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"Capricor needs to counter the FDA's arguments and convince enough committee members of the unmet medical need that deramiocel meets," said Edward Tenthoff, an analyst at Piper San

2026-07-27·newswire-us-stock-161522

"Capricor needs to counter the FDA's arguments and convince enough committee members of the unmet medical need that deramiocel meets," said Edward Tenthoff, an analyst at Piper Sandler (Overweight), noting that the stock price was under.

"Capricor needs to counter the FDA's arguments and convince enough committee members of the unmet medical need that deramiocel meets," said Edward Tenthoff, an analyst at Piper Sandler (Overweight), noting that the stock price was under "significant pressure" following the release of the briefing document.

He emphasized that the FDA was concerned that hypersensitivity reactions in deramiocel patients compared with placebo patients increased the risk of unblinding the trial, which meant "bias may have been introduced, prompting Capricor to change the statistical analysis plan (SAP)."

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"Capricor needs to counter the FDA's arguments and convince enough committee members of the unmet medical need that deramiocel meets," said Edward Tenthoff, an analyst at Piper Sandler (Overweight), noting that the stock price was under

"Capricor needs to counter the FDA's arguments and convince enough committee members of the unmet medical need that deramiocel meets," said Edward Tenthoff, an analyst at Piper Sandler (Overweight), noting that the stock price was under "significant pressure" following the release of the briefing document. He emphasized that the FDA was concerned that hypersensitivity reactions in deramiocel patients compared with placebo patients increased the risk of unblinding the trial, which meant "bias may have been introduced, prompting Capricor to change the statistical analysis plan (SAP)."

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