CAPR Stock On Track To Clock Weekly Gains Ahead Of Critical FDA Panel — Retail Deems It A ‘Binary Event’

• The FDA refused to approve Capricor’s application for Deramiocel last year, citing insufficient evidence of effectiveness.
• The agency resumed review after the company submitted additional data.
• The FDA is expected to issue a decision on approving Deramiocel by August 22.

Shares of Capricor Therapeutics (CAPR) advanced this week, positioning the biotech for its first weekly gain in five weeks after a 33% decline over the past month, as investors await an FDA committee meeting on the company’s application, which investors deem to be a binary event.

On Thursday, the stock closed 5% higher, recovering from recent lows amid heightened investor focus on next week’s regulatory milestone.

FDA Panel Meeting Next Week

An FDA advisory committee will review Capricor’s application for Deramiocel on July 29. The experimental cell therapy is designed to treat Duchenne muscular dystrophy, a rare and progressive muscle disease, with a focus on heart-related complications. The FDA is expected to issue a decision on the application by August 22.

The application is backed by results from the late-stage HOPE-3 study, which showed improvements in arm function and heart health. Longer-term data from an earlier study also indicated the treatment may slow the disease’s progression.

The FDA refused to approve Capricor’s application for Deramiocel last year, citing insufficient evidence of effectiveness. The agency resumed review after the company submitted additional data. Deramiocel is Capricor’s lead and only late-stage product candidate.

Analysts Weigh In

Wall Street remains constructive, with a unanimous ‘Buy’ consensus among roughly 10 analysts and an average price target of $53.6, presenting a potential upside of over 170% from the stock’s closing price on Thursday, according to data from Koyfin.

Oppenheimer reiterated an ‘Outperform’ rating with a $54 target this week, citing a former FDA reviewer’s view that the package appears approvable and labeling could incorporate cardiac data.

Independent biotech analyst Dirk Haussecker said in a post on X that Deramiocel clinical data looks solid, but the short-sellers are stubbornly ignoring it because the science “felt wrong” at first, and that stubbornness could cost them a lot of money when the stock rises.

“$capr short squeeze incoming. Thesis: since science seemed implausible, positive clinical result claims must be fraudulent. Good luck with that one,” he wrote in a post on Thursday. “Shorts’ main argument: science sounds dodgy and we therefore disregard any positive, placebo-controlled trial data. To me, that sounds like a financial death wish,” he wrote earlier this week.

Capricor ended the first quarter with $278.6 million in cash, projected to fund operations through late 2027. CEO Linda Marbán has emphasized the HOPE-3 results as clinically meaningful for preserving function in DMD patients.  

How Did CAPR Retail Traders React?

On Stocktwits, retail sentiment around CAPR stock stayed within ‘bullish’ over the past 24 hours, while message volume increased from ‘normal’ to ‘high’ levels.

A Stocktwits user said the upcoming committee meeting will be a “binary event” where either longs or shorts get decimated.

CAPR stock has lost 31% year-to-date. 

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