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LEXINGTON, Mass. - Keros Therapeutics, Inc. (NASDAQ:KROS), a biotech company with impressive gross profit margins of 94% and a market capitalization of $633 million, announced additional clinical data from its Phase 1 trial of KER-065 in healthy male volunteers at the American Society of Bone and Mineral Research Annual Meeting on Saturday. According to InvestingPro analysis, the company maintains a strong financial health rating, with more cash than debt on its balance sheet.
The randomized, double-blind, placebo-controlled trial evaluated the company’s modified activin receptor ligand trap designed to treat Duchenne muscular dystrophy (DMD) and bone disorders. While the stock has seen a significant 37% gain over the past six months, InvestingPro data suggests the company remains undervalued relative to its Fair Value.
According to the press release statement, treatment with KER-065 was generally well-tolerated across all tested dose levels, with no serious adverse events or dose-limiting toxicities reported. Most adverse events were mild to moderate and resolved. One grade 4 treatment-emergent adverse event of elevated creatine kinase levels was observed but deemed unrelated to treatment.
The data showed that KER-065 treatment resulted in changes in bone biomarkers indicating increased bone formation and reduced bone resorption. These changes were consistent with observed increases in bone mineral density (BMD).
Improvements in whole body BMD measured at Day 85 were sustained through Day 141, which is three months after the final dose in multiple ascending dose cohorts. The company also reported increased lumbar spine BMD following three doses that persisted through Day 141.
"We are pleased to present additional data that highlights the broad therapeutic potential of KER-065, including its robust bone anabolic activity," said Jasbir S. Seehra, President and Chief Executive Officer of Keros.
KER-065 is designed to inhibit the biological effects of myostatin and activin A to increase skeletal muscle regeneration, muscle size and strength, reduce body fat, reduce skeletal muscle fibrosis, and increase bone strength.
DMD is the most common form of muscular dystrophy, affecting approximately one in every 3,500 male births worldwide, according to the National Organization for Rare Disorders. With analyst price targets ranging from $15 to $35 per share and expected sales growth this year, investors can access more detailed financial analysis and 12 additional exclusive insights through InvestingPro.
In other recent news, Keros Therapeutics announced that the U.S. Food and Drug Administration granted Orphan Drug designation to its investigational therapy KER-065 for the treatment of Duchenne muscular dystrophy (DMD). This development comes as the company advances KER-065 into Phase 2 clinical trials. Additionally, Keros has decided to discontinue the development of cibotercept, a move aligned with its strategic realignment to concentrate on KER-065. This decision followed an analysis of data from the TROPOS Phase 2 clinical trial. Meanwhile, Keros has also dosed the first patient in its Phase 3 RENEW clinical trial for elritercept, which has triggered a $10 million payment under a global license agreement with Takeda. In another strategic update, H.C. Wainwright lowered its price target for Keros to $20 from $25, maintaining a Buy rating, as the firm focuses on its internal clinical program. Furthermore, ADAR1 Capital Management, the largest shareholder of Keros, expressed disappointment over the company’s refusal to engage in strategic discussions, highlighting ongoing tensions.
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