Why Is CAPRICOR THERAPEUTIC (CAPR) Stock Moving Today?

Why CAPR stock is moving today

Capricor Therapeutics stock is moving higher today, with shares surging over 18% at one point in the session. The primary driver is the U.S. Food and Drug Administration’s extension of its review period for the company’s investigational cell therapy, Deramiocel. The FDA has pushed back the target action date for the Biologics License Application by three months, to November 22, 2026, citing the need for additional time to evaluate recent amendments and data.

What Happened

Capricor Therapeutics announced on August 24 that the FDA has extended its review of Deramiocel, a potential treatment for Duchenne muscular dystrophy. The extension was attributed to the submission of new clinical data related to upper limb function, which the company says strengthens the therapy’s case. The news was accompanied by a class action notice from Berger Montague, advising investors to inquire about potential securities fraud claims. Meanwhile, Capricor’s stock opened with a 1.6% gap up and reached an intraday high of $9.10 before settling at $6.69 in late trading.

What The Data Shows

The stock has seen significant intraday movement, with a high of $9.10 and a low of $6.34. Volume has already reached 6.2 million shares, more than 1.7 times the 3-month average. Over the past eight sessions, the stock has risen 49.5%, from $4.26 to $6.37. However, the stock has printed 14 fresh 52-week lows on August 24. Recent insider transactions include four sales totaling $1.5 million over the past 90 days, with no insider purchases reported.

What To Watch

Investors should monitor the FDA’s final decision on Deramiocel, which is now expected by November 22. The stock’s volatility and recent legal developments also warrant continued attention.