Shares of Capricor Therapeutics<\/strong> (CAPR Quick QuoteCAPR<\/a> – Free Report<\/a>) tanked 33% on Friday after it announced that the FDA issued a complete response letter (\u201cCRL\u201d) to the biologics license application (\u201cBLA\u201d) seeking approval for cell therapy deramiocel, to treat cardiomyopathy associated with Duchenne muscular dystrophy (\u201cDMD\u201d).<\/p>\n DMD is a serious genetic disorder showing progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles with mortality at a median age of approximately 30 years.<\/p>\n Per the CRL, the FDA informed the company that it had concluded review of the BLA but could not approve the application in the current form. The regulatory body specifically noted that the application failed to meet the statutory requirement for substantial evidence of effectiveness and highlighted the need for additional clinical data.<\/p>\n The CRL also highlighted certain unresolved issues within the Chemistry, Manufacturing and Controls (\u201cCMC\u201d) section of the application. Management believes that most of these concerns have already been addressed in its prior communications with the FDA. However, the FDA did not review these materials, as they were submitted too close to the issuance of the CRL.<\/p>\n Year to date, shares of Capricor have plunged 44.7% compared with the industry<\/a>\u2019s decline of 0.9%.<\/p>\n CRL to CAPR’s BLA Comes as a Major Surprise<\/p>\n The investor community seemed surprised by the CRL, especially after the FDA accepted and granted a priority review to the BLA for deramiocel in March. A decision was due on Aug. 31, 2025. More so, the FDA also did not identify any review issues with the BLA.<\/p>\n In a regulatory update provided last month, the company also confirmed that the FDA indicated an Advisory Committee meeting would not be required for the application.<\/p>\n The BLA was based on data from its phase II HOPE-2 and an open-label extension study compared with natural history data.<\/p>\n A potential approval could have made deramiocel the first therapy to treat DMD cardiomyopathy. However, the latest CRL is likely to delay the approval for deramiocel, which could have given Capricor its first approved product.<\/p>\n The company plans to hold further discussions with the FDA to determine the next steps of development for deramiocel.<\/p>\n CAPR’s Zacks Rank & Stocks to Consider<\/p>\n Capricor currently carries a Zacks Rank #3 (Hold).<\/p>\n Some better-ranked stocks from the biotech sector are Arvinas<\/strong> (ARVN Quick QuoteARVN<\/a> – Free Report<\/a>) , Alkermes<\/strong> (ALKS Quick QuoteALKS<\/a> – Free Report<\/a>) and BioXcel Therapeutics<\/strong> (BTAI Quick QuoteBTAI<\/a> – Free Report<\/a>) , each sporting a Zacks Rank #1 (Strong Buy). You can see\u00a0the complete list of today\u2019s Zacks #1 Rank stocks here<\/strong><\/a>.<\/p>\n In the past 60 days, Arvinas\u2019 2025 loss per share estimates have improved from $1.60 to $1.51. Loss per share estimates for 2026 have narrowed from $3.28 to $2.98 during the same period. ARVN stock has plunged 59.3% year to date.<\/p>\n Arvinas\u2019 earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%.<\/p>\n In the past 60 days, estimates for Alkermes\u2019 earnings per share have increased from $1.74 to $1.79 for 2025. During the same time, earnings per share estimates for 2026 have risen from $1.79 to $1.91. Year to date, shares of ALKS have gained 5.3%.<\/p>\n Alkermes\u2019 earnings beat estimates in one of the trailing four quarters, while missing the same on the remaining three occasions, the negative average surprise being 8.24%.<\/p>\n In the past 60 days, BioXcel Therapeutics\u2019 2025 loss per share estimates have improved from $16.44 to $8.60. Loss per share estimates for 2026 have narrowed from $23.76 to $7.02 during the same period. BTAI stock has declined 67.1% year to date.<\/p>\n BioXcel Therapeutics\u2019 earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 42.84%.<\/p>\n","protected":false},"excerpt":{"rendered":"Key Takeaways CAPR’s BLA for deramiocel in DMD cardiomyopathy received an FDA complete response letter. The FDA cited…\n","protected":false},"author":3,"featured_media":65212,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[18217,6764,815,4313,268,18213,18215,18216,18214,18218,18219,159,9580,2437,18220,8727,67,132,68],"class_list":{"0":"post-65211","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-genetics","8":"tag-financial","9":"tag-financial-planning","10":"tag-genetics","11":"tag-investing","12":"tag-investment","13":"tag-investment-advice","14":"tag-online-investment","15":"tag-online-stock-trading","16":"tag-online-trading","17":"tag-quote","18":"tag-quotes","19":"tag-science","20":"tag-stock","21":"tag-stock-market","22":"tag-stock-quotes","23":"tag-stocks","24":"tag-united-states","25":"tag-unitedstates","26":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/114852334547258543","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/65211","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=65211"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/65211\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/65212"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=65211"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=65211"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=65211"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"Zacks](\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2025\/07\/113311.jpg\"\/)
Image Source: Zacks Investment Research<\/p>\n