Capricor Therapeutics and Parent Project Muscular Dystrophy to Host Webinar Highlighting Positive Phase 3 HOPE-3 Topline Results in Duchenne Muscular Dystrophy

Rhea-AI Summary

Capricor Therapeutics (NASDAQ: CAPR) and Parent Project Muscular Dystrophy will host a community webinar on December 17, 2025 at 1:00 p.m. ET to review positive topline results from Capricor’s Phase 3 HOPE-3 trial of Deramiocel for Duchenne muscular dystrophy (DMD). The session will explain the HOPE-3 findings, discuss how the results inform ongoing regulatory discussions with the U.S. Food and Drug Administration, and allow participants to submit questions in advance.

Registration and a replay will be available on Parent Project Muscular Dystrophy’s website. Capricor noted Deramiocel and its StealthX platform remain investigational; Capricor has an exclusive U.S. and Japan commercialization agreement for Deramiocel with Nippon Shinyaku subsidiary NS Pharma, subject to regulatory approval.

Key Figures

Webinar time 1:00 p.m. ET Community webinar on HOPE-3 topline results, Dec 17, 2025

Market Reality Check

$26.02 Last Close

Volume Volume 1,244,920 vs 20-day average 5,837,789 indicates subdued trading ahead of the webinar low

Technical Shares at $26.55 are trading above the $9.59 200-day moving average, reflecting a strong pre-existing uptrend

Peers on Argus

CAPR gained 2.04% while key biotech peers like CADL (-10.12%) and OMER (-9.8%) declined, pointing to stock-specific strength rather than a sector-wide move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 05	Equity offering priced	Negative	+5.4%	Priced $150M equity offering at $25 per share under S-3 shelf.
Dec 04	Offering proposed	Negative	-14.9%	Proposed underwritten common stock offering using effective S-3 registration.
Dec 03	Phase 3 topline data	Positive	+371.1%	HOPE-3 met primary and key secondary endpoints with significant efficacy signals.
Nov 24	Platform data update	Positive	-19.3%	Presented scalable exosome loading framework for siRNA and PMO at AAEV 2025.
Nov 10	Quarterly results	Negative	-6.2%	Q3 2025 loss, zero revenue, HOPE-3 timing and BLA resubmission plans outlined.

Pattern Detected

Clinical milestones, especially HOPE-3 data, have triggered strong positive reactions, while offerings and platform updates have produced mixed or contrarian moves.

Recent Company History

Over the last months, Capricor highlighted multiple catalysts, capped by positive Phase 3 HOPE-3 results on Dec 3, 2025 with Deramiocel meeting key functional and cardiac endpoints. Subsequent equity offerings on Dec 4 and Dec 5 used the effective S-3 shelf to raise $150 million, with mixed price responses. Earlier, exosome-platform data on Nov 24 and Q3 results on Nov 10 underscored both R&D progress and ongoing losses. Today’s webinar announcement extends the HOPE-3 narrative to the DMD community and ongoing regulatory discussions with the FDA.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-09-10

$300,000,000 registered capacity

An effective S-3 shelf filed on Sep 10, 2025 allows Capricor to offer up to $300,000,000 in various securities and, under a separate equity distribution agreement, up to $150,000,000 of common stock over time, highlighting substantial authorized capacity for future capital raises.

Market Pulse Summary

This announcement highlights a community webinar on Dec 17, 2025 to review positive Phase 3 HOPE-3 topline results for Deramiocel in Duchenne muscular dystrophy and discuss how they inform ongoing FDA interactions. It builds directly on the pivotal data disclosed on Dec 3, 2025 and keeps focus on the DMD program’s regulatory path. Investors may watch for any new color on regulatory next steps, patient and clinician reception, and how Capricor frames future milestones for Deramiocel and its exosome platform.

Key Terms

Duchenne muscular dystrophy medical

"cell therapy for the treatment of Duchenne muscular dystrophy (DMD)"

A rare, inherited condition that progressively weakens muscles, Duchenne muscular dystrophy causes the body’s muscle fibers to break down over time, often leading to severe disability. For investors, it matters because the small, well-defined patient population, high unmet medical need and complex regulatory and pricing dynamics mean successes or failures in clinical trials, approvals, or therapies can have outsized effects on a company’s valuation and future revenue prospects.

cell therapy medical

"Deramiocel, the Company’s investigational cell therapy for the treatment of Duchenne"

Cell therapy uses living human or animal cells as the medicine: cells are collected, sometimes grown or altered, and then given to a patient to repair, replace, or boost damaged tissue or immune function. For investors, cell therapies can transform markets because they may offer one-time or highly effective treatments that command premium prices, but they also carry high development, manufacturing and regulatory costs and commercial risks, like building a custom factory rather than making a simple product.

exosome-based therapeutics medical

"developing transformative cell and exosome-based therapeutics"

Therapies that use exosomes — tiny, natural packets cells send to communicate — to deliver therapeutic molecules or signals to other cells. Think of them as a biological mailing service that can carry instructions or repair tools to specific tissues; for investors they represent a potential new class of targeted medicines with advantages in precision and safety, but they also carry development, manufacturing and regulatory risks common to early-stage biotech.

