Tuesday, Leerink Partners maintained their Outperform rating and $73.00 price target on Keros Therapeutics (NASDAQ:KROS), following the completion of patient enrollment for the Phase 2 TROPOS trial. This trial is studying cibotercept in pulmonary arterial hypertension (PAH) patients. The enrollment exceeded the initial goal by approximately 25%, with 113 patients enrolled over the initial target of 90.
Keros Therapeutics announced that the TROPOS trial, which evaluates cibotercept in combination with background therapy, has successfully enrolled more patients than anticipated. Participants in the study will be randomized to receive varying doses of cibotercept or placebo via subcutaneous injection every four weeks for a 24-week period. The primary outcome being measured is the change from baseline in pulmonary vascular resistance at week 24, with a key secondary outcome being the change from baseline in six-minute walk distance.
The over-enrollment in the TROPOS trial and the accelerated trial timeline are seen as indicators of high interest and enthusiasm from both investigators and patients. This development also alleviates concerns about enrollment being affected by the availability of Winrevair, a competing treatment approved in March 2024.
Keros Therapeutics has reaffirmed that the top-line data from the TROPOS trial are expected to be reported in the second quarter of 2025. Analysts believe that cibotercept has the potential to differentiate itself from Winrevair through a broader therapeutic window, potentially greater efficacy at higher doses, a more favorable safety profile, and a more convenient dosing regimen.
The completion of enrollment for the TROPOS trial is part of Keros Therapeutics' broader clinical development efforts. The company is focused on advancing its pipeline of TGF-β signaling therapeutics, with multiple clinical data updates anticipated over the next 12 months, which could provide significant value to KROS shares.
In other recent news, Keros Therapeutics has successfully wrapped up enrollment for its Phase 2 clinical trial, TROPOS, exceeding the initial target with a total of 113 patients. This trial is designed to evaluate the efficacy of cibotercept (KER-012) in combination with background therapy for patients suffering from pulmonary arterial hypertension (PAH). The company anticipates presenting the topline data from this trial in the second quarter of 2025.
In addition to this significant progress, Keros Therapeutics has also been receiving positive attention from Guggenheim. The firm has assigned a 'Buy' rating to the biotech company due to its promising drug candidates. Guggenheim specifically highlighted elritercept, a drug under investigation for the treatment of myelodysplastic syndromes and myelofibrosis, and cibotercept, the drug candidate being evaluated in the TROPOS trial for PAH treatment.
These recent developments underscore Keros Therapeutics' commitment to developing effective treatments for diseases associated with imbalances in the TGF-β pathway. As a part of this effort, the company is leveraging the extensive experience of its CEO, Jasbir Seehra, in TGF-β superfamily ligand trap drug development.
InvestingPro Insights
As Keros Therapeutics (NASDAQ:KROS) progresses with its clinical trials, particularly the TROPOS study for cibotercept, investors might benefit from additional financial insights. According to InvestingPro data, Keros has a market capitalization of $2.18 billion, reflecting significant investor interest in its potential.
InvestingPro Tips highlight that Keros holds more cash than debt on its balance sheet, which is crucial for a biotech company funding extensive clinical trials. This financial stability is further supported by the fact that its liquid assets exceed short-term obligations, providing a buffer for ongoing research and development expenses.
Despite these positive financial indicators, it's important to note that Keros is not currently profitable, with a negative gross profit margin in the last twelve months. This is not uncommon for biotech companies in the development stage, as they often prioritize research over immediate profitability.
Interestingly, Keros has shown strong returns over various time frames, including a remarkable 82.15% return over the past year. This performance aligns with the positive developments in its clinical trials and the market's optimism about the company's pipeline.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Keros Therapeutics, providing a deeper understanding of the company's financial health and market position.
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