Rocket Pharmaceuticals shares crash 60% after FDA clinical hold.

A securities class action lawsuit has been filed against Rocket Pharmaceuticals, alleging that investors who purchased shares between February 27, 2025 and May 26, 2025 suffered losses after the FDA put a clinical hold on the company's Phase 2 pivotal trial for RP-A501. Investors who suffered substantial losses are urged to submit their losses by August 11, 2025.

San Francisco, California—July 2, 2025—Rocket Pharmaceuticals, Inc. (RCKT) is facing a securities class action lawsuit after the FDA placed a clinical hold on its Phase 2 pivotal trial for RP-A501, an experimental therapy intended to treat patients with Danon disease. The lawsuit, styled Ho v. Rocket Pharmaceuticals, Inc., et al., No. 3:25-cv-10049 (D. N.J.), seeks to represent investors who purchased or otherwise acquired RCKT securities between February 27, 2025 and May 26, 2025 [1].

The lawsuit alleges that Rocket Pharmaceuticals made materially false and misleading statements while failing to disclose to investors the true state of RP-A501's safety and clinical trial protocol. Specifically, the complaint alleges that the company knew Serious Adverse Events (SAEs), including patient deaths, were at risk and that it amended the trial protocol to introduce a novel immunomodulatory agent to the pretreatment regimen without notifying the FDA or investors [2].

Investors learned the truth on May 27, 2025, when Rocket Pharmaceuticals revealed that the FDA had put a clinical hold on its Phase 2 study after a patient suffered a SAE and ultimately died. During a May 27, 2025 update call, management revealed that the company had amended the trial protocol several months prior, information that analysts were seemingly unaware of before the update call. This news drove the price of Rocket Pharmaceuticals' shares crashing $3.94 (-62%) the same day [1].

"We're investigating claims that Rocket Pharmaceuticals may have misled investors about its Phase 2 protocol and whether it secretly amended it without first notifying the FDA and investors," said Reed Kathrein, the Hagens Berman partner leading the investigation [1].

Investors who suffered substantial losses are urged to submit their losses by August 11, 2025. For more information, visit www.hbsslaw.com/investor-fraud/rckt or contact Hagens Berman at RCKT@hbsslaw.com or 844-916-0895 [1].

References:
[1] https://www.globenewswire.com/news-release/2025/07/02/3109591/0/en/Rocket-Pharmaceuticals-Inc-RCKT-Faces-Securities-Class-Action-Amid-Protocol-Change-and-FDA-s-Clinical-Hold-on-Gene-Therapy-Trial-Hagens-Berman.html
[2] https://www.tradingview.com/news/reuters.com,2025-07-03:newsml_NFC6Dr5p6:0-rocket-pharmaceuticals-inc-rckt-faces-securities-class-action-amid-protocol-change-and-fda-s-clinical-hold-on-gene-therapy-trial-hagens-berman/