Capricor CFO Sells $753K in Shares Capricor CFO sold $753,000 of stock per an SEC filing dated Apr 1, 2026 (Investing.com); institutional investors should review the Form 4 and cash-runway implications for CAPR.

Capricor CFO Sells $753K in Shares: Capricor CFO sold $753,000 of stock per an SEC filing dated Apr 1, 2026 (Investing.com); institutional investors should review the Form 4 and cash-runway implications for CAPR. 👈 Read full analysis #Capricor #CFO #Investing #StockMarket #FinanceNews

Schall Law Firm Invites CAPR Investors to Lead Legal Action Against Capricor Therapeutics Investors in Capricor Therapeutics are urged to join a class action lawsuit led by the Schall Law Firm for potential securities fraud violations.

Schall Law Firm Invites CAPR Investors to Lead Legal Action Against Capricor Therapeutics #USA #Los_Angeles #Schall_Law_Firm #CAPR #Capricor

Capricor Therapeutics Faces Class Action for Misleading Investors Over Drug Approval Capricor Therapeutics, Inc. is embroiled in a class action lawsuit for allegedly making false claims about its drug approval process. Take action now!

Capricor Therapeutics Faces Class Action for Misleading Investors Over Drug Approval #USA #Los_Angeles #Securities_Law #DJS_Law_Group #Capricor

Faruqi & Faruqi Urges Capricor Investors to Join Class Action by September 15, 2025 Faruqi & Faruqi, a prominent securities law firm, reminds investors in Capricor Therapeutics to act before the September 15, 2025 deadline for a class action lawsuit.

Faruqi & Faruqi Urges Capricor Investors to Join Class Action by September 15, 2025 #USA #New_York #Class_Action #Faruqi_&_Faruqi #Capricor

Important Class Action Notice for Shareholders of Capricor Therapeutics (CAPR) Shareholders of Capricor Therapeutics, Inc. are urged to join a class action suit by The Gross Law Firm. Deadline is September 15, 2025.

Important Class Action Notice for Shareholders of Capricor Therapeutics (CAPR) #United_States #New_York #Class_Action #Gross_Law_Firm #Capricor

Capricor Therapeutics Faces Class Action for Securities Violations: What Investors Need to Know Investors in Capricor Therapeutics, Inc. may be eligible for a class action lawsuit concerning securities law violations. Here’s what you need to know.

Capricor Therapeutics Faces Class Action for Securities Violations: What Investors Need to Know #United_States #Los_Angeles #Securities_Law #DJS_Law_Group #Capricor

Examining Allegations Against Capricor Therapeutics by Pomerantz Law Firm Pomerantz Law Firm has launched an investigation into claims made by investors of Capricor Therapeutics, particularly regarding potential securities fraud and business misconduct.

Examining Allegations Against Capricor Therapeutics by Pomerantz Law Firm #United_States #New_York #biotechnology #Pomerantz #Capricor

Important Class Action Notice for Capricor Therapeutics Investors with a Deadline of September 15, 2025 Levi & Korsinsky, LLP alerts Capricor Therapeutics investors about a class action lawsuit. Join before the September 15, 2025 deadline.

Important Class Action Notice for Capricor Therapeutics Investors with a Deadline of September 15, 2025 #USA #New_York #Class_Action #Levi_&_Korsinsky #Capricor

Capricor Therapeutics Investors Urged to Lead Class Action on Securities Fraud Claims Investors of Capricor Therapeutics, Inc. may join a class action lawsuit after fraudulent activities related to their securities. Key deadlines are approaching.

Capricor Therapeutics Investors Urged to Lead Class Action on Securities Fraud Claims #USA #New_York #Securities_Fraud #Rosen_Law_Firm #Capricor

Faruqi & Faruqi, LLP Investigates Capricor Therapeutics Shareholder Claims – We Want to Help You Faruqi & Faruqi, LLP, a prominent national securities law firm, investigates potential claims for Capricor Therapeutics investors following a major setback from the FDA.

