We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Cytokinetics (CYTK) to Continue ALS Study on Reldesemtiv
Read MoreHide Full Article
Cytokinetics, Incorporated (CYTK - Free Report) has announced that it will continue the COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS) study following the first interim analysis. However, shares lost 1.11% in regular trading and 4.85% in after-hours trading.
COURAGE-ALS, a phase III, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv, is expected to enroll approximately 555 patients with amyotrophic lateral sclerosis (ALS).
Reldesemtiv is a fast skeletal muscle troponin activator (FSTA) being evaluated for the potential treatment of ALS.
The Data Monitoring Committee (“DMC”) for COURAGE-ALS recently convened to conduct the first planned interim analysis of this ongoing study, which assessed the potential of futility. The first interim analysis was triggered 12 weeks after approximately one-third or more of the intended number of patients were randomized to participate in COURAGE-ALS.
The DMC reviewed unblinded data from COURAGE-ALS and then recommended the continuation of the study.
The phase III study will continue to the second interim analysis, which is expected in 2023. The analysis will also assess for potential futility and allow for a fixed increase in total enrollment, if deemed necessary, to augment the trial's statistical power.
Shares of Cytokinetics have gained 4.6% so far this year against the industry’s decrease of 28.3%.
Image Source: Zacks Investment Research
Other candidates in the pipeline include omecamtiv mecarbil, a novel cardiac myosin activator, CK-136 (formerly known as AMG 594), aficamten, a novel cardiac myosin inhibitor, and CK-3772271 (CK-271), its second novel cardiac myosin inhibitor.
Omecamtiv mecarbil is being evaluated for the potential treatment of heart failure. In February 2022, the FDA accepted the filing of its new drug application (NDA) for omecamtiv mecarbil to treat heart failure with reduced ejection fraction (HFrEF).
The FDA has extended the target action date for omecamtiv mecarbil to Feb 28, 2023, due to additional pharmacokinetic analyses of the drug provided to the FDA upon request and that are deemed to constitute a major amendment to the NDA.
The company has also received notice that the FDA plans to convene an Advisory Committee meeting (currently scheduled for Dec 13, 2022) to review the NDA for omecamtiv mecarbil.
The FDA has also granted a Breakthrough Therapy designation to aficamten for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The successful development of these candidates will be a big boost for the company.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. Earnings surpassed estimates in three of the trailing four quarters and missed the mark in the remaining one, the average beat being 2.39%.
Estimates for Novartis’ 2022 earnings per share have increased from $6.06 to $6.09 in the past 60 days.
Earnings of Novartis beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 1.39%, on average. In the last reported quarter, NVS delivered an earnings surprise of 3.31%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Cytokinetics (CYTK) to Continue ALS Study on Reldesemtiv
Cytokinetics, Incorporated (CYTK - Free Report) has announced that it will continue the COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS) study following the first interim analysis. However, shares lost 1.11% in regular trading and 4.85% in after-hours trading.
COURAGE-ALS, a phase III, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv, is expected to enroll approximately 555 patients with amyotrophic lateral sclerosis (ALS).
Reldesemtiv is a fast skeletal muscle troponin activator (FSTA) being evaluated for the potential treatment of ALS.
The Data Monitoring Committee (“DMC”) for COURAGE-ALS recently convened to conduct the first planned interim analysis of this ongoing study, which assessed the potential of futility. The first interim analysis was triggered 12 weeks after approximately one-third or more of the intended number of patients were randomized to participate in COURAGE-ALS.
The DMC reviewed unblinded data from COURAGE-ALS and then recommended the continuation of the study.
The phase III study will continue to the second interim analysis, which is expected in 2023. The analysis will also assess for potential futility and allow for a fixed increase in total enrollment, if deemed necessary, to augment the trial's statistical power.
Shares of Cytokinetics have gained 4.6% so far this year against the industry’s decrease of 28.3%.
Image Source: Zacks Investment Research
Other candidates in the pipeline include omecamtiv mecarbil, a novel cardiac myosin activator, CK-136 (formerly known as AMG 594), aficamten, a novel cardiac myosin inhibitor, and CK-3772271 (CK-271), its second novel cardiac myosin inhibitor.
Omecamtiv mecarbil is being evaluated for the potential treatment of heart failure. In February 2022, the FDA accepted the filing of its new drug application (NDA) for omecamtiv mecarbil to treat heart failure with reduced ejection fraction (HFrEF).
The FDA has extended the target action date for omecamtiv mecarbil to Feb 28, 2023, due to additional pharmacokinetic analyses of the drug provided to the FDA upon request and that are deemed to constitute a major amendment to the NDA.
The company has also received notice that the FDA plans to convene an Advisory Committee meeting (currently scheduled for Dec 13, 2022) to review the NDA for omecamtiv mecarbil.
The FDA has also granted a Breakthrough Therapy designation to aficamten for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The successful development of these candidates will be a big boost for the company.
Cytokinetics currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) , Novartis (NVS - Free Report) and Dynavax (DVAX - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. Earnings surpassed estimates in three of the trailing four quarters and missed the mark in the remaining one, the average beat being 2.39%.
Estimates for Novartis’ 2022 earnings per share have increased from $6.06 to $6.09 in the past 60 days.
Earnings of Novartis beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 1.39%, on average. In the last reported quarter, NVS delivered an earnings surprise of 3.31%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.