGH – is being developed in two late-stage studies as a treatment for growth hormone deficiency. A phase I study is evaluating the other candidate – TransCon CNP – for treating achondroplasia.
The company has collaboration with Sanofi (SNY - Free Report) and Genentech, a subsidiary of Roche (RHHBY - Free Report) , to develop TransCon-based anti-VEGF and peptides for the treatment of ophthalmic diseases and diabetes, respectively.
Although the company believes that all its clinical-stage candidates target markets with blockbuster capacity, absence of any commercialized drug and rising research costs may hinder Ascendis Pharma’s growth prospects. However, the company’s liquid resources are seemingly strong.
Zacks Rank & Stock to Consider
Ascendis Pharma currently carries a Zacks Rank #3 (Hold). Galectin Therapeutics Inc. (GALT - Free Report) is a better-ranked stock from the healthcare space, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Galectin’s loss per share estimates have narrowed from 44 cents to 38 cents for 2018 and from $1.12 to 98 cents for 2019 over the past 60 days. The company delivered positive earnings surprise in all the last four quarters, with the average beat being 18.65%. Share price of the company has risen 8.5% in the past six months.
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