[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]  quantumup [@Quantumup1](/creator/twitter/Quantumup1) on x 3524 followers Created: 2025-07-07 11:46:48 UTC Stifel reiterated $LXEO Buy-$21. $SLNO $BIIB $LRMR $PTCT $SRPT Stifel said in its note: " $LXEO announced that they received Breakthrough Designation for LX2006 in FA-CM -- the company also disclosed that they've been selected to participate in a CMC pilot program to expedite timelines, and they're actively working with FDA to finalize an SAP for their pivotal trial, where they remain on-track to start in early-2026. Recall, earlier this year $LXEO shared that following an RMAT Type-B meeting, they aligned on a registrational study with an external control (currently enrolling patients) along with co-primary endpoints that we view as favorable/a reasonably-low bar based on prior ph1/2 data (≥10% reduction in LVMI from baseline and any increase in baseline FXN via LCMS). Most importantly, we view receipt of BTD here after the FDA has reviewed clinical data to be a bullish sign for their regulatory prospects -- of note this also occurred for $SLNO in PWS -- and continuing to show that for rare/GTx, FDA may continue to remain flexible/accommodating." XXXXX engagements  **Related Topics** [fxn](/topic/fxn) [aav](/topic/aav) [pdf](/topic/pdf) [sap](/topic/sap) [$7846t](/topic/$7846t) [breakthrough](/topic/breakthrough) [$srpt](/topic/$srpt) [$lrmr](/topic/$lrmr) [Post Link](https://x.com/Quantumup1/status/1942188548423066074)
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quantumup @Quantumup1 on x 3524 followers
Created: 2025-07-07 11:46:48 UTC
Stifel reiterated $LXEO Buy-$21. $SLNO $BIIB $LRMR $PTCT $SRPT Stifel said in its note: " $LXEO announced that they received Breakthrough Designation for LX2006 in FA-CM -- the company also disclosed that they've been selected to participate in a CMC pilot program to expedite timelines, and they're actively working with FDA to finalize an SAP for their pivotal trial, where they remain on-track to start in early-2026.
Recall, earlier this year $LXEO shared that following an RMAT Type-B meeting, they aligned on a registrational study with an external control (currently enrolling patients) along with co-primary endpoints that we view as favorable/a reasonably-low bar based on prior ph1/2 data (≥10% reduction in LVMI from baseline and any increase in baseline FXN via LCMS).
Most importantly, we view receipt of BTD here after the FDA has reviewed clinical data to be a bullish sign for their regulatory prospects -- of note this also occurred for $SLNO in PWS -- and continuing to show that for rare/GTx, FDA may continue to remain flexible/accommodating."
XXXXX engagements
Related Topics fxn aav pdf sap $7846t breakthrough $srpt $lrmr