Solid Biosciences shares are up! Shares of the Massachusetts-based drug manufacturing company Solid Biosciences Inc. (NASDAQ:SLDB) rose nearly 50% after it was announced on Monday that the US Food and Drug Administration (FDA) had removed its clinical hold of the company’s Phase I/II SGT-001 clinical trial.
Solid Biosciences Inc. | Clinical Trial
The trial, which is meant to investigate the company’s clinical microdystrophin gene transfer SGT-001 for the treatment of Duchenne muscular dystrophy (DMD), was put on hold by the FDA earlier in April this year.
The decision was made due to a lowering in the count of platelets and red blood cells in the first patient that had been dosed with SGT-001. Ultimately, no signs of abnormalities were found in the patient, who received treatment and remained stable until the issue had been resolved.
According to Solid Biosciences’ official press release, the FDA has acknowledged that the company has answered all questions on the clinical hold satisfactorily.
The company will now begin to restart the clinical trial and will also be restarting patient enrollment as soon as possible.
Ilan Ganot, Founder and Chief Executive Officer of Solid Biosciences, has said that the company is “pleased to have been able to provide the FDA with a comprehensive response resulting in the removal of the clinical hold so [they] can continue development of this important potential treatment.”
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Due to the clinical hold, Solid Biosciences is expecting to report data from the SGT-001 trial in the second half of 2019.
Trial Resumption Leads to Rising of Solid Biosciences Shares
The share value of Solid Biosciences went up by nearly 50% on Tuesday after the announcement was made. As of 3:00 pm EDT, the company was hovering near $42.75 USD and had already reached a high of $54.83.
In comparison, the company only closed at $29.38 on Monday and reached a high of $30.00.
This is the first time Solid Biosciences share value has gone above $30.00 since March 2018.
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