After the company disclosed that the Food and Drug Administration has awarded fast-track status to its lead drug candidate, omecamtiv mecarbil, shares in Cytokinetics (NASDAQ: CYTK) are surging 24.5% higher at 12:00 pm EST on Monday. Omecamtiv mecarbil is currently under evaluation by the biotech company in a large-scale phase 3 clinical trial, GALACTIC-HF, that's expected to have top-line results available in Q4, 2020. Since the treatment has the potential to help heart patients with reduced ejection fraction, the FDA awarded it a fast-track designation, which provides increased FDA guidance and a streamlined process of application for approval.

CYTK earnings call for the period ending March 31, 2020.

A sense of cautious optimism is looming over the Street given the progress in the reopening of the U.S. economy, and while the recent uptick isn’t necessarily indicative of a full recovery, it’s certainly a step forward. Against this backdrop, Wall Street pros argue that certain sectors are holding up substantially better than the rest, and within these areas, compelling plays can be found. Highlighting the biotech space, the pros say there are names that have not only received a lot of love from the analyst community, but also stand to deliver hefty returns through 2020 and beyond.Inspired by the pros, we used TipRanks’ database to pinpoint noteworthy biotech stocks. We found three that tick the boxes; each has amassed enough bullish calls to earn a “Strong Buy” consensus rating and offers up serious upside potential.Cytokinetics, Inc. (CYTK)Historically, diseases related to heart failure have been treated the same way, but Cytokinetics is shaking things up. Unlike its peers, it focuses on normalizing muscle contractility rather than solely on volume or rate control. For this reason, several analysts believe this biotech’s future is only going to get brighter.One of these analysts is Mizuho Securities’ Salim Syed. Speaking to CYTK’s differentiated approach, he commented, “In our view, there's good clinical evidence that it's not just a theory. In this regard, the therapies that Cytokinetics is working on, beginning with its lead asset, omecamtiv mecarbil, have the potential to be foundational ‘backbones’ and shift the broader treatment paradigm that really had its start decades ago.”Given how common heart failure is in the U.S., with the condition affecting more than 6 million people, Syed argues that the possibility of a new treatment angle is “extraordinary”. Compare this to the prevalence of Alzheimer’s, which afflicts over 5 million people, and the significance of diseases that cause heart failure becomes clearer.On top of this, Syed points out that investor focus has locked in on a key upcoming catalyst. A data readout for omecamtiv mecarbil in the Phase 3 heart failure cardiovascular outcomes trial (CVOT), GALACTIC-HF, is slated for the fourth quarter of 2020, with investors anxiously waiting to see if the therapy can reduce cardiovascular death and heart failure events.After conducting a deep and step-wise analysis of each parameter of the GALACTIC-HF trial design, looking at historical CVOTs, available regression data and other nuances, Syed believes the probability of success (PoS) is high. “Overall, through our work, what seems to be a competitive / clinically meaningful bar on the primary endpoint and also CV death alone is about a 15-20% relative risk reduction, and we believe that omecamtiv mecarbil may produce an 18-22% relative risk reduction on the primary endpoint (with a similar number on CV death), which would likely be a win,” he stated.With a 70% PoS, Syed estimates that worldwide end-user unadjusted sales could come in at $4.2 billion. Not to mention CYTK is using its contractility work to find solutions for indications in the skeletal muscle disease space like ALS and SMA.It should come as no surprise, then, that Syed decided to join the bulls. He initiated coverage with a Buy rating and $31 price target, implying upside potential in the shape of 88%. (To watch Syed’s track record, click here)Does the rest of the Street agree with Syed? As it turns out, they do. With 100% Street support, or 5 Buys to be exact, the message is clear: CYTK is a Strong Buy. At $26.60, the average price target puts the upside potential at 62.5%. (See Cytokinetics stock analysis on TipRanks)Keros Therapeutics (KROS)Leading the way when it comes to understanding the role of the Transforming Growth Factor- β (TGF- β) family of proteins, which regulate red blood cell and platelet production as well as the growth, repair and maintenance of muscle and bone, Keros develops treatments for patients with hematologic and musculoskeletal disorders. Based on its strong pipeline of assets targeting TGF- β, Wall Street has high hopes for this biotech, which IPO’d only a month ago.Writing for H.C. Wainwright, five-star analyst Andrew Fein told clients, “As a pioneer in developing novel TGF- β targeted therapies, Keros is able to rapidly translate biological insights into drug candidates. Following strong IPO performance since last month, we believe components of Keros' pipeline and platform remain underappreciated by the Street for multiple reasons.”These reasons include the recent approval of Acceleron’s Reblozyl as it validates the clinical utility of TGF- β ligand traps in multiple