Capricor Therapeutics

Capricor Therapeutics, Inc. engages in the discovery, development and commercialization of first-in-class biological therapies for the treatment of cardiac and other serious medical conditions. Its product candidate consists of CAP-1002, Cenderitide, Exosomes, CAP-1001, CU-NP and CSps. The company was founded on June 17, 1996 and is headquartered in San Diego, CA.

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Capricor Therapeutics reports strong Q4 performance and advances DMD therapy

Capricor Therapeutics showcased strong financial performance, progress in DMD therapy, and strategic partnerships with Nippon Shinyaku and NS Pharma.
The company faces challenges in FDA interactions, share sales, and potential acquisition decisions, but opportunities lie in market expansion and community engagement.
Overall, Capricor's confidence in its therapies and partnerships positions it well for future growth and impact in the Duchenne Muscular Dystrophy space.
The call concluded with gratitude towards participants, supporters, and the Capricor team, highlighting a positive outlook for the company's future endeavors.

Capricor Therapeutics advances DMD programs and secures Japan distribution

Capricor Therapeutics made significant progress in Q1 2023 with advancements in DMD programs, manufacturing, and clinical trials.
While facing financial losses, the company's strategic strengths include FDA discussions, partnerships, and international expansion.
Challenges in financial stability and operational efficiency need to be addressed, but opportunities in funding, market expansion, and innovation are promising.

Capricor Therapeutics reports Q2 progress with positive clinical outcomes

Capricor Therapeutics showcased solid financial performance amid ongoing R&D investments, with a focus on advancing innovative therapies for Duchenne muscular dystrophy.
The company's strengths lie in positive clinical trial outcomes, regulatory support, and strategic board additions, positioning Capricor for future growth and success.
Challenges include financial sustainability, trial coordination, and manufacturing scalability, which require careful management to navigate effectively.
Opportunities in new indications, partnerships, upcoming milestones, and technology advancement offer avenues for expansion, value creation, and competitive differentiation.

Capricor Therapeutics achieves enrollment goal, eyes FDA approval acceleration

Capricor Therapeutics is making significant strides in its clinical trials and manufacturing capabilities, supported by a strong financial position. While challenges exist in managing expenses and navigating regulatory processes, the company is well-positioned to capitalize on growth opportunities in the biopharmaceutical sector.

Capricor Therapeutics reports positive trial results and strategic partnerships for growth

Capricor Therapeutics' Q4 2023 performance reflects a strong financial position but with a net loss, driven by positive trial results for CAP-1002 in DMD.
The company's strengths include successful trial outcomes, strategic partnerships, and advancements in exosome technology development.
Challenges include operational losses, regulatory hurdles, and market competition, while opportunities exist in partnerships, FDA interactions, and technology development.
Overall, Capricor Therapeutics is poised for growth with a focus on commercialization, regulatory progress, and expanding therapeutic applications.

Capricor Therapeutics excels in Q1 2024, poised for market expansion

Capricor Therapeutics shows strong financial performance and progress in DMD trial, positioning CAP-1002 favorably in the market.
Strategic focus on regulatory alignment, commercial readiness, and potential expansions highlight growth opportunities.
Challenges in regulatory compliance, operational execution, and market competition require proactive management strategies.
Overall, Capricor's advancements in therapy development and market positioning indicate a promising outlook for future growth.

Capricor Therapeutics reports Q3 progress, eyes market expansion opportunities

Capricor Therapeutics demonstrated financial resilience with steady revenue growth and a strong cash position, despite a net loss.
The company's focus on product development, market expansion, and strategic collaborations underscores a commitment to innovation and growth.
While facing challenges in managing expenses and navigating regulatory complexities, Capricor is well-positioned to capitalize on opportunities in new therapeutic areas and market access.
Overall, Capricor's progress on deramiocel, manufacturing scale-up, and future development plans signal a promising trajectory for sustained growth and market success.

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Capricor Therapeutics, Inc. engages in the discovery, development and commercialization of biological therapies for the treatment of cardiac and other serious medical conditions. Its product candidate consists of CAP-1002, Cenderitide, Exosomes, CAP-1001, CU-NP and CSps. The company was founded on June 17, 1996 and is headquartered in San Diego, CA.

