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CARA

Cara Therapeutics

$25.91

0.57 (2.25%)

07:03
07/22/19
07/22
07:03
07/22/19
07:03

Cara Therapeutics says no modifications in trial size for Phase 2 KORSUVA trial

Cara Therapeutics announced the completion of an interim statistical assessment of its Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with stage III-V chronic kidney disease. In addition, the Company announced that the trial is now fully enrolled at 240 patients. Based on the recommendation of the Independent Data Monitoring Committee, the trial does not require any modifications to the original enrollment target of 240 patients. The IDMC's recommendation was based on the results of a prespecified interim conditional power assessment conducted after approximately 50% of the 240 patients had completed the designated 12-week treatment period. The Phase 2, multicenter, randomized, double-blind, placebo-controlled, 12-week trial is designed to evaluate the safety and efficacy of three dose levels of Oral KORSUVA versus placebo in approximately 240 stage III-V CKD patients with moderate-to-severe pruritus. The primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24-hour Worst Itch Numeric Rating Scale score at Week 12 of the treatment period. Secondary endpoints include change from baseline in itch-related quality of life scores at the end of Week 12, as assessed by the total Skindex-10 and 5-D itch scales, as well as the proportion of patients achieving an improvement from baseline greater than or equal to3 points with respect to the weekly mean of the daily 24-hour Worst Itch NRS score at Week 12.

CARA Cara Therapeutics
$25.91

0.57 (2.25%)

05/29/19
NEED
05/29/19
NO CHANGE
Target $35
NEED
Strong Buy
Cara Therapeutics price target raised to $35 from $28 at Needham
Needham analyst Alan Carr raised his price target for Cara Therapeutics to $35 from $28 after the company reported that the Korsuva Phase 3 KALM-1 trial met all primary and secondary endpoints. Statistically significant and clinically meaningful effects were observed across pruritus and quality of life assessments, Carr tells investors in a research note. The analyst assumes the FDA will recommend Cara submit a new drug application after the "nearly identical" KALM-2 trial is completed in the second half of 2019. He keeps a Buy rating on the shares.
05/29/19
HCWC
05/29/19
NO CHANGE
Target $28
HCWC
Buy
Cara Therapeutics price target raised to $28 from $26 at H.C. Wainwright
H.C. Wainwright analyst Oren Livnat raised his price target for Cara Therapeutics to $28 from $26 saying this morning's "robust" KALM-1 results bolster his "bullish" expectations. KALM-1 delivered, with highly statistically significant results versus placebo on all primary and secondary endpoints, Livnat tells investors in a research note. The analyst adds that the general consistency from Phase 2b supports his confidence in likely success of the global KALM-2 study for which he expects topline data by Q4. Livnat maintains an "already high" 80% probability of success on IV Korsuva and keeps a Buy rating on Cara Therapeutics.
05/29/19
JEFF
05/29/19
NO CHANGE
Target $34
JEFF
Buy
Jefferies boosts Cara Therapeutics target to $34 on 'home run' data
Jefferies analyst Chris Howerton raised his price target for Cara Therapeutics to $34 from $25 saying he views the KALM-1 results as "very positive." The efficacy is a "home run" scenario, and there was no surprise in the adverse events profile, Howerton tells investors in a research note. The analyst now has increased confidence on Cara's entire pipeline. He keeps a Buy rating on the shares. Cara Therapeutics in late morning trading is up 11%, or $2.00, to $19.98.
07/01/19
PIPR
07/01/19
NO CHANGE
Target $35
PIPR
Overweight
Piper reiterates Overweight on Cara Therapeutics after nephrologist survey
Piper Jaffray analyst David Amsellem polled 25 nephrologists who manage a significant number of hemodialysis patients to gauge perceptions of the intravenous form of Cara Therapeutics' Korsuva in pruritus associated with chronic kidney disease. There is good familiarity with the body of data in the dialysis setting, most respondents perceive an unmet medical need, and most respondents have favorable impressions of Cara's data, Amsellem tells investors in a research note. The analyst says the survey reinforced our view that IV Korsuva will emerge as a valued anti-pruritic in hemodialysis patients. He views the U.S. sales opportunity "well north" of $400M-$500M and reiterates an Overweight rating on Cara Therapeutics with a $35 price target.

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