hematologic diseases. Fein also points out that Keros’ lead protein therapeutic product candidate, KER-050, which was designed for use in patients with myelodysplastic syndromes (MDS) and myelofibrosis (MF), is differentiated and even superior to Reblozyl. He backs up this claim by citing data in healthy volunteers that demonstrated favorable safety as well as PK/PD.Looking at the MDS market, which is valued at $1.6 billion, Fein argues initial data from the Phase 2 study could inflect substantial value, while validating the platform as a whole. It also doesn’t hurt that KER-050’s opportunity in the MDS market can be viewed along with additional diseases caused by ineffective hematopoiesis and exhibiting anemia and/or thrombocytopenia, including myelofibrosis (MF) and beta-thalassemia.If that wasn’t enough, KROS also boasts promising earlier stage therapies. Both KER-047 and KER-012 have already seen encouraging results, and are supported by strong scientific rationale. This gives the company optionality in the near- to mid-term, in Fein’s opinion.Fein added, “Led by industry veterans from Acceleron, the Keros team possesses not only the scientific know-how as related to creating TGF- β targeted therapies, but also deep insights into the clinical pathway for each of their drug candidates. As such, we view Keros as a true platform play that should continuously fuel its pipeline with highly differentiated assets to drive value in the long run.”To this end, Fein kicked off his KROS coverage by putting a Buy recommendation and $50 price target on the stock. Should this target be met, a twelve-month gain of 72% could be in store. (To watch Fein’s track record, click here)Judging by the consensus breakdown, other analysts are also impressed. 4 Buys and no Holds or Sells add up to a Strong Buy consensus rating. The $41 average price target is less aggressive than Fein’s but it still leaves room for shares to surge 37.5% in the next year. (See Keros stock analysis on TipRanks)Black Diamond Therapeutics (BDTX)Using its technology platform that’s focused on identifying previously-undrugged allosteric mutations, Black Diamond wants to stomp out cancer. As this technology allows it to identify more selective, orally-bioavailable compounds that can exhibit greater efficacy and better safety and tolerability than currently marketed drugs as well as agents in development, some members of the Street are betting on BDTX.H.C. Wainwright’s Ram Selvaraju is doing just that. The five-star analyst notes that “Black Diamond as a leader in the discovery and design of novel therapeutics aimed at allosteric mutations in well-known oncogenes, hitherto unaddressable with existing medications.”Highlighting its Mutations-Allostery-Pharmacology (MAP) platform, Selvaraju said, “MAP provides a unique edge in pinpointing previously undrugged mutations and prioritizing those with the greatest oncogenic potential—i.e., the highest propensity to cause and drive cancer... Black Diamond intends to position its molecules as safer and more potent, capable of rapid advancement via pathways established for precision medicines in oncology. These can be deployed across cancers regardless of tissue of origin to treat those patients carrying specific mutations.”Selvaraju’s excitement isn’t limited to BDTX’s platform. Pointing to its most advanced pipeline candidate, BDTX-189, which is currently in a Phase 1/2 trial, MasterKey-01, designed to evaluate the molecule in patients with non-small cell lung cancer (NSCLC), breast cancer and other solid tumors, the analyst likes what he’s seeing. The candidate has already demonstrated high selectivity for allosteric HER2 mutations and exon 20 insertions in the HER2 and EGFR gene, which are known to cause cancerous cell creation. Thanks to its highly selective nature, Selvaraju thinks BDTX-189 will be able to produce more anti-tumor activity, as well as be safer and better tolerated.As a result, BDTX-189 could see peak total annual sales hit $2.5 billion by 2030 in the U.S. and Europe, but this only factors in NSCLC patients with exon 20 insertion mutations and HER2 allosteric mutations in breast cancer plus other solid tumors.Expounding on this, Selvaraju commented, “In our view, the drug could be priced at $22,000 per month—over $260,000 per year—given pricing for other precision oncology drugs in the $20-30,000 per month range and pricing for tucatinib at over $18,000 per month for a larger patient population. We note that these markets constitute areas of high unmet medical need in which existing standard-of-care medications have already proven unsuccessful. We expect BDTX-189 to be deployed across tumor types, similar to drugs like Vitrakvi (larotrectinib) and Rozlytrek (entrectinib) but targeting larger patient groups overall.”Based on all of the above, it’s no wonder Selvaraju started out his coverage of this biotech by publishing a Buy rating. His $53 price target coveys his confidence in BDTX’s ability to climb 47% higher in the next year. (To watch Selvaraju’s track record, click here)Turning now to the rest of the Street, other analysts are also bullish. Only Buy ratings have been assigned in the last three months, making the consensus rating a Strong Buy. Not to mention the $48 average price target suggests 33% upside potential. (See Black Diamond stock analysis on TipRanks)

