Cytokinetics Faces Wave of Investor Lawsuits as Lead Plaintiff Deadline Nears
Plaintiffs allege Cytokinetics overstated its aficamten approval timeline by submitting an NDA without a REMS after FDA safety discussions.
Overview
- Investor notices from Rosen, Holzer & Holzer, Bragar Eagel & Squire, The Schall Law Firm, DJS Law Group, and Levi & Korsinsky urge shareholders to seek lead-plaintiff status by November 17, 2025.
- Complaints say the company pointed to a September 26, 2025 PDUFA date and told investors to expect FDA approval in the second half of 2025.
- Filings assert Cytokinetics held multiple pre-NDA meetings on safety yet submitted the aficamten NDA without a REMS.
- Press materials state the May 6, 2025 earnings call disclosed the REMS omission and reliance on labeling and education, leading to investor losses.
- The actions cite federal securities laws including Exchange Act Sections 10(b) and 20(a) and SEC Rule 10b-5, and no class has been certified.