H2R
2 년 전
AdCom: 8 to 3 against!
SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) 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 heart failure with reduced ejection fraction (HFrEF).
“We are disappointed there was not a greater consensus amongst Committee members relating to the benefit-risk of omecamtiv mecarbil, and we maintain our conviction in the strength of evidence supporting its potential benefit for patients suffering from HFrEF,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We continue to believe omecamtiv mecarbil can be a valuable add-on therapy for patients with worsening heart failure who remain at high risk for heart failure events and hospitalization despite treatment with available guideline-directed medical therapy. We plan to engage constructively with FDA as it completes its review of the application for omecamtiv mecarbil.”
Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator. If approved by the FDA, omecamtiv mecarbil will become the first therapy indicated for HFrEF that directly targets the mechanisms of the heart responsible for contraction – or its pumping function.
Best of luck with your investments!
H2R
2 년 전
Trading halted today
FDA Advisory Committee to Review the New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure with Reduced Ejection Fraction
SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Nasdaq has halted the trading of the Company’s common stock. The U.S. Food & Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) is meeting today to review the New Drug Application (NDA) for omecamtiv mecarbil, an investigational selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF).
The advisory committee meeting, which is being held virtually, is scheduled to begin at 9:00 AM ET today. Briefing materials and webcast information for the meeting can be accessed at https://www.fda.gov/advisory-committees/advisory-committee-calendar/december-13-2022-cardiovascular-and-renal-drugs-advisory-committee-meeting-announcement-12132022. The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA.
The NDA for omecamtiv mecarbil is based on the results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 clinical trial of omecamtiv mecarbil. The Prescription Drug User Fee Act (PDUFA) target action date for the NDA is February 28, 2023.
https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-stock-trading-halted-today
H2R
2 년 전
SA Article
CM in Q4 of 2022. With proof of concept established with omecamtiv mecarbil for heart failure, plus several catalysts expected within a year, these are the reasons why I believe that Cytokinetics is a great speculative biotech play to look into.
Omecamtiv Mecarbil Holds Great Potential With A Few Catalysts
The main drug in the pipeline for Cytokinetics would be omecamtiv mecarbil. That's because not only has it established proof of concept by meeting the primary composite endpoint for the phase 3 GALACTIC-HF study, but it now has two catalysts on the way which traders/investors can focus on. Before going over these catalysts though, it's important to highlight why the biotech was able to move on to file a New Drug Application (NDA) to the FDA. The reason again is because of the impressive results it was able to obtain from the late-stage GALACTIC-HF study. There was a total of 8,256 patients who were recruited that were at risk of hospitalization or death, despite still receiving ongoing standard of care (SOC) therapy. It was noted that omecamtiv mecarbil met on the primary composite endpoint compared to placebo. That is, treatment with Omecamtiv mecarbil reduced the risk of cardiovascular death or heart failure events compared to placebo (patients who received standard of care). With this primary composite endpoint being met, it now provides Cytokinetics the avenue to move towards possible FDA approval. It has already met with the FDA and because additional data was sent to the agency, it needed additional time to review it. Thus, one major catalyst which investors can look forward to would be the PDUFA date established for omecamtiv mecarbil for the treatment of heart failure patients, which is set for February 28, 2023. That's not the only catalyst which investors have to look forward to either. Before this FDA final decision for omecamtiv, the FDA advisory panel committee is going to review the drug first on December 13, 2022. If the advisory committee review goes well, plus the FDA chooses to ultimately approve it for marketing of this heart failure indication, then the expected launch would happen in Q1 of 2023.
H2R
2 년 전
SA Article
CM in Q4 of 2022. With proof of concept established with omecamtiv mecarbil for heart failure, plus several catalysts expected within a year, these are the reasons why I believe that Cytokinetics is a great speculative biotech play to look into.
Omecamtiv Mecarbil Holds Great Potential With A Few Catalysts
The main drug in the pipeline for Cytokinetics would be omecamtiv mecarbil. That's because not only has it established proof of concept by meeting the primary composite endpoint for the phase 3 GALACTIC-HF study, but it now has two catalysts on the way which traders/investors can focus on. Before going over these catalysts though, it's important to highlight why the biotech was able to move on to file a New Drug Application (NDA) to the FDA. The reason again is because of the impressive results it was able to obtain from the late-stage GALACTIC-HF study. There was a total of 8,256 patients who were recruited that were at risk of hospitalization or death, despite still receiving ongoing standard of care (SOC) therapy. It was noted that omecamtiv mecarbil met on the primary composite endpoint compared to placebo. That is, treatment with Omecamtiv mecarbil reduced the risk of cardiovascular death or heart failure events compared to placebo (patients who received standard of care). With this primary composite endpoint being met, it now provides Cytokinetics the avenue to move towards possible FDA approval. It has already met with the FDA and because additional data was sent to the agency, it needed additional time to review it. Thus, one major catalyst which investors can look forward to would be the PDUFA date established for omecamtiv mecarbil for the treatment of heart failure patients, which is set for February 28, 2023. That's not the only catalyst which investors have to look forward to either. Before this FDA final decision for omecamtiv, the FDA advisory panel committee is going to review the drug first on December 13, 2022. If the advisory committee review goes well, plus the FDA chooses to ultimately approve it for marketing of this heart failure indication, then the expected launch would happen in Q1 of 2023.