Faruqi & Faruqi, LLP Investigates Capricor Therapeutics Shareholder Claims – We Want to Help You #USA #New_York #LLC #Faruqi_&_Faruqi #Capricor

Capricor Therapeutics Faces Class Action Lawsuit for Securities Violations Linked to Misleading Drug Claims Investors in Capricor Therapeutics are reminded of a class action lawsuit due to alleged securities law violations, especially regarding misleading drug approval claims.

Capricor Therapeutics Faces Class Action Lawsuit for Securities Violations Linked to Misleading Drug Claims #USA #Los_Angeles #DJS_Law_Group #CAPR #Capricor

Investors Advised of Class Action Lawsuit Against Capricor Therapeutics by Levi & Korsinsky Levi & Korsinsky alerts shareholders of Capricor Therapeutics about a class action lawsuit due to alleged securities fraud affecting stock value.

Investors Advised of Class Action Lawsuit Against Capricor Therapeutics by Levi & Korsinsky #United_States #New_York #Securities_Fraud #Lawsuit #Capricor

Investors of Capricor Therapeutics Face Class Action Lawsuit Amid Allegations of Securities Fraud Capricor Therapeutics, Inc. investors are reminded of the ongoing class action lawsuit with a lead plaintiff deadline approaching. Learn more about the claims and potential compensation.

Investors of Capricor Therapeutics Face Class Action Lawsuit Amid Allegations of Securities Fraud #USA #New_York #Class_Action #Securities_Fraud #Capricor

Capricor Therapeutics Investors Targeted for Class Action Over Significant Losses Bronstein, Gewirtz & Grossman LLC has launched a class action lawsuit for investors of Capricor Therapeutics, addressing substantial financial losses. Investors are encouraged to join.

Capricor Therapeutics Investors Targeted for Class Action Over Significant Losses #USA #New_York #Class_Action #Bronstein #Capricor

Capricor Therapeutics Investors Encouraged to Join Class Action Following Significant Losses Shareholders of Capricor Therapeutics, Inc. are invited to join a class action suit after the company's failure to secure FDA approval for a critical drug caused stock values to plummet.

Capricor Therapeutics Investors Encouraged to Join Class Action Following Significant Losses #United_States #New_York #Class_Action #deramiocel #Capricor

Capricor shares sink as US FDA declines to approve cell therapy (Reuters) -The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics (NASDAQ:CAPR)’ cell therapy for a heart condition, the company said on Friday, sending its shares tumbling 30% in early trading. In its "complete response letter," the agency said the evidence submitted for the therapy, Deramiocel, does not meet efficacy requirements and asked for more data. Capricor was seeking approval to treat cardiomyopathy, or a heart muscle disease, in patients with Duchenne muscular dystrophy, a genetic disorder characterized by progressive muscle degeneration. The letter was issued more than a month ahead of the FDA’s scheduled priority review date of August 31. Capricor plans to resubmit the application in the third quarter with data from an ongoing late-stage study. JonesTrading analyst Catherine Novack had earlier said that an August approval was unlikely due to the sudden cancellation of an advisory panel meeting and the dismissal of key officials at the Center for Biologics Evaluation and Research (CBER), the primary regulatory body for cell therapies. Cell therapy developers are also set to face increased regulatory scrutiny since the appointment of Vinay Prasad as CBER chief in May. "Prasad has been vocal in his opposition to single-arm trials and accelerated approval," said Piper Sandler analyst Edward Tenthoff. B. Riley Securities analysts said the FDA cited technical limitations in the data, but "keeps the door open" by allowing late-stage data as a major amendment instead of requiring a full resubmission. The company said it was surprised by the decision and was seeking a meeting with the FDA to discuss the next steps. "We do not believe that a new BLA (marketing application) will be necessary," CEO Linda Marban told analysts on a conference call. With valuations skyrocketing in 2024, many investors are uneasy putting more money into stocks. Sure, there are always opportunities in the stock market – but finding them feels more difficult now than a year ago. Unsure where to invest next? One of the best ways to discover new high-potential opportunities is to look at the top performing portfolios this year. ProPicks AI offers 6 model portfolios from Investing.com which identify the best stocks for investors to buy right now. For example, ProPicks AI found 9 overlooked stocks that jumped over 25% this year alone. The new stocks that made the monthly cut could yield enormous returns in the coming years. Is CAPR one of them?

