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Investing.com - H.C. Wainwright maintained its Buy rating and $77.00 price target on Capricor Therapeutics (NASDAQ:CAPR) Monday, with the stock currently trading at $8.26 after falling over 33% in the past week. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $22 to $77.
The research firm emphasized that investors should avoid over-interpreting recent events, including the administrative leave of key FDA gene therapy personnel and the withdrawal of an advisory committee meeting notice for the company’s lead drug candidate deramiocel. InvestingPro analysis shows the company maintains a strong financial position with a current ratio of 6.55 and more cash than debt on its balance sheet.
H.C. Wainwright stated these developments likely reflect broader changes at the regulatory agency rather than specific concerns about Capricor’s therapy, potentially relating to other matters such as Elevidys approval issues or the FDA’s recent stance on CAR-T manufacturing in China.
The firm described deramiocel as a "first-in-class therapeutic profile with strong clinical and manufacturing support," noting the recent release of four-year open-label extension data from the HOPE-2 clinical trial.
H.C. Wainwright characterized last week’s stock volatility as an "overreaction" and continues to view the current situation as a buying opportunity ahead of deramiocel’s August 31 PDUFA date, when the FDA is scheduled to make an approval decision. InvestingPro’s Fair Value analysis suggests the stock is currently undervalued, with analysts expecting profitability this year. For deeper insights into Capricor’s financial health and growth prospects, access the comprehensive Pro Research Report available on InvestingPro.
In other recent news, Capricor Therapeutics has reported significant developments surrounding its lead drug candidate, Deramiocel. The company announced four-year safety and efficacy results from its ongoing HOPE-2 Open-Label Extension study for Duchenne Muscular Dystrophy, which showed preservation of cardiac function in treated patients. This comes as the U.S. FDA granted Orphan Drug Designation to Deramiocel for Becker Muscular Dystrophy, expanding its potential application beyond Duchenne Muscular Dystrophy. Meanwhile, Oppenheimer has lowered its price target for Capricor to $22.00 from $43.00 due to concerns about the FDA review process, though it maintained an Outperform rating. The revision was influenced by a STAT article detailing the removal of key FDA reviewers for Deramiocel. In contrast, H.C. Wainwright reaffirmed its Buy rating and $77.00 price target, viewing recent FDA administrative actions as non-critical. The FDA withdrew its notice for an Advisory Committee meeting, citing the need for additional time, but has not directly communicated any changes to Capricor. These developments follow news of two top FDA officials, crucial to Capricor’s drug application, being placed on administrative leave, raising concerns about regulatory stability.
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