How Investors May Respond To Capricor Therapeutics (CAPR) Deramiocel Regulatory Uncertainty After Wider Q1 Loss
Capricor Therapeutics reported a wider net loss of US$33.94 million in Q1 2026, leading to increased uncertainty for investors. While there is optimism for FDA approval of Deramiocel, its commercialization timing is now in question due to legal actions, pushing the expected launch to 2027 and removing a significant milestone payment. This situation highlights the importance of the FDA decision and Capricor’s ability to manage cash burn amidst commercialization delays, despite a projected high fair value.
What is the latest on Capricor Therapeutics' Deramiocel and its FDA journey
Capricor Therapeutics' lead asset, Deramiocel, is back under FDA review for Duchenne Muscular Dystrophy (DMD) with a PDUFA target date of August 22, 2026, following positive Phase 3 HOPE-3 trial results. The therapy showed significant benefits in both skeletal and cardiac function. With $318 million in cash and a partnership with Nippon Shinyaku, Capricor is well-positioned for a potential market launch, drawing a "Strong Buy" consensus from analysts.
CAPR (NASDAQ: CAPR) lists recent purchases and awards in Form 144
A recently filed Form 144 by CAPR (Capricor Therapeutics, Inc.) details multiple stock awards and open-market purchases of its common stock. The filing lists significant awards such as 34,000 shares on August 7, 2024, and 16,156 shares on April 23, 2024, alongside purchases. Notably, the document does not indicate any sales of shares during the past three months.
CAPRICOR (CAPR) CFO exercises stock options to acquire 3,000 shares
CAPRICOR Therapeutics CFO Anthony Bergmann exercised stock options to purchase 3,000 common shares at an exercise price of $1.39 per share. This transaction increases his direct holdings to 11,223 common shares. The options originated from a 2016 grant, which was subsequently adjusted for a reverse stock split and a share reprice.
(CAPR) and the Role of Price-Sensitive Allocations
This article provides an AI-driven analysis of Capricor Therapeutics Inc. (NASDAQ: CAPR), highlighting a weak near and mid-term sentiment but a strong long-term positive outlook. It identifies an exceptional risk-reward setup targeting a 31.0% gain with minimal risk, and outlines three distinct institutional trading strategies for various risk profiles. The analysis also includes multi-timeframe signal analysis with support and resistance levels.
CAPR SEC Filings - Capricor Therapeutics Inc 10-K, 10-Q, 8-K Forms
This page provides access to Capricor Therapeutics' (CAPR) SEC filings, including annual (10-K), quarterly (10-Q), and material event (8-K) reports. It highlights recent filings from August 2025, detailing financial results such as increased R&D spend and a decline in marketable securities, alongside information regarding financial needs and legal actions. The resource aims to offer investors and traders comprehensive regulatory information for the biotechnology company.
Capricor Faces Revenue Risk as Dependence on Nippon Shinyaku Puts Deramiocel Commercialization in Jeopardy
Capricor Therapeutics, Inc. (CAPR) faces a significant revenue risk due to its high dependence on Nippon Shinyaku for the commercialization of Deramiocel in the U.S. and Japan. The company's future revenue is tied to distribution agreements, and any failure by Nippon Shinyaku to effectively commercialize the product could materially constrain Capricor's financial condition and operating results. Analysts currently project an 82.82% upside potential for CAPR stock, with an average price target of $54.50.
Capricor Therapeutics (NasdaqGS:CAPR) Stock Forecast & Analyst Predictions
Capricor Therapeutics is projected to experience significant earnings and revenue growth, with analysts forecasting profitability within the next three years. However, recent developments include a lawsuit challenging the distribution agreement for its key drug Deramiocel and increased stock volatility, leading to a revised, lower price target from some analysts. The company recently presented positive Phase 3 HOPE-3 data for Deramiocel in Duchenne muscular dystrophy and awaits an FDA PDUFA date of August 22, 2026.
Capricor Therapeutics (CAPR) director boosts stake via 3,937-share option exercise
Capricor Therapeutics director Frank Litvack exercised stock options for 3,937 shares of common stock at $1.39 per share, increasing his direct holdings in the company. This routine transaction converted a derivative position into direct share ownership, with no open-market purchases or sales reported. Litvack now holds 133,776 common shares directly and 46,278 indirectly through a family trust.
