Healthcare stock under pressure: Solid Biosciences Inc (NASDAQ: SLDB)

Solid Biosciences Inc (NASDAQ: SLDB) stock surged 46.36% after the company announced that the US Food and Drug Administration (FDA) has lifted its clinical hold on SGT-001, its gene therapy, which treats the degenerative disease Duchenne muscular dystrophy. The FDA’s clinical hold on its Phase 1/2 trial for SGT-001 called IGNITE DMD was put in place last March after the first patient dosed with SGT-001 fell ill. The patient’s platelet count and red blood cell count decreased, and his renal activity was also impaired. After being treated, he made a full recovery. Further, FDA has acknowledged that it has addressed all of its concerns and the company has already started to move toward restarting enrollment in the trial. It is planning to enroll and dose several children before dosing adolescents.

 

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Moreover, as part of the lifting of the clinical hold, SLDB has made changes to the study’s protocol. It’s adding IV glucocorticoids in the first weeks after the administration of SGT-001 and beefing up its monitoring system. The company has also planned to enroll and give doses to several children before dosing additional adolescents. The company expects to report initial data from an interim analysis of IGNITE DMD in the second half of next year.

Meanwhile, SLDB has announced the presentation of new preclinical data from its gene therapy development programs for Duchenne muscular dystrophy (DMD). New data for SGT-001, which is the company’s lead microdystrophin gene transfer candidate, further demonstrate its potential to produce long-term and body-wide microdystrophin expression that correlates with significant improvements in muscle function. Additionally, the company has presented data supporting the development of novel promoters and capsids as part of its next generation gene therapy discovery efforts.

Moreover, for the first quarter 2018 SDLB had reported a net loss of $15.9 million for the first quarter of 2018 as compared to $13.9 million for the first quarter of 2017. The increase in net loss for the year was due to increased research and development expenses, as well as investments in the Company’s infrastructure. The company ended the first quarter of 2018 with $182.4 million in cash, cash equivalents and available-for-sale securities as compared to $69.1 million as of December 31, 2017. The increase was primarily the result of the completion of the Company’s initial public offering on January 30, 2018.

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