Solid soars as FDA lifts clinical hold on IGNITE DMD trial

Shares of Solid Biosciences (Nasdaq: SLDB) closed a massive 70% higher on Thursday and were up a further 4.6% at $3.30 pre-market today, after the biotech firm said yesterday that the US Food and Drug Administration has lifted the clinical hold placed on the company’s IGNITE DMD Phase I/II clinical trial. of SGT-001, a gene transfer candidate under investigation for Duchenne muscular dystrophy (DMD).

As announced in July 2020, the FDA had requested further manufacturing information, updated safety and efficacy data for all patients dosed, and provided direction on total viral load to be administered per patient. Based on the company’s response to these requests, the FDA acknowledged that Solid had satisfactorily addressed all clinical hold questions.

In November 2019, the study was put on clinical hold, for the second time, after a seven-year-old boy experienced serious complications related to the drug candidate