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CNCE

Concert Pharmaceuticals

$10.10

0.06 (0.60%)

07:03
06/12/19
06/12
07:03
06/12/19
07:03

Concert Pharmaceuticals reports results from two Phase 1 CTP-692 studies

Concert Pharmaceuticals reported results from two studies in its Phase 1 program evaluating CTP-692, a deuterium-modified form of D-serine being developed as an adjunctive treatment for schizophrenia. The safety assessments in the single- and multiple-ascending dose trials in healthy volunteers showed that the drug was well tolerated over the dose ranges tested, which include the doses expected to be evaluated in Phase 2 testing. Key blood and urine markers of kidney function did not indicate any signs of renal impairment. These data are consistent with preclinical findings with CTP-692 indicating an improved renal safety profile compared to non-deuterated D-serine which is known to produce renal toxicity in rats. Despite evidence of benefit in multiple published clinical studies of non-deuterated D-serine in the treatment of schizophrenia, its use has been limited due to renal safety concerns. Furthermore, in contrast to non-deuterated D-serine, which has been reported to display highly variable pharmacokinetic behavior in humans, CTP-692 was found to have low inter-individual pharmacokinetic variability. The company expects data from the single-and multiple-ascending dose Phase 1 trials to be presented at a future scientific meeting. The Phase 1 program was designed to assess CTP-692's safety, tolerability and pharmacokinetic profile in healthy volunteers. The Phase 1 program includes three studies: a crossover comparison of CTP-692 versus D-serine, a single-ascending dose study that also assessed the effect of food on the pharmacokinetics of CTP-692 and a multiple-ascending dose trial assessing CTP-692 dosed orally over seven days. In the single- and multiple-ascending dose trials, CTP-692 was evaluated across doses ranging from 0.5 to 4 grams compared to placebo in a total of 72 volunteers. CTP-692 demonstrated a favorable safety, tolerability and pharmacokinetic profile with no serious adverse events reported. In a separate study in 11 healthy volunteers treated in a crossover design with both CTP-692 and D-serine, CTP-692 was found to have increased plasma exposure compared to D-serine.

  • 13

    Jun

CNCE Concert Pharmaceuticals
$10.10

0.06 (0.60%)

12/18/18
MZHO
12/18/18
NO CHANGE
Target $26
MZHO
Buy
Concert remains best-in-class after Aclaris data, says Mizuho
Mizuho analyst Difei Yang reiterates a Buy rating on Concert Pharmaceuticals (CNCE) after competitor Aclaris Therapeutics (ACRS) reported data from its topical Janus kinase 1/3 inhibitor for the treatment of alopecia areata. While a number of patients were responders in the eyebrow and alopecia totalis/alopecia universalis Phase 2 trials, improvements on Severity of Alopecia Tool scores were not disclosed and a few patients withdrew from the studies, Yang tells investors in a research note. The analyst sees Concert Pharmaceuticals' CTP-543 as best-in-class and more competitive for the treatment of moderate/severe alopecia areata. Yang keeps a $26 price target on Concert shares.
02/07/19
MZHO
02/07/19
NO CHANGE
Target $26
MZHO
Buy
Concert Pharmaceuticals undervalued ahead of 2019 catalysts, says Mizuho
After holding investor meetings with management, Mizuho analyst Difei Yang says shares of Concert Pharmaceuticals are undervalued ahead of important catalysts in 2019. Catalysts include a Patent Trial and Appeal Board decision related to the CTP-543 patent litigation expected by April 9, top-line data from the CTP-543 12mg cohort in Q3, Phase 3 data in Alzheimer's Agitation possibly in Q2, and Phase 1 data from CTP-692 in schizophrenia in the first half of 2019, Yang tells investors in a research note. The analyst sees "strong potential" in CTP-543, regardless of the intellectual property litigation outcome, and believes the asset has potential to be first-to-market for the treatment of alopecia areata. She keeps a Buy rating on Concert Pharmaceuticals with a $26 price target.
04/09/19
STFL
04/09/19
NO CHANGE
Target $18
STFL
Buy
Concert Pharmaceuticals price target lowered to $18 from $27 at Stifel
Stifel analyst Adam Walsh said the USPTO ruling that the claims of Concert Pharmaceuticals' patent covering composition of matter for CTP-543 is not patentable significantly reduces his expected duration of market exclusivity upon approval to 5.5 years from his previous assumption of protection out to 2033. Given this lowered exclusivity assumption, he cut his price target on Concert shares to $18 from $27. However, Walsh keeps a Buy rating on the stock and said the recent selloff seems overdone given his view on several near-term potential catalysts.
04/09/19
JMPS
04/09/19
NO CHANGE
Target $20
JMPS
Outperform
Concert Pharmaceuticals price target lowered to $20 from $26 at JMP Securities
JMP Securities analyst Liisa Bayko lowered her price target on Concert Pharmaceuticals (CNCE) shares to $20 from $26 after USPTO ruled in favor of Incyte (INCY) that claims in Concert's '149 patent are not patentable. Concert said it will appeal the decision, but Bayko thinks a reversal of the PTAB decision is unlikely. She now assumes only 5.5 years of exclusivity for CTP-543, continues to recommend Concert, stating that she sees a $1B opportunity in alopecia areata given the size, unmet need, and competitive landscape. Bayko keeps an Outperform rating on Concert shares.

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PZZA

Papa John's

$50.74

0.28 (0.55%)

17:09
06/14/19
06/14
17:09
06/14/19
17:09
Hot Stocks
Papa John's dismisses KPMG as auditors, hires Ernst & Young »

In a regulatory filing,…

03/08/13
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  • 17

    Jun

  • 20

    Jun

  • 20

    Jun

  • 13

    Nov

EPZM

Epizyme

$11.62

-0.36 (-3.01%)

16:55
06/14/19
06/14
16:55
06/14/19
16:55
Conference/Events
Epizyme to hold a conference call »

Conference call to…

03/08/13
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  • 21

    Jun

CACI

CACI

$202.80

-1.205 (-0.59%)

16:54
06/14/19
06/14
16:54
06/14/19
16:54
Conference/Events
CACI to hold a conference call »

Management holds a fiscal…

03/08/13
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  • 20

    Jun

HCR

Hi-Crush Inc.

$2.84

0.115 (4.22%)

16:53
06/14/19
06/14
16:53
06/14/19
16:53
Syndicate
Hi-Crush Inc files $1B mixed securities shelf »

The company also files to…

03/08/13
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SHIP

Seanergy Marine

$0.63

-0.0381 (-5.70%)

16:51
06/14/19
06/14
16:51
06/14/19
16:51
Earnings
Seanergy Marine reports Q1 EPS ($3.23), two estimates ($2.85) »

Reports Q1 revenue…

03/08/13
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FELP

Foresight Energy

$0.79

-0.04 (-4.82%)

16:46
06/14/19
06/14
16:46
06/14/19
16:46
Hot Stocks
Foresight Energy discloses NYSE listing standard notice »

Foresight Energy is…

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