Cytokinetics, Inc.

The FDA has endorsed Cytokinetics' Myqorzo as a treatment for obstructive hypertrophic cardiomyopathy. It will compete with Bristol Myers Squibb's Camzyos in the indication. Slated for a Dec. 26 decision on Cytokinetics’ aficamten, the FDA has delivered an early Christmas present, awarding the South San Francisco biotech its first U.S. nod since its 1997 founding.The agency has signed off on Cytokinetics’ hypertrophic cardiomyopathy (oHCM) treatment, a potential blockbuster which will go by the commercial name of Myqorzo.Cytokinetics enters a market already occupied by a drug it helped create—Bristol Myers Squibb’s Camzyos. A 2012 partnership between Cytokinetics and MyoKardia led to the development of Camzyos. Eight years later, BMS bought out MyoKardia for $13.1 billion, following with a 2022 approval for Camzyos.Myqorzo and Camzyos are cardiac myosin inhibitors. They bind to the protein myosin and block the interactions which cause HCM, reducing cardiac contractions and obstruction in the left ventricle outflow tract (LVOT).In a statement, Cytokinetics CEO Robert Blum called the nod a “historic moment” for the company, adding: “Our first FDA approval stands as a testament to the strength of our science and the bold, trailblazing research that has defined Cytokinetics’ leadership in muscle biology.”Because it relaxes the heart muscle, Myqorzo poses the risk of heart failure and thus carries a boxed warning. Additionally, Myqorzo’s use is restricted through a Risk Evaluation and Mitigation Strategy (REMS) program.While Camzyos also carries a boxed warning and REMS restrictions, analysts say there is significant differentiation between their profiles.“Myqorzo seems the safer drug and easier to use,” Salim Syed, of Mizuho Securities, wrote in a note to investors, citing the med's “convenience factor,” which he said is particularly key for treatment-naïve patients.Cory Kasimov of Evercore ISI explained that the cardiac myosin inhibitors are “clearly differentiated in important ways,” because of Myqorzo’s “unique kinetics and drug profile.”“We expect the cumulative effect of all these benefits to resonate with docs, especially high-prescribing physicians,” Kasimov wrote. “Myqorzo’s patient- and clinic-friendly profile should eventually position it as the primary treatment of choice in new oHCM patients.”Blum added in the company’s release that he was “pleased that the approved label and REMS reflect the distinct characteristics of Myqorzo, including a straightforward, flexible dosing regimen, no requirement for drug-drug interaction monitoring, and a predictable safety profile.”Myqorzo should become a blockbuster in its third year on the market, according to Visible Pharma, an estimate that roughly matches the growth trajectory of Camzyos. BMS reported Camzyos sales of $602 million in 2024 and $715 million through the first nine months of this year.Cytokinetics said that it plans to launch Myqorzo in the second half of January. It did not reveal a price for Myqorzo, which will be closely watched as the annual wholesale acquisition cost of Camzyos comes to $104,000.Earlier this month, Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for Myqorzo, with an official approval decision expected in the first quarter. The U.S. nod also comes just a few days after Myqorzo was approved in China, where Sanofi owns rights to the treatment. Cytokinetics has retained rights to Myqorzo in the rest of the world and told Fierce last month that it plans to commercialize the treatment itself in the U.S. and Europe.Backing the nods was a phase 3 study that showed Myqorzo improved patients’ exercise capacity, as measured by increasing peak oxygen uptake compared to placebo. A separate late-stage study in patients with less severe cases of oHCM showed that the drug improved oxygen capacity by 1.1 milliliters per kilogram per minute in patients with genetic heart enlargement, easily besting the 1.2-point loss in those given a standard-of-care beta blocker. HCM is the most common monogenic inherited cardiovascular disorder, with well over 300,000 patients diagnosed in the U.S. However, there are an estimated 400,000 to 800,000 additional patients who remain undiagnosed, Cytokinetics said. Approximately half of patients with HCM have oHCM and half have non-obstructive HCM (nHCM). The biotech is currently running a phase 3 study in nHCM, a condition in which the heart muscle is thickened but not enough to block blood flow.“Living with symptomatic obstructive HCM means managing physical limitations and burdensome symptoms every day of your life,” Lisa Salberg, founder and CEO of the Hypertrophic Cardiomyopathy Association (HCMA), said in the release. “For far too long, we’ve had few options to address our needs, and the approval of Myqorzo is a long-awaited and major addition to bring new hope to patients living with oHCM.”