H2R
2 년 전
December 13, 2022 as AdCom Date for Omecamtiv Mecarbil,
(from StreetInsider)
PDUFA of February 28, 2023
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that the previously announced meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the New Drug Application for omecamtiv mecarbil is currently scheduled for December 13, 2022. The FDA has assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2023. Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF).
The Dec 13 AdCom should give a good indication as to the true potential for approval by the FDA on or before Feb. 28th for omecamtiv mecarbil.
Getting close to some resolution, hopefully a positive one.
Best of luck with your investments!
H2R
2 년 전
SA article / Ph III ALS - DMC recommended Continuation
Same news packaged in a different way on SA:
Cytokinetics (NASDAQ:CYTK) said a data monitoring committee (DMC) recommended the continuation of a phase 3 trial of reldesemtiv to treat amyotrophic lateral sclerosis (ALS), after reviewing unblinded data.
The DMC had assemble to conduct the first planned interim analysis of the ongoing phase 3 study, dubbed COURAGE-ALS, which assessed for the potential of futility.
The first interim analysis was done 12 weeks after about one-third or more of the intended number of patients were randomized to participate in the study.
The study is expected to enroll ~555 patients with ALS who will receive either 300 mg of reldesemtiv or matching placebo dosed orally twice daily for 24 weeks, followed by a 24-week period in which all patients will receive 300 mg of reldesemtiv twice daily.
The main efficacy goal is change from baseline to 24 weeks in the ALS Functional Rating Scale – Revised (ALSFRS-R).
ALS is a progressive nervous system disorder affecting nerve cells in the brain and spinal cord, leading to loss of muscle control.
https://seekingalpha.com/news/3889962-cytokinetics-gets-monitoring-panels-nod-to-continue-phase-3-trial-of-als-drug-reldesemtiv
H2R
2 년 전
Continuation of COURAGE-ALS Following First Interim Analysis
October 10 2022 - 07:30AM
GlobeNewswire Inc.
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Data Monitoring Committee (DMC) for COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), recently convened to conduct the first planned interim analysis of this ongoing Phase 3 clinical trial which assessed for the potential of futility. The DMC reviewed unblinded data from COURAGE-ALS and recommended that conduct of the clinical trial of reldesemtiv continue. Reldesemtiv is a fast skeletal muscle troponin activator (FSTA) in clinical development for the potential treatment of amyotrophic lateral sclerosis (ALS).
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.
A second interim analysis, which is anticipated to occur in the first half of next year, will also assess for potential futility and will also allow for a fixed increase in total enrollment, if deemed necessary, to augment the statistical power of the trial.
Best of luck with your investments!
H2R
3 년 전
NJ Common Pension Fund D Acquires 6,275 Shares of Cytokinetics
State of New Jersey Common Pension Fund D grew its position in Cytokinetics, Incorporated (NASDAQ:CYTK – Get Rating) by 9.1% during the first quarter, HoldingsChannel.com reports. The fund owned 75,013 shares of the biopharmaceutical company’s stock after acquiring an additional 6,275 shares during the quarter. State of New Jersey Common Pension Fund D’s holdings in Cytokinetics were worth $2,761,000 at the end of the most recent reporting period.
A number of other large investors have also added to or reduced their stakes in CYTK. Assenagon Asset Management S.A. boosted its holdings in Cytokinetics by 3,287.6% during the 1st quarter. Assenagon Asset Management S.A. now owns 1,489,952 shares of the biopharmaceutical company’s stock valued at $54,845,000 after acquiring an additional 1,445,969 shares during the period. Invesco Ltd. lifted its holdings in shares of Cytokinetics by 77.9% in the 4th quarter. Invesco Ltd. now owns 759,669 shares of the biopharmaceutical company’s stock worth $34,625,000 after buying an additional 332,610 shares during the period. Lisanti Capital Growth LLC bought a new position in shares of Cytokinetics in the 4th quarter worth $9,976,000. Allspring Global Investments Holdings LLC acquired a new position in Cytokinetics during the 4th quarter valued at about $9,951,000. Finally, Pictet Asset Management SA increased its position in Cytokinetics by 9.0% during the 4th quarter. Pictet Asset Management SA now owns 2,604,797 shares of the biopharmaceutical company’s stock valued at $118,727,000 after buying an additional 214,005 shares in the last quarter.