Assessing Capricor Therapeutics (CAPR) Valuation After Strong Multi Year Gains And Recent Share Price Pullback
Capricor Therapeutics (CAPR) has experienced significant multi-year gains despite a recent share price pullback. The article discusses two valuation perspectives: one narrative that views CAPR as 44.5% undervalued with a fair value of $54.67 based on future Deramiocel approval and market demand, and Simply Wall St's DCF model which estimates a much higher fair value of $314.18. Both analyses highlight the strong potential but also the risks associated with the clinical-stage biotechnology company developing treatments for Duchenne Muscular Dystrophy.
CAPRICOR THERAPEUTICS, INC. 1Q 2026: Revenue $9.4M, EPS ($0.59) — 10-Q Summary
CAPRICOR THERAPEUTICS, INC. reported Q1 2026 results with revenue of $9.4 million and a diluted loss per share of ($0.59), reflecting increased revenue year-over-year but wider losses due to higher operating investments. The company is advancing its Deramiocel BLA towards an August 22, 2026 PDUFA date, expanding commercial manufacturing, and progressing its R&D pipeline.
[10-Q] CAPRICOR THERAPEUTICS, INC. Quarterly Earnings Report
Capricor Therapeutics, Inc. (CAPR) has filed its quarterly earnings report (10-Q) for the period ending March 31, 2026. The company reported a net loss of $33.9 million for the quarter, an increase from $24.4 million in the same period last year, primarily due to increased R&D and G&A expenses aimed at preparing for the potential commercialization of Deramiocel. Capricor also disclosed a lawsuit against Nippon Shinyaku Co., Ltd. and NS Pharma, Inc. for alleged breaches of their U.S. Distribution Agreement, seeking its rescission and the right to distribute Deramiocel directly or through other partners.
Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q1 2026 Earnings Call Transcript
Capricor Therapeutics (NASDAQ:CAPR) held its Q1 2026 earnings call, focusing on the regulatory path for deramiocel, commercial readiness, and legal action against NS Pharma. The Biologics License Application (BLA) for deramiocel is under active FDA review with an August 22, 2026 PDUFA date, following a successful resubmission based on positive HOPE-3 trial results. Capricor filed a lawsuit against NS Pharma to rescind their distribution agreement, citing an unworkable pricing structure and NS Pharma's failure in commercialization efforts, and aims to distribute deramiocel independently.
Loss-Making Capricor Therapeutics, Inc. (NASDAQ:CAPR) Expected To Breakeven In The Medium-Term
Capricor Therapeutics, a loss-making biotechnology company, is projected to reach cash flow breakeven within the next two years. Analysts expect the company to report profits for the first time in 2026, with an average annual earnings growth rate of 67.5% over the next three years. However, concerns remain about its high debt-to-equity ratio and the potential for greater share dilution.
Earnings call transcript: Capricor Therapeutics misses Q1 2026 EPS expectations
Capricor Therapeutics reported a wider-than-expected Q1 2026 EPS loss of -$0.59 against a forecast of -$0.52, yet its stock saw a modest aftermarket increase. The company maintains a strong financial position, with cash reserves extending into Q4 2027 and its lead product, deramiocel, undergoing active FDA review with a PDUFA date of August 22, 2026. Capricor has also initiated legal action against its former U.S. distributor, NS Pharma, to regain distribution rights due to contractual pricing flaws and a lack of commercialization preparedness.
CAPR: Capricor Therapeutics Inc Latest Stock Price, Analysis, News and Trading Ideas
Capricor Therapeutics Inc. (CAPR) reported a GAAP EPS of -$0.59, down 11.32% year-over-year, but expects its $279M cash balance to fund operations through Q4 2027. The company's Deramiocel BLA is under FDA review with a PDUFA date of August 22, 2026, supported by positive HOPE-3 trial data. However, a legal dispute regarding its U.S. distribution agreement contributed to increased operating expenses and a higher net loss in Q1 2026.
Capricor: Q1 Earnings Snapshot
Capricor Therapeutics Inc. (CAPR) reported a first-quarter loss of $33.9 million, or 59 cents per share, which did not meet Wall Street expectations. Five analysts surveyed by Zacks Investment Research had estimated a loss of 55 cents per share. The report was generated by Automated Insights using data from Zacks Investment Research.
Capricor Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
Capricor Therapeutics announced its Q1 2026 financial results and provided a corporate update, including its Deramiocel BLA under FDA review with a PDUFA date of August 22, 2026. The company reported a net loss of $33.9 million and a cash balance of $278.6 million, expected to fund operations through Q4 2027. Capricor also filed a lawsuit against NS Pharma to rescind a distribution agreement, citing a structural barrier to patient access.
