Capricor Therapeutics Surges After Piper Sandler Upgrade Ahead of FDA Decision

Capricor Therapeutics Inc. (NASDAQ:CAPR) shares rose sharply in premarket trading on Tuesday after an analyst at Piper Sandler upgraded the stock and significantly increased its price target. The move reflects growing optimism ahead of a key regulatory decision for the company's lead drug candidate.

Analyst Action

Piper Sandler analyst Edward Tenthoff upgraded Capricor shares to Overweight from a Neutral rating, according to a note published Tuesday. The firm also dramatically raised its price target on the stock to $25 from a previous target of $2.

In response to the upgrade, Capricor's stock climbed 5.5% in premarket trading. The analyst noted that the shares have already rallied 58% since the U.S. Food and Drug Administration (FDA) extended its review of the company's drug candidate, deramiocel.

FDA Decision Looms

The primary catalyst for the upgrade is the upcoming Prescription Drug User Fee Act (PDUFA) date for deramiocel, now set for November 22. The FDA extended the original review timeline after accepting a major amendment to Capricor's Biologics License Application (BLA).

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The amendment included 24-month data from the HOPE-3 Open-Label Extension (OLE) study and a request for a more specific indication related to upper limb function. Tenthoff noted that while an extension for a major amendment is standard procedure and does not guarantee approval, Piper Sandler believes the risk/reward profile favors owning the stock into the decision date.

Clinical Data and Financials

Deramiocel is being developed for the treatment of Duchenne muscular dystrophy. According to data previously published in *The Lancet*, the drug demonstrated a significant slowing in the loss of upper limb function.

• At 12 months, the absolute decrease in the Performance of the Upper Limb (PUL2.0) score was 1.2 points less with deramiocel than with a placebo.
• This represented an approximate 54% slowing of the loss of upper limb function for patients receiving the treatment.

From a financial standpoint, Capricor Therapeutics reported ending the second quarter of fiscal 2026 with $238 million in cash.