Click Subscribe #Capricor #FDA #CellTherapy #BiotechNews #StockMarket

Pharmalittle: We're reading about a FDA offer on drug reviews, a Moderna Covid approval, and more FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U.S. and other countries

Pharmalot.. Pharmalittle.. Good Morning: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval & more news.. statnews.com/pharmalot/20... #pharma #Zantac #Covid #vaccines #FDA #Duchenne #epilepsy #Pfizer #Sanofi #GSK #Capricor #Moderna

Capricor stock plunges after FDA rejects Duchenne drug application Investing.com -- Capricor Therapeutics (NASDAQ:CAPR) stock plunged 53% after the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) rejecting its application for Deramiocel, a cell therapy for Duchenne muscular dystrophy (DMD). The FDA stated that the Biologics License Application (BLA) "does not meet the statutory requirement for substantial evidence of effectiveness" and requires additional clinical data. The agency also noted outstanding Chemistry, Manufacturing, and Controls (CMC) issues, though Capricor believes it had addressed most of these in prior communications. Capricor CEO Linda Marbán expressed surprise at the decision, noting that "prior to the CRL, the review had advanced without major issues, including a successful pre-licensure inspection and completion of the mid-cycle review." The company had been granted Priority Review for the application in March 2025. The biotechnology company now plans to resubmit its BLA with data from its ongoing Phase 3 HOPE-3 trial, which is expected to produce topline results in Q3 2025. The HOPE-3 study is a randomized, double-blind, placebo-controlled trial involving 104 patients. The FDA has offered Capricor the opportunity to request a Type A meeting to discuss next steps toward potential approval. The company remains focused on pursuing the indication for treating cardiomyopathy associated with DMD. Capricor’s original submission included data from the HOPE-2 trial, its open-label extension, and natural history comparisons from FDA-funded datasets, which ultimately proved insufficient for approval. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C. Don't miss out on the next big opportunity! Stay ahead of the curve with ProPicks AI – 6 model portfolios fueled by AI stock picks with a stellar performance this year... In 2024 alone, ProPicks AI identified 2 stocks that surged over 150%, 4 additional stocks that leaped over 30%, and 3 more that climbed over 25%. That's an impressive track record. With portfolios tailored for Dow stocks, S&P stocks, Tech Stocks, and Mid Cap stocks, you can explore various wealth-building strategies. So if CAPR is on your watchlist, it could be very wise to know whether or not it made the ProPicks AI lists.

Click Subscribe #Capricor #FDA #Duchenne #StockMarket #Investing

#Capricor #CAPR is on the move following a key regulatory update: Capricor confirms no AdCom is required for Deramiocel’s BLA in Duchenne Muscular Dystrophy. FDA Priority Review remains intact with PDUFA set for August 31.

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Capricor Advances Toward FDA Approval for Deramiocel; Reports Loss in Q1 2025 Capricor Therapeutics (CAPR), a clinical-stage biotechnology company, announced financial results for the first quarter of 2025 and shared a regulatory update o

Capricor Therapeutics ( #CAPR) is progressing toward FDA approval for its Duchenne muscular dystrophy therapy, DERAMIOCEL, while reporting a Q1 2025 net loss.
#BiotechNews #Capricor #FDAApproval #DMD #Biopharma
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Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular Dystrophy Capricor Therapeutics, a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the U.S. Food and Drug Administration (“FDA”) has accepted for review its Biologics License Application (“BLA”) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (“DMD”) cardiomyopathy.

Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular Dystrophy

👉 Read More: dmdwarrior.com

#dmd #duchenne #deramiocel #capricor

Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy -If approved, deramiocel would be first approved therapy for Duchenne muscular dystrophy cardiomyopathy. -BLA submission triggers $10 million milestone payment to Capricor from Nippon Shinyaku.

Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy

#dmd #duchenne #bmd #becker #genetherapy #dmdwarrior #dmdwarriors #duchennewarriors #duchenne #musculardystrophy #Capricor #Deramiocel #fda

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Aries
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Leo
"With charisma and confidence, Leo rules the pride. 🦁 #LeadershipVibes #LeoPower"

Capricorn
"Hard work meets strategy—Capricorn climbs to the top. 🏔️ #LeaderInAction #Capricor