Keros Therapeutics, Inc. (KROS) Halts PAH Drug Development After Safety Concerns in TROPOS Trial
Keros Therapeutics, Inc. (NASDAQ:KROS) has announced it will discontinue all development of cibotercept (KER-012) for pulmonary arterial hypertension (PAH) after topline data from the TROPOS Phase 2 trial revealed significant safety concerns.
The trial was halted early following a dose-dependent increase in pericardial effusions, a serious cardiac side effect, particularly at higher doses of 3.0 mg/kg and 4.5 mg/kg. In January 2025, all dosing, including lower-dose and placebo arms, was stopped as new adverse events emerged during ongoing safety reviews. The incidence and severity of pericardial effusions in the cibotercept arms exceeded those seen in placebo and were notably higher than rates reported in comparable studies of MRK's Winrevair (sotatercept).
A picture of a pharma technician preparing an IV injection of a biopharmaceutical product.
Efficacy outcomes were also disappointing, with no clinically meaningful improvements observed in pulmonary vascular resistance or six-minute walk distance. No major safety signals for other adverse events, such as hemoglobin changes or bleeding, were detected. Due to the early termination, interpretation of the 24-week data is limited.
In response, Keros Therapeutics, Inc. (NASDAQ:KROS) will reduce its workforce by about 45%, leaving 85 full-time employees and aiming for $17 million in annualized cost savings.
Keros Therapeutics, Inc. (NASDAQ:KROS) will now explore strategic alternatives and reassess cibotercept's potential in other indications.
While we acknowledge the potential of KROS to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than KROS and that has 100x upside potential, check out our report about this
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Alnylam Receives European Commission Approval for AMVUTTRA® (vutrisiran) for the Treatment of ATTR Amyloidosis with Cardiomyopathy Share 'Estimates show approximately 100,000 people are affected by ATTR amyloidosis across Europe, most with cardiomyopathy, so this approval marks a critical step toward addressing this underserved patient population,' said Pushkal Garg, M.D., Chief Medical Officer at Alnylam. 'AMVUTTRA is supported by a well-established efficacy and safety profile, with over 6,000 patient-years of global experience in the treatment of hATTR with polyneuropathy. By delivering rapid and sustained knockdown of TTR through convenient, quarterly dosing, it offers a clinically differentiated approach with the potential to transform outcomes for patients living with this debilitating and potentially fatal disease. We now look forward to securing access to AMVUTTRA for eligible patients across the EU as quickly as possible.' 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