Theravance's NDA for COPD Candidate Gets FDA Acceptance

Theravance Biopharma, Inc. TBPH and partner Mylan (MYL) have announced that the new drug application (NDA) for their pipeline candidate, revefenacin (TD-4208), has been accepted by the FDA for treatment of adults with chronic obstructive pulmonary disease (COPD). A response from the regulatory body is expected on Nov 13, 2018.

Notably, revefenacin is an experimental once-daily nebulized long-acting muscarinic antagonist (LAMA) therapy for COPD.

Notably, Theravance and Mylan had entered into a development and commercialization agreement for revefenacin back in February 2015. Under the contractual terms, 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 product’s commercial manufacturing.

Shares of Theravance have underperformed the industry in a year’s time. The stock has gained 0.2% while the broader industry increased 17.2%.

We remind investors that Theravance submitted the NDA to the FDA for revefenacin in November 2017 for the aforementioned indication. The NDA submission was supported by positive data from two replicate pivotal phase III efficacy studies and a single 12-month, open-label, active comparator safety trial. In October 2016, the company reported positive data from both the phase III trials. The programs met the primary endpoints, demonstrating statistically significant improvements over placebo after 12 weeks of dosing, each comprising 88 mcg of revefenacin once daily and 175 mcg once daily, respectively.

Significantly, the company initiated a phase IIIb study last March, evaluating revefenacin on patients with low peak inspiratory flow rate. Data from the study is likely to be out by early 2018.

Per the company’s press release, COPD is the third leading cause for death in the United States. This grim picture suggests that while 15.7 million Americans are diagnosed with the disease, a larger number of patients still remains undiagnosed. An approval will thus be a huge boost to those patients, preferring nebulized therapy but with no access to a nebulized LAMA. Hence, there is a large commercial countrywide opportunity awaiting revefenacin in the COPD area.

Theravance Biopharma, Inc. Price

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

Zacks Rank & Key Picks

Theravance carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Exelixis, Inc. EXEL, XOMA Corporation XOMA and Sucampo Pharmaceuticals, Inc. SCMP, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Exelixis’ earnings per share estimates have been revised upward from 72 cents to 77 cents for 2018 over the last 60 days. The company pulled off a positive surprise in all the trailing four quarters with an average beat of 572.92%. Share price of the company has soared 71.5% in a year’s time.

XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 over the last 60 days. The company came up with an average beat of 47.92%. The stock has skyrocketed 706.4% in the last 12 months.

Sucampo delivered a positive surprise in three of the last four quarters with an average beat of 15.63%. The company’s share price has surged 67% in a year.

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