Investigation Launched Against Keros Therapeutics, Inc. Over Possible Securities Law Violations
New York, NY – In a recent development, Levi & Korsinsky, a leading securities law firm, has announced the initiation of an investigation into Keros Therapeutics, Inc. (Keros Therapeutics, Inc.) (NASDAQ: KROS) over potential securities law violations. The investigation comes in the wake of a safety review that led Keros to halt dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms of its ongoing Phase 2 clinical trial, TROPOS, for its drug cibotercept (KER-012).
Background of the TROPOS Trial
The TROPOS trial is a study aimed at evaluating the efficacy and safety of cibotercept in combination with background therapy in patients with pulmonary arterial hypertension (PAH). PAH is a rare and progressive disease characterized by increased pressure in the arteries that supply blood to the lungs, leading to shortness of breath and heart failure. Cibotercept is an investigational monoclonal antibody designed to inhibit a specific protein believed to be involved in the development of PAH.
Safety Review and Clinical Trial Halt
On December 12, 2024, Keros Therapeutics issued a press release announcing that it had voluntarily halted dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms of the TROPOS trial due to the unanticipated observation of pericardial effusion adverse events in the trial. Pericardial effusion is the accumulation of fluid in the sac surrounding the heart, which can lead to chest pain, shortness of breath, and other cardiac symptoms. The safety review was conducted by the independent Data Monitoring Committee (DMC), which is responsible for monitoring the safety of participants in clinical trials.
Impact on Keros Therapeutics
The sudden halt of the clinical trial has raised concerns among investors, leading to a significant drop in Keros Therapeutics’ stock price. The company’s shares fell by over 30% in the days following the announcement. The investigation by Levi & Korsinsky adds to the uncertainty surrounding the future of the TROPOS trial and the prospects for cibotercept as a potential treatment for PAH.
Impact on Patients and the Wider Community
The safety concerns raised by the DMC and the halt of the clinical trial have raised questions about the safety and efficacy of cibotercept as a potential treatment for PAH. Patients currently receiving the drug in the clinical trial will be closely monitored, and those in the halted treatment arms will be offered alternative therapies. The wider community of PAH patients and their families will be watching closely to see how this situation unfolds and what it means for the future of potential treatments for this debilitating disease.
Conclusion
The investigation by Levi & Korsinsky into Keros Therapeutics over potential securities law violations adds to the uncertainty surrounding the future of the TROPOS trial and the prospects for cibotercept as a potential treatment for PAH. The safety concerns raised by the DMC and the halt of the clinical trial have raised questions about the safety and efficacy of the drug. Patients and investors will be closely watching developments as the situation unfolds.
- Keros Therapeutics initiates an investigation into possible securities law violations
- Clinical trial for cibotercept halted due to safety concerns
- Drug designed to treat pulmonary arterial hypertension
- Sudden halt leads to significant drop in Keros Therapeutics’ stock price
- Uncertainty surrounding the future of the TROPOS trial and cibotercept
- Impact on patients and their families to be closely monitored
