Concert Pharmaceuticals, Inc. shares were down almost 8% on Wednesday after the company announced that the FDA has placed a clinical hold on a mid-stage study evaluating its pipeline candidate CTP-543 for the treatment of alopecia areata.
Shares of Concert Pharma have outperformed the Zacks Classified Medical - Drugs industry so far this year. The company has gained 44.4% while the industry rose 4.9% in the period.
The FDA had previously approved the initiation of a phase IIa study on CTP-543, which began earlier this month. However, just before the start of patient dosing, the FDA yesterday informed Concert that the agency needs to review data from one recently completed non-clinical toxicology study. There was no safety concern cited by the FDA. However, agency clarified they intend to review this additional non-clinical data as support to one year dosage data from the planned phase IIa study.
With the FDA placing a clinical hold, new patient enrollment in the study has been halted for the time being. The company is actively working with the FDA to resume enrollment in the Phase IIa trial by submitting the requested non-clinical study reports as soon as possible. The FDA will notify Concert about the status of clinical hold within 30 days after the company’s response.
We note that Concert is developing CTP-543 for the treatment of alopecia areata, an autoimmune disease resulting in partial or complete loss of hair on the scalp and body. CTP-543 was discovered by applying its deuterium chemistry technology to modify Incyte Corporation’s (INCY - Free Report) oncology drug, Jakafi. Jakafi selectively inhibits Janus kinases 1 and 2, enzymes controlling signal transmission in cells and believed to be involved in this autoimmune disorder. Jakafi has been evaluated in academic settings and reported to promote hair growth in individuals suffering from moderate-to-severe alopecia areata.
We remind investors that Concert had inked a definitive deal with Vertex Pharmaceuticals Incorporated (VRTX - Free Report) in Mar 2017 to sell the worldwide development and commercialization rights of its cystic fibrosis (CF) pipeline candidate, CTP-656 for an upfront payment of $160 million in cash.
Zacks Rank & Key Pick
Concert Pharma currently has a Zacks Rank #4 (Sell). A better-ranked healthcare stock is VIVUS, Inc. . Vivus sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vivus’ loss per share estimates narrowed 22% to 39 cents for 2017 over the last 60 days. The company posted positive surprises in all the four trailing quarters with an average beat of 233.69%.
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Concert Pharmaceuticals, Inc. shares were down almost 8% on Wednesday after the company announced that the FDA has placed a clinical hold on a mid-stage study evaluating its pipeline candidate CTP-543 for the treatment of alopecia areata.
Shares of Concert Pharma have outperformed the Zacks Classified Medical - Drugs industry so far this year. The company has gained 44.4% while the industry rose 4.9% in the period.
The FDA had previously approved the initiation of a phase IIa study on CTP-543, which began earlier this month. However, just before the start of patient dosing, the FDA yesterday informed Concert that the agency needs to review data from one recently completed non-clinical toxicology study. There was no safety concern cited by the FDA. However, agency clarified they intend to review this additional non-clinical data as support to one year dosage data from the planned phase IIa study.
With the FDA placing a clinical hold, new patient enrollment in the study has been halted for the time being. The company is actively working with the FDA to resume enrollment in the Phase IIa trial by submitting the requested non-clinical study reports as soon as possible. The FDA will notify Concert about the status of clinical hold within 30 days after the company’s response.
We note that Concert is developing CTP-543 for the treatment of alopecia areata, an autoimmune disease resulting in partial or complete loss of hair on the scalp and body. CTP-543 was discovered by applying its deuterium chemistry technology to modify Incyte Corporation’s (INCY - Free Report) oncology drug, Jakafi. Jakafi selectively inhibits Janus kinases 1 and 2, enzymes controlling signal transmission in cells and believed to be involved in this autoimmune disorder. Jakafi has been evaluated in academic settings and reported to promote hair growth in individuals suffering from moderate-to-severe alopecia areata.
We remind investors that Concert had inked a definitive deal with Vertex Pharmaceuticals Incorporated (VRTX - Free Report) in Mar 2017 to sell the worldwide development and commercialization rights of its cystic fibrosis (CF) pipeline candidate, CTP-656 for an upfront payment of $160 million in cash.
Zacks Rank & Key Pick
Concert Pharma currently has a Zacks Rank #4 (Sell). A better-ranked healthcare stock is VIVUS, Inc. . Vivus sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vivus’ loss per share estimates narrowed 22% to 39 cents for 2017 over the last 60 days. The company posted positive surprises in all the four trailing quarters with an average beat of 233.69%.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
See This Ticker Free >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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