Best of luck with your investments!
H2R
3 년 전
AdCom scheduled for December 13, 2022.
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that the previously announced meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the New Drug Application for omecamtiv mecarbil is currently scheduled for December 13, 2022. The FDA has assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2023. Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF).
https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-date-fda-advisory-committee-meeting
Best of luck with your investments.
H2R
3 년 전
PDUFA now Feb. 28, 2023
(Nasdaq: CYTK) today announced that, in response to a request from the U.S. Food and Drug Administration (FDA), the company recently provided additional pharmacokinetic analyses of omecamtiv mecarbil related to the company’s new drug application (NDA). After an initial review of the company’s submission, FDA has communicated that the additional data provided constitutes a major amendment to the NDA and has extended the PDUFA date by three months to February 28, 2023 to provide time for a full review of the submission.
Best of luck with your investments!
H2R
3 년 전
omecamtiv mecarbil growing body of evidence
Cytokinetics Reports Positive Data From Trials of Aficamten, Omecamtiv Mecarbil
BY MT Newswires
— 12:27 PM ET 05/23/2022
12:27 PM EDT, 05/23/2022 (MT Newswires) -- Cytokinetics (CYTK) reported positive data Monday regarding investigational drugs aficamten and omecamtiv mecarbil.
The biopharmaceutical company said that aficamten, which is currently being studied in a phase 2 clinical trial, showed sustained and substantial reductions in left ventricular outflow tract gradients, as well as improvements in functional class and symptoms. It also said overall safety and tolerability were favorable.
The company said that data from a phase 3 trial of omecamtiv mecarbil to treat heart failure with reduced ejection fraction was greater than in the overall population, and that blood pressure was not adversely affected with safety similar to placebo.
Cytokinetics (CYTK) said the findings "add to the growing body of evidence demonstrating that patients with clinical features suggestive of high-risk heart failure respond favorably to omecamtiv mecarbil."
Best of luck with your investments!
Whalatane
3 년 전
Rose ...that was a preplanned sale
Still like CYTK more than AMRN, AUPH, AXSM at these levels .... they are presenting at AHA
We need the infringement case to proceed for AMRN to move. Auto switching at pharmacies are killing their script numbers .
AUPH ...market is for severe LN .. about 10% of those with LN imho . Stock will drop at least 20% if they GIA.
AXSM ...looked like a down grade today ? The earning report was OK but I didn't like them saying they needed weeks to months to cure the deficiencies raised by the FDA ...if I heard that correctly
SOUTH SAN FRANCISCO, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced two presentations at the American Heart Association (AHA) Scientific Sessions 2021, taking place online from November 13, 2021 – November 15, 2021, including the presentation of additional results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on stroke in patients with heart failure with reduced ejection fraction (HFrEF), and the presentation of preclinical data relating to a cardiac troponin activator that is a closely related analog to CK-3828136 (CK-136).[/quote]
Kiwi
LearningEveryTrade
3 년 전
That was a few days ago, the 28th. Today the 30th, something new is up.
Could simply be price being setup for the Oct 7th deal.
I think the MM will have the SP priced in for good news, and then plenty of room for a slide/short if nothing too interesting is said.
Perhaps some info, like data, got leaked in prep for it??
So many unknowns!
Should be a fun Week or Two !!!
LearningEveryTrade
3 년 전
Inv Conference on Oct 7.
SOUTH SAN FRANCISCO, Calif., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK), today announced that it will host an Analyst and Investor Day on Thursday, October 7, 2021 from 8:30 AM to 11:30 AM ET. The event will be held at the Westin Grand Central Hotel in New York City, and streamed live online. Members of Cytokinetics’ senior management will be joined by expert clinicians to provide updates on the company’s plans for commercialization and advancing cardiovascular pipeline.
A panel discussion on the challenges of treating patients with heart failure with reduced ejection fraction (HFrEF) and the unmet need in this patient population will feature the following experts:
Tariq Ahmad, MD, MPH, FACC, Associate Professor of Medicine; Medical Director of Advanced Heart Failure, Cardiovascular Medicine, Yale School of Medicine
Alanna Morris, MD, MSc, FHFSA, FACC, FAHA, Associate Professor of Medicine, Division of Cardiology; Director of Heart Failure Research, Emory University Clinical Cardiovascular Research Institute
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