Capricor (NASDAQ: CAPR) Q1 loss widens amid Deramiocel FDA review
Capricor Therapeutics reported a wider net loss of $33.9 million in Q1 2026, compared to $24.4 million a year prior, as the company continues to advance the late-stage development of Deramiocel for Duchenne muscular dystrophy. The company's revenue remained $0, and increased R&D and G&A expenses contributed to the expanded loss, partially offset by investment income. Capricor highlighted the ongoing FDA review of Deramiocel with a PDUFA target action date of August 22, 2026, and also disclosed legal action against NS Pharma regarding commercialization arrangements.
Earnings Flash (CAPR) Capricor Therapeutics, Inc. Reports Q1 Revenue $0
Capricor Therapeutics, Inc. (CAPR) has reported $0 revenue for its first quarter, ending March 31, 2026. The company, a biotechnology firm focused on rare diseases like Duchenne muscular dystrophy, published these financial results on May 12, 2026. This report follows other announcements from the company, including widening Q1 losses and an upcoming earnings call.
Capricor Therapeutics, Inc. Q1 2026 earnings preview
This article provides a preview of Capricor Therapeutics, Inc.'s first-quarter 2026 earnings. It is likely to discuss analyst expectations, revenue forecasts, and other financial metrics ahead of the official earnings report. Investors will be looking for insights into the company's performance and future outlook.
Did Capricor’s (CAPR) Deramiocel Distribution Lawsuit Just Reframe Its Commercialization Risk Narrative?
Capricor Therapeutics has filed a lawsuit against Nippon Shinyaku and NS Pharma to terminate their 2022 distribution agreement for Deramiocel, citing pricing issues and inadequate commercial launch preparations. This legal action highlights Capricor's efforts to control the commercialization pathway for its Duchenne muscular dystrophy therapy, especially as it approaches a critical FDA PDUFA decision on August 22, 2026. Despite potential legal and launch uncertainty, the primary focus for investors remains the FDA's regulatory review of Deramiocel, supported by encouraging Phase 3 data.
Capricor Therapeutics, Inc. Q1 2026 earnings preview
This article is a preview for Capricor Therapeutics, Inc.'s Q1 2026 earnings. It implies that investors should be aware of the upcoming financial results. However, the article's content is missing, preventing a detailed summary.
Has Capricor Therapeutics (CAPR) Run Too Far After Its Multi Year Share Price Surge
Capricor Therapeutics (CAPR) has seen a significant share price surge, with a 386.9% return over the last year. Despite this, a Discounted Cash Flow (DCF) analysis suggests the stock might be undervalued by 89.2%, indicating a potential intrinsic value of $313.25 per share against its current price of $33.94. However, its Price-to-Book ratio of 6.42x is higher than the biotech industry average, challenging a straightforward valuation.
Capricor Therapeutics Says NS Pharma Delays Could Threaten Access To Duchenne Therapy
Capricor Therapeutics has filed a lawsuit against Nippon Shinyaku and its U.S. subsidiary NS Pharma. Capricor alleges that flaws in their U.S. distribution agreement for the Duchenne muscular dystrophy treatment Deramiocel could limit patient access to the therapy, particularly due to pricing terms affecting patients covered by Medicare, Medicaid, and private insurance. Capricor's CEO emphasized the urgency of making Deramiocel available to patients, while the company continues its commercial readiness plans ahead of the FDA's target PDUFA action date of August 22, 2026.
Capricor Therapeutics Accuses Nippon Shinyaku of Mishandling Duchenne Muscular Dystrophy Treatment Launch, May 8, 2026
Capricor Therapeutics has publicly accused Nippon Shinyaku and its U.S. subsidiary of mishandling the launch plans for their Duchenne muscular dystrophy treatment. The accusation was made on Friday, May 8, 2026, with Capricor Therapeutics alleging that Nippon Shinyaku has not effectively executed the drug's rollout.
Capricor drops following filing of lawsuit against Nippon Shinyaku
Capricor Therapeutics' stock dropped about 11% after the company announced it is suing Nippon Shinyaku. The lawsuit alleges a "fundamental pricing flaw" in a January 2022 agreement between the two companies.
Oppenheimer Maintains Capricor Therapeutics(CAPR.US) With Buy Rating, Maintains Target Price $54
Oppenheimer has reiterated its Buy rating for Capricor Therapeutics (CAPR.US) and maintained its price target of $54. This decision reflects continued positive sentiment from the analyst firm regarding the company's prospects.
Capricor Therapeutics Says NS Pharma Delays Could Threaten Access To Duchenne Therapy
Capricor Therapeutics has filed a lawsuit against NS Pharma, alleging that pricing terms in their distribution agreement for the investigational Duchenne muscular dystrophy therapy, Deramiocel, could restrict patient access. The biotechnology company claims NS