Latest news with #KER-065
Yahoo
2 days ago
- Business
- Yahoo
Keros Therapeutics' Quiet Near-Term Outlook Overshadows Pipeline Potential: Analyst
Bank of America Securities analyst Jason Zemansky downgraded Keros Therapeutics, Inc. (NASDAQ:KROS) from Buy to Neutral, lowering the price forecast from $32 to $18. Zemansky noted that Keros has wrapped up its strategic review, with the board deciding to advance KER-065 for Duchenne muscular dystrophy (DMD) and return $375 million in excess capital to shareholders. The analyst highlights that the stock has been downgraded not due to concerns about the platform or pipeline, which remains compelling, but because of limited near-term favorable valuation and a solid cash buffer, Zemansky writes that the stock may stay range-bound given that meaningful updates on KER-065 are unlikely soon, with FDA discussions not expected until the third quarter. As a result, other investment opportunities may offer better near-term potential. The analyst slashed the price forecast to reflect adjustments to the cash balance and a higher weighted average cost of capital (WACC) of 16%, now aligned with peers at a similar stage. On June 9, 2025, ADAR1 Capital Management, the largest shareholder of Keros Therapeutics, stated that the recent board election results signal 'widespread dissatisfaction' among investors. ADAR1 highlighted that two directors received support from only about a third of outstanding shares, reflecting a loss of confidence in the board's management and capital allocation. While acknowledging Keros's recent decision to halt a drug program and cut staff, ADAR1 called the actions 'wholly insufficient.' The firm heavily criticized the board's plan to return only a portion of its cash to shareholders, arguing the amount retained is excessive for Keros's limited clinical pipeline. To address this, ADAR1 issued specific demands for the board to take immediate action. The firm called for Keros to increase its capital return by an additional $100 million for a total of $475 million, to be paid through a special dividend by the end of Q3 2025. Furthermore, ADAR1 urged the company to create a contingent value right (CVR) to allow shareholders to directly benefit from the Takeda partnership. ADAR1 warned that if the board does not adopt a more aggressive, investor-focused strategy, it will not hesitate to nominate new directors for the 2026 annual meeting to ensure the will of shareholders is respected. Zemansky acknowledged that the board had limited strategic options aside from fully dissolving the company. However, he writes that bearish investors may have expected a more aggressive outcome than just the potential $375 million capital return, especially since the exact structure and terms of the buyback remain undecided. Zemansky pointed out that beyond the longer development timelines, overall sentiment toward Keros likely remains cautious, which could continue to pressure the stock. While the company's three board nominees were elected despite activist opposition, a notable portion of votes were withheld for the two targeted candidates, indicating lingering investor discontent. He stresses the point that frustration may persist, particularly given the recent setback with TROPOS and skepticism that last month's cost-cutting measures were sufficient. Although some bulls might argue that the stock has been unfairly punished, especially given the added hurdles of developing drugs that target the TGF-β pathway, Zemansky writes most investors will likely wait for more meaningful progress and risk reduction before 'returning to the story.' Price Action: KROS shares are trading lower by 2.34% to $13.76 at last check Tuesday. Read Next:Image via Shutterstock Date Firm Action From To Dec 2020 SVB Leerink Maintains Outperform Dec 2020 HC Wainwright & Co. Maintains Buy May 2020 Piper Sandler Maintains Overweight View More Analyst Ratings for KROS View the Latest Analyst Ratings UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article Keros Therapeutics' Quiet Near-Term Outlook Overshadows Pipeline Potential: Analyst originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
4 days ago
- Business
- Yahoo
Keros Announces Return of $375 Million in Excess Capital to Stockholders
Concludes Strategic Alternatives Review and Provides Update on Development of KER-065 LEXINGTON, Mass., June 09, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ('Keros' or the 'Company') (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ('TGF-ß') family of proteins, today announced that the Company has concluded its previously announced review process to evaluate strategic alternatives to maximize stockholder value for the Company. As a result of this process, the Company's Board of Directors (the 'Board') unanimously determined to initiate a process to return $375 million of excess capital to stockholders. The terms and structure of this capital return remain under consideration and are expected to be announced at a future date. Jean-Jacques Bienaimé, Lead Independent Director, said, 'Our Board and management team are taking action to enhance stockholder value. To that end, we intend to return a significant amount of excess capital to stockholders while continuing to pursue development of our lead product candidate, KER-065, for the treatment of neuromuscular diseases, with an initial focus on Duchenne muscular dystrophy. This reflects a thorough review of our capital requirements, feedback from our stockholders, and our confidence in the potential for Keros to provide meaningful and potentially disease-modifying benefits to patients.' During the strategic review process, the Board, with the assistance of the strategic committee of the Board and outside financial and legal advisors, evaluated a comprehensive range of strategic alternatives, including but not limited to a sale of the Company or other business combination transaction, continued investment in the Company's pipeline, and/or return of excess capital to stockholders. The evaluation of these alternatives involved outreach to a number of third parties and engagement with Company stockholders. This press release is not an offer to sell or a solicitation of an offer to buy any of the Company's securities. About Keros Therapeutics, Inc. Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins. Keros is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including blood, bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, Keros has discovered and is developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros' lead product candidate, KER-065, is being developed for the treatment of neuromuscular diseases, with an initial focus on Duchenne muscular dystrophy. Keros' most advanced product candidate, elritercept (KER-050), is being developed for the treatment of cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and in patients with myelofibrosis. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as 'anticipates,' 'believes,' 'continue,' 'expects,' 'enable,' 'intention,' 'potential' and 'will' or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning the intention, terms, structure and timing of return of excess capital by the Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the terms and structure of the capital return; the timing of the capital return; the risk that the capital return could have an adverse effect on the ability of the Company to retain and hire key personnel and maintain relationships with partners, suppliers, employees, stockholders and other business relationships and on its operating results and business generally; the risk of any litigation relating to the strategic review; Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its product candidates, KER-065 and elritercept; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; and Keros' dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission (the 'SEC'), including the 'Risk Factors' section of the Company's Quarterly Report on Form 10-Q, filed with the SEC on May 6, 2025, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contacts Investor Contact:Justin Frantzjfrantz@ Media Contact:Mahmoud Siddig / Adam Pollack / Viveca TressJoele Frank, Wilkinson Brimmer Katcher(212) 355-4449Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
10-04-2025
- Business
- Yahoo
Keros Therapeutics considers sale amid investor pressure
Keros Therapeutics' board of directors has authorised a 'poison pill defence'— in response to increasing investor interest in 'influencing the company's control'. The move comes after certain investors – including one individual holding 11.2% of Keros's outstanding common stock as of 6 April 2025 – expressed a desire to shape the company's strategic decisions. US-based Keros stated that the limited-duration stockholder rights plan is designed to protect the integrity of its ongoing strategic review process, which could include the potential sale of the company. As a result of the announcement, Keros's shares jumped by 13%, reaching $11.67 per share at market open. The company confirmed it has initiated a process to evaluate strategic alternatives and plans to provide updates on the process within 60 days of the 10 April announcement. This update follows a series of challenges faced by Keros related to its cibotercept clinical programme for pulmonary arterial hypertension (PAH). In December 2024, Keros halted higher-dose cohorts from the Phase II TROPOS study (NCT05975905) after a safety review revealed concerning adverse events, including fluid buildup around the heart – a development that saw the company's shares plunge by more than 77%. Keros suspended the two higher-dose groups and eventually ended the study in January 2025, citing 'the ongoing safety review due to new observations of pericardial effusion adverse events'. The candidate was positioned as a rival to MSD's PAH drug Winrevair (sotatercept). The US Food and Drug Administration (FDA) approved Winrevair in March 2024 and it is projected to reach blockbuster status, generating up to $6.4bn in global sales by 2030, as per GlobalData, the parent company of Pharmaceutical Technology. Keros's lead candidate is a TGF-beta inhibitor dubbed elritercept. The candidate is being investigated in the ongoing Phase III RENEW study (NCT06499285), targeting transfusion-dependent anaemia in very low, low or intermediate-risk myelodysplastic syndrome (MDS) patients. In December 2024, Takeda inked a deal worth up to $1.3bn with Keros to further develop, manufacture and commercialise elritercept worldwide outside of mainland China, Hong Kong and Macau. According to GlobalData's Pharma Intelligence Center, elritercept is projected to generate up to $425m in 2030, if approved. Keros is also advancing its pipeline with KER-065, a candidate for Duchenne muscular dystrophy (DMD), which has shown positive early-stage results. The company announced in March 2025 that KER-065 was well tolerated in Phase I trials, with evidence of activin inhibition across 'tissues of interest'. Following this announcement, Keros said it plans to engage with regulatory authorities in Q3 2025, with a Phase II trial for DMD expected to begin in Q1 2026, pending regulatory feedback. "Keros Therapeutics considers sale amid investor pressure" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
31-03-2025
- Business
- Yahoo
Keros Therapeutics Announces Initial Topline Results from the Phase 1 Clinical Trial of KER-065 in Healthy Volunteers
Trial achieved key objectives for safety, tolerability, pharmacokinetics and pharmacodynamics Clinical data from this trial, together with preclinical data, support the therapeutic potential of KER-065 for broad impact in Duchenne muscular dystrophy ('DMD') and other neuromuscular indications Keros plans on advancing KER-065 into a Phase 2 clinical trial in DMD, subject to positive regulatory interaction Keros to host a conference call and webcast today, March 31, 2025, at 8:00 a.m. ET LEXINGTON, Mass., March 31, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ('Keros') (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ('TGF-ß') family of proteins, today announced initial topline results from the Phase 1 clinical trial of KER-065 in healthy volunteers. Topline results from this ongoing trial are through the multiple ascending dose ('MAD') treatment period (Day 85). 'We are pleased to report topline results that met the key objectives of the Phase 1 clinical trial and provided important insights to inform the development of KER-065 for patients with DMD,' said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. 