Solid Biosciences Shares Drop After Clinical Trial is Placed on Hold by FDA

Solid Biosciences

Shares of Solid Biosciences Inc. (NASDAQ: SLDB) continue to drop today, reaching a low of approximately -9.38%. The company opened with $9.19 USD and has since fallen to $8.33 USD, which is assumed to be as a result of the FDA putting a hold on the company ’s most recent clinical trial.

The life-sciences company has focused on finding more positive therapies for Duchenne Muscular Dystrophy (DMD) and has recently been working on ”SGT-001′, an Adeno-associated viral (AAV) vector-mediated gene transfer’ that would be able to help detect the underlying genetic cause of DMD.

The company planned to enter Phase I/II testing of the SGT-001 gene transfer, but the first patient was hospitalized several days after receiving the first dose of SGT-001. Solid Biosciences reported the incident to the US Food and Drug Administration (FDA) and then received news on March 14 that the FDA had put their clinical trial on hold.

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According to the company’s press release, the patient, a non-ambulatory adolescent, was hospitalized due to a low platelet count and a reduced red blood cell count. However, the patient did not show symptoms of coagulopathy and had no relevant changes from the baseline in a liver function test. The patient responded well to treatment and is now at home with no further symptoms.

While the trial is on hold, the company has also suspended any further enrollment and dosing in regards to the SGT-001 gene trials.

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Solid Biosciences will be working with the principal investigator and the FDA on this case but will be waiting for notice from the FDA on when they would be able to resume the clinical trials of SGT-001.

Shares of Solid Biosciences Inc. are continuing to fall and it looks as though they may not rise until either the clinical trials begin again, or if a positive result is achieved upon trial completion.

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