CAPRCapricor Therapeutics, Inc.

Deramiocel faces regulatory headwinds; management pursues upper limb indication.

Capricor Therapeutics, Inc. (NASDAQ:CAPR) closed 58% higher at $6.65 on August 14 after the company said the FDA was willing to review an amendment containing 24-month data for deramiocel, its Duchenne muscular dystrophy treatment. The shares had traded as much as 94% above the previous close before surrendering part of the gain. The rebound recovered […]

Goldman increased its stake in Sellas by 5.2% to 585,035 shares, worth $8.64 million.

Capricor Therapeutics (CAPR) is back in focus after two securities class action lawsuits accused the company of failing to disclose FDA concerns about changes to the statistical analysis plan for its lead drug candidate, Deramiocel. See our latest analysis for Capricor Therapeutics. The lawsuits arrive after a difficult stretch for Capricor Therapeutics, with the share price falling 76.5% year to date and 76.3% over 90 days, even though the stock has a 5 year total shareholder return of...

Moby summary of Capricor Therapeutics, Inc.'s Q2 2026 earnings call

In the past week, Capricor Therapeutics reported Q2 2026 results showing a net loss of US$40.73 million and higher per-share losses, while also facing growing legal and regulatory scrutiny over its lead Duchenne muscular dystrophy candidate, Deramiocel. The combination of widening losses and class action lawsuits alleging inadequate disclosure of FDA-related concerns around Deramiocel’s statistical analysis plan has intensified questions about the company’s transparency and regulatory risk...

Cantor Fitzgerald upgraded Capricor to ‘Overweight’ from ‘Neutral’ and raised its price target to $28 from $3.50, just weeks after the firm slashed its price target to $3.50 from $62.

The FDA is “willing to review” an updated submission for Capricor’s Duchenne cell therapy, its CEO said. Elsewhere, a heart drug battle spilled into court and Rigel priced the first “Protac” medicine.

Despite an advisory committee vote against deramiocel for cardiomyopathy, Capricor is pivoting to an upper limb indication with a strong cash position and promising HOPE-3 data.

CEO Marbán said Capricor remains focused on delivering the therapy to patients and is working closely with the FDA on a path forward centered on improvements in upper-limb skeletal muscle function demonstrated in trials.

Capricor Therapeutics (NASDAQ:CAPR) said its biologics license application for deramiocel remains under U.S. Food and Drug Administration review, while the company prepares to submit an amendment seeking a refined indication centered on upper limb skeletal muscle function in Duchenne muscular dystro

Capricor Therapeutics is back in focus after analysts reduced their fair value estimates from about US$49.44 to about US$4.38, bringing price targets much closer to the low single digits. This reset aligns with recent commentary that now centers on regulatory risk around deramiocel, legal overhangs, and a more cautious view on the company’s earnings potential and execution. Read on to see how the analyst narrative is evolving and how you can keep up with the shifting story around Capricor...

Decisions are due by August 23 at the latest on therapies ranging from an mRNA flu vaccine to a gene therapy for a rare metabolic disorder, putting biotech investors on high alert.

Capricor Therapeutics’ stock has closed lower for the past five consecutive days, erasing nearly 80% from the company’s market capitalization.

Investors responded by aggressively selling the stocks as concerns mounted over their near-term outlook.

Humana upgraded, Las Vegas Sands downgraded: Wall Street's top analyst calls

Capricor stock is headed for its worst week on record after a negative FDA advisory committee vote rattled Wall Street.

Some advisers viewed the upper-limb data more favorably, fueling hopes for a narrower approval focused on that benefit.

A Food and Drug Administration advisory panel voted 9-3 Wednesday against Capricor Therapeutics’ experimental therapy for a Duchenne muscular dystrophy-related heart condition. Panelists expressed concern about how the company analyzed the data to show improvement.

Earlier this week, the FDA questioned how Capricor analyzed results from its late-stage HOPE-3 trial, sending the stock sharply lower and raising doubts about a potential approval.

The publication comes ahead of a crucial U.S. Food and Drug Administration advisory committee meeting and the agency’s final approval decision in August.

Alliance Global said that the upcoming FDA advisory committee meeting now appears to be an ‘uphill battle’ for Capricor.

Wall Street turned more cautious, with Roth, B. Riley and Cantor flagging elevated approval risk.

The documents released by the FDA on Monday, ahead of an advisory committee meeting to review Capricor’s application for Deramiocel, have raised a divide among Wall Street experts over what to expect.

The FDA released briefing documents, raising concerns over whether Capricor’s lead therapy, Deramiocel, has demonstrated sufficient effectiveness in treating cardiomyopathy in patients with Duchenne muscular dystrophy.

Capricor Therapeutics (NASDAQ:CAPR) shares fell about 67% on Monday after US Food and Drug Administration (FDA) staff reviewers raised concerns about the evidence supporting the effectiveness of the company's experimental cell therapy, deramiocel, for Duchenne muscular dystrophy (DMD)-associated...

The FDA released briefing documents, raising concerns over whether Capricor’s lead therapy, Deramiocel, has demonstrated sufficient effectiveness in treating cardiomyopathy in patients with Duchenne muscular dystrophy.

Capricor Therapeutics (NASDAQ:CAPR) shares dropped 40% on Monday after the U. S.

In July 2026, Capricor Therapeutics signed a lease for approximately 171,000 square feet in San Diego to serve as its new headquarters, with expanded manufacturing cleanrooms, R&D labs and offices, on terms that are contingent on FDA approval of its Duchenne muscular dystrophy therapy Deramiocel by December 31, 2026. This headquarters move, structured around regulatory milestones and including rent abatements and tenant improvement support, underlines how central the pending Deramiocel FDA...

Capricor shares lost much of their value ahead of a high-stakes advisory committee meeting. Elsewhere, Ying Huang’s resignation extended a stock slide for Legend and AstraZeneca disclosed more pipeline trouble.

Capricor Therapeutics (CAPR) has drawn investor attention after securing a long term lease for a 171,000 square foot San Diego headquarters, which is tied in part to potential FDA approval of its Deramiocel therapy. See our latest analysis for Capricor Therapeutics. Despite the lease announcement and upcoming FDA decisions around Deramiocel, Capricor Therapeutics has seen mixed momentum, with the share price down 25.5% over 30 days and 42% over 90 days. However, a 1-year total shareholder...

Capricor Therapeutics stock has delivered a very strong 5 year return, yet current valuation checks point to a mixed picture rather than a clear bargain or clear overvaluation at the recent US$19.70 close. Capricor Therapeutics has returned about 350.8% over 5 years, which puts recent weakness into context for investors looking at the longer run. Future revenue and cash flow expectations around Capricor Therapeutics can support the current price. However, any setback in funding, trial...

Focused on rare disease therapeutics, this biotech firm reported a notable insider sale amid a year of substantial stock gains.

The days ahead pack several binary or near-binary catalysts for U.S. biotech and biopharma companies—decisions that could sharply reshape valuations overnight.

An FDA advisory committee will review Capricor’s application for Deramiocel on July 29.

The Food and Drug Administration’s Advisory Committee is scheduled to meet on July 29 to review Capricor’s Biologics License Application for Deramiocel.