SAN DIEGO, June 25, 2024 (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 U.S. Food and Drug Administration (FDA) has scheduled a Pre-BLA (Biologics License Application) meeting with the Company in the third quarter of 2024 for deramiocel (CAP-1002), for the treatment of Duchenne Muscular Dystrophy (DMD). Capricor's goal for this meeting will be to finalize its BLA filing plans based on all currently available data as well as to work with the FDA to outline the rolling BLA submission timeline.

Capricor Therapeutics Announces for the Treatment of Duchenne Muscular Dystrophy

Capricor Therapeutics, Inc.'s rolling BLA submission of CAP-1002 for the treatment of patients with DMD, expected in Q3 of 2024. Top-line results from Cohort A of the phase 3 HOPE-3 study, using CAP-1002 for the treatment of patients with DMD, expected Q4 of 2024. Additional results from phase 2 HOPE-2 study, using CAP-1002 for patients with DMD, to be presented at the upcoming PPMD 30th Annual conference between June 27th - 29th of 2024.

Capricor: Rolling BLA Submission Of CAP-1002 To Get DMD Treatment Program Going

--FDA Grants Pre-BLA Meeting Request and Rolling BLA Submission after Review of HOPE-2 and HOPE-2 OLE 3-Year Results-- SAN DIEGO, June 11, 2024 (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 successful completion of a Type-B meeting with the U.S. Food and Drug Administration (FDA) on next steps for the Biologics License Application (BLA) submission with its lead asset, CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD). Additionally, Deramiocel has been selected as the proposed International Nonproprietary Name (INN) for CAP-1002 by the World Health Organization.

Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy with an Aim to Expedite BLA Pathway

Capricor Therapeutics CAPR, a biotechnology firm focused on innovative therapies for rare diseases, has announced favorable three-year results from the ongoing HOPE-2 open-label extension (OLE) study on CAP-1002 for Duchenne muscular dystrophy.

Capricor Advances in DMD Therapy With Positive Study Data

Capricor (CAPR) anticipates announcing top-line results from the Phase 3 HOPE-3 pivotal trial by the fourth quarter of 2024.

Capricor (CAPR) Advances in DMD Therapy With Positive Study Data

Capricor Therapeutics, Inc. (NASDAQ:CAPR ) Q1 2024 Earnings Call Transcript May 13, 2024 4:30 PM ET Company Participants AJ Bergmann - CFO Linda Marban - CEO Conference Call Participants Kristen Kluska - Cantor Fitzgerald Ted Tenthoff - Piper Sandler Joe Pantginis - H.C. Wainwright Aydin Huseynov - Ladenburg Thalmann & Co. Operator Good afternoon, ladies and gentlemen, and welcome to the Capricor Therapeutics First Quarter 2024 Earnings Call.

Capricor Therapeutics, Inc. (CAPR) Q1 2024 Earnings Call Transcript

Capricor Therapeutics (CAPR) came out with a quarterly loss of $0.31 per share versus the Zacks Consensus Estimate of a loss of $0.11. This compares to loss of $0.31 per share a year ago.

Capricor Therapeutics (CAPR) Reports Q1 Loss, Misses Revenue Estimates

–Phase 3, HOPE-3 Trial (Cohort A) of CAP-1002 in Duchenne Muscular Dystrophy Fully Enrolled; On Track to Report Top-Line Data in Q4 2024–

Capricor Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

-Preclinical findings show exosome-based therapeutic approach for the treatment of arginase-1 deficiency (ARG1-D)- -Presentation to be featured in an oral session being held on May 9, 2024- SAN DIEGO, May 09, 2024 (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 an abstract featuring new preclinical data highlighting the therapeutic potential of its StealthX™ exosome platform technology has been selected for an oral presentation at the ASGCT 27 th Annual Meeting taking place in Baltimore, Maryland from May 7–11, 2024. The findings highlight a potential exosome-based approach for the treatment of arginase-1 deficiency (ARG1-D), a rare genetic metabolic disease characterized by complete or partial lack of the enzyme arginase in the liver and red blood cells.

Capricor Therapeutics to Present Exosome Platform Updates at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting

SAN DIEGO, May 08, 2024 (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 present at various upcoming scientific and medical conferences.

Capricor Therapeutics to Present at Upcoming Scientific and Medical Conferences

SAN DIEGO, May 06, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, will release its financial results for the first quarter ended March 31, 2024, after the market close on Monday, May 13, 2024. Management will then host a webcast and conference call at 4:30 p.m.

