- The February filing centers on Deramiocel’s Phase 3 Hope-3 data, following the FDA's request for the full clinical study report without requiring new trials.
- The company's Phase 3 results showed skeletal muscle and heart-related benefits for patients with DMD.
- Capricor said the submission will address the items raised in a Complete Response Letter it received in July 2025.
Shares of Capricor Therapeutics, Inc. (CAPR) have surged nearly 30% this week as investors position themselves ahead of a key February FDA filing that could move its Duchenne Muscular Dystrophy (DMD) therapy closer to approval.
On Thursday, CAPR stock jumped over 14% to its highest level and strongest session since December, when the company reported its DMD therapy met its Phase 3 primary endpoint.
February FDA Step In Focus
In January, Capricor said the U.S. Food and Drug Administration (FDA) formally requested the full clinical study report from its Phase 3 Hope-3 trial as part of the ongoing review of the company’s application to market Deramiocel.
Deramiocel is the drugmaker’s cell therapy that preserves skeletal muscle and heart function in patients with DMD, a genetic disorder that progressively weakens muscles and often leads to heart failure.
The company had said that preparation of the Hope-3 report is “well underway” and that it plans to submit the requested materials in February. Capricor said the submission will address the items raised in a Complete Response Letter it received in July 2025 and allow the FDA to continue its review, including setting a new target decision date.
Notably, the FDA did not ask for any new clinical trials or additional patient data as part of the request.
What Hope-3 Showed
The February submission comes on the heels of positive topline data Capricor reported in December from its Phase 3 Hope-3 trial. The study met its primary endpoint, showing a statistically significant slowing of the decline in upper limb function, and also demonstrated improvement on a key cardiac endpoint measuring left ventricular ejection fraction.
The trial enrolled 106 boys and young men with DMD, including people who cannot walk, and showed both skeletal muscle and heart-related benefits. Capricor said the therapy maintained a safety profile consistent with earlier studies.
Analysts Turn More Bullish
Following the Hope-3 readout and regulatory update, several Wall Street firms raised price targets and reiterated positive ratings on Capricor shares.
B. Riley lifted its price target to ‘$50’ from ‘$21’ and maintained a ‘Buy’ rating, citing a higher probability of approval based on “statistically significant and clinically meaningful data.” The firm said its updated assumptions reflect a 75% probability of success and risk-adjusted sales exceeding $1 billion by 2030.
Piper Sandler raised its target to ‘$45’ from ‘$20’ and kept an ‘Overweight’ rating, saying the Hope-3 data support a potential approval timeline as early as mid-2026 following a standard review.
Oppenheimer boosted its target to ‘$54’ from ‘$22’ with an ‘Outperform’ rating, arguing Deramiocel’s clinical profile compares favorably with existing Duchenne therapies and said its projected 2031 sales of about $1.1 billion in the U.S. alone through partner NS Pharma may prove “conservative.”
Other brokerages, including H.C. Wainwright, Maxim, and Alliance Global, also raised targets to the $48-$60 range while maintaining ‘Buy’ ratings following the Phase 3 results.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment for CAPR was ‘extremely bullish’ amid ‘extremely high’ message volume.
One user said, “Tomorrow looking to be a very interesting Friday indeed. Last two days don't suggest a profit taking sell-off, this was a structurally solid two days.”
Another user said that a BLA resubmission could eventually lead to FDA approval and, if the drug reaches the market, longs will be rewarded with upside benefits.
CAPR stock has risen 1% year to date.
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