Capricor Therapeutics: HOPE-3 Success, De-Risked Regulatory Path, and Priority Review Voucher Upside Support Buy Rating

In a report released today, Joseph Pantginis from H.C. Wainwright reiterated a Buy rating on Capricor Therapeutics, with a price target of $60.00.

Joseph Pantginis has given his Buy rating due to a combination of factors that, in his view, materially strengthen Capricor Therapeutics’ outlook. He highlights the December 2025 HOPE-3 trial results as a pivotal success that not only offers meaningful clinical benefit for Duchenne muscular dystrophy patients but also directly responds to the FDA’s earlier guidance and addresses issues that led to the prior complete response letter. Pantginis expects the company to pursue a Type A meeting with regulators in the near term, using both management and external key opinion leaders to clearly present the robustness and clinical relevance of the data, thereby limiting regulatory uncertainty. He models a conservative approval timeline around mid-2026 but anticipates that, from a trading perspective, the stock could appreciate sooner, helped in part by potential short covering following the strong dataset and reversal of negative sentiment.
In addition, Pantginis underscores Capricor’s ongoing strategy of proactively aligning with FDA expectations, which he believes reduces approval risk and shortens feedback cycles. He also notes that the Priority Review Voucher tied to deramiocel’s rare pediatric disease designation could represent a significant future cash inflow, though the value is partly contingent on legislative timelines and the drug’s approval before the current September 20, 2026 cut-off. While acknowledging this policy-related uncertainty, he views the combination of compelling clinical data, a clearer regulatory path, and potential non-dilutive capital from the voucher as creating a favorable risk-reward profile for investors. Collectively, these elements support his conclusion that Capricor shares are attractively positioned, justifying a Buy recommendation.

In another report released on January 15, TipRanks – Google also reiterated a Buy rating on the stock with a $28.00 price target.