Oppenheimer has maintained an Outperform rating on Capricor Therapeutics (NASDAQ:CAPR) with a steady price target of $15.00.
The firm's positive stance comes ahead of Capricor's anticipated regulatory update on deramiocel for Duchenne muscular dystrophy (DMD), which is expected to follow recent interactions with the FDA and a pre-Biologics License Application (BLA) meeting.
Capricor hinted at the possibility of an accelerated approval pathway for deramiocel in the United States during their quarterly update call last month.
This pathway could be based on the data from Phase 2 and extension studies previously reported. The update, expected tomorrow, is likely to affirm this potential, enhancing the outlook for the drug's registration.
The optimism is further bolstered by Capricor's expanded partnership with Nippon Shinyaku, now encompassing the U.S., EU, and Japan, which was announced last week.
Moreover, the potential cardioprotective benefits of deramiocel may be acknowledged in the drug's labeled indication, taking into account the shown advantages in this area. Such recognition could position Capricor favorably for pricing and reimbursement opportunities, especially considering the current lack of approved treatments for DMD-associated cardiomyopathy, which is the leading cause of death in DMD patients.
In other recent news, Capricor Therapeutics recently hosted a webcast to discuss regulatory developments concerning its Duchenne muscular dystrophy (DMD) program.
The focus of the webcast was the company's lead product candidate, deramiocel, currently in Phase 3 clinical development for DMD treatment. Also, Capricor is working on exosome-based therapeutics through its proprietary StealthX™ platform, which is still in the preclinical phase.
Capricor has an exclusive agreement with Nippon Shinyaku Co., Ltd. for the commercialization and distribution of deramiocel in the United States and Japan, contingent on regulatory approval.
Furthermore, Capricor Therapeutics has secured a significant financial agreement with Nippon Shinyaku, totaling up to $35 million, which includes a $15 million equity investment and an upfront payment of $20 million.
Despite reporting a net loss of approximately $11 million for Q2 2024, the company generated revenue of around $4 million and maintains a strong cash position of $29.5 million. On the analysts' front, Capricor has maintained its Buy rating from H.C. Wainwright and has seen its price target upgraded to $15 by Oppenheimer.
InvestingPro Insights
As Capricor Therapeutics (NASDAQ:CAPR) approaches a pivotal regulatory update, investors and analysts are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Capricor holds a market capitalization of approximately $186.94 million, reflecting the market's current valuation of the company. Despite a significant revenue growth of 187.15% over the last twelve months as of Q2 2024, the company's gross profit margin remains negative at -37.73%, indicating challenges in maintaining profitability.
InvestingPro Tips highlight that Capricor is quickly burning through cash, which is a critical consideration for investors given the company's ambitious clinical development plans. Additionally, with two analysts having revised their earnings downwards for the upcoming period, there may be concerns about the company's near-term financial performance. However, it is noteworthy that the stock has experienced a significant return over the last week, with a 14.51% price total return, which could be a response to recent developments or market sentiments.
For those looking to delve deeper into Capricor's financials and stock performance, InvestingPro offers a suite of additional tips, providing a comprehensive view of the company's prospects. Visit https://www.investing.com/pro/CAPR to explore further insights and analytics.
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