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Investing.com - Stifel has reiterated its Buy rating and $21.00 price target on Lexeo Therapeutics (NASDAQ:LXEO), currently trading at $4.45, following the company’s announcement of Breakthrough Therapy Designation for its LX2006 treatment. Analyst consensus remains strongly bullish with targets ranging from $10 to $28, according to InvestingPro data.
The Breakthrough Therapy Designation was granted for LX2006 in Friedreich’s ataxia cardiomyopathy (FA-CM). Lexeo also disclosed its selection to participate in a Chemistry, Manufacturing, and Controls (CMC) pilot program designed to expedite development timelines. The company maintains a strong liquidity position with a current ratio of 3.42 and more cash than debt on its balance sheet.
Lexeo Therapeutics is actively working with the FDA to finalize a Statistical Analysis Plan (SAP) for its pivotal trial, which remains on track to begin in early 2026. The company previously aligned with regulators on a registrational study design that will use an external control group.
The agreed study will employ co-primary endpoints: a minimum 10% reduction in left ventricular mass index (LVMI) from baseline and any increase in baseline frataxin (FXN) measured via liquid chromatography-mass spectrometry (LCMS).
Stifel views the Breakthrough Therapy Designation, granted after FDA review of clinical data, as a positive indicator for Lexeo’s regulatory prospects, noting this designation suggests potential regulatory flexibility for rare disease gene therapies. InvestingPro subscribers can access 11 additional investment tips and comprehensive financial metrics to better evaluate LXEO’s potential.
In other recent news, Lexeo Therapeutics announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to its investigational treatment for Friedreich ataxia, LX2006. This designation is based on interim data showing improvements in cardiac biomarkers and functional measures. The FDA also included LX2006 in its Chemistry, Manufacturing, and Controls Development and Readiness Pilot program to expedite development. Additionally, Lexeo has secured approximately $80 million through a private placement led by Frazier Life Sciences and Janus Henderson Investors, which is expected to extend the company’s cash runway into 2028. The funds will support the development of LX2006 and other clinical programs. In related financial updates, Leerink Partners reduced Lexeo’s price target to $10 but maintained an Outperform rating, while H.C. Wainwright lowered its target to $15, keeping a Buy rating. Both firms cited recent financial and sector developments as reasons for their adjustments. Furthermore, Lexeo’s stockholders elected two Class II directors and ratified KPMG LLP as the company’s auditor during the 2025 Annual Meeting.
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