Capricor Therapeutics (CAPR) Stock Climbs On Data!

Capricor Therapeutics CAPR Stock News

Capricor Therapeutics Inc (NASDAQ: CAPR) is having an incredibly strong start to the trading session with early gains of more than 100%. The gains come after the company announced positive data in a rare disease indication. Here’s what’s happening:

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CAPR Stock Rockets On Positive Data

In a premarket press release issued early this morning, Capricor Therapeutics announced positive data from an interim analysis in a key clinical trial. The trial, known as HOPE-2 is assessing CAP-1002 as a poential option for young patients with Duchenne muscular dystrophy. According to the release, interim data proved to be incredibly promising.

The HOPE-2 trial is a randomized, double-blind, placebo-controlled Phase II study of CAP-1002. The treatment is being given to steroid-treated boys and young men who are in advanced stages of DMD.

Characterized by progressive weakness and chronic inflammation ot the skeletal, heart, and respiratory muscles, DMD is a highly debilitating condition.

The interim analysis included top-line data from 17 patients. CAPR said that 10 of these patients were provided with a placebo while 7 of them received CAP-1002. About 80% of these patients were non-ambulant.

According to the analysis, the treatment led to a statistically significant outcome when compared to placebo at 6 months. Positive treatment effects were seen in some independent skeletal and pulmonary assessments. Also, positive trends were seen in various skeletal, pulmonary and cardiac measures.

While the data is promising, it’s important to note that it is still too early to draw any conclusions regarding the treatment yet. Nonetheless, the positive data is a promising sign that CAPR may be onto something big here.

In a statement, Linda Marban, President and CEO at CAPR, had the following to offer:

We are extremely pleased and it is truly extraordinary that even in such as small sample size, we achieved statistically significant improvements in several clinically relevant parameters. In these older patients, functional improvement in the upper limb is highly meaningful for their quality of life. To our knowledge, this is the first randomized double-blind, placebo-controlled study in DMD that has shown statistically significant functional improvement in steroid treated boys.

Regulatory Notes

Should all go well in the trial, Capricor is on track for a relatively quick regulatory process. In fact, the company has already been granted both RMAT and Orphan Drug Designation by the FDA.

There are several benefits to these designations. First and foremost, these designations mean that CAPR will receive additional support from the FDA throughout the development process. Moreover, due to these designations, should the company receive approval for CAP-1002, it will receive extra market exclusivity.

With priority review status, increased market exclusivity, and positive data being released today, CAPR is a stock that’s well worth paying attention to.

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