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CYTK

Cytokinetics

$19.23 /

-0.09 (-0.47%)

07:39
07/19/21
07/19
07:39
07/19/21
07:39

Cytokinetics announces topline results of REDWOOD-HCM

Cytokinetics announced positive topline results from Cohorts 1 and 2 of REDWOOD-HCM, the Phase 2 clinical trial of CK-3773274, an investigational next-generation cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy. The results of REDWOOD-HCM inform dose selection and support progression of CK-274 to a planned Phase 3 registrational clinical trial which is expected to start before year end. Results from Cohorts 1 and 2 of REDWOOD-HCM demonstrated that treatment with CK-274 for 10 weeks resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular outflow tract pressure gradient and the average post-Valsalva LVOT-G. The majority of patients treated with CK-274 achieved the target goal of treatment, defined as resting gradient less than30 mmHg and post-Valsalva gradient less than50 mmHg at Week 10 compared to placebo. Reductions in LVOT-G occurred within two weeks of initiating treatment with CK-274, were maximized within two to six weeks of the start of dose titration, and were sustained until the end of treatment at 10 weeks. The observed reductions in LVOT-G were dose dependent, with patients achieving greater reductions of LVOT-G with increasing doses of CK-274. Treatment with CK-274 in REDWOOD-HCM was generally well tolerated. The incidence of adverse events was similar between treatment arms. No serious adverse events were attributed to CK-274 and no treatment interruptions occurred on CK-274. No new cases of atrial fibrillation in patients treated with CK-274 were reported. In this dose-range finding trial, one patient experienced a transient decrease in left ventricular ejection fraction that required dose adjustment but not dose interruption. LVEF returned to baseline within two weeks after the end of treatment in both cohorts, which was consistent with the reversibility of LVEF decreases that were similarly observed in healthy participants in the Phase 1 study of CK-274. REDWOOD-HCM is a multi-center, randomized, placebo-controlled, double-blind, dose finding clinical trial of CK-274 in patients with symptomatic obstructive HCM on background medical therapy. The primary objective of the trial is to determine the safety and tolerability of CK-274. The secondary objectives are to describe the concentration-response relationship of CK-274 on the resting and post-Valsalva left ventricular outflow tract gradient as measured by echocardiography during 10 weeks of treatment, to describe the dose response relationship of CK-274, and to evaluate the plasma concentrations of CK-274 in patients with oHCM. Seventeen investigative sites in North America and Europe screened for patients to enroll in Cohort 1 and 2 of REDWOOD-HCM. Topline results from REDWOOD-HCM include data from two sequentially conducted cohorts, Cohort 1 and Cohort 2 which randomized treatment of patients 2:1 to CK-274 or placebo. Patients received up to three escalating doses of CK-274 once daily or placebo. Patients had an echocardiogram after two weeks of treatment at each dose to determine potential up-titration to the next higher dose. Overall, treatment duration for each patient in REDWOOD-HCM was 10 weeks with an echocardiogram conducted 2 weeks after the last dose. For patients on CK-274 in Cohort 1, the average resting LVOT-G changed from 53.8 mmHg at baseline to 13.4 mmHg at 10 weeks; for patients on CK-274 in Cohort 2 the average resting LVOT-G changed from 58.2 mmHg at baseline to 15.1 mmHg at 10 weeks; and for patients in the combined placebo group the average resting LVOT-G changed from 52.1 at baseline to 44.0 mmHg at 10 weeks. For patients on CK-274 in Cohort 1 the average Valsalva LVOT-G changed from 74.4 mmHg at baseline to 38.1 mmHg at 10 weeks; for patients on CK-274 in Cohort 2 the average Valsalva LVOT-G changed from 82.3 mmHg at baseline to 29.8 mmHg at 10 weeks; and for patients in the combined placebo group the average Valsalva LVOT-G changed from 84.6 at baseline to 76.0 mmHg at 10 weeks. The average ejection fraction for patients on CK-274 in Cohort 1 changed from 73.2% at baseline to 67.4% at 10 weeks; for patients on CK-274 in Cohort 2 the average ejection fraction changed from 75.4% at baseline to 64.1% at 10 weeks, and for patients in the combined placebo group the average ejection fraction changed from 74.5% at baseline to 74.9% at 10 weeks. Overall, the incidence of adverse events was similar between treatment arms. Treatment with CK-274 in REDWOOD-HCM was generally well tolerated in patients being treated with current standard of care with adverse events reported as mild or moderate in severity. There were no treatment related serious adverse events reported by investigators. No patients who received CK-274 in Cohort 1 had an LVEF less than50%. In Cohort 2, one patient with an LVEF at baseline of 58% was up-titrated to 20 mg of CK-274 and experienced transient LVEF reduction to less than50% requiring down titration. No interruptions or discontinuations of treatment with CK-274 occurred in any patients across both cohorts. The distribution of patients across doses of CK-274 in REDWOOD-HCM informs dose selection for the planned Phase 3 trial with the objective to assess clinical outcomes at the lowest effective individualized dose of CK-274.

