Lexeo Therapeutics shares rose to an 11-month high on Tuesday following a series of analyst upgrades that have rekindled investor interest in the biotech's gene therapy LX2006 for heart problems associated with Friedreich's ataxia.

The rally came after Lexeo said the U.S. Food and Drug Administration has expressed willingness to consider an accelerated approval pathway for LX2006. Such a move would allow Lexeo to combine data from its current early-stage studies with results from an ongoing pivotal trial, potentially reducing the time to commercialization.

Leerink Partners lifted the firm's price target to $20 from $9 and reiterated an 'Outperform' rating, noting that the FDA's willingness to pool data from the ongoing Phase I/II SUNRISE-FA and pivotal studies represents“regulatory flexibility and a relatively straightforward path to approval.” 

The brokerage stated that the FDA's decision to assess the left ventricular mass index (LVMI), the therapy's key cardiac endpoint, earlier than planned could accelerate timelines. Additionally, further clinical data show dose-dependent, durable LVMI reductions and clean safety profiles.

H.C. Wainwright raised its price target to $15 from $9 and maintained a 'Buy' rating, saying the FDA feedback improves the probability of approval to 50% from 40%. The firm also advanced its expected commercial launch to 2028 from 2030, pointing to a faster and smaller pivotal trial.

Chardan followed with an increase to $17 from $15, also keeping a 'Buy' rating. The firm stated that the FDA's decision to allow the pooling of Phase I/II and pivotal data supports the potential for accelerated approval, while updated results showed“sustained and dose-dependent improvements” in cardiac measures.

The bullish revisions followed Lexeo's announcement that the FDA was open to a Biologics License Application (BLA) that combines data from its Phase I/II studies with new pivotal data to support accelerated approval. The agency also agreed to assess LVMI improvements earlier than 12 months.

Interim results from the ongoing LX2006 trials showed encouraging efficacy, with participants who had abnormal heart mass at baseline achieving an average 18% reduction in LVMI at six months and 23% at 12 months, well above the FDA's 10% improvement threshold. 

Neurological function also improved as measured by patients' scores on the modified Friedreich Ataxia Rating Scale (mFARS) and reductions in cardiac biomarkers, including troponin I and lateral wall thickness. The therapy was well tolerated, with no serious adverse events. The company plans to initiate the pivotal study in the first half of 2026, pending completion of final protocol and manufacturing comparability reviews.

LX2006 has received Breakthrough Therapy, Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations, among others, and is part of the FDA's CMC Development and Readiness Pilot (CDRP) program. The company expects the therapy to advance into its pivotal stage within the next year and believes the new framework could bring approval two years earlier than previously projected.

On Stocktwits, retail sentiment for Lexeo was 'extremely bullish' amid a 6,200% surge in 24-hour message volume.

One user called the FDA update a major win but warned of a dilution risk, noting that Lexeo's $75 million shelf registration and recent $80 million private placement could lead to a share sale if the stock continues to rise. They said it's a typical biotech setup with big news, big move, then dilution.

Another user took a more upbeat tone, suggesting a rapid rally ahead, stating that a swift move to $20 could be on the way. 

Lexeo's stock has risen 27% so far in 2025.

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