Markets

CAPR Stock Skyrockets 144% in a Month: What Is Driving the Rally?

September 7, 2026 12:21 PM GMT · Nasdaq

Shares of Capricor Therapeutics CAPR have surged 144% over the past month. The rally reflects a combination of encouraging phase III data for its lead cell therapy candidate, deramiocel, in Duchenne muscular dystrophy (DMD), renewed FDA engagement and growing expectations that deramiocel could still reach the market despite earlier regulatory setbacks.

Regulatory Progress for Deramiocel Is the Key Catalyst

Capricor’s deramiocel has undergone a volatile but increasingly constructive regulatory journey since 2024. The company began its rolling biologics license application (BLA) submission in October 2024, seeking approval for DMD-associated cardiomyopathy, based largely on data from the phase II HOPE-2 and its open-label extension. The BLA was completed in December 2024 and subsequently received FDA priority review.

However, in July 2025, the FDA issued a complete response letter (CRL) citing insufficient evidence to support approval and requesting additional clinical and manufacturing information. Following a type A meeting in August 2025, Capricor obtained a clearer regulatory pathway, with the FDA indicating that results from the ongoing phase III HOPE-3 study could help address the deficiencies.

A major turning point came in December 2025, when the HOPE-3 study met its primary endpoint, demonstrating a statistically significant benefit in PUL 2.0, a measure of upper-limb function. Capricor subsequently incorporated the data into its response to the CRL. The FDA accepted the response as a class 2 resubmission and established a new PDUFA date as of Aug. 22, 2026, returning deramiocel to active regulatory review.

Capricor Therapeutics, Inc. Price and Consensus

Capricor Therapeutics, Inc. price-consensus-chart | Capricor Therapeutics, Inc. Quote

In July 2026, HOPE-3 data published in The Lancet reinforced the upper-limb efficacy signal, showing approximately a 54% reduction in the decline of upper-limb function versus placebo. However, updated cardiac analyses weakened the cardiomyopathy case and the FDA advisory committee voted 3-9 against supporting efficacy for DMD cardiomyopathy.

Following the advisory committee meeting, Capricor submitted additional 24-month HOPE-3 data and robustness analyses last month, while proposing a refined indication focused on upper-limb function, the study’s successful primary endpoint. The FDA accepted the submission as a major amendment and extended the PDUFA date by three months to Nov. 22, 2026, to review additional information.

Why Are Investors Optimistic?

Capricor’s recent rally stands in stark contrast to its year-to-date performance, signaling a significant shift in investor sentiment. While CAPR shares declined 67.5% year to date, the stock has rebounded sharply, gaining 144% over the past month compared with the industry’s 4.9% growth.

Investor sentiment toward Capricor has improved as deramiocel has moved from a failed cardiomyopathy-focused application to a potentially approvable therapy supported by positive phase III upper-limb data. The successful HOPE-3 primary endpoint, longer-term follow-up, continued FDA engagement and refined indication have provided a new regulatory pathway.

Despite substantial regulatory risk, the November PDUFA decision has emerged as a major catalyst for CAPR. FDA approval could significantly reduce regulatory uncertainty and create a new commercial opportunity for Capricor. However, another CRL would likely hurt the stock significantly.

CAPR's Zacks Rank & Stocks to Consider

Capricor currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Precigen PGEN, AC Immune ACIU, and Aldeyra Therapeutics ALDX, which carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 69.9% year to date.

Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.

Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 8.9% year to date.

AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.

Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 71.5% year to date.

Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.

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