Theravance Biopharma, Inc. TBPH, along with its partner Mylan MYL, recently announced the presentation of additional efficacy and safety data from two pivotal phase III studies evaluating its key late-stage pipeline candidate, revefenacin (TD-4208). The presentation was made at the American Thoracic Society (ATS) International Conference.

Revefenacin is an experimental once-daily nebulized long-acting muscarinic antagonist, which is being developed for the treatment of chronic obstructive pulmonary disease (COPD).

We remind investors that Theravance and Mylan entered into development and commercialization agreement for revefenacin in Feb 2015. Under the terms of the agreement, the companies will co-develop revefenacin for COPD and other respiratory diseases. While Theravance will lead the U.S. registration development program, Mylan will be responsible for the commercial manufacture of the product. Theravance is entitled to receive up to $220 million in development and sales milestone payments. Theravance is also eligible for a profit-sharing arrangement with Mylan on U.S. sales and double-digit royalties on ex-U.S. sales.

Shares of Theravance have significantly outperformed the Zacks classified Medical-Drugs industry so far this year. The stock has gained 14.6% during the period, while the broader industry has witnessed an increase of 7.2%.

Coming back to the latest news, the company reported positive top-line data from two similar three-month phase III studies in Oct 2016. Data from the two studies were announced in two separate presentations at the 2017 ATS meeting. While the first presentation was focused on efficacy outcomes, the second presentation featured safety and tolerability data. Data from the first presentation demonstrated statistically significant and clinically meaningful improvements compared to placebo.

The studies were conducted in more than 1,250 patients with moderate to very severe COPD. Moreover, data from a single 12-month safety study evaluating the candidate is expected in mid-2017. Positive data from the safety study would allow Theravance to file a new drug application for revefenacin in the U.S. by the end of 2017.

Meanwhile, the company initiated a phase IIIb study evaluating revefenacin in patients with low peak inspiratory flow rate in Mar 2017. Data from the study is expected in early 2018.

Per the company’s press release, COPD is the third-leading cause of death in the U.S. This is mainly because 12.7 million Americans are diagnosed with the disease, while an almost an equal number of patients remain undiagnosed. An approval will be a huge boost as there is large commercial opportunity for revefenacin in the COPD area.

Theravance Biopharma, Inc. Price

Theravance Biopharma, Inc. Price | Theravance Biopharma, Inc. Quote

Zacks Rank & Key Picks

Theravance currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in healthcare sector are VIVUS, Inc. VVUS and Regeneron Pharmaceuticals, Inc. REGN. Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017 in the last 30 days. The company delivered positive earnings surprises in all the four trailing quarters with an average beat of 233.69%.

Regeneron’s earnings per share estimates increased from $10.16 to $10.52 for 2017 and from $10.90 to $12.10, over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters with an average beat of 0.45%.

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