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On Monday, Capricor Therapeutics (NASDAQ:CAPR) received a new Buy rating from Jones Trading, with a price target set at $40.00. The firm began its coverage on the biotechnology company, highlighting the potential of Capricor's leading drug candidate, deramiocel.
Deramiocel is a cell therapy designed for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD-CM). Jones Trading has expressed a positive outlook on the drug due to several factors. The absence of approved therapies for DMD-CM, which is now the leading cause of death in DMD patients, presents a significant opportunity for deramiocel.
Feedback from cardiologists has reportedly shown a high level of enthusiasm for the therapy. This optimism is also supported by the potential for functional outcomes data to serve as the basis for approval in the European Union, where the DMD market has not been fully tapped.
Capricor has established a partnership with Nippon Shinyaku for the commercial distribution of deramiocel in the United States, European Union, and Japan. The company has begun a rolling Biologics License Application (BLA) process and anticipates possible approval from the U.S. Food and Drug Administration (FDA) by the end of 2025.
In other recent news, Capricor Therapeutics has presented an update on their progress with deramiocel, a treatment for cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The company plans to submit a Biologics License Application (BLA) to the FDA by the end of 2024. Capricor has also strengthened its financial standing through successful fundraising, amassing a cash balance of approximately $165 million to support the upcoming commercial launch and manufacturing expansion.
In addition to these developments, the company is exploring opportunities to expand the treatment's use to Becker muscular dystrophy and advancing its StealthX exosome technology for future therapeutics. Capricor is collaborating with Nippon Shinyaku for marketing in Europe, with potential milestone payments of up to $1.5 billion. However, the company reported a net loss of approximately $12.6 million for the third quarter of 2024.
Despite this, Capricor's San Diego facility is prepared for production, and plans for a new manufacturing site are underway to meet anticipated demand. These are among the recent developments at Capricor Therapeutics.
InvestingPro Insights
As Capricor Therapeutics (NASDAQ:CAPR) receives a new Buy rating from Jones Trading with a $40 price target, InvestingPro data offers additional context for investors. The company's market capitalization stands at $846.19 million, reflecting the market's current valuation of its potential.
Notably, Capricor's stock has shown remarkable performance, with a 512.17% price total return over the past year and a 369.95% return in the last three months. This aligns with the positive outlook on deramiocel and the company's progress towards potential FDA approval.
However, investors should be aware of some financial challenges. InvestingPro Tips indicate that Capricor suffers from weak gross profit margins and is not profitable over the last twelve months. The company's gross profit margin for the last twelve months as of Q3 2024 stands at -95.25%, highlighting the current cost pressures in developing its promising therapies.
Despite these challenges, Capricor holds more cash than debt on its balance sheet, which could provide financial flexibility as it pursues FDA approval for deramiocel. This solid cash position may be crucial for supporting the company's research and development efforts in the lead-up to potential commercialization.
For investors seeking a deeper understanding of Capricor's financial health and market position, InvestingPro offers 14 additional tips, providing a comprehensive analysis to inform investment decisions in this dynamic biotechnology company.
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