Harmony Biosciences vs Capricor Therapeutics: why the prices moved differently

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

Harmony Biosciences Holdings (HRMY)

Q3 202627 Jul – 30 Sep 2026

▼3▲1

FDA Panel Rejects Deramiocel In late July, the FDA's advisory committee voted 9-3 that Deramiocel was not effective for cardiomyopathy, and the FDA's briefing document questioned its efficacy. Shares fell 64.5% as approval prospects dimmed.
This was the single largest driver of CAPR's price decline during the quarter.
Securities Fraud Investigations Multiple securities fraud investigations and class actions were launched, alleging Capricor misled investors about trial data and FDA talks. These add legal uncertainty and costs, further pressuring the stock.
Legal issues emerged as a new overhang on the stock during the quarter.
FDA Extends Review, Analyst Skepticism The FDA extended its review period for Deramiocel, and analysts grew skeptical of Capricor's plan to submit open-label extension data. This prolonged uncertainty weighed on investor sentiment.
Regulatory delay and analyst doubts added to the negative outlook.
Positive 24-Month HOPE-3 Data New 24-month HOPE-3 and extension data showed sustained benefit and were included in the FDA review, briefly lifting the stock. However, this positive was overshadowed by the regulatory setback.
This was the main positive development that provided a temporary boost.

August 20262 Aug – 30 Sep 2026

▼3▲1

Securities fraud investigations and class actions pile up Multiple law firms launched investigations and class actions alleging Capricor misled investors about deramiocel's clinical data and FDA talks. This legal cloud pressures the stock by raising uncertainty and potential costs, and keeps the FDA data dispute in the spotlight.
Explains a major overhang on the stock from the period.
FDA advisory committee rejects cardiomyopathy claim; review extended An FDA advisory panel voted 9-3 against deramiocel's effectiveness for cardiomyopathy, and the FDA extended its review while Capricor plans a BLA amendment. This delays a potential approval and makes a rejection more likely, weighing on the stock.
Directly affects the likelihood and timing of deramiocel approval.
Analyst skepticism grows over deramiocel's prospects A STAT News report questioned Capricor's plan to submit open-label extension data, calling it a stall tactic and raising doubts about the drug's chances. This negative commentary can erode investor confidence and push the stock lower.
Shows external skepticism that can influence investor sentiment.
New 24-month data supports deramiocel's longer-term benefit Capricor presented 24-month HOPE-3 and open-label extension data at a medical congress, showing sustained benefit and included in the FDA review. This positive data could improve the drug's approval odds and lifted the stock.
Provides a potential counterweight to negative regulatory news.

Latest2 Aug – 30 Sep 2026

▼3▲1

Securities fraud investigations and class actions pile up Multiple law firms launched investigations and class actions alleging Capricor misled investors about deramiocel's clinical data and FDA talks. This legal cloud pressures the stock by raising uncertainty and potential costs, and keeps the FDA data dispute in the spotlight.
Explains a major overhang on the stock from the period.
FDA advisory committee rejects cardiomyopathy claim; review extended An FDA advisory panel voted 9-3 against deramiocel's effectiveness for cardiomyopathy, and the FDA extended its review while Capricor plans a BLA amendment. This delays a potential approval and makes a rejection more likely, weighing on the stock.
Directly affects the likelihood and timing of deramiocel approval.
Analyst skepticism grows over deramiocel's prospects A STAT News report questioned Capricor's plan to submit open-label extension data, calling it a stall tactic and raising doubts about the drug's chances. This negative commentary can erode investor confidence and push the stock lower.
Shows external skepticism that can influence investor sentiment.
New 24-month data supports deramiocel's longer-term benefit Capricor presented 24-month HOPE-3 and open-label extension data at a medical congress, showing sustained benefit and included in the FDA review. This positive data could improve the drug's approval odds and lifted the stock.
Provides a potential counterweight to negative regulatory news.

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.

27 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.