This Capricor Insider Sold 24,000 Shares Before the Drop. With a New Catalyst on the Way, Is It Time to Buy? Focused on rare disease therapeutics, this biotech firm reported a notable insider sale amid a year of substantial stock gains.
Capricor Therapeutics Eyes FDA Approval Path for Duchenne Cell Therapy Capricor Therapeutics (
NASDAQ:CAPR ) executives said the company is in active discussions with the U.S. Food and Drug Administration as it works toward a potential approval decision for deramiocel, its allogeneic cardiac-derived cell therapy for Duchenne muscular dystrophy.
Speaking at a Goldman Sac
Capricor Therapeutics Q1 Earnings Call Highlights Capricor Therapeutics (
NASDAQ:CAPR ) said its Duchenne muscular dystrophy therapy candidate deramiocel remains under active FDA review, while the company is preparing to commercialize the product itself amid a legal dispute with distribution partner NS Pharma and parent company Nippon Shinyaku.
On t
Capricor's Insider Just Sold Big — Her Options Tell the rest of the Story Focused on advanced cell therapies for rare diseases, this biotech firm reported a notable insider sale in its latest SEC filing.
CAPR Stock Slumps But Wall Street Reiterates Optimism For Deramiocel Approval On the company’s fourth-quarter (Q4) earnings call on Thursday, CEO Linda Marban rejected the possibility that the Deramiocel therapy could receive only a conditional approval.
CAPR Stock Heads For Best Week In Nearly A Month: CEO Says 'No Way' Deramiocel Gets Only Conditional Approval The FDA has accepted Capricor’s resubmitted biologics license application, setting an Aug. 22 PDUFA decision date for Deramiocel in DMD.
Capricor Reports Wider Quarterly Loss Than Expected But All Eyes Are On Muscle Disease Therapy For the fourth quarter, the company reported a net loss of $0.62 per share, compared to loss of $0.16 per share in the corresponding quarter of 2024.
Capricor Therapeutics’ DMD Treatment Study Shows Improvement In Key Heart Function Measures The update comes as the therapy’s regulatory application awaits a decision from the U.S. Food and Drug Administration later this year.
CAPR Stock Surged 17% Today — What’s Fueling The Rally? The FDA has lifted a previous Complete Response Letter and resumed review of the company’s Biologics License Application for Deramiocel.
CAPR Stock In Spotlight As Investors Eye Next Week’s DMD Trial Data Showing Muscle And Cardiac Gains The FDA review of Deramiocel remains ongoing and could eventually lead to the assignment of a new PDUFA decision date.
Capricor Or Sarepta: Two DMD Stocks Enter A High-Stakes Week – Which One Has More Upside? Capricor is approaching a regulatory filing timeline and earnings, while Sarepta heads into results under legal and safety pressure.
CAPR Stock Rallied Nearly 30% So Far This Week — Here’s The February FDA Catalyst Investors Are Betting On Shares jumped over 14% on Thursday to their highest level and strongest session since December, when the company reported strong DMD trial results.
CAPR Stock Slides After FDA Requests More Data For Genetic Disorder Therapy — What Does Retail Think? The FDA has formally requested the full HOPE-3 clinical study report (CSR) and supporting data, Capricor said on Tuesday.
Here's Why This Biotechnology Skyrocketed by 439% in December A successful Phase 3 trial and a public offeringof stock boosted prospects for this company to receive approval for an exciting new treatment.
On Friday, there are stocks with unusual volume. Let's take a look. The trading volume of these stocks is deviating from the norm in today's session.
