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Cytokinetics (CYTK) Dips 20% so Far in 2023 on Setbacks
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It has been a rough year so far for late-stage biopharmaceutical company, Cytokinetics, Incorporated (CYTK - Free Report) . Shares of the company have moved down 20.5% compared with the industry’s decline of 4.7%.
The company suffered a setback last month and its shares fell on the same. The FDA issued a complete response letter (CRL) to the company’s new drug application (NDA) for candidate omecamtiv mecarbil.
The NDA is seeking approval for omecamtiv mecarbil, an investigational, selective, small molecule-cardiac myosin activator, for treating heart failure with reduced ejection fraction (HFrEF).
The CRL stated that results from the phase III GALACTIC-HF study alone do not establish substantial evidence of effectiveness sufficient for approval. GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) was a late-stage study on omecamtiv mecarbil that enrolled patients with HFrEF at risk of hospitalization and death despite being treated with standard-of-care therapy.
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The regulatory body stated that results from an additional clinical trial of omecamtiv mecarbil are required to establish substantial evidence of effectiveness for the treatment of HFrEF with benefits that outweigh the risks.
The company expects to request a meeting with FDA to understand the agency’s views regarding the CRL and the additional information required to support potential approval of the candidate. However, Cytokinetics has no plans to conduct another clinical trial of omecamtiv mecarbil. Its focus remains on the development program for aficamten, the next-in-class cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, a phase III clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM).
In December 2022, the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 8 to 3 that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of HFrEF.
Additionally, Cytokinetics recently announced that it would discontinue the phase III study of pipeline candidate reldesemtiv for amyotrophic lateral sclerosis (ALS) after the Data Monitoring Committee (DMC) found no effect on primary or key secondary endpoints.
The DMC reviewed unblinded data from COURAGE-ALS and recommended the discontinuation of the clinical trial due to futility, as it found no evidence of effect in patients treated with reldesemtiv relative to placebo on the primary endpoint of change from baseline to 24 weeks in ALSFRS-R or in key secondary endpoints.
These setbacks will weigh on the shares and it remains to be seen how the company progresses with aficamten. The candidate is also being evaluated in non-obstructive HCM and the company plans to begin a phase III study later this year.
Some well-placed stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) , both sporting a Zacks Rank #1 at present.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.
Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters and missed in the remaining three.
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Cytokinetics (CYTK) Dips 20% so Far in 2023 on Setbacks
It has been a rough year so far for late-stage biopharmaceutical company, Cytokinetics, Incorporated (CYTK - Free Report) . Shares of the company have moved down 20.5% compared with the industry’s decline of 4.7%.
The company suffered a setback last month and its shares fell on the same. The FDA issued a complete response letter (CRL) to the company’s new drug application (NDA) for candidate omecamtiv mecarbil.
The NDA is seeking approval for omecamtiv mecarbil, an investigational, selective, small molecule-cardiac myosin activator, for treating heart failure with reduced ejection fraction (HFrEF).
The CRL stated that results from the phase III GALACTIC-HF study alone do not establish substantial evidence of effectiveness sufficient for approval. GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) was a late-stage study on omecamtiv mecarbil that enrolled patients with HFrEF at risk of hospitalization and death despite being treated with standard-of-care therapy.
Image Source: Zacks Investment Research
The regulatory body stated that results from an additional clinical trial of omecamtiv mecarbil are required to establish substantial evidence of effectiveness for the treatment of HFrEF with benefits that outweigh the risks.
The company expects to request a meeting with FDA to understand the agency’s views regarding the CRL and the additional information required to support potential approval of the candidate. However, Cytokinetics has no plans to conduct another clinical trial of omecamtiv mecarbil. Its focus remains on the development program for aficamten, the next-in-class cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, a phase III clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM).
In December 2022, the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 8 to 3 that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of HFrEF.
Additionally, Cytokinetics recently announced that it would discontinue the phase III study of pipeline candidate reldesemtiv for amyotrophic lateral sclerosis (ALS) after the Data Monitoring Committee (DMC) found no effect on primary or key secondary endpoints.
The DMC reviewed unblinded data from COURAGE-ALS and recommended the discontinuation of the clinical trial due to futility, as it found no evidence of effect in patients treated with reldesemtiv relative to placebo on the primary endpoint of change from baseline to 24 weeks in ALSFRS-R or in key secondary endpoints.
These setbacks will weigh on the shares and it remains to be seen how the company progresses with aficamten. The candidate is also being evaluated in non-obstructive HCM and the company plans to begin a phase III study later this year.
Cytokinetics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some well-placed stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) , both sporting a Zacks Rank #1 at present.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.
Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters and missed in the remaining three.