Health and Healthcare

FDA Lifts Clinical Hold on Solid Biosciences

Chris Lange

Published: June 18, 2018 9:40 am

Last Updated: January 11, 2020 10:13 pm

Solid Biosciences Inc. (NASDAQ: SLDB) watched its shares surge to kick off the week. This comes after the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the company’s treatment for Duchenne muscular dystrophy (DMD). Currently, SGT-001 is in Phase 1/2.

In its letter, the FDA acknowledged that the company satisfactorily addressed all clinical hold questions. Solid Biosciences has begun activities to resume the clinical trial and plans to reinitiate enrollment as quickly as possible.

Originally, the FDA placed a clinical hold on the treatment following a report of a serious adverse event in the first patient dosed with SGT-001. The event was characterized by a decrease in platelet count followed by a reduction in red blood cell count, transient renal impairment and evidence of complement activation.

As a result of the clinical hold, Solid Biosciences now expects to report initial data from a pre-specified interim analysis of IGNITE DMD in the second half of 2019.

Ilan Ganot, founder and CEO of Solid Biosciences, commented:

We believe SGT-001 has the potential to offer significant benefit to patients with DMD, regardless of their age or stage of disease. We are pleased to have been able to provide the FDA with a comprehensive response resulting in the removal of the clinical hold so we can continue development of this important potential treatment.

Shares of Solid Biosciences traded up more than 11% early Monday at $29.55, with a consensus analyst price target of $24.70 and a 52-week trading range of $6.83 to $33.74.