Immediately after the conclusion of the Annual Meeting of Stockholders, Robert I. Blum, President and Chief Executive Officer, is scheduled to present an overview of Cytokinetics’ performance. Due to the COVID-19 pandemic, Cytokinetics will be taking certain precautionary measures to ensure the health and safety of those in attendance. Attendees will be required to wear a face mask, comply with social distancing guidelines and pass a touchless, infrared temperature check prior to entering Cytokinetics’ facilities.

Top-line Results for GALACTIC-HF Expected in Q4 2020 Ended Q1 with More Than Two Years of Going Forward Cash Based on 2020 Guidance SOUTH SAN FRANCISCO, Calif., May 06,.

Robert Blum has been the CEO of Cytokinetics, Incorporated (NASDAQ:CYTK) since 2007. This analysis aims first to...

Q4 2019 Cytokinetics Inc Earnings Call

Interested parties may access the live webcast of this presentation by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. 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 next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining.

Cytokinetics is a sponsor of the 2020 ALS Roundtables and ALS Focus, a patient and caregiver led survey program to learn about individual experiences with ALS. Cytokinetics is also a Platinum Level Sponsor for initiatives led by The ALS Association Golden West Chapter, including grant funding for care services for people with ALS in the Bay Area. “We are proud to continue our longstanding partnership with The ALS Association and The ALS Association Golden West Chapter,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer.

SOUTH SAN FRANCISCO, Calif., March 30, 2020 -- In the press release published at 7:30 AM ET on March 30, 2020, due to a newswire service error, the quotation from John.

Amgen (AMGN) and Cytokinetics, Incorporated (CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin activator, also known as a cardiac myotrope,1 being developed for the potential treatment of chronic heart failure with reduced ejection fraction (HFrEF). “This Fast Track designation represents an important milestone in the development of omecamtiv mecarbil,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Today, half of heart failure patients will die within five years of diagnosis, underscoring the urgent need for new therapies for this grievous condition.”

Biopharma’s shares up 40% year to date. It reports 1st-quarter results May 6 Continue reading...

SOUTH SAN FRANCISCO, Calif., March 20, 2020 -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that patient baseline characteristics and demographics from GALACTIC-HF.

Q1 2020 Cytokinetics Inc Earnings Call

Cytokinetics (CYTK) possesses 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 the European Medicines Agency (EMA) has granted orphan medicinal product designation to reldesemtiv for the treatment of amyotrophic lateral sclerosis (ALS). Previously reldesemtiv was granted orphan drug designation for the treatment of ALS by the U.S. Food & Drug Administration. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA), as a potential treatment for people with ALS, SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue.

