|Day's Range||0.7000 - 0.7000|
Faster Progressing Patients Who Received Reldesemtiv in the Trial Demonstrated Statistically Significant Differences in the Decline in ALSFRS-R Total ScoreSOUTH SAN FRANCISCO, Calif., Oct. 04, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced additional analyses of FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS). Post-hoc analyses relating to the effect of reldesemtiv on the change in ALS Functional Rating Scale – Revised (ALSFRS-R) total score observed during the trial were presented by Jeremy M. Shefner, M.D., Ph.D., Lead Investigator of FORTITUDE-ALS, Professor and Chair of Neurology at Barrow Neurological Institute, and Professor and Executive Chair of Neurology at the University of Arizona, Phoenix, at the 2019 Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting in Clearwater Beach, FL. The post-hoc analyses evaluated change in ALSFRS-R from baseline based on patients’ estimated rate of pre-trial disease progression. Patients were divided into faster, middle, and slower progression tertiles, based on their onset date of ALS symptoms and their ALSFRS-R total score at baseline. Results of these analyses showed that, in the combined middle and faster progressing tertiles, the decline in ALSFRS-R total score from baseline to week 12 was smaller in patients who received any dose of reldesemtiv versus placebo (LS mean treatment difference 1.15, p = 0.011), while no significant difference was observed in slower progressing patients who received reldesemtiv versus placebo. Additionally, use of durable medical equipment (DME, including manual wheelchair, power wheelchair, non-invasive ventilator, feeding tube, and speech generating device) was numerically reduced in all dosing groups treated with reldesemtiv compared to placebo. Combining all doses of reldesemtiv, the hazard ratio compared to placebo was 0.62 (CI 0.40, 0.954, p = 0.027). These analyses showed statistically significant differences in the decline in ALSFRS-R in the combined group of middle and faster progressing tertiles of patients who received any dose of reldesemtiv, and that the timing and use of DME may have been affected by treatment with reldesemtiv, which suggests a potential clinical benefit for patients.“It’s encouraging to see that faster and middle progressing tertiles of patients treated with reldesemtiv experienced a significant slowing of disease progression,” said Fady I. Malik, MD, PhD, Cytokinetics’ Executive Vice President, Research and Development. “These data indicate that, although FORTITUDE-ALS did not achieve statistical significance in the primary analysis of change from baseline in slow vital capacity (SVC) or a similar analysis for ALSFRS-R, favorable outcomes of treatment with reldesemtiv appear evident in more rapidly progressing patients, which supports continued evaluation of reldesemtiv as a treatment for patients with ALS.”About FORTITUDE-ALS FORTITUDE-ALS was a Phase 2, double-blind, randomized, dose-ranging, placebo-controlled, parallel group study of reldesemtiv in patients with ALS. 458 eligible ALS patients from centers in the U.S., Canada, Europe and Australia were randomized (1:1:1:1) to receive either 150 mg, 300 mg or 450 mg of reldesemtiv or placebo dosed orally twice daily for 12 weeks. The primary efficacy endpoint was the change from baseline in the percent predicted SVC, a measure of respiratory function, at 12 weeks. Secondary endpoints included change from baseline in the ALSFRS-R total score and the slope of the change from baseline in the mega-score of muscle strength measured by hand held dynamometry and handgrip dynamometry in patients on reldesemtiv; incidence and severity of treatment-emergent adverse events (TEAEs); and plasma concentrations of reldesemtiv at the sampled time points during the clinical trial. Data from FORTITUDE-ALS were presented at the American Academy of Neurology Annual Meeting in Philadelphia in May 2019 and showed that the trial did not achieve statistical significance for a pre-specified dose-response relationship in the primary endpoint (p=0.11). Similar analyses of the ALSFRS-R total score and the slope of the Muscle Strength Mega-Score yielded p-values of 0.09 and 0.31, respectively. However, patients on all dose groups of reldesemtiv declined numerically less than patients on placebo for SVC and ALSFRS-R, with larger and clinically meaningful differences emerging over time.About ALSAmyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that afflicts approximately 20,000 people in the United States and a comparable number of patients in Europe. Approximately 5,000 new cases of ALS are diagnosed each year in the United States. The average life expectancy of an ALS patient is approximately three to five years after diagnosis and only approximately 10 percent of patients survive for more than 10 years. Death is usually due to respiratory failure because of diminished strength in the skeletal muscles responsible for breathing. Few treatment options exist for these patients, resulting in a high unmet need for new therapies to address functional deficits and disease progression. About CytokineticsCytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to develop reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for diseases of neuromuscular dysfunction, including SMA and ALS. Astellas holds an exclusive worldwide license to develop and commercialize reldesemtiv. Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential benefits of reldesemtiv; Cytokinetics’ continued evaluation of reldesemtiv as a treatment for patients with ALS; and the properties and potential benefits of Cytokinetics’ other drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Astellas’ decisions with respect to the design, initiation, conduct, timing and continuation of development activities for reldesemtiv; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.Contact: Cytokinetics Diane Weiser Vice President, Corporate Communications, Investor Relations (415) 290-7757
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the Cantor Fitzgerald Global Healthcare Conference on Thursday, October 3, 2019 at 10:40 AM ET at the InterContinental New York Barclay Hotel in New York City. The webcast replay of the presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event. Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining.
SOUTH SAN FRANCISCO, Calif., Sept. 26, 2019 -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional results from FORTITUDE-ALS (Functional Outcomes in.
Cytokinetics, Incorporated (CYTK) today announced a call for proposals for the second annual Cytokinetics Communications Fellowship Grant program. The Fellowship program provides a total of $100,000 in grants to five selected patient advocacy organization serving the amyotrophic lateral sclerosis (ALS), heart failure, hypertrophic cardiomyopathy (HCM), or spinal muscular atrophy (SMA) communities, and is intended to support increased capacity in communications, awareness building and community engagement. “After the success of our pilot program last year, we look forward to selecting patient advocacy organizations which may benefit from added support to amplify their messages, connect with more advocates, and expand their reach in the communities they serve,” said Diane Weiser, Cytokinetics’ Vice President of Corporate Communications and Investor Relations.
It’s no question that the biotech space is booming. According to Global Market Insights, the global biotech market is expected to reach $775 billion by 2024, up from $399.4 billion in 2017. While they tend to be more volatile, biotech stocks can offer substantial upside given the fact that a single positive catalyst can send shares soaring. For a few biotechs, positive trial results might just be that catalyst. Wall Street analysts have pinpointed 3 biotech stocks that have seen share prices rise recently in response to new positive data. Each of these stocks has garnered support from the rest of the Street with a “Strong Buy” analyst consensus. This consensus is generated using the last three months’ worth of ratings from all other analysts.With investors on average allocating 2%-6% of their portfolios to these biotechs based on TipRanks Smart Portfolio users, we wanted to learn more about the 3 stocks highlighted by analysts. Should you invest now? Here’s the low-down. Moderna Inc.Moderna (MRNA\- Get Report) uses messenger RNA (mRNA), or molecules that transfer the instructions needed to make proteins located in DNA, to tell patients’ own cells to create proteins to treat, cure or even prevent diseases such as cancer, cardiovascular disease, infectious diseases as well as other rare diseases. Since its September 12 announcement that its Phase 1 Cytomegalovirus (CMV) and Chikungunya programs demonstrated promising results, shares jumped 10% higher. CMV affects one in 150 newborns and can cause jaundice, poor liver function, microencephaly, pneumonia and several other symptoms. Chikungunya is spread through mosquito bites with symptoms including fever and joint pain. According to Needham’s Alan Carr, the CMV vaccine represented a “potent vaccine and compares favorably to the that of the Merck V160 attenuated vaccine”. Adding to the good news, management stated that it expects rapid progression through a Phase 2 trial to a single registration trial to test the vaccine’s ability to prevent the spread of infection from pregnant women to their babies. As there currently aren’t any treatments or vaccines for CMV, these results are an important milestone for MRNA. In addition, its Chikungunya vaccine looks solid as it demonstrated antibody production similar to that of its preclinical program in non-human primates. The analyst believes this could translate to other programs in earlier stage development including methylmalonic acidemia (MMA), which Carr deems the “next clinical catalyst