Lexeo climbs after regulatory update on Friedreich ataxia drug

[FDA headquarters in Washington DC.]
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Lexeo Therapeutics (NASDAQ:LXEO [https://seekingalpha.com/symbol/LXEO]) added ~29% in the premarket on Tuesday after the company announced that the U.S. FDA has defined a pathway that will allow a potential accelerated approval for LX2006, LXEO’s experimental therapy for a neurodegenerative disorder called Friedreich ataxia.

Citing recent interactions with the regulator, the gene therapy developer said that the FDA is open to a submission of a Biologics License Application (BLA) for LX2006 under the agency's Accelerated Approval pathway.

According to the company, the decision will permit the company to combine data from its ongoing Phase I/II studies for LX2006 with new clinical data from a pivotal study, which is expected to begin in H1 2026.

Lexeo (NASDAQ:LXEO [https://seekingalpha.com/symbol/LXEO]) added that the size and duration of the pivotal trial will be smaller due to the FDA feedback, and as a result, it can expedite the timeline to file the BLA. [https://seekingalpha.com/pr/20256458-lexeo-therapeutics-announces-progress-in-fda-discussions-for-accelerated-approval-pathway-and]

MORE ON LEXEO THERAPEUTICS

* Seeking Alpha’s Quant Rating on Lexeo Therapeutics [https://seekingalpha.com/symbol/LXEO/ratings/quant-ratings]
* Historical earnings data for Lexeo Therapeutics [https://seekingalpha.com/symbol/LXEO/earnings]
* Financial information for Lexeo Therapeutics [https://seekingalpha.com/symbol/LXEO/income-statement]