Why Is CAPR Stock Rising Today? Piper Sandler Says Risk-Reward Favors Owning Stock Into FDA Decision

• The brokerage believes the risk-reward favors the stock heading into FDA’s decision in November.
• Last week, the FDA extended the review deadline for Capricor’s Deramiocel to Nov. 22, 2026.
• CAPR shares gained more than 157% in August, their highest gains since December 2025.

Capricor Therapeutics (CAPR) was in the spotlight on Tuesday after Piper Sandler turned positive on the biotech firm, saying that the potential upside from a U.S. Food and Drug Administration (FDA) approval of its Duchenne muscular dystrophy (DMD) treatment now outweighs the downside risk.

Piper Sandler Turns Bullish On Capricor

Analyst Edward Tenthoff upgraded Capricor to ‘Overweight’ from ‘Neutral’ and sharply raised his price target to $25 from $2, according to The Fly. This represents a roughly 150% upside potential from current levels.

At the time of writing, CAPR shares were trading 2.8% higher in pre-market trading, having gained around 57% since the FDA postponed the PDUFA date.

CAPR shares gained more than 157% in August, their highest gains since December 2025.

FDA Extends Deramiocel Review

The call comes after the FDA extended the review deadline for Capricor’s Deramiocel last week to Nov. 22, 2026. Tenthoff said the FDA’s acceptance of a major amendment for review and extension of the action date is a standard procedure and does not guarantee approval. A Complete Response Letter (CRL), which essentially means rejection, is also possible.

Still, the brokerage believes the risk-reward favors owning Capricor shares heading into the November decision, given the potential upside if Deramiocel is approved.

Capricor Narrows Focus To Upper-Limb Function 

Capricor submitted 24-month follow-up data from its Phase 3 Hope-3 study, along with additional analyses supporting a narrower proposed indication focused on preserving upper-limb function.

The biotech firm said the late-phase trial met its primary endpoint, showing a statistically significant benefit in upper-limb function.

The narrower focus follows an FDA advisory committee’s 9-3 vote in July that the available evidence did not support Deramiocel’s effectiveness in treating DMD-related cardiomyopathy.

CAPR Stock: Retail Investors Watch Resistance 

Retail sentiment surrounding CAPR on Stocktwits remained ‘neutral’ over the past 24 hours.

One user highlighted two key resistance points.

The stock has declined around 65% so far this year.

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