The market is on the move, and this time stocks took off on an upward trajectory. On Wednesday April 29, all three of the major U.S. stock indexes posted gains at the closing bell, climbing higher on encouraging data from the government trial for Gilead Sciences’ COVID-19 treatment, remdesivir. The antiviral therapy met its primary endpoint, and while there’s still a long way to go until it could be available for use, it’s exciting progress. Stocks were also helped by the Federal Reserve’s statement that it will keep rates close to zero for as long as it takes and provide the economy with additional help.However, it should be noted that this surge came as investors brushed off weak U.S. gross domestic product, with the figure’s first quarter decline bigger than expected and marking the largest contraction of economic activity since the financial crisis.So, is it still possible to find stocks going up, up and away? Wall Street pros say yes. They argue that in spite of COVID-19's impact on the broader market, several healthcare names are undervalued as they have held up strong and are set to deliver even more returns in the long run.Heeding this advice, we used TipRanks’ database to zero in on three healthcare stocks that are poised to rip higher and handsomely reward investors over the long-term. Not only have all of the tickers amassed enough bullish calls from analysts to be given “Strong Buy” consensus ratings, but each could also see substantial share price appreciation in the next year. Here’s the lowdown.Fate Therapeutics (FATE)Fate Therapeutics is at the forefront of the cellular immunotherapy space, with it taking healthy donor cells, which are then modified ex vivo using pharmacologic modulators, to improve the cells’ biological properties and therapeutic function. Despite already rising 48% year-to-date, several analysts believe its growth story is only just beginning.Part of the excitement surrounding this name is related to its collaboration with Janssen to develop iPSC NK and T-cell therapies against four tumor-associated antigens. As per the terms of the agreement, FATE will be paid $50 million in cash up front and receive a $50 million equity investment. In addition, FATE is eligible for as much as $1.8 billion in developmental and regulatory milestones and $1.2 billion in commercial milestones, with $898 million applying to the first candidate.Only when the company gets reimbursed for preclinical development going as far as the IND filing will Janssen get an exclusive option to assume development and commercialization. It should also be noted that FATE will have an option for U.S. co-commercialization or mid-teen royalties when proof-of-concept data is available for each candidate.Weighing in for Piper Sandler, five-star analyst Edward Tenthoff also sees potential stemming from its FT596 asset. “Encouragingly, the first patient was dosed with FT596 in a Phase I study of B-cell malignancies and chronic lymphocytic leukemia... We could see first-ever data at ASH in December pending enrollment impact with respect to COVID-19,” he wrote.To top it all off, Tenthoff thinks there are additional potential catalysts that could be capable of catapulting shares. FATE is focusing FT500 on non-small-cell lung carcinoma (NSCLC) with stable disease in 4/8 monotherapy and 2/3 CPI combo patients initially and data for its FT516 candidate in AML and B-cell lymphoma could be released in December.While management stated that COVID-19 could affect clinical trial enrollment, Tenthoff points out that FATE remains on-course to file INDs for FT538 and FT819. To this end, he stayed with the bulls, reiterating an Overweight rating. He also bumped up the price target from $57 to $63, implying 117% upside potential. (To watch Tenthoff’s track record, click here)Meanwhile, the rest of the Street also likes what it’s seeing. 11 Buys and a single Hold add up to a Strong Buy consensus rating. At $39.08, the average price target puts the upside potential at 35%. (See Fate Therapeutics stock analysis on TipRanks)Cytokinetics Inc. (CYTK)Using its differentiated muscle biology platform, Cytokinetics develops therapies for cardiac and skeletal muscle diseases. Since the start of 2020, shares have climbed 53% higher, and market watchers want to know if there’s more fuel left in the tank.Cantor Fitzgerald’s Charles Duncan says yes. The five-star analyst tells investors that ahead of the Phase 3 GALACTIC-HF readout for its Omecamtiv mecarbil (ome’) drug in heart failure, he sees a significant opportunity, with the “binary and potentially transformational milestone” potentially coming earlier than he expected in Q4 2020.Expounding on this, Duncan stated, “Additionally, we believe that the probability of success (PoS) for GALACTIC-HF, which is being conducted by partner Amgen, is underappreciated and that current powering assumptions provide a degree of ‘immunity’ against potential confounding results with CV-driven death/hospitalizations due to COVID-19... To us, robust powering suggests that a risk-mitigating buffer is in place if the pandemic drives missing data or adjudicated events that reduce the number of patients used in per-protocol primary or secondary efficacy