H2R
1月前
Positive Earnings Call
Summary
U.S. Launch of MYQORZO® (aficamten) in Late January Met with Strong Demand;
Over 275 HCPs Prescribed MYQORZO to an estimated 680 Patients in Q1
ACACIA-HCM Met Dual Primary Endpoints of KCCQ and Maximal Exercise Performance;
Full Results to be Presented at Upcoming Medical Congress
MYQORZO Approved by the European Commission for Adults with Symptomatic Obstructive HCM;
Supplemental NDA for MAPLE-HCM Accepted for Filing by FDA with PDUFA Date of November 14, 2026
Net Product Revenues for MYQORZO of $4.8 Million for Initial Partial Quarter;
~$1.1 Billion in Cash, Cash Equivalents and Investments as of March 31, 2026
A lot of activity.
Revenues
Total revenues for the first quarter of 2026 were $19.4 million, compared to $1.6 million for the same period in 2025. Total revenues in the first quarter of 2026 include:
$4.8 million MYQORZO net product revenue which represents approximately 9 weeks of sales in the U.S. in the first quarter,
$2.6 million in collaboration revenue compared to $1.6 million for the same period in 2025, and
$11.9 million from the achievement of a milestone tied to the first sale of MYQORZO in the U.S. under the Bayer license agreement.
Research and Development (R&D) Expenses
R&D expenses for the first quarter of 2026 were $95.5 million, which included $13.6 million of non-cash stock-based compensation expense, compared to $98.3 million for the same period in 2025, which included $11.7 million of non-cash stock-based compensation expense. The decrease was primarily due to higher clinical trial activity in 2025 partially offset by higher personnel-related costs in 2026.
Best of luck with your investments!
H2R
5月前
PPS Impact: What if other trials are successful:
I asked ChatGPT what PPS impact might successful trials, mainly ACACIA-HCM, COMET-HF and AMBER-HF, ACACIA being the most near term potential catalyst. The ChatGPT session is a bit long. Here is the gist:
Putting it together: cumulative PPS impact
Starting from a ~$65–70 base:
| Catalyst | Incremental PPS |
| ---------------------- | --------------: |
| MAPLE fully recognized | +$30–60 |
| ACACIA success | +$60–100 |
| COMET signal | +$10–30 |
| AMBER signal | +$25–100 |
The way I see it, the PPS will have very little down pressure and the total upside is 5 times. I don't expect a 5 times increase, I just want to see the room the PPS has to play with.
Now, I asked about what a potential timeline could be. Again, the gist below:
| Year | Catalyst recognized by market | PPS range (successful case) |
| ----- | ----------------------------- | --------------------------- |
| 2025 | Approval, early launch | $60–70 |
| 2026 | MAPLE commercial proof | $90–130 |
| 2027 | ACACIA success | $150–220 |
| 2027 | COMET signal | $165–250 |
| 2028+ | AMBER success | $190–350+ |
This is all conjecture, based on the most optimistic view of success in clinical trials, launch, etc.
Again, I'm looking at the room the PPS has to grow into, and its timeline. To me,there is little risk on the downside, and plenty of room on the upside, and I can hold for a few years, check the news, how the launch is going, if Europe and Japan approve, etc.
Best of luck with your investments!
H2R
6月前
Interesting estimate of market penetration
Our market research supports our belief that MYQORZO is likely to achieve greater than 50% CMI preference share and grow the cardiac myosin inhibitor category based on 3 launch drivers: clinical evidence; our bespoke patient services and support; and the REMS [...]
And the combination of a second trial, confirming efficacy, safety, showing data that's from a clinical trial that beta blockers are impacting gradients, and if our expectation is correct, and that MAPLE or beta is added -- or at least the results are added in influencing guidelines, I think the combination of those things, it would increase prescribing beyond the current prescribing base.
https://x.com/biotecharutaka/status/2003111274364731598
Best of luck with your investments!
H2R
6月前
Planning on H2 available in the U.S.
MYQORZO is expected to be available in the U.S. in the second half of January 2026. Cytokinetics will support patients with MYQORZO & You™, a personalized program for patients prescribed MYQORZO in the U.S. to help navigate the treatment journey, provide disease and product education, and offer support with insurance benefits investigations or financial assistance for those eligible. For more information, call 833-MYQORZO (833-697-6796).
“HCM is a heart muscle disease associated with a significant symptom burden. This approval of a new drug, MYQORZO, represents a meaningful addition to the treatment options available for symptomatic obstructive HCM patients,” said Martin Maron, M.D., Director, Hypertrophic Cardiomyopathy Center, Lahey Hospital and Medical Center, and Principal Investigator of SEQUOIA-HCM. “In SEQUOIA-HCM, MYQORZO improved exercise capacity and reduced symptoms while also being well-tolerated. For these reasons, MYQORZO represents an important step forward in how we care for people living with obstructive HCM.”
Best of luck with your investments!
H2R
6月前
FDA Approves of MYQORZO™ (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms
Cytokinetics Announces FDA Approval of MYQORZO™ (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms
>>> MYQORZO, a Cardiac Myosin Inhibitor, Directly Addresses Underlying Hypercontractility Associated with Obstructive HCM
FDA Approval Based on Results of SEQUOIA-HCM
MYQORZO is Company’s First FDA-Approved Medicine
Company to Host Investor Conference Call Today at 4:30 PM Eastern Time
SOUTH SAN FRANCISCO, Calif., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has approved MYQORZO™ (aficamten), 5 mg, 10 mg, 15 mg, 20 mg tablets for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.
“This is a historic moment for our company and for the patients we serve, as we fulfill our promise to translate our science into medicines that may make a meaningful difference in patients’ lives,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “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. I’m 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. I am profoundly grateful for the many years of passion and persistence shown by patients with obstructive HCM, as well as healthcare professionals, advocates, partners and employees who have contributed so importantly to reaching this key milestone.”
