Workflow
Capricor Therapeutics(CAPR)
icon
Search documents
Capricor Therapeutics: Heavily Derisked After BLA Submission And OLE Data
Seeking Alpha· 2025-02-24 02:13
…deramiocel was slowing the trajectory of cardiac dysfunction in DMD measuredCapricor Therapeutics (NASDAQ: CAPR ) recently submitted its BLA for lead candidate deramiocel for patients with Duchenne muscular dystrophy (DMD) cardiomyopathy. As the company noted in their earnings call:About the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any t ...
Capricor Therapeutics to Participate in Upcoming Investor Conferences
Globenewswire· 2025-02-10 14:00
SAN DIEGO, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the Company is scheduled to participate in the following upcoming investor conferences. Event:Oppenheimer 35thAnnual Healthcare Life Sciences Conference (Virtual)Date:February 12, 2025 from 12:00-12:30 p.m. ETWebcast LinkClick here Event:Barclays 27thAnnual Global Healthcare Conferenc ...
Wall Street Analysts Believe Capricor (CAPR) Could Rally 208.09%: Here's is How to Trade
ZACKS· 2025-01-16 16:01
Capricor Therapeutics (CAPR) closed the last trading session at $13.47, gaining 7.6% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $41.50 indicates a 208.1% upside potential.The mean estimate comprises six short-term price targets with a standard deviation of $18.52. While the lowest estimate of $25 indicates an 85.6% increase from the current price level, the most optimistic ana ...
CAPR Stock Up on Completion of Rolling Submission of DMD Drug BLA
ZACKS· 2025-01-03 16:35
Shares of Capricor Therapeutics (CAPR) gained 8.4% on Thursday following the completion of the submission of a biologics license application (BLA) to the FDA seeking full approval for deramiocel to treat patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. CAPR’s lead product candidate and only clinical pipeline asset, deramiocel, is an investigational, allogeneic cardiac-derived cell therapy. A final decision of the FDA is anticipated in the second half of 2024.Capricor initiated its r ...
Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
Globenewswire· 2025-01-02 14:15
-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- SAN DIEGO, Jan. 02, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of the submission of its Biologics License Application (BLA) to the U.S. Food and ...
Capricor Therapeutics(CAPR) - 2024 Q3 - Quarterly Report
2024-11-14 21:30
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended September 30, 2024 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to Commission File Number: 001-34058 CAPRICOR THERAPEUTICS, INC. (Exact Name Of Registrant As Specified In Its Charter) Delaware 88-0363465 (State ...
Capricor Therapeutics(CAPR) - 2024 Q3 - Earnings Call Transcript
2024-11-14 04:12
Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q3 2024 Earnings Conference Call November 13, 2024 4:30 PM ET Company Participants A.J. Bergmann - Chief Financial Officer Linda Marbán - Chief Executive Officer Conference Call Participants Ted Tenthoff - Piper Sandler Leland Gershell - Oppenheimer Rick Miller - Cantor Fitzgerald Aydin Huseynov - Ladenburg Operator Good afternoon, ladies and gentlemen and welcome to the Capricor's Third Quarter 2024 Financial Results and Corporate Update Call. At this time, all par ...
Capricor Therapeutics (CAPR) Reports Q3 Loss, Misses Revenue Estimates
ZACKS· 2024-11-13 23:11
Capricor Therapeutics (CAPR) came out with a quarterly loss of $0.38 per share versus the Zacks Consensus Estimate of a loss of $0.34. This compares to loss of $0.25 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -11.76%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.32 per share when it actually produced a loss of $0.35, delivering a surprise of -9.38%.Over the last four quarters, the ...
Capricor Therapeutics(CAPR) - 2024 Q3 - Quarterly Results
2024-11-13 21:02
Deramiocel Development and Commercialization - Capricor initiated a rolling BLA submission for deramiocel in October 2024, with full submission expected by year-end 2024, targeting a potential PDUFA date in the second half of 2025[1][4] - Capricor signed a binding term sheet with Nippon Shinyaku for European expansion and commercialization of deramiocel, with potential milestones totaling approximately $1.5 billion[1][5] - Capricor plans to provide clinical data on skeletal muscle myopathy from the Phase 3 HOPE-3 trial to support potential label expansion for deramiocel[4] Financial Performance and Position - Capricor reported Q3 2024 revenues of approximately $2.3 million, down from $6.2 million in Q3 2023, primarily from ratable recognition of $40 million upfront and milestone payments from Nippon Shinyaku[9] - Revenue for Q3 2024 was $2.26 million, a decrease from $6.19 million in Q3 2023[18] - Total revenue for the nine months ended September 30, 2024, was $11.14 million, down from $13.09 million in the same period in 2023[18] - Capricor's Q3 2024 net loss was approximately $12.6 million, or $0.38 per share, compared to a net loss of $6.4 million, or $0.25 per share, in Q3 2023[11] - Net loss for Q3 2024 was $12.56 million, compared to $6.39 million in Q3 2023[18] - Comprehensive loss for Q3 2024 was $12.62 million, compared to $6.46 million in Q3 2023[18] - Capricor's cash position as of September 30, 2024, was approximately $85.0 million, up from $39.5 million at the end of 2023, supported by recent equity offerings[8] - Cash, cash equivalents, and marketable securities increased to $85.03 million as of September 30, 2024, from $39.49 million as of December 31, 2023[18] - Total assets grew to $92.95 million as of September 30, 2024, from $58.73 million as of December 31, 2023[18] - Total liabilities decreased to $24.69 million as of September 30, 2024, from $36.13 million as of December 31, 2023[18] - Total stockholders' equity increased to $68.26 million as of September 30, 2024, from $22.60 million as of December 31, 2023[18] Clinical Trial Results and Data - Capricor presented positive 3-year safety and efficacy results from the HOPE-2 OLE trial, showing improvements in cardiac function and a statistically significant benefit in PUL v2.0 total score[5] StealthX™ Exosome Platform and Project NextGen - Capricor's StealthX™ exosome platform was selected for Project NextGen, with manufacturing underway and delivery to NIAID planned for Q1 2025, with preliminary data expected in Q2 2025[7] Capital Raising and Cash Runway - Capricor completed a public offering of common stock, raising gross proceeds of approximately $86 million, extending its cash runway into 2027[1][8] Manufacturing and Production Expansion - Capricor is exploring GMP production expansion to meet potential product demand in the U.S. and other regions[4]
Here's Why Momentum in Capricor (CAPR) Should Keep going
ZACKS· 2024-11-11 14:51
When it comes to short-term investing or trading, they say "the trend is your friend." And there's no denying that this is the most profitable strategy. But making sure of the sustainability of a trend to profit from it is easier said than done.The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the st ...