'Considering the limitations of currently available therapies, the need for additional treatments in DMD remains high, and KER-065 has the potential to address multiple aspects of the disease, including across important tissues and underlying genetic deficiencies. Our strong financial foundation enables us to continue advancing our promising pipeline of novel therapeutics, and we look forward to engaging with regulators towards the aim of moving KER-065 to a Phase 2 clinical trial in the first quarter of 2026.' Key findings of this trial as of a February 6, 2025 data cut-off date include the following: KER-065 was generally well-tolerated, with no major safety signals observed to date No serious adverse events or dose-limiting toxicities reported Evidence for activin inhibition across tissues of interest, as KER-065 elicited: Increases in bone specific alkaline phosphate (BSAP), a biomarker of bone formation, and decreases in C-Terminal Telopeptide (CTX), a biomarker of bone resorption Increases in adiponectin, a biomarker of fat mobilization, and decreases in leptin, a biomarker of fat mass Changes in body composition, as demonstrated by increases in bone mineral density and muscle mass and decreases in fat mass, which in totality were consistent with activin inhibition 'We observed evidence of activin inhibition based on multiple biomarkers and body composition data. These data, coupled with preclinical and mechanistic insights on the pivotal role of the activin pathway in neuromuscular pathobiology, demonstrate the exciting therapeutic potential of KER-065 in DMD and other neuromuscular disorders,' said Yung H. Chyung, M.D., Chief Medical Officer. Keros plans on engaging with regulatory authorities, starting in the third quarter of 2025. Subject to the outcome of these regulatory interactions, Keros expects to initiate a Phase 2 clinical trial of KER-065 in patients with DMD in the first quarter of 2026. Conference Call and Webcast Information Keros will host a conference call and webcast today, March 31, 2025, at 8:00 a.m. Eastern time. The conference call will be webcast live at: The live teleconference may be accessed by dialing (877) 407-0309 (domestic) or (201) 389-0853 (international). An archived version of the call will be available in the investors section of the Keros website at for 90 days following the conclusion of the call. About the KER-065 Phase 1 Clinical Trial The KER-065 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, two-part dose escalation (single ascending dose and MAD) trial in healthy volunteers. The primary objectives of this trial were to assess safety, tolerability and pharmacokinetics of KER-065. Exploratory endpoints include assessments of the pharmacodynamic effect on bone, adipose, muscle, cardiac tissue and fibrosis. About KER-065 KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB that is fused to the portion of the human antibody known as the Fc domain. KER-065 is designed to act as a ligand trap and inhibit the biological effects of myostatin and activin A, two ligands that signal through activin receptors, to increase skeletal muscle regeneration, increase muscle size and strength, reduce body fat, reduce fibrosis of the skeletal muscle and increase bone strength. We are developing KER-065 for the treatment of neuromuscular diseases, with an initial focus on DMD. About Duchenne Muscular Dystrophy (DMD) DMD is the most common form of muscular dystrophy and results in muscle degeneration and premature death. DMD results from the lack of functional dystrophin protein that helps promote myofiber stability, caused by a gene mutation. The lack of dystrophin, an important structural component of muscle cells, causes muscle cells to have increased susceptibility to damage and to progressively die. Additionally, the absence of dystrophin in muscle cells leads to significant cell damage and ultimately causes muscle cell death and the replacement of muscle with fibrotic and fatty tissue. The replacement of muscle fibers with fatty and fibrotic tissue leads to progressive loss of muscle strength and function leading to immobility and respiratory and cardiac complications. In DMD patients, heart muscle cells progressively die and are replaced with scar tissue. This cardiomyopathy eventually leads to heart failure, which is currently the leading cause of death among those with DMD. The National Organization for Rare Disorders estimates that approximately one in every 3,500 male births is affected by DMD worldwide. About Keros Therapeutics, Inc. Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins. Keros is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including blood, bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, Keros has discovered and is developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. One of Keros' product candidates, cibotercept (KER-012), is being developed for the treatment of pulmonary arterial hypertension and for the treatment of cardiovascular disorders. Keros' second product candidate, KER-065, is being developed for the treatment of neuromuscular diseases. Keros' most advanced product candidate, elritercept (KER-050), is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and in patients with myelofibrosis. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as 'anticipates,' 'believes,' 'continue,' 'expects,' 'enable,' 'potential' and 'will' or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros' expectations regarding its strategy and timing of its Phase 2 clinical trial for KER-065, including its plans to engage with regulatory authorities; Keros' ability to advance its pipeline of novel therapeutics; and the potential therapeutic benefits of KER-065. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros' limited operating history and historical losses; Keros' ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros' dependence on the success of its product candidates, cibotercept, KER-065 and elritercept; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros' ability to obtain, maintain and protect its intellectual property; and Keros' dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in Keros' filings with the Securities and Exchange Commission ('SEC'), including the 'Risk Factors' section of the Company's Annual Report on Form 10-K, filed with the SEC on February 26, 2025, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact:Justin Frantzjfrantz@ in to access your portfolio
