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Theravance (TBPH) Advances TD-0714, Submits IND to FDA

Theravance Biopharma, Inc.TBPH announced that it has submitted an investigational new drug (IND) application to the FDA to conduct a phase I single-ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy subjects.

The company is working to develop a best-in-class selective neprilysin (NEP) inhibitor for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases such as diabetic nephropathy. TD-0714 is the lead NEP inhibitor candidate at Theravance Biopharma. Subject to FDA action on the IND, the company plans to initiate the phase I study in the fourth quarter of 2015.

TD-0714 has the potential to be administered once daily and can be combined with other approved drugs or candidates. Theravance Biopharma is looking for a partner for the development and commercialization of TD-0714 and is currently engaged in active discussion with a number of potential collaborators.

We are pleased with the pipeline advancement at Theravance Biopharma. Last month, the company initiated a phase III registrational program on revefenacinIn (TD-4208), a key late-stage pipeline candidate, for the treatment of chronic obstructive pulmonary disease. Theravance is collaborating with Mylan MYL for the development and commercialization of revefenacinIn.

Theravance Biopharma carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK and Amgen Inc. AMGN . Both Anika and Amgen hold a Zacks Rank #1 (Strong Buy).

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AMGEN INC (AMGN): Free Stock Analysis Report

MYLAN NV (MYL): Free Stock Analysis Report

ANIKA THERAPEUT (ANIK): Free Stock Analysis Report

THERAVANCE BIO (TBPH): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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