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Concert Offers Update on Cystic Fibrosis Drug, Stock Down
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Concert Pharmaceuticals, Inc. provided update on the development plan of its next generation CFTR potentiator, CTP-656, for the treatment of cystic fibrosis in the U.S. and Europe. Shares of the company were down approximately 14% on the news.
Moreover, Concert’s share price has declined 39.7% in the past one year compared with Zacks classified Medical-Drugs industry’s fall of 7.8%.
Coming back to the release, Concert commenced a placebo-controlled phase II study in Dec 2016 in the U.S. to assess CTP-656 in cystic fibrosis patients with gating mutations. Following the initiation of the study, FDA asked the company, that in order to support dose selection for phase III, an adequate washout period, in which Vertex Pharmaceuticals Incorporated’s (VRTX - Free Report) Kalydeco treatment is withheld, would be required along with placebo-control study. The company plans to discuss the additional feedback with the FDA. Top-line data from the study should be out by the end of 2017.
Concert, on the other hand, plans to start an open-label phase II study on the candidate in the second quarter of 2017. The study will enroll 14 cystic fibrosis patients with gating mutations stable on Kalydeco. In the study, patients will be switched to one dose of CTP-656 for two weeks followed by a switch to a higher dose of CTP-656 for further two weeks. Consequently, patients will resume treatment with Kalydeco. Topline data from this study should also be out by the end of 2017.
Last year in Feb, We note that Concert had reported new data in late Feb from part 1 of a multiple ascending dose phase I study on CTP-656 comparing the candidate to Vertex’s Kalydeco for the treatment of patients with cystic fibrosis. Results from the study confirmed that CTP-656 has a superior pharmacokinetic profile to Kalydeco. This included a longer half-life of approximately 15 hours, a reduction in the rate of clearance and a substantial increase in exposure and greater plasma levels at 24 hours.
Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 35.3% in the past one year.
Enzo’s loss estimates for 2016 narrowed 5.9% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 48.7% in the past one year.
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>
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Concert Offers Update on Cystic Fibrosis Drug, Stock Down
Concert Pharmaceuticals, Inc. provided update on the development plan of its next generation CFTR potentiator, CTP-656, for the treatment of cystic fibrosis in the U.S. and Europe. Shares of the company were down approximately 14% on the news.
Moreover, Concert’s share price has declined 39.7% in the past one year compared with Zacks classified Medical-Drugs industry’s fall of 7.8%.
Coming back to the release, Concert commenced a placebo-controlled phase II study in Dec 2016 in the U.S. to assess CTP-656 in cystic fibrosis patients with gating mutations. Following the initiation of the study, FDA asked the company, that in order to support dose selection for phase III, an adequate washout period, in which Vertex Pharmaceuticals Incorporated’s (VRTX - Free Report) Kalydeco treatment is withheld, would be required along with placebo-control study. The company plans to discuss the additional feedback with the FDA. Top-line data from the study should be out by the end of 2017.
Concert, on the other hand, plans to start an open-label phase II study on the candidate in the second quarter of 2017. The study will enroll 14 cystic fibrosis patients with gating mutations stable on Kalydeco. In the study, patients will be switched to one dose of CTP-656 for two weeks followed by a switch to a higher dose of CTP-656 for further two weeks. Consequently, patients will resume treatment with Kalydeco. Topline data from this study should also be out by the end of 2017.
Last year in Feb, We note that Concert had reported new data in late Feb from part 1 of a multiple ascending dose phase I study on CTP-656 comparing the candidate to Vertex’s Kalydeco for the treatment of patients with cystic fibrosis. Results from the study confirmed that CTP-656 has a superior pharmacokinetic profile to Kalydeco. This included a longer half-life of approximately 15 hours, a reduction in the rate of clearance and a substantial increase in exposure and greater plasma levels at 24 hours.
Zacks Rank & Key Picks
Concert currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) and Enzo Biochem, Inc. (ENZ - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 35.3% in the past one year.
Enzo’s loss estimates for 2016 narrowed 5.9% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 48.7% in the past one year.
Concert Pharmaceuticals Inc. Price
Concert Pharmaceuticals Inc. Price | Concert Pharmaceuticals Inc. Quote
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>