The full U.S. Prescribing Information for MYQORZO includes a Boxed WARNING for the risk of heart failure. MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF <50% and =40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction. Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program. Please see additional Important Safety Information including Boxed WARNING below.
[...]
“Living with symptomatic obstructive HCM means managing physical limitations and burdensome symptoms every day of your life,” said Lisa Salberg, Founder and CEO of the Hypertrophic Cardiomyopathy Association (HCMA). “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. We are so grateful to the team at Cytokinetics for listening to the patient community and working in true partnership to bring this therapy to so many in need.”
Best of luck with your investments!
H2R
6月前
China approves MYQORZO (aficamten), triggering $7.5m payment!!!
SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MYQORZO® (aficamten) has been approved by the China National Medical Products Administration (NMPA) for the treatment of adults with New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM), to improve exercise capacity and symptoms.
Under the terms of its license and collaboration agreement with Cytokinetics, Sanofi has exclusive rights to develop and commercialize MYQORZO for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. The approval of MYQORZO in oHCM in China triggers a $7.5 million milestone payment from Sanofi to Cytokinetics. Cytokinetics remains eligible to receive up to $142.5 million in development and commercial milestone payments from Sanofi as well as royalties in the low-to-high teens on future sales of MYQORZO in Greater China.
MYQORZO is only approved for use in China. Aficamten is currently under regulatory review in the U.S, where the FDA is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. On December 12, 2025 the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending marketing authorization in the European Union (EU) for aficamten, and a final decision is anticipated from the European Commission in the first quarter of 2026.
Best of luck with your investments!
H2R
6月前
Aficamten in Europe: Positive CHMP opinion!
The PDUFA in the US is in 11 days. The decision could fall before that.
In the meantime, the approval process is moving along in Europe. And it's looking good, based on the CHMP opinion!
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. A final decision is anticipated from the European Commission in the first quarter of 2026.
[...]
Aficamten is currently under regulatory review in the U.S., where the Food & Drug Administration (FDA) is reviewing a New Drug Application (NDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025.
Additionally, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) is reviewing an NDA for aficamten with Priority Review.
https://ir.cytokinetics.com/press-releases/press-release-details/2025/Cytokinetics-Announces-Positive-CHMP-Opinion-of-MYQORZO-Aficamten-for-the-Treatment-of-Obstructive-Hypertrophic-Cardiomyopathy/default.aspx
Looking good. Now, the FDA can do as they choose, they are not shy with CRLs, that's for sure. Still, I'm hopeful given all the data that's been accumulating over the years.
Best of luck with your investments!
H2R
6月前
18 days to PDUFA. Could be less, since the PDUFA falls on Christmas day, the 25th.
The FDA already moved once the PDUFA, so it would be a bit strange if they moved it again. Of course, it's the FDA, they can do whatever they please, but it would not look good for them.
SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company’s proposed Risk Evaluation and Mitigation Strategy (REMS).
https://ir.cytokinetics.com/press-releases/press-release-details/2025/Cytokinetics-Announces-New-PDUFA-Date-for-Aficamten-in-Obstructive-Hypertrophic-Cardiomyopathy-05-01-2025/default.aspx
The initial PDUFA was September 29th. So the FDA should have had enough time to review and come up with a decision.
Hoping for a positive decision Early.
Best of luck with your investments!
H2R
9月前
H.C. Wainwright: Buy rating and $120.00 price target
https://www.investing.com/news/analyst-ratings/cytokinetics-stock-maintains-buy-rating-at-hc-wainwright-ahead-of-pdufa-93CH-4248571
Investing.com - H.C. Wainwright has reiterated its Buy rating and $120.00 price target on Cytokinetics (NASDAQ:CYTK), currently trading at $48.66, as the company approaches the December 26, 2025 PDUFA date for its drug aficamten. With a market capitalization of $5.8 billion, the stock has shown strong momentum, according to InvestingPro data, with analyst targets ranging from $41 to $120.
The firm’s decision follows Cytokinetics’ virtual investor event where the company presented new data from the Phase 3 MAPLE-HCM trial comparing aficamten to standard-of-care metoprolol in obstructive hypertrophic cardiomyopathy (oHCM) patients.
Results from the MAPLE-HCM trial demonstrated aficamten’s superior efficacy in improving functional capacity, symptoms, hemodynamics, and cardiac biomarkers compared to metoprolol across all prespecified patient subgroups, while the standard treatment showed worsening of clinical outcomes, particularly in exercise capacity.
The FOREST-HCM open-label extension study showed sustained hemodynamic and clinical benefits with aficamten, along with a low incidence of left ventricular ejection fraction below 50% and new-onset atrial fibrillation, potentially differentiating it from competitor Camzyos, which carries a black box warning.
H.C. Wainwright believes these data support not only aficamten’s potential approval with a favorable label and minimal REMS requirements but also possible future label expansion as a first-line treatment for oHCM patients.
Best of luck with your investments. In biotech especially, one needs a bit of luck!
H2R
9月前
About 4M shares in the first 30 minutes. The average volume is 2M/day.
The weekend ESC conference news is making the rounds.
Now, the FDA's decision in December is not a given. It's never a given in biotech.
If you listened to the Web conf this morning, you'll have heard that metoprolol, the current SOC, is not as effective as previously believed after 60 years of usage for o-HCM. Au contraire. And Aficamten is. As a monotherapy.
The FDA can still reject on any kinds of ground, CMC, lack of data, whatever. We'll see.
Best of luck with your investements!
H2R
3年前
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
3年前
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
4年前
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
4年前
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.
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