Keros Therapeutics, Inc. Stock Price, News & Analysis

Keros Therapeutics (NASDAQ: KROS) has announced that its Board of Directors has initiated a formal strategic alternatives review process to maximize stockholder value. The review will be overseen by a newly formed Strategic Committee of independent directors who will evaluate options including:

• potential sale of the company
• business combination transactions
• continued pipeline investment
• return of excess capital to stockholders

Additionally, the Board has implemented a -duration stockholder rights plan ('poison pill') in response to significant stock accumulations, including an 11.2% stake by an individual investor as of April 6, 2025. The rights plan triggers if any entity acquires 10% ownership (15% for passive institutional investors) without Board approval. The plan expires on April 9, 2026. The company expects to provide a preliminary update on the strategic review within 60 days.

Keros Therapeutics (NASDAQ: KROS) has announced positive initial topline results from its Phase 1 clinical trial of KER-065 in healthy volunteers. The trial successfully met its key objectives for safety, tolerability, and pharmacological measures through the multiple ascending dose treatment period.

Key findings as of February 6, 2025, showed that KER-065 was generally well-tolerated with no serious adverse events or dose-limiting toxicities. The drug demonstrated evidence of activin inhibition through:

• Increases in bone formation biomarkers and decreases in bone resorption markers
• Positive changes in fat mobilization biomarkers
• Improvements in body composition, including increased bone mineral density and muscle mass

Based on these results, Keros plans to engage with regulatory authorities in Q3 2025 and aims to initiate a Phase 2 clinical trial for Duchenne muscular dystrophy (DMD) patients in Q1 2026.

Keros Therapeutics (Nasdaq: KROS), a clinical-stage biopharmaceutical company specializing in TGF-ß family protein signaling disorders, has announced its upcoming participation in two major healthcare conferences.

The company's Chair and CEO, Jasbir S. Seehra, Ph.D., will present at:

• The TD Cowen 45th Annual Healthcare Conference on March 3, 2025, at 9:50 a.m. ET
• The Leerink Partners Global Healthcare Conference on March 10, 2025, at 1:40 p.m. ET

Both presentations will be in a fireside chat format, with archived replays available on the Keros website's Investor section for 90 days post-event.

Keros Therapeutics (NASDAQ: KROS) reported its Q4 and full-year 2024 financial results, highlighting a net loss of $46.0M for Q4 and $187.4M for the full year. The company's revenue increased to $3.0M in Q4 and $3.6M for 2024, primarily due to a milestone achievement under the Hansoh license agreement.

Research and development expenses rose to $173.6M for 2024, up from $135.3M in 2023, reflecting increased pipeline development activities. The company's cash position was significantly strengthened by a $200M upfront payment from Takeda Pharmaceuticals through an exclusive license agreement for elritercept development.

With cash and cash equivalents of $559.9M as of December 31, 2024, plus the Takeda payment, Keros expects to fund operations into 2029. The company anticipates reporting initial Phase 1 data for KER-065 in healthy volunteers in Q1 2025 and data from the Phase 2 TROPOS trial evaluating cibotercept in pulmonary arterial hypertension patients.

Keros Therapeutics (NASDAQ: KROS), a clinical-stage biopharmaceutical company specializing in TGF-ß family protein signaling disorders, has announced its upcoming participation in the Guggenheim SMID Cap Biotech Conference. The company's Chair and CEO, Jasbir S. Seehra, Ph.D., will engage in a fireside chat presentation on Thursday, February 6, 2025, at 10:00 a.m. Eastern time.

The presentation will be accessible through a live audio webcast at the provided link, and an archived version will remain available on the Keros website's Investor section for up to 90 days after the event. This presentation represents an opportunity for investors and interested parties to gain insights into the company's developments and strategies.

Keros Therapeutics (Nasdaq: KROS) announced the effectiveness of its global development and commercialization license agreement with Takeda (TSE:4502/NYSE:TAK) for elritercept, effective January 16, 2025. The agreement, initially announced on December 3, 2024, was finalized following the expiration of the Hart-Scott Rodino Antitrust Improvements Act waiting period. As part of the agreement, Takeda will make an upfront payment of $200.0 million to Keros, a clinical-stage biopharmaceutical company focused on developing therapeutics for disorders linked to dysfunctional TGF-ß family protein signaling.

Keros Therapeutics (NASDAQ: KROS) has announced the complete halt of dosing in its Phase 2 TROPOS trial of cibotercept (KER-012) for pulmonary arterial hypertension (PAH) due to new observations of pericardial effusion adverse events. This decision extends to all treatment arms, including the 1.5 mg/kg and placebo groups, following a previous halt of the 3.0 mg/kg and 4.5 mg/kg treatment arms announced on December 12, 2024.

The company has notified investigators and regulatory authorities, including the FDA, about the early termination of the trial. Patients will be monitored through end-of-trial visits. Despite the setback, Keros maintains its timeline to present topline data from all treatment arms in the second quarter of 2025.

Keros Therapeutics (NASDAQ: KROS) has announced the voluntary halt of dosing in the 3.0 mg/kg and 4.5 mg/kg treatment arms of its Phase 2 TROPOS trial, which studies cibotercept (KER-012) for pulmonary arterial hypertension (PAH). This decision follows the unanticipated observation of pericardial effusion adverse events.

The 1.5 mg/kg treatment arm continues following a risk-benefit assessment by the independent Data Monitoring Committee and Keros team. The trial is fully enrolled, and the company maintains its timeline to present topline data from all treatment arms in Q2 2025. The FDA and other regulatory authorities have been notified of these developments.

Keros Therapeutics (KROS) presented data from two ongoing Phase 2 clinical trials of elritercept at the 66th ASH Annual Meeting. The first trial in lower-risk myelodysplastic syndromes (MDS) showed that 55.2% of patients achieved overall erythroid response, with a median transfusion independence duration of 134.1 weeks. Of high transfusion burden patients, 31.4% achieved transfusion independence for at least eight weeks.

The second trial in myelofibrosis (MF) demonstrated that 82.8% of non-transfusion dependent patients showed increased hemoglobin levels, while 63.4% of transfusion-dependent patients showed reduced transfusion burden. Additionally, 40% of patients showed reduced spleen volume, and 66.7% experienced reduced disease symptoms at week 24.

Elritercept was generally well-tolerated in both trials, with most adverse events being mild to moderate.