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Class action lawsuits

Rocket Pharmaceuticals Faces Shareholder Class Action Lawsuit Amid Clinical Trial Controversy

Strategic Insights

— 1 min read

A securities class action lawsuit has been filed against Rocket Pharmaceuticals, a biotechnology company developing gene therapies for rare diseases, alleging that the company misled investors about the safety and progress of its critical RP-A501 gene therapy trial for Danon disease. The lawsuit centers on whether Rocket provided materially false and misleading statements regarding the safety, efficacy, and clinical protocol of its RP-A501 Phase 2 pivotal trial, particularly regarding significant protocol changes and known risks of Serious Adverse Events (SAEs).

Key Takeaways:

  • The lawsuit, filed on May 27, 2025, alleges that Rocket Pharmaceuticals misled investors about the safety and progress of its RP-A501 gene therapy trial for Danon disease, a rare multi-organ lysosomal-associated disorder.
  • The class action complaint alleges that Rocket had amended the study protocol months earlier to introduce a novel immunomodulatory agent in the trial's pretreatment regimen, but failed to disclose this change to shareholders.
  • On February 27, 2025, Rocket told investors that it had "made strong progress in advancing our gene therapy" and cited the Phase 1 results of RP-A501 as evidence of "safety and meaningful efficacy up to five years."
  • The company's shares closed at $9.40 that day, but plummeted 62% in a single day on May 27, 2025, after the FDA placed a clinical hold on the RP-A501 trial following a patient's SAE and subsequent death.
  • The lawsuit claims that Rocket's earlier statements created an artificially inflated stock price, and investors suffered heavy losses once the undisclosed risks and protocol changes became public.
  • The deadline to seek lead plaintiff status is August 11, 2025.

Statistics:

  • The stock price of Rocket Pharmaceuticals plummeted 62% in a single day on May 27, 2025, after the FDA placed a clinical hold on the RP-A501 trial.
  • The company's shares closed at $9.40 on February 27, 2025, but down 75% from that closing price by May 27, 2025.
  • Hagens Berman, the law firm investigating the case, has secured over $2.9 billion in recoveries for investors and consumers in similar cases.

Sources:

  • Globe Newswire, "Rocket Pharmaceuticals, Inc. (RCKT) Securities Class Action: UPDATE Detox Special Situations" (May 27, 2025)
  • Hagens Berman, "Rocket Pharmaceuticals Investor Lawsuit Investigation" (2025)
  • Securities and Exchange Commission, "SEC Whistleblower Program" (n.d.)
  • Hagens Berman, "Frequently Asked Questions: Rocket Pharmaceuticals" (n.d.)
  • Hagens Berman, "About Hagens Berman" (n.d.)

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