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.
Why Edgewise Therapeutics And Cytokinetics Stocks Just Diverged
Shares of Edgewise Therapeutics and Cytokinetics diverged Wednesday after safety questions highlighted a heart disease study from Edgewise. The post Why Edgewise Therapeutics And Cytokinetics Stocks Just Diverged appeared first on Investor's Business Daily.
Cytokinetics (CYTK) Moves 5.4% Higher: Will This Strength Last?
Cytokinetics (CYTK) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
Cytokinetics Nears Approval: 'Buy' The New Potential Cardiology Franchise With Aficamten
Cytokinetics is now rapidly moving into commercialization efforts with Aficamten. If all goes well, it could be approved by September 2025. Aficamten had favorable Phase 3 data, so it could have solid competitive prospects if approved, possibly with better safety and simpler dosing. Although CYTK looks a bit pricey today, Aficamten's $10 billion TAM by 2035 makes CYTK's valuation much more reasonable.
Cytokinetics Q4 Loss Wider Than Expected, Aficamten in Focus
CYTK reports a wider-than-expected Q4 loss as operating expenses increase. CYTK is gearing up to launch lead candidate aficamten upon a potential FDA approval.
Cytokinetics, Incorporated (CYTK) Q4 2024 Earnings Call Transcript
Cytokinetics, Incorporated (NASDAQ:CYTK ) Q4 2024 Earnings Conference Call February 27, 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 Paul Choi - Goldman Sachs Cory Kasimov - Evercore ISI Salim Syed - Mizuho James Condulis - Stifel Tess Romero – JPMorgan Leonid Timashev - RBC Capital Markets Akash Tewari - Jefferies David Lebowitz - Citi Sean McCutcheon - Raymond James Srikripa Devarakonda - Truist Securities Roanoke Ruiz - Leerink Partners Joe Pantginis - H. C. Wainwright Mayank Mamtani - B.
Cytokinetics (CYTK) Reports Q4 Loss, Misses Revenue Estimates
Cytokinetics (CYTK) came out with a quarterly loss of $1.26 per share versus the Zacks Consensus Estimate of a loss of $1.22. This compares to loss of $1.38 per share a year ago.