Capricor Therapeutics to Present First Quarter 2024 Financial Results and Recent Corporate Update on May 13

-Company Aligned with FDA on Demonstration of Non-Clinical Comparability; Allowing for Immediate Use of San Diego Manufacturing Facility-

Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy

The average of price targets set by Wall Street analysts indicates a potential upside of 218.2% in Capricor (CAPR). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Wall Street Analysts Predict a 218.18% Upside in Capricor (CAPR): Here's What You Should Know

The mean of analysts' price targets for Capricor (CAPR) points to a 229.2% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

How Much Upside is Left in Capricor (CAPR)? Wall Street Analysts Think 229.15%

SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that the Company is scheduled to present at two upcoming investor conferences.

Capricor Therapeutics to Present at Upcoming Investor Conferences

The average of price targets set by Wall Street analysts indicates a potential upside of 261.3% in Capricor (CAPR). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Can Capricor (CAPR) Climb 261.27% to Reach the Level Wall Street Analysts Expect?

Presentation Highlights Positive 24-Month Results from HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy Presentation Highlights Positive 24-Month Results from HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy

Capricor Therapeutics Presents at 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference

Capricor Therapeutics, Inc. (CAPR) Q4 2023 Earnings Call Transcript

-Enrollment Complete in Cohort A of Phase 3, Pivotal, HOPE-3 Trial of CAP-1002 in Duchenne Muscular Dystrophy; Announced Successful Interim Futility Analysis; On Track to Report Top-Line Data in Q4 2024-

Capricor Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- – Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, announced today that the Company has been granted an in-person Type-B meeting with the U.S. Food & Drug Administration (FDA) scheduled for late March. In the upcoming meeting with the FDA, the Company intends to discuss its proposed chemistry, manufacturing and controls (CMC) plans for commercial launch, if approved which may enable opportunities to expedite the pathway to a Biologics License Application (BLA) submission. The Company has previously been granted Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designations for the use of CAP-1002 in Duchenne muscular dystrophy (DMD) and these designations enable sponsors to work closely with the FDA and receive its guidance on potential expedited pathways for approval.

Capricor Therapeutics Announces Upcoming Type-B Meeting with the FDA to Discuss Commercial Manufacturing Planning with an Aim to Expedite BLA Pathway for CAP-1002 in Duchenne Muscular Dystrophy

SAN DIEGO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, will release its financial results for the fourth quarter and full year ended December 31, 2023, after the market close on Thursday, February 29, 2024. Management will then host a webcast and conference call at 4:30 p.m.

Capricor Therapeutics to Present Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Update on February 29

-Cohort B of HOPE-3, Phase 3 Clinical Trial Expected to Complete Enrollment in Second Quarter 2024- SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, announced today the scale-up to expand manufacturing capacity of CAP-1002 to its new state-of-the-art manufacturing facility, intended for commercial use, subject to regulatory approval, located in San Diego. Furthermore, the Company announced that Cohort B of its HOPE-3, Phase 3 clinical study is enrolling rapidly and is expected to complete full enrollment (n=44) in the second quarter of 2024.

Capricor Therapeutics Announces Manufacturing Scale-Up of CAP-1002 Production at New San Diego Facility as it Continues Plans Toward Commercialization

-Project NextGen Collaboration will Support Capricor's StealthX™ Exosome Platform and Provide Non-Dilutive Support for Advancement into the Clinic-

Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine for SARS-CoV-2

--Favorable Interim Futility Analysis Results-- --Successful Completion Triggers First Milestone Payment Under U.S. Agreement with Nippon Shinyaku--

Capricor Therapeutics Announces Continuation of Phase 3 HOPE-3 Trial of CAP-1002 in Duchenne Muscular Dystrophy Based on Completion of Interim Futility Analysis

Capricor Therapeutics, Inc. (NASDAQ:CAPR ) Q3 2023 Results Conference Call November 14, 2023 4:30 PM ET Company Participants AJ Bergmann - CFO Linda Marbán - CEO Conference Call Participants Joe Pantginis - H.C. Wainwright Aydin Huseynov - Ladenburg Operator Good afternoon, ladies and gentlemen and welcome to the Capricor's Third Quarter 2023 Financial Results and Corporate Update Call.

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