Capricor Therapeutics (NASDAQ:CAPR) Announces Quarterly Earnings Results

Capricor Therapeutics (NASDAQ:CAPR) posted its quarterly earnings data on Tuesday. The biotechnology company reported ($0.73) EPS for the quarter, missing the consensus estimate of ($0.44) by ($0.29), FiscalAI reports.

Here are the key takeaways from Capricor Therapeutics’ conference call:

• Capricor said HOPE-3 met its primary endpoint, with a 1.1-point difference on the upper-limb function measure versus placebo (p=0.029). The company also highlighted supportive two-year open-label results and analyses combining HOPE-2 and HOPE-3, while noting the open-label findings are descriptive.
• The FDA review of deramiocel remains ongoing, with a PDUFA date of November 22, 2026. Capricor submitted a major amendment including 24-month HOPE-3 data and additional analyses; its proposed indication focuses on upper-limb impairment in DMD patients older than nine.
• Capricor says its San Diego GMP facility is ready to supply an initial launch if the drug is approved, with further build-out expected to support 2,000–2,500 patients annually at full capacity. The company is preparing launch functions and says it does not expect the NS Pharma dispute to prevent commercialization.
• Third-quarter operating expenses rose to $44.7 million from $26.3 million a year earlier, and net loss widened to $42.7 million; the company reported no revenue. Capricor had $198.5 million in cash, restricted cash and marketable securities and expects funding for at least 12 months, but also reduced its workforce by about 10% and slowed some pipeline work.
• The contractual dispute with Nippon Shinyaku and NS Pharma is proceeding to arbitration, with a hearing expected to begin in mid-2027. Capricor is preparing to commercialize independently and said it is not currently seeking another partner.

Capricor Therapeutics Trading Up 12.7%

Shares of NASDAQ CAPR traded up $1.13 during mid-day trading on Wednesday, reaching $10.00. The company had a trading volume of 3,132,278 shares, compared to its average volume of 3,160,746. The stock has a market cap of $581.33 million, a price-to-earnings ratio of -4.08 and a beta of 0.80. Capricor Therapeutics has a 52 week low of $2.96 and a 52 week high of $40.37. The business’s 50-day moving average is $8.06 and its 200-day moving average is $20.05.

Latest Capricor Therapeutics News

Here’s some of the latest news about CAPR:

• Positive Sentiment: Capricor said Deramiocel’s application is in the FDA’s final review and reiterated confidence ahead of the Nov. 22 PDUFA date. The approaching decision is a major potential catalyst, though approval is not yet assured. CAPR Stock Rallies After-Hours As Capricor Reaffirms Deramiocel Confidence Ahead Of Nov. 22 Decision
• Positive Sentiment: Deramiocel’s Phase 3 cardiac results received the American Heart Association’s Outstanding Research Award in Pediatric Cardiology, adding recognition to the program as the FDA decision nears. Capricor’s HOPE-3 Phase 3 Cardiac Results Win AHA Award
• Neutral Sentiment: Capricor outlined manufacturing validation work extending into 2027. That provides a view of the company’s manufacturing plans, but the timeline may also leave questions about readiness to scale if Deramiocel is approved. Capricor Outlines 2027 Manufacturing Validation

Wall Street Analyst Weigh In

A number of equities analysts recently commented on the stock. Maxim Group cut shares of Capricor Therapeutics from a “buy” rating to a “hold” rating in a research note on Thursday, July 30th. Alliance Global Partners lowered shares of Capricor Therapeutics from a “buy” rating to a “neutral” rating and set a $7.00 price objective on the stock. in a research report on Tuesday, July 28th. Wall Street Zen downgraded shares of Capricor Therapeutics from a “sell” rating to a “strong sell” rating in a research note on Saturday, August 1st. Piper Sandler raised shares of Capricor Therapeutics from a “neutral” rating to an “overweight” rating in a research note on Tuesday, September 1st. Finally, LADENBURG THALM/SH SH cut Capricor Therapeutics from a “buy” rating to a “neutral” rating in a research note on Thursday, July 30th. Four equities research analysts have rated the stock with a Buy rating, six have given a Hold rating and one has given a Sell rating to the stock. According to MarketBeat, Capricor Therapeutics presently has an average rating of “Hold” and a consensus price target of $30.25.

Capricor Therapeutics Company Profile

Capricor Therapeutics is a biotechnology company developing cell- and exosome-based therapies for serious diseases. Its research focuses on using these technologies to address conditions with limited treatment options. The company’s leading program is deramiocel, also known as CAP-1002, an investigational therapy made from donor-derived cardiac cells. Capricor is developing it for Duchenne muscular dystrophy, a rare genetic disorder that causes progressive muscle weakness. Capricor is also advancing an exosome-based technology platform for potential therapeutic applications.