Shares of Keros Therapeutics KROS, a clinical-stage biotech, have plunged 80.9% in the past three months. The massive decline was primarily due to the company’s voluntary decision to halt dosing in the ongoing mid-stage study of its pipeline candidate, cibotercept (KER-012), to treat patients with pulmonary arterial hypertension (PAH), a kind of lung disease.

Keros Therapeutics’ decision was based on unexpected adverse pericardial effusion events that were observed during the study's safety review by an independent data monitoring committee (DMC). Cibotercept is an investigational modified ActRIIB fusion protein.

The phase II TROPOS study is evaluating three doses of cibotercept (1.5 mg/kg, 3 mg/kg and 4.5 mg/kg) in combination with background therapy to treat PAH patients. After consulting with the DMC, Keros Therapeutics initially chose to suspend dosing in the 3 mg/kg and 4.5 mg/kg treatment arms of the TROPOS study while continuing dosing in the 1.5 mg/kg arm. However, earlier this month, the company announced the suspension of dosing in the 1.5 mg/kg and placebo arms as well, following the observation of new adverse pericardial effusion events during an ongoing safety review.

In the past year, KROS shares have plunged 79.8% compared with the industry’s 12% decline.

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Keros Therapeutics has informed investigators and certain regulatory authorities, including the FDA, of this decision and is in the process of notifying other relevant regulatory bodies. The TROPOS study is being concluded ahead of schedule, with patients expected to be monitored through their end-of-trial visits. The company still plans to present top-line data from all treatment arms of the mid-stage study in the second quarter of 2025.

Other Developmental Programs in KROS’ Pipeline

Keros has two other novel investigational candidates in its clinical-stage pipeline, elritercept (KER-050), ActRIIA fusion protein, and KER-065, a selective activin receptor ligand trap.

Elritercept is currently being evaluated in two ongoing phase II studies to treat patients with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS) and patients with myelofibrosis. KROS is also gearing up to initiate enrollment in a planned, registrational phase III study of elritercept called RENEW to treat adult patients with transfusion-dependent anemia with very low-, low-, or intermediate-risk MDS. Last month, the company also signed a global licensing agreement with Takeda to advance the development and commercialization of elritercept.

Keros Therapeutics’ KER-065 is being developed for the treatment of obesity and neuromuscular diseases. Currently, a phase I study is evaluating single and multiple ascending doses of thecandidate in healthy adults. Top-line data is anticipated in the first quarter of 2025. Upon completing this early-stage study, KROS plans to initiate a proof-of-concept study of KER-065 in obese patients.  

Keros Therapeutics, Inc. Price and Consensus

Keros Therapeutics, Inc. price-consensus-chart | Keros Therapeutics, Inc. Quote

KROS’ Zacks Rank & Other Stocks to Consider

Keros Therapeutics currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the sector are Castle Biosciences CSTL, BioMarin Pharmaceutical BMRN and CytomX Therapeutics CTMX. While CSTL and BMRN currently sporta Zacks Rank #1 (Strong Buy), CTMX carries a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have increased from 34 cents to 39 cents per share. During the same timeframe, loss per share for 2025 has remained constant at $1.84. In the past three months, shares of Castle Biosciences have plunged 16.3%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have decreased from $4.05 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 11.9%.

BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.

In the past 30 days, estimates for CytomX Therapeutics’ 2024 loss per share have remained constant at 5 cents. Estimates for 2025 loss per share have remained constant at 35 cents during the same timeframe. In the past three months, shares of CytomX Therapeutics have lost 22.4%.

CTMX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.

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