  • 05

    Aug

CYTK Cytokinetics
$19.23 /

-0.09 (-0.47%)

05/11/21 Mizuho
Cytokinetics price target raised to $36 from $26 at Mizuho
03/11/21 Wolfe Research
Cytokinetics initiated with an Outperform at Wolfe Research
02/18/21 Barclays
Cytokinetics initiated with an Overweight at Barclays
01/20/21 H.C. Wainwright
Cytokinetics price target raised to $41 from $22 at H.C. Wainwright

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Recommendations
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ServiceNow price target raised to $775 from $700 at Oppenheimer
10/20/21 BofA
ServiceNow price target raised to $800 from $700 at BofA
10/18/21 Mizuho
ServiceNow price target raised to $680 from $650 at Mizuho
NOW ServiceNow
$664.99 /

-11.99 (-1.77%)

NOW ServiceNow
$664.99 /

-11.99 (-1.77%)

NOW ServiceNow
$664.99 /

-11.99 (-1.77%)

Earnings
West Pharmaceutical reports Q3 adjusted EPS $2.06, consensus $1.80 » 06:17
10/28/21
10/28
06:17
10/28/21
06:17
WST

West Pharmaceutical

$421.86 /

+1.29 (+0.31%)

Reports Q3 revenue…

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WST West Pharmaceutical
$421.86 /

+1.29 (+0.31%)

WST West Pharmaceutical
$421.86 /

+1.29 (+0.31%)

11/09/20 KeyBanc
West Pharmaceutical initiated with an Overweight at KeyBanc
WST West Pharmaceutical
$421.86 /

+1.29 (+0.31%)

Recommendations
Edwards Lifesciences price target raised to $120 from $113 at Citi » 06:17
10/28/21
10/28
06:17
10/28/21
06:17
EW

Edwards Lifesciences

/

+

Citi analyst Joanne…

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EW Edwards Lifesciences
/

+

EW Edwards Lifesciences
/

+

09/21/21 Raymond James
Opsens price target raised to C$6.00 from C$2.75 at Raymond James
09/14/21 Piper Sandler
CMS full repeal proposal of MCIT negative for med tech, says Piper Sandler
07/30/21 Canaccord
Edwards Lifesciences price target raised to $124 from $103 at Canaccord
07/30/21 Jefferies
Edwards Lifesciences price target raised to $130 from $110 at Jefferies
EW Edwards Lifesciences
/

+

EW Edwards Lifesciences
/

+

EW Edwards Lifesciences
/

+

Downgrade
Teva downgraded to Market Perform from Outperform at Raymond James » 06:17
10/28/21
10/28
06:17
10/28/21
06:17
TEVA

Teva

$8.94 /

-0.475 (-5.05%)

Raymond James analyst…

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TEVA Teva
$8.94 /

-0.475 (-5.05%)

TEVA Teva
$8.94 /

-0.475 (-5.05%)

04:47 Today Raymond James
Teva downgraded to Market Perform from Outperform at Raymond James
06/22/21 JPMorgan
Opioid settlement would be best case for manufacturers, says JPMorgan
05/04/21 UBS
Teva downgraded to Neutral from Buy at UBS
04/06/21 RBC Capital
Teva transferred with a Sector Perform at RBC Capital
TEVA Teva
$8.94 /

-0.475 (-5.05%)

TEVA Teva
$8.94 /

-0.475 (-5.05%)

TEVA Teva
$8.94 /

-0.475 (-5.05%)

TEVA Teva
$8.94 /

-0.475 (-5.05%)

Earnings
WNS Holdings reports Q3 EPS 86c, consensus 76c » 06:16
10/28/21
10/28
06:16
10/28/21
06:16
WNS

WNS Holdings

$84.81 /

-0.195 (-0.23%)

Reports Q3 revenue less…

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WNS WNS Holdings
$84.81 /

-0.195 (-0.23%)

08/17/21 JPMorgan
WNS Holdings price target raised to $99 from $89 at JPMorgan
07/16/21 Cowen
WNS Holdings price target raised to $90 from $82 at Cowen
07/16/21 Barrington
WNS Holdings price target raised to $95 from $84 at Barrington
07/16/21 Deutsche Bank
WNS Holdings price target raised to $85 from $80 at Deutsche Bank
WNS WNS Holdings
$84.81 /

-0.195 (-0.23%)

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