Theravance Stock Up On Fast Track Status For Velusetrag
Zacks Investment Research | Dec 06, 2016 08:55PM ET
Theravance Biopharma, Inc.’s (NASDAQ:TBPH) shares were up 5.1% after the company announced that the FDA has granted Fast Track status to one of its pipeline candidates, velusetrag (a selective 5-HT4 receptor agonist), for the treatment of symptoms associated with idiopathic and diabetic gastroparesis.
Theravance’s year-to-date share price movement shows that the stock has outperformed the Zacks classified Medical-Drugs industry. Specifically, the stock has gained 86.1% so far this year, while the industry witnessed a decline of 25.2%.
We note that the FDA grants Fast Track status to facilitate the development and accelerate the review process of candidates that are being developed for the treatment of serious conditions with unmet medical need. The status will allow the company to communicate with the FDA frequently during the development, making the candidate eligible for accelerated approval and/or priority review, if the required criteria are met. Additionally, the company is eligible to submit completed sections of the new drug application on a rolling basis, resulting in the possibility of a faster review process.
Velusetrag is currently being evaluated in a multi-center, double-blind, randomized, placebo-controlled, parallel-group, phase IIb study in patients with confirmed gastroparesis of either diabetic or idiopathic origin. Data from the study are anticipated mid 2017.
Additionally, a phase II proof-of-concept study on velusetrag in patients with chronic idiopathic constipation has been completed.
We are encouraged by the FDA granting Fast Track status to velusetrag. According to the press release issued by Theravance, gastroparesis is estimated to affect about six million people in the U.S.
Given the lack of treatment options for idiopathic gastroparesis with just one FDA-approved product for diabetic gastroparesis, there exists strong unmet medical need.
We note that Theravance is developing velusetrag in collaboration with Alfa Wassermann. Per the agreement terms, the bulk of phase II costs is being funded by Alfa Wassermann with an exclusive option to develop and commercialize velusetrag in the EU, Russia, China, Mexico and certain other countries. Theravance, on the other hand, retains the full rights to velusetrag in the U.S., Canada, Japan and certain other countries.
Apart from velusetrag, Theravance’s pipeline comprises promising candidates like revefenacin. Currently, revefenacin is being evaluated in a phase III program as a once-daily, nebulized treatment for chronic obstructive pulmonary disease.
THERAVANCE BIO Price and Consensus
Zacks Investment Research
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.