Solid Biosciences Clinical Trial Put on Hold by FDA, Sends Share Price Tumbling

When a company’s clinical trial is put on hold, one of the biggest worries for that company is that it may negatively impact the patients the trial was designed to save.

On Thursday (March 15), Solid Biosciences’ (NASDAQ:SLDB) phase 1 IGNITE DMD trial, which was testing the safety and efficacy of SGT-001 for Duchenne muscular dystrophy (DMD), was put on hold following negative laboratory findings.

Negative findings included a decrease in platelet count, reduction in red blood cell count and evidence of complement activation, which could cause coagulopathy (a bleeding disorder) although the patient tested didn’t report signs or symptoms of the disorder. Solid Biosciences followed up by reporting the event to the FDA, which was then classified as a Suspected Unexpected Serious Adverse Reaction resulting in the trial being put on hold.

The company is now waiting for a formal letter from the FDA with requirements on how to resume the trial, and plans to work closely with the regulatory agency to have it resolved.

SGT-001 is a gene transfer under investigation to address the underlying genetic cause of DMD. The disorder is caused by mutations in the dystrophin gene resulting in an absent or near-absent dystrophin protein.

DMD is a rare genetic disorder with progressive muscle degeneration and weakness, just one type of the nine muscular dystrophies. Diagnosis usually occurs in children ages three to five, mainly affecting boys.

Solid is a life science company with its entire focus on finding therapies for DMD and is founded by people affected by the disease. Aside from SGT-001 in the clinical stage, another candidate in the company’s pipeline is in the discovery phase and another medical device is in development stage.

Investor takeaway

Normally if a clinical trial has been put on hold, it doesn’t always mean a negative future for shareholders. The tricky part with Solid is that its pipeline is quite small and the company only went public in January, meaning investors haven’t yet had the chance to build trust with the company.

Solid has a market cap of $318.29 million and a share price of $9.32. On Thursday, its share price saw a staggering decrease of 64.58 percent. J.P. Morgan analyst Anupam Rama downgraded the share to a “sell” with a price target of $10.51.

Investors should keep in mind, however, that this is only the phase 1 of the trial, which is generally the least expensive for the company. The company could bounce back from this setback, especially if the trial does continue.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.