analysis. In addition, we note that the FDA recently issued guidance on clinical trial conduct, including amended data management and/or statistical analysis plans, protocol-specified clinical visits and method of drug/pbo distribution, which can further mitigate COVID-19 risk.”Speaking to the trial’s design, Duncan is also optimistic when comparing it to two other heart failure studies, the VICTORIA-HF trial for vericiguat and PARADIGM-HF trial for ENTRESTO. “We believe that the GALACTIC-HF study has enrolled an at-risk population that falls between the two other studies, which will facilitate a clear signal-to-noise readout and clinical interpretation, in our view. We believe that this factor, in combination with the nuanced patient inclusion/exclusion criteria, including NT-proBNP cutoff specifically for pts with atrial fibrillation/flutter and systolic blood pressure cutoffs among others, increases the PoS for this study, which we believe should enhance PoS for a positive readout,” he commented.Both the study’s design and overall patient population prompted Duncan to increase the PoS, and thus the price target also gets a boost. In addition to his Overweight call, he lifted the target from $12 to $23, suggesting 41% upside potential. (To watch Duncan’s track record, click here)Looking at the consensus breakdown, the stock has earned 100% Street support, or 4 Buy ratings to be exact. Therefore, the message is clear: CYTK is a Strong Buy. Based on the $25.50 average price target, shares could rise 57% in the next year. (See Cytokinetics stock analysis on TipRanks)Iovance Biotherapeutics (IOVA)Fighting the good fight against cancer, Iovance is developing transformative immuno-oncology tumor-infiltrating lymphocytes (TIL) therapies that harness a patient's own immune system. Up 21% year-to-date, several members of the Street think that IOVA’s future is only going to get brighter.Writing for H.C. Wainwright, five-star analyst Joseph Pantginis points to the Moffitt study results as renewing his confidence. On April 28, Moffitt Cancer Center, IOVA’s partner, provided an updated glimpse at the Phase 1 trial evaluating TILs plus nivolumab in CKI-naïve metastatic NSCLC patients. Delivering strong results, efficacy was seen in 25% of patients, with the therapy demonstrating two complete responses (CRs). Additionally, ongoing clinical responses were witnessed in half of patients and one active response is pending.The outcome gets even better. “Although TIL clonotype persistence declines with time in the blood of these patients, persistent and stable levels of infused T cells associated with higher tumor killing and response. Thus, we believe that methods to enrich for these TIL populations, such as Iovance’s next generation TILs could be critical to drive better clinical responses,” Pantginis said. It should also be noted that TILs were capable of spurring an immune response against several cancer clones, which could produce better clinical outcomes.Even though some investors expected data from a larger number of patients with a longer follow-up date, Pantginis argues that the results should be viewed as encouraging. He added, “We remind investors that metastatic NSCLC is not an easy indication: (1) most patients rapidly progress; and (2) low activity of CKI. Thus, achieving a DCR of 50% is still meaningful, in our belief. More importantly, the study is ongoing with 8 clinical responses underway.”It should come as no surprise, then, that Pantginis left a Buy recommendation on the stock. Along with his bullish call, he attached a new $48 price target, up from $36. Should this target be met, a twelve-month gain of 44% could be in store. (To watch Pantginis’ track record, click here)Turning now to the rest of the Street, other analysts have also been impressed with IOVA. Only Buy ratings have been assigned, 9 in the last three months. As a result, the healthcare name gets a unanimous Strong Buy consensus rating. With a $47 average price target, the upside potential comes in just below Pantginis’ forecast at 41%. (See Iovance stock analysis on TipRanks) To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

Cytokinetics, Incorporated (CYTK) today announced that it is scheduled to report first quarter results on May 6, 2020 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.

SOUTH SAN FRANCISCO, Calif., March 30, 2020 -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that patient baseline characteristics and demographics from GALACTIC-HF.

Cytokinetics continues to assess the potential impact of the pandemic on its pipeline and business operations and expects to provide further updates in connection with the reporting of its first quarter financial results in May. GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), a large, Phase 3, global, event-driven, cardiovascular outcomes trial of omecamtiv mecarbil completed enrollment in mid-2019 with 8,256 participants in over 1,000 clinical sites. As previously reported, the Data Monitoring Committee (DMC) for GALACTIC-HF recently completed the second and final planned interim analysis of data from the trial, which included consideration of pre-specified criteria for futility and superiority.