Cytokinetics has been on a tear as the biotech pioneers more drugs to fight heart ailments
Shares of Cytokinetics, which targets medicines for specialty heart diseases, have jumped about 69% over the past three months and are up 31% year to date.
Can CYTK Clinch a Potential FDA Nod for Its Cardiovascular Drug?
Cytokinetics' aficamten shows superiority over metoprolol in late-stage oHCM trial, boosting investor confidence despite FDA delay.
Cytokinetics: Specialty Franchise With Aficamten And Ulacamten
CYTK's Aficamten is easily their main value driver. It has an oHCM PDUFA for December 26, 2025. Aficamten's late-cycle FDA meeting is in September. Plus, it has a potential future as a monotherapy, pediatric application, and nHCM Phase 3 expansion. In my view, Aficamten has great safety compared to Camzyos, which failed in its nHCM Phase 3.
Cytokinetics, Incorporated (CYTK) Q2 2025 Earnings Call Transcript
Cytokinetics, Incorporated (NASDAQ:CYTK ) Q2 2025 Earnings Conference Call August 7, 2025 4:30 PM ET Company Participants & - Corporate Participant Andrew M. Callos - Executive VP & Chief Commercial Officer Diane Weiser - Senior Vice President of Corporate Affairs Fady Ibraham Malik - Executive Vice President of Research Development Robert I.
Cytokinetics (CYTK) Reports Q2 Loss, Tops Revenue Estimates
Cytokinetics (CYTK) came out with a quarterly loss of $1.12 per share versus the Zacks Consensus Estimate of a loss of $1.34. This compares to a loss of $1.31 per share a year ago.
Cytokinetics Merits A Speculative Buy Rating
Cytokinetics continues to near unaminous positive analyst sentiment, with most price targets well above current levels, reflecting strong growth expectations. The company's NDA around its lead drug candidate was delayed by three months recently. However, Cytokinetics maintains a robust cash position of $1.1 billion, supporting ongoing operations and R&D. If all goes according to schedule, Cytokinetics should receive the first of many FDA approvals late this year and has several potential catalysts on the horizon.
Cytokinetics: PDUFA Date Extension For Aficamten Is Not At All Earth Shattering
Cytokinetics' PDUFA date for aficamten was extended to December 26th of 2025, due to the FDA's need to review a submitted REMS. Positive phase 3 MAPLE-HCM study results show aficamten significantly outperformed metoprolol in treating symptomatic obstructive hypertrophic cardiomyopathy patients. The company is also targeting non-obstructive HCM patients with the ongoing phase 3 ACACIA-HCM study, with topline results expected in the first half of 2026.
Cytokinetics' heart disease drug meets main goal in late-stage study
Cytokinetics said on Tuesday its experimental heart disease drug met the main goal in a late-stage study.
Cytokinetics Q1 Earnings Beat, Aficamten Target Action Date Extended
CYTK reports narrower-than-expected Q1 loss. However, the target action date for aficamten in obstructive HCM has been extended by the FDA to provide time for reviewing a REMS submission made at the agency's request.
Cytokinetics: Strong Buy As FDA's 3-Month Delay Doesn't Derail Aficamten's Approval Outlook
The FDA extended aficamten's review by three months for REMS safety program finalization, causing Cytokinetics' stock to drop over 11%. The REMS requirement is expected and does not indicate fundamental issues; the delay is logistical, not a signal of rejection. Aficamten's strong clinical efficacy and safety data, combined with Breakthrough Therapy Designation, support a high likelihood of approval.
Cytokinetics, Incorporated (CYTK) Q1 2025 Earnings Call Transcript
Cytokinetics, Incorporated (NASDAQ:CYTK ) Q1 2025 Earnings Conference Call May 6, 2025 4:30 PM ET Company Participants Diane Weiser - Senior Vice President, Corporate Affairs Robert Blum - President & Chief Executive Officer Andrew Callos - Executive Vice President & Chief Commercial Officer Fady Malik - Executive Vice President, R&D Isaac Ciechanover - EVP Corporate Development and Chief Business Officer Stuart Kupfer - Senior Vice President & Chief Medical Officer Sung Lee - Executive Vice President & Chief Financial Officer Conference Call Participants Sean McCutcheon - Raymond James Salim Syed - Mizuho Gena Wang - Barclays Paul Choi - Goldman Sachs Cory Kasimov - Evercore ISI Roanna Ruiz - Leerink Partners Akash Tewari - Jefferies Charles Duncan - Cantor Fitzgerald Tessa Romero - JPMorgan Maxwell Skor - Morgan Stanley David Lebowitz - Citigroup Inc. Mayank Mamtani - B. Riley Securities Srikripa Devarakonda - Truist Securities James Condulis - Stifel Jason Zemansky - Bank of America Leland Gershell - Oppenheimer Jason Butler - Citizens JMP John Gionco - Needham & Company Yasmeen Rahimi - Piper Sandler Operator Good afternoon, and welcome to Cytokinetics' First Quarter 2025 Conference Call.
Cytokinetics (CYTK) Reports Q1 Loss, Lags Revenue Estimates
Cytokinetics (CYTK) came out with a quarterly loss of $1.36 per share versus the Zacks Consensus Estimate of a loss of $1.41. This compares to loss of $1.33 per share a year ago.
