Capricor Therapeutics vs Agios Pharm: why the prices moved differently

Weekly · monthly · quarterly news summaries, side by side in time

Capricor Therapeutics Inc (CAPR)

Q3 202627 Jul – 31 Jul 2026

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FDA Briefing Document Questions Deramiocel Efficacy On July 27, the FDA released a briefing document stating that Capricor's Duchenne therapy Deramiocel lacked substantial evidence of effectiveness and had an unfavorable benefit-risk profile. This threatens the drug's approval and caused the stock to plunge 64.5% to $7.00.
This is the core event that triggered the stock crash and all subsequent fallout.
FDA Advisory Committee Votes Against Deramiocel On July 30, an FDA advisory committee voted 3 to 9 that Deramiocel is not effective for Duchenne cardiomyopathy. This raises serious doubts about approval ahead of the August 22 PDUFA date, pushing the stock down further.
The panel vote is a major new negative development that directly impacts the likelihood of FDA approval.
Multiple Securities Fraud Investigations Launched Several law firms (Kirby McInerney, Bragar Eagel & Squire, Hagens Berman, Lowey Dannenberg, Holzer & Holzer, Glancy Prongay) have opened investigations into whether Capricor misled investors about Deramiocel's trial results. These probes add legal uncertainty and could lead to lawsuits, weighing on the stock.
The investigations are a new consequence of the FDA news and create ongoing legal overhang for the stock.

July 202627 Jul – 31 Jul 2026

▼3

FDA Briefing Document Questions Deramiocel Efficacy On July 27, the FDA released a briefing document stating that Capricor's Duchenne therapy Deramiocel lacked substantial evidence of effectiveness and had an unfavorable benefit-risk profile. This threatens the drug's approval and caused the stock to plunge 64.5% to $7.00.
This is the core event that triggered the stock crash and all subsequent fallout.
FDA Advisory Committee Votes Against Deramiocel On July 30, an FDA advisory committee voted 3 to 9 that Deramiocel is not effective for Duchenne cardiomyopathy. This raises serious doubts about approval ahead of the August 22 PDUFA date, pushing the stock down further.
The panel vote is a major new negative development that directly impacts the likelihood of FDA approval.
Multiple Securities Fraud Investigations Launched Several law firms (Kirby McInerney, Bragar Eagel & Squire, Hagens Berman, Lowey Dannenberg, Holzer & Holzer, Glancy Prongay) have opened investigations into whether Capricor misled investors about Deramiocel's trial results. These probes add legal uncertainty and could lead to lawsuits, weighing on the stock.
The investigations are a new consequence of the FDA news and create ongoing legal overhang for the stock.

Latest27 Jul – 31 Jul 2026

▼3

FDA Briefing Document Questions Deramiocel Efficacy On July 27, the FDA released a briefing document stating that Capricor's Duchenne therapy Deramiocel lacked substantial evidence of effectiveness and had an unfavorable benefit-risk profile. This threatens the drug's approval and caused the stock to plunge 64.5% to $7.00.
This is the core event that triggered the stock crash and all subsequent fallout.
FDA Advisory Committee Votes Against Deramiocel On July 30, an FDA advisory committee voted 3 to 9 that Deramiocel is not effective for Duchenne cardiomyopathy. This raises serious doubts about approval ahead of the August 22 PDUFA date, pushing the stock down further.
The panel vote is a major new negative development that directly impacts the likelihood of FDA approval.
Multiple Securities Fraud Investigations Launched Several law firms (Kirby McInerney, Bragar Eagel & Squire, Hagens Berman, Lowey Dannenberg, Holzer & Holzer, Glancy Prongay) have opened investigations into whether Capricor misled investors about Deramiocel's trial results. These probes add legal uncertainty and could lead to lawsuits, weighing on the stock.
The investigations are a new consequence of the FDA news and create ongoing legal overhang for the stock.