H.C. Wainwright Reiterates Buy Rating on Capricor Therapeutics (CAPR)

H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating and $24.00 price target on Capricor Therapeutics (NASDAQ: CAPR).

The analyst commented: "Last week the FDA publicly posted a batch of Complete Response Letters (CRL) for recently unapproved BLAs, including the CRL for deramiocel for cardiomyopathy associated with DMD. However, the agency did not publish a response letter submitted by Capricor shortly after receiving the CRL. This written response contains clarifications to the FDA's feedback and outlines the company’s proposed plan to address the outstanding issues. Earlier this week, Capricor published its response letter to provide additional transparency and visibility and to help clarify the next steps moving forward. Key takeaways include: 1) The agency cites the HOPE-2 study failed to demonstrate efficacy in a prespecified 12-month change in the mid-level (elbow) dimension of the PUL 1.2 metric. However, when the company adjusted its statistical strategy and used a non-parametric test, which it felt is more appropriate, the difference was statically significant (p=.014); and 2) Although the FDA did not believe HOPE-2 was aptly designed to assess effectiveness for the treatment of cardiomyopathy in DMD, patients, the response letter highlights deramiocel's origin from cardiac cells and the importance of maintaining cardiovascular function in the natural history of the disease. Like many, we were surprised when the FDA issued a CRL for deramiocel's BLA. However, the released CRLs and the company's response letter provide useful perspectives from both sides of the process that sheds light current and potentially future decision-making. The company is now waiting for official minutes from a recent Type A meeting with the FDA that are expected to help inform the next steps forward with agency and regulatory review. Reiterate Buy rating and $24 PT."

For an analyst ratings summary and ratings history on Capricor Therapeutics click here. For more ratings news on Capricor Therapeutics click here.

Shares of Capricor Therapeutics closed at $6.44 yesterday.

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