Investigation Launched Against Keros Therapeutics, Inc. Over Potential Securities Law Violations
New York, NY – January 27, 2025
Levi & Korsinsky, a leading securities law firm, has announced the initiation of an investigation into Keros Therapeutics, Inc. (Keros Therapeutics, Inc.) (NASDAQ: KROS) following the biopharmaceutical company’s announcement of a safety review leading to the halt of dosing in two arms of its ongoing TROPOS trial. The trial is evaluating cibotercept (KER-012) in combination with background therapy for the treatment of pulmonary arterial hypertension (PAH).
Background on the TROPOS Trial
On December 12, 2024, Keros Therapeutics, Inc. released a statement revealing that the trial’s Data Safety Monitoring Board (DSMB) had recommended the halt due to the occurrence of unanticipated pericardial effusion adverse events. Pericardial effusion is the accumulation of fluid in the sac surrounding the heart, which can lead to several complications, including cardiac tamponade, if not treated promptly. The halt affected the 3.0 mg/kg and 4.5 mg/kg treatment arms of the trial.
Implications for Keros Therapeutics, Inc.
The unexpected pause in the TROPOS trial could have significant consequences for Keros Therapeutics, Inc. The company’s stock price dropped substantially following the announcement, with shares trading down more than 30% on the day of the announcement. The halt in dosing may cause delays in the development timeline for cibotercept, potentially leading to increased costs and potential loss of market share to competitors. Furthermore, the safety concerns raised by the pericardial effusion adverse events may result in increased regulatory scrutiny and potential legal action.
Impact on Patients and the Wider Community
The halt in the TROPOS trial may have implications for the PAH patient community, as the trial was evaluating a potential treatment for this debilitating condition. PAH is a progressive and often fatal condition characterized by increased blood pressure in the arteries that supply blood to the lungs, making it more difficult for the heart to pump blood effectively. Cibotercept is a potential treatment that targets the angiopoietin-2 pathway, which is involved in the development and progression of PAH. The safety concerns raised by the pericardial effusion adverse events may delay the availability of a potential new treatment option for PAH patients.
Conclusion
The investigation launched by Levi & Korsinsky into Keros Therapeutics, Inc. following the unexpected halt of the TROPOS trial and the associated safety concerns is a significant development for both the company and the PAH patient community. The potential consequences for Keros Therapeutics, Inc. include increased regulatory scrutiny, legal action, and delays in the development timeline for cibotercept. The halt in the trial may also delay the availability of a potential new treatment option for PAH patients, underscoring the importance of ongoing safety monitoring in clinical trials.
- Keros Therapeutics initiated an investigation into potential securities law violations.
- The investigation follows the halt of dosing in the TROPOS trial due to safety concerns.
- Pericardial effusion adverse events were the cause of the halt.
- The halt may result in increased costs, delays, and potential loss of market share for Keros Therapeutics, Inc.
- The halt may delay the availability of a potential new treatment option for PAH patients.
