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Investing.com - Oppenheimer has reiterated an Outperform rating and $22.00 price target on Capricor Therapeutics (NASDAQ:CAPR) stock despite recent share weakness. According to InvestingPro data, analyst targets range from $12 to $29, with the stock currently trading at levels suggesting potential upside based on Fair Value analysis.
Capricor shares have declined approximately 12% over the last two sessions, compared to a 3% drop in the XBI biotech index. The stock has seen a significant 58% decline over the past six months, though InvestingPro analysis shows the company maintains strong liquidity with a current ratio of 6.55. Oppenheimer attributes this weakness to events related to Sarepta Therapeutics (NASDAQ:SRPT) rather than Capricor-specific issues.
The firm views heightened safety concerns around gene therapies incorporating Elevidys’s viral vector as "neutral at worst" and "potentially favorable" for Capricor’s cell-based deramiocel, which is derived from human donor hearts. While the company faces near-term challenges with cash burn, InvestingPro data indicates it maintains more cash than debt on its balance sheet.
Capricor is awaiting FDA interactions for regulatory strategy clarity following a complete response letter for deramiocel in Duchenne cardiomyopathy, which came after a review based on what Oppenheimer describes as "a small yet supportive Phase 2 dataset."
The investment firm remains optimistic about the upcoming HOPE-3 topline readout expected later this quarter, projecting potential sales exceeding $1 billion for deramiocel whether viewed from a cardiac or skeletal muscle perspective.
In other recent news, Capricor Therapeutics has faced significant developments regarding its Biologics License Application for Deramiocel, a cell therapy intended for Duchenne muscular dystrophy. The U.S. Food and Drug Administration issued a Complete Response Letter, rejecting the application due to insufficient evidence of effectiveness from the OLE HOPE-2 trial and outstanding Chemistry, Manufacturing, and Controls issues. In light of this, H.C. Wainwright adjusted its price target for Capricor to $24, down from $77, while maintaining a Buy rating. Despite this setback, Capricor plans to resubmit data to address the FDA’s concerns. Meanwhile, B.Riley has initiated coverage of Capricor with a Buy rating and a $21 price target, highlighting the potential of Deramiocel as a pioneering therapy for cardiomyopathy in Duchenne muscular dystrophy patients. Additionally, Capricor announced that the FDA will not require an Advisory Committee meeting for Deramiocel, and the application remains under Priority Review with a target action date set for August 31, 2025. An in-person late-cycle review meeting with the FDA is scheduled for mid-July. These recent developments are crucial for investors monitoring Capricor’s progress in the therapeutic landscape.
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