iStock, Jolygon Stifel analysts said the label for cardiac myosin inhibitor Myqorzo is in line with their expectations and is differentiated compared with BMS’ Camzyos. Cytokinetics has won FDA approval of its cardiac myosin inhibitor, positioning the biotech to challenge Bristol Myers Squibb for the heart disease market. The approval covers aficamten in adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), an inherited disease that causes thickening of the heart muscles. People with oHCM have symptoms including shortness of breath. Cytokinetics, which calls the newly approved product Myqorzo, won approval after linking the molecule to significantly improved exercise capacity in patients with the disease. With analysts expecting Cytokinetics to win approval, the details of the Risk Evaluation and Mitigation Strategy (REMS) were a key focus going into the decision. The FDA delayed the review by three months in May to give itself time to review the biotech’s REMS proposal. Data from the MAPLE-HCM study, presented at the 2025 European Society of Cardiology Congress in September, showed that after 24 weeks of treatment, patients on aficamten saw a 1.1-mL/kg/min increase in pVO2, a measure of oxygen supply that indicates exercise capacity. Counterparts on the standard-of-care beta-blocker metoprolol saw a 1.2 mL/kg/min decrease in pVO2 over the same time span. Stifel analysts said in a note to investors that the approved REMS is in line with their expectations and is differentiated compared with BMS’ Camzyos. Cytokinetics’ REMS gives physicians the flexibility to titrate as early as two weeks and perform echocardiogram assessments two to eight weeks after dose initiation and any subsequent dose change. A patient’s dosing may be titrated after each echo with no delay. Cardiovascular disease Cytokinetics’ Moment of Truth: Can Aficamten Take On BMS in Hypertrophic Cardiomyopathy? After 27 years in business, Cytokinetics hopes to pit its own cardiac myosin inhibitor against one it initially developed—now owned by Bristol Myers Squibb—in a market worth billions. Aficamten has a PDUFA date of Dec. 26. December 19, 2025 · 5 min read · Dan Samorodnitsky Read More Andrew Callos, Cytokinetics’ chief commercial officer, said on a Friday call with analysts to discuss the approval that patients on 10 or 15 mg of Myqorzo can expect to reach their target dose as quickly as four or six weeks, respectively. Stifel analysts listed the more flexible titration requirements alongside the ability to down-titrate, rather than interrupt treatment, and the absence of drug-drug interaction monitoring as positives of the REMS requirements. Yet the need for Myqorzo patients to undergo maintenance echos every six months, the same cadence as people on Camzyos, has raised questions about how differentiated the new drug is versus its rival. Stifel analysts said the debate “ultimately misses the big picture,” which in their view is that the rigidity of Camzyos’ REMS is the biggest logistical burden. “Overall, aficamten requires fewer echos with a flexible and predictable clinical profile, that allows physicians to actually manage their patients as they see fit (vs. a rigid/formal algorithm essentially with Camzyos),” the analysts said. Cytokinetics plans to launch Myqorzo in the second half of January. Callos said the company will reveal pricing before the launch. The Cytokinetics executive reiterated the biotech’s plans to set a price that is roughly in line with current pricing in the category. Stifel analysts said Cytokinetics can leverage BMS’ “significant market build-out, but with a best-in-class profile.” The analysts said annual Camzyos sales are around $1.2 billion, despite BMS penetrating less than 20% of the market. Myqorzo has a $4.4 billion global opportunity in oHCM, the analysts said, plus a potential $1.2 billion opportunity in the non-obstructive form of the disease.

Dive Brief:The Food and Drug Administration has approved a new treatment for an inherited form of heart failure in a decision that also gives the medicines maker, Cytokinetics, the first U.S. approval in its nearly three-decade history.The agency on Friday approved Cytokinetics Myqorzo for adults with obstructive hypertrophic cardiomyopathy, a potentially deadly condition that impairs the hearts ability to pump blood. The drug has specifically been cleared to help improve functional capacity and symptoms in patients whose disease severity is categorized as Class II or Class III. It will be available in the second half of January, according to the company.Myqorzos prescribing information includes somewhat less restrictive risk mitigation measures than whats mandated for people taking Bristol Myers Squibbs Camzyos, the only other available medication for the disease. Wall Street analysts and investors were closely watching whether Myqorzos risk management protocol might be different than Camzyos, as more permissive labeling could help Cytokinetics win market share.Dive Insight:Fridays approval represents a breakthrough for Cytokinetics, a biotech that was founded in 1997 and is just now bringing its first product to market.The company suffered two big setbacks in 2023, when one drug it had been developing for ALS failed in late-stage testing and the FDA rejected another would-be therapy for cardiovascular disease. But Myqorzos progress enabled a rebound. Over the last couple years, the drug emerged as a viable threat to Camzyos, which is expected to top $1 billion in sales this year. Cytokinetics was rumored to be a buyout target along the way, lifting shares to levels the company hadnt seen in years.The investor interest stems from Myqorzos potential to distinguish itself from Camzyos. Both drugs are so-called cardiac myosin inhibitors, designed to essentially relax the heart muscles and, in doing so, improve organ function. Both are now approved for the obstructive, or more common form of HCM.Camzyos, though, has a strict warning on its label for the risk of heart failure and an FDA-mandated plan to manage that risk. The plan involves close patient monitoring, screening for drug interactions and regular echocardiograms that could result in dose adjustments if necessary. Myqorzo was handed a similar heart failure warning, but its risk protocol includes more flexible dose adjusting, less frequent echocardiograms and minimal drug interaction monitoring, wrote RBC Capital Markets Leonid Timashev.Those factors should materially lower barriers to prescribing instead of Camzyos, he wrote.Still, Cytokinetics shares were little changed upon Fridays approval, as the FDA decision and drug labeling met, rather than exceeded, investor expectations, wrote Stifels James Condulis. Theres still debate about the extent of Myqorzos differentiation, he added.According to Condulis, investors focus has already shifted to Cytokinetics next chance to clearly separate Myqorzo from Camzyos. Next year, itll report results from a trial testing its drug in people with the non-obstructive form of HCM. Camzyos failed a Phase 3 study in that setting, stirring debate that other drugs like it might similarly struggle. However, some analysts have suggested that Myqorzo, which has a wider potential range of safe and therapeutic doses, might have a better chance of success.We're bullish and expect [Myqorzo] to become the best [and] only drug for the entire HCM spectrum, Condulis wrote.The drug will have a list price in line with Camzyos and be revealed ahead of its availability in January, according to a spokesperson. It was cleared in China early last week. Camzyos launched with a yearly wholesale acquisition cost of $89,500. '