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Lexeo Therapeutics finalizes SUNRISE-FA 2 protocol for LX2006 BLA
The company said the finalized protocol and analysis plan are intended to support an FDA Biologics License Application for its gene therapy under the 2028 approval pathway.
Lexeo Therapeutics finalized the critical trial protocol for SUNRISE-FA 2 and also completed the statistical analysis plan aimed at generating clinical evidence for a Biologics License Application to the U.S. FDA, Yahoo Finance reported. The company said the BLA submission is for its gene-based therapy candidate, LX2006, under the 2028 approval pathway. Lexeo’s Chief Medical Officer, Narinder Bhalla, characterized the step as completing a critical study design that sets a path to assess LX2006 in Friedreich’s ataxia cardiomyopathy.
Bhalla said patients living with FA, especially those with cardiac involvement, have an unmet need for new treatment options, and the progress brings the program closer to a potential therapy. The company also said it is working to initiate the pivotal study and enroll the first patient by the end of the month, per the report.
Yahoo Finance further noted that JPMorgan reduced its target price for LXEO from $12 to $9 while maintaining an Overweight rating, citing a revised model that incorporates the latest company updates. The report said the change implies an adjusted upside potential of over 92%.