U.S. Food and Drug Administration regulatory

"ongoing regulatory discussions, including next steps with the U.S. Food and Drug Administration (FDA)"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

cardiac-derived cell therapy medical

"Deramiocel, an allogeneic cardiac-derived cell therapy that is currently in late-stage"

A cardiac-derived cell therapy uses living cells taken from heart tissue and grown or processed to treat damaged heart muscle; think of it as sending specialized repair crews made from heart material to patch or stimulate healing in a failing heart. Investors care because these therapies aim to change long-term patient outcomes rather than just manage symptoms, which can create durable demand, high development costs, regulatory risk, and potentially large market value if proven safe and effective.

immunomodulatory medical

"demonstrated Deramiocel’s potent immunomodulatory and anti-fibrotic effects"

Immunomodulatory describes a drug, therapy, or compound that changes how the immune system responds—either boosting, calming, or redirecting its activity. For investors, immunomodulatory products matter because they target many large markets (autoimmune diseases, infections, cancer) and carry distinct safety, trial-design and regulatory risks; think of them as a thermostat for the immune system, where small adjustments can strongly affect effectiveness, side effects and approval chances.

anti-fibrotic medical

"demonstrated Deramiocel’s potent immunomodulatory and anti-fibrotic effects"

Anti-fibrotic describes a drug or therapy that slows, stops, or reverses fibrosis—the buildup of scar tissue in organs (such as lungs, liver, or heart) that stiffens tissue and reduces function. For investors, anti-fibrotic treatments matter because they address chronic conditions with large unmet needs and potential long-term markets; like repairing a clogged pipe before it bursts, successful therapies can preserve organ function, affect patient outcomes, and drive regulatory, clinical and commercial value.

oligonucleotides medical

"targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics"

Short strands of DNA or RNA designed to bind specific genetic sequences, oligonucleotides act like targeted messages that can turn genes on or off, block harmful proteins, or help detect disease. For investors, they matter because they represent a class of therapeutic and diagnostic products with potential for highly specific treatments, large market value, and distinct development, manufacturing and regulatory risks that can drive big gains or setbacks depending on clinical success and approval.

AI-generated analysis. Not financial advice.

– Webinar to be held Wednesday, December 17, 2025, at 1:00 p.m. ET –

SAN DIEGO, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics, today announced that Parent Project Muscular Dystrophy (PPMD) will host a community webinar to share and discuss positive topline results from Capricor’s Phase 3 HOPE-3 trial evaluating Deramiocel, the Company’s investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD).

The webinar will provide patients and families with an overview of the HOPE-3 results and how the findings inform ongoing regulatory discussions, including next steps with the U.S. Food and Drug Administration (FDA). The webinar will be held on Wednesday, December 17, 2025, at 1:00 p.m. ET. Participants are encouraged to submit questions in advance.

To register for the webinar, please click here.

For additional details, please visit Parent Project Muscular Dystrophy’s website. A replay of the webinar will be made available on PPMD’s website.

About Capricor Therapeutics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, Deramiocel, an allogeneic cardiac-derived cell therapy that is currently in late-stage clinical development for the treatment of Duchenne muscular dystrophy (DMD). Extensive preclinical and clinical data have demonstrated Deramiocel’s potent immunomodulatory and anti-fibrotic effects in helping to preserve cardiac and skeletal muscle function in DMD. Capricor is also leveraging the power of its exosome technology, using its proprietary StealthX™ platform in preclinical development focused on vaccinology and the targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics, with the potential to treat and prevent a wide range of diseases. At Capricor, we are committed to pushing the boundaries of possibility and forging a path toward transformative treatments for those in need. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and X.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including future interactions with regulatory authorities and the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval; the ability to achieve product milestones and to receive milestone payments from commercial partners; and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 26, 2025, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, as filed with the Securities and Exchange Commission on November 10, 2025. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

Capricor has entered into an agreement for the exclusive commercialization and distribution of Deramiocel for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Deramiocel and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any indication.

For more information, please contact:

Capricor Media Contact:
Raquel Cona
KCSA Strategic Communications
rcona@kcsa.com
212.896.1204

Capricor Company Contact:
AJ Bergmann, Chief Financial Officer
abergmann@capricor.com
858.727.1755

FAQ

When is the Capricor (CAPR) webinar on Phase 3 HOPE-3 topline results?

The webinar is scheduled for December 17, 2025 at 1:00 p.m. ET.

What will Capricor discuss about Deramiocel (CAPR) in the December 17 webinar?

The webinar will summarize the positive topline HOPE-3 results and how they inform next steps with the U.S. FDA.

How can patients and families register for the CAPR HOPE-3 webinar and access the replay?

Register and access the replay via Parent Project Muscular Dystrophy’s website; a replay will be posted there after the event.

Does Capricor (CAPR) have a commercialization partner for Deramiocel?

Yes; Capricor has an exclusive U.S. and Japan commercialization agreement with Nippon Shinyaku/NS Pharma, pending regulatory approval.

Will the webinar detail regulatory timing for Deramiocel (CAPR)?

The webinar will discuss how HOPE-3 topline results inform ongoing regulatory discussions, but it does not specify regulatory meeting dates.

Are Deramiocel and StealthX approved therapies for DMD?

No; the release states both Deramiocel and StealthX are investigational and not approved for commercial use.