KROS Begins Dosing in Phase II Study With Rinvatercept in DMD
Keros Therapeutics KROS announced that it has dosed the first patient in the phase II study evaluating its lead pipeline candidate, rinvatercept, in patients with Duchenne muscular dystrophy (DMD).
The open-label, multi-cohort basket study is designed to evaluate rinvatercept in late-ambulatory and early non-ambulatory patients with DMD. The primary objective of the phase II study is to assess the candidate’s safety and tolerability.
The key secondary objectives include evaluating pharmacokinetics, anti-drug antibodies, body composition, and functional improvements across skeletal muscle, motor, cardiac and pulmonary measures.
Initial data from the phase II study are expected in the first half of 2027.
KROS Price Performance
Year to date, shares of Keros have plunged 44.6% against the industry’s increase of 8.3%.
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According to Keros, glucocorticoids — the current standard of care for DMD — are associated with significant long-term side effects, including muscle catabolism, increased fat accumulation and accelerated bone loss.
Hence, the successful development of rinvatercept in DMD could provide an important clinical catalyst for the company.
Besides DMD, Keros is also developing rinvatercept to treat amyotrophic lateral sclerosis (ALS). The company plans to engage with regulatory authorities in the second half of 2026 to discuss the design of a phase II study evaluating rinvatercept in patients with ALS.
KROS’ Other Pipeline Development Activities
Keros has a license agreement with Japan-based Takeda Pharmaceutical TAK to develop, manufacture and commercialize its second pipeline candidate, elritercept, worldwide, excluding mainland China, Hong Kong and Macau. The agreement, which became effective on Jan. 16, 2025, provides Keros with funds in the form of milestone payments.
Elritercept is in late-stage development for cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes (MDS) and myelofibrosis. Takeda holds exclusive rights to develop, manufacture and commercialize the candidate worldwide outside mainland China, Hong Kong and Macau.
In July 2026, Keros announced that it will receive a $20 million development milestone payment from Takeda following the dosing of the first patient in the phase III ELRiSE MDS study evaluating elritercept in patients with very low-, low- or intermediate-risk MDS.
Under its global licensing agreement with Takeda, Keros is eligible for development, commercial and sales milestones that could exceed $1.1 billion, in addition to tiered royalties on net sales.
KROS’ Zacks Rank & Stocks to Consider
Keros currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Regeneron Pharmaceuticals REGN and Precigen PGEN, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Regeneron’s 2026 earnings per share have risen from $46.55 to $53.11, while estimates for 2027 have increased from $54.83 to $59.89 during the same time. REGN’s shares have lost 2.2% year to date.
Regeneron’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.93%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents to earnings of 24 cents. Earnings estimates for 2027 have increased from 25 cents to 73 cents per share during the same time. PGEN’s shares have rallied 86.9% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
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This article originally published on Zacks Investment Research (zacks.com).
