12:52 PM EST, 01/21/2025 (MT Newswires) -- Solid Biosciences ( SLDB ) said Tuesday that the US Food and Drug Administration granted fast track designation to its potential treatment for Friedreich's ataxia, a degenerative disease caused by inadequate frataxin protein levels.

The company said SGT-212 will deliver the full-length frataxin gene through dual routes of administration incorporating intradentate nucleus and intravenous infusions that aim to restore therapeutic levels of the frataxin protein.

With this designation for SGT-212, Solid Biosciences ( SLDB ) said it will have more frequent interactions with the FDA and the potential to gain priority review eligibility.

The company said the planned phase 1b trial will assess the contemporaneous systemic intravenous and bilateral intradentate nucleus administration of SGT-212, with dosing expected to start in H2 and participants to be followed for five years after receiving the treatment.

The company's shares were down nearly 3% in recent trading.

Price: 3.18, Change: -0.09, Percent Change: -2.75