NetworkNewsBreaks – Concert Pharmaceuticals’ (NASDAQ: CNCE) CTP-656 Obtains Orphan Drug Designation from FDA

Concert Pharmaceuticals (NASDAQ: CNCE) this morning reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for CTP-656, a next generation CFTR potentiator for the treatment of cystic fibrosis. The designation provides incentives such as tax credits related to clinical trial expenses, an exemption from the FDA user fee, FDA assistance in clinical trial design, and potential market exclusivity for seven years following approval. In December 2016, Concert initiated a phase 2 trial in the U.S. evaluating CTP-656 in cystic fibrosis patients with gating mutations. Topline data from the ongoing phase 2 trial is expected by year-end 2017. “We are developing CTP-656 to potentially offer advantages over standard of care, and our team is committed to advancing the clinical development program to address the unmet needs of individuals with cystic fibrosis,” Concert president and CEO Roger Tung, Ph.D. stated in the news release.

To view the full press release, visit: http://nnw.fm/9ZctX

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to address unmet patient needs. The company’s approach starts with approved drugs in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert has a broad pipeline of innovative medicines targeting pulmonary diseases, including cystic fibrosis, central nervous systems (CNS) disorders, as well as autoimmune and inflammatory diseases. For more information, please visit www.concertpharma.com

About NetworkNewsBreak

NetworkNewsBreak (NNB) provides a rapid summary of corporate news that caught the attention of NetworkNewsWire (NNW). NNB keeps you up-to-date on active US Public Companies complementary to NNW’s broader scope as a provider of news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and distribution company with an extensive team of journalists and writers, NNW is uniquely positioned to best serve private and public companies who need to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

For more information, visit https://www.NetworkNewsWire.com.

Please see full disclaimers on the NetworkNewsWire website: http://nnw.fm/Disclaimer

NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s