Cytokinetics ($CYTK) Delayed Drug Review Due to Incomplete FDA Submission Case

Court: N.D. California

Case: 3:25-cv-07923

• CYTK investors filed a claim against Cytokinetics for misleading statements about its regulatory timeline, failure to disclose key risks in its FDA submission, and artificially inflating stock prices.
• After disclosing the FDA delay due to a missing REMS and revealing it had knowingly omitted required materials, CYTK fell over 15% in early May 2025.
• CYTK investors can join this case to be notified about potential recovery.

Case Details:

Between December 27, 2023, and May 6, 2025, Cytokinetics repeatedly assured investors that its lead drug candidate, aficamten, was progressing smoothly through the FDA approval process. The company highlighted positive results from its SEQUOIA-HCM Phase 3 trial and consistently reiterated that it expected FDA approval by September 26, 2025 — a timeline reinforced in press releases, earnings calls, and investor presentations.

In reality, Cytokinetics had omitted a required Risk Evaluation and Mitigation Strategy (REMS) from its original New Drug Application (NDA), despite multiple meetings with the FDA where safety concerns and REMS were specifically discussed. The company chose to rely instead on voluntary education and labeling tools and failed to inform investors that this strategy risked rejection or delay.

On May 1, 2025, the company revealed that the FDA had extended the PDUFA review date by three months to December 26, 2025, due to the late REMS submission. This admission came after months of misleading guidance that approval was on track.

Following this CYTK dropped 13% on May 2, and by May 7, a total decline of over 15% in one week.

During the May 6 earnings call, CEO Robert Blum confirmed that the company had intentionally withheld the REMS, despite knowing it could be necessary, further validating investor concerns about transparency and risk management.

Based on these events, CYTK investors filed a claim against Cytokinetics, alleging the company:

• It omitted key regulatory requirements in its FDA submission for aficamten.
• It misled investors about the likelihood and timing of FDA approval.
• It artificially inflated stock prices by concealing critical risk factors.

Investors argue Cytokinetics misled the market about its regulatory preparedness and clinical transparency, exposing shareholders to losses when the truth came out.