FDA Clinical Hold on RP-A501 Trial Triggers Rocket Pharmaceuticals (RCKT) Stock Plunge and Class Action– Hagens Berman
SAN FRANCISCO, July 17, 2025 (GLOBE NEWSWIRE) -- When, on May 27, 2025, Rocket Pharmaceuticals (NASDAQ: RCKT) revealed that the FDA put a clinical hold on its Phase 2 pivotal trial for RP-A501, an experimental therapy intended to treat patients with a rare gene disorder called Danon disease, investors in the company’s shares saw their investment crash over 60% that day.
Danon disease is a multi-organ lysosomal-associated disorder leading to early death due to heart disorder.
Since the May 27 announcement, a securities class action lawsuit styled Ho v. Rocket Pharmaceuticals, Inc., et al., No. 3:25-cv-10049 (D. N.J.) has been filed and seeks to represent investors who purchased or otherwise acquired Rocket Pharmaceuticals securities between February 27, 2025 and May 26, 2025.
Hagens Berman urges Rocket Pharmaceuticals investors who suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys.
Class Period: Feb. 27, 2025 – May 26, 2025
Lead Plaintiff Deadline: Aug. 11, 2025
Visit: www.hbsslaw.com/investor-fraud/rckt
Contact the Firm Now: RCKT@hbsslaw.com
844-916-0895
The Rocket Pharmaceuticals, Inc. (RCKT) Securities Class Action:
The litigation focuses on the propriety of Rocket Pharmaceutical’s disclosures about the trial protocol being implemented in the RP-A501 Phase 2 trial.
Rocket Pharmaceuticals, a biotechnology company developing gene therapies for rare diseases, is at the center of a shareholder class action lawsuit following allegations that it misled investors about the safety and progress of its critical RP-A501 gene therapy trial for Danon disease.
The federal litigation, which covers shareholders who purchased Rocket stock between February 27 and May 26, 2025, centers on whether the company provided materially false and misleading statements regarding the safety, efficacy, and clinical protocol of its RP-A501 Phase 2 pivotal trial.
Plaintiffs allege that, while Rocket publicly highlighted its advances and expressed confidence in meeting trial endpoints, it failed to alert investors to significant protocol changes and known risks of Serious Adverse Events (SAEs), including patient deaths.
On February 27, 2025, Rocket told investors 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, buoyed by these statements and later updated references to www.ClinicalTrials.gov for more detail about the ongoing Phase 2 study.
The class action complaint alleges that behind the scenes, Rocket had amended the study protocol months earlier to introduce a novel immunomodulatory agent in the trial’s pretreatment regimen—an adjustment allegedly not disclosed to shareholders at the time. Plaintiffs claim that, despite knowledge of heightened risks, the company failed to inform the public of such changes or the potential for SAEs.
The company’s narrative unraveled on May 27, 2025, when Rocket revealed in an update call that the U.S. Food and Drug Administration had placed a clinical hold on the RP-A501 trial following a patient’s SAE and subsequent death. During that call, Rocket management confirmed, in response to questioning, that the trial amendment introducing the new agent had been made “several months ago”—a detail that appeared to surprise many analysts and investors. The stock price plummeted 62% in a single day and down 75% from its February 27, 2025 closing price.
The lawsuit contends 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.
“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.
If you invested in Rocket Pharmaceuticals and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »
If you’d like more information and answers to frequently asked questions about the Rocket Pharmaceuticals case and our investigation, read more »
Whistleblowers: Persons with non-public information regarding Rocket Pharmaceuticals should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email RCKT@hbsslaw.com.
About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
Contact:
Reed Kathrein, 844-916-0895
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