for the stock”. “Both sets of data represent an important step forward for the company,” he explained. The three-star analyst also cites its ongoing immuno-oncology programs for melanoma and ovarian cancer as important areas to watch. All of this lends itself to his conclusion that MRNA could see massive gains. As a result, he reiterated his Buy rating and $28 price target on September 13. He sees 55% upside potential for MRNA.Wall Street appears to be on the same page. MRNA boasts significant support from the Street as it has only received Buy ratings in the last three months, giving it a ‘Strong Buy’ analyst consensus. Its $33 average price target indicates 80% upside potential. Cytokinetics Inc. Cytokinetics (CYTK\- Get Report) wants to use muscle activators to improve the muscle function in patients suffering from cardiovascular disease and neuromuscular diseases. While shares dipped 1% on September 20, the company has achieved 106% growth year-to-date. On top of its already impressive year-to-date gain, CYTK shares have surged 5% in the last five days after it announced data from the Phase 1 study of its CK-274 drug in healthy patients at the annual Heart Failure Society of America (HFSA) meeting. The results suggested that the drug was well-tolerated and met safety requirements. Based on the data, the company can move forward with its Phase 2 clinical trial to treat patients with obstructive hypertrophic cardiomyopathy (HCM), an inherited condition that causes part of the heart to get thicker affecting its ability to pump blood.Its competitor MyoKardia’s (MYOK) mavacamten drug has already gone through a Phase 2 trial, but it should be noted that CYTK’s drug offers a shorter half life as well as a shallower dose response relationship, which is good news for CYTK. With CYTK expected to start the Phase 2 trial by the end of 2019, Needham analyst Chad Messer takes a bullish stance on the biotech. As a result, he reiterated his Buy rating and $16 price target on September 16. His price target only suggests 23% upside potential as it doesn’t include the recent findings. The four-star analyst only factored in its omecamtiv mecarbil drug, which was created from a collaboration with Amgen (AMGN), into CYTK’s price target as this drug has already gone through seven Phase 2 clinical trials. He deems CYTK’s early pipeline as strictly upside. Wall Street sees even more potential when it comes to CYTK. With 5 Buy ratings vs 1 Hold received in the last three months, CYTK has a ‘Strong Buy’ analyst consensus. In general, the Street forecasts 55% upside based on the $20 average price target. Atara BiotherapeuticsThe last biotech stock on our list has developed an allogenic T-cell immunotherapy to target cancerous or diseased cells rather than healthy cells. Atara (ATRA\- Get Report) hopes to use this treatment for patients with cancer, autoimmune diseases as well as viral diseases. While its 54% year-to-date decline is alarming, some analysts point to its 4% climb since it reported new data on September 13 as a step in the right direction. On September 13, ATRA announced initial efficacy data and new safety data from its ongoing Phase 1 study of its ATA188 drug at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The drug was designed to treat patients with multiple sclerosis (MS), a chronic neurological autoimmune disease that can cause vision problems and muscle weakness.ATA188 targets B cells infected with Epstein-Barr Virus (EBV) which is thought to play a role in the development of MS. The results demonstrated a favorable safety profile as well as significant efficacy, with its second cohort exhibiting clinical improvement. These results combined with its completion of the fourth and final Phase 1 dose escalation cohort could be a potential catalyst for the company as MS affects more than two million people globally.While Roth Capital analyst Anthony Butler notes that he would have liked to see more granular data, he believes the results are promising. Following this development, the four-star analyst reiterated his Buy rating and $30 price target on September 13. The price target reflects his confidence in ATRA's ability to gain 90% over the next twelve months.The rest of the Street is just as bullish. ATRA boasts a ‘Strong Buy’ analyst consensus and a $35 average price target, implying 119% upside potential. Find analysts’ favorite stocks with the Top Analysts’ Stocks tool
Cytokinetics, Incorporated (CYTK) today announced data from the Phase 1 study of CK-3773274 (CK-274) were presented in a poster session at the HFSA 23rd Annual Scientific Meeting in Philadelphia. The study met its primary and secondary objectives to assess the safety and tolerability of single and multiple oral doses of CK-274, describe the pharmacokinetics (PK) of CK-274 and its pharmacodynamic effects (PD) as measured by echocardiography, as well as to characterize the PK/PD relationship with regards to cardiac function.
SOUTH SAN FRANCISCO, Calif., Sept. 06, 2019 -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced two poster presentations at the 23rd Annual Heart Failure Society of.
Interested parties may access the live webcast of these presentations by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of each presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of each event. Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining.
Cure SMA and Cytokinetics (CYTK) today announced the renewal of their partnership to increase education, awareness, public policy and fundraising for spinal muscular atrophy (SMA). Cytokinetics will lend support for several of Cure SMA’s upcoming initiatives at the national level and continues to support and participate in events in its local community throughout the year. Cytokinetics remains committed to serving the interests of patients and caregivers fighting SMA, a genetic disease that robs people of their physical strength and can take away their ability to walk, eat or breathe. This year Cytokinetics was a Platinum Sponsor of the 2019 Annual SMA Conference, a unique event that brings together families affected by SMA, along with researchers and clinicians, to network, learn, and collaborate.
Cytokinetics (CYTK) delivered earnings and revenue surprises of -5.66% and 4.88%, respectively, for the quarter ended June 2019. Do the numbers hold clues to what lies ahead for the stock?
Completed Enrollment in GALACTIC-HF with More than 8,200 Heart Failure Patients Results from Phase 1 Study of CK-274 to be Presented at HFSA in September 2019; Phase 2 Clinical.
Cytokinetics (CYTK) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Cytokinetics, Incorporated (CYTK) today announced that preclinical data for CK-3773274 (CK-274) were presented at the American Heart Association’s Basic Cardiovascular Sciences (BCVS) Scientific Sessions in Boston, showing that CK-274 decreased cardiac contractility in vitro, in vivo in healthy animals, and in vivo in a mouse model of hypertrophic cardiomyopathy (HCM). CK-274 is a novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of HCM which may result from increased cardiac contractility.
If you own shares in Cytokinetics, Incorporated (NASDAQ:CYTK) then it's worth thinking about how it contributes to the...
Cytokinetics, Incorporated (CYTK) today announced that it is scheduled to report second quarter results on August 8, 2019 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future. The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com.
Cytokinetics, Incorporated (CYTK) today announced the publication of data in The Journal of Physiology demonstrating that a fast skeletal muscle troponin activator (FSTA) can decrease skeletal muscle fatigue by increasing the metabolic efficiency of muscle contraction. The manuscript, titled “Fast Skeletal Muscle Troponin Activator CK-2066260 Increases Fatigue Resistance by Reducing the Energetic Cost of Muscle Contraction,” was published this month. Cytokinetics conducted the research in collaboration with the laboratory of Professor Håkan Westerblad at the Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
Cytokinetics, Incorporated (CYTK) today announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation to reldesemtiv for the potential treatment of spinal muscular atrophy (SMA). In collaboration with Astellas, Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA), as a potential treatment for people with SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue.
SOUTH SAN FRANCISCO, Calif., July 22, 2019 -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that two preclinical poster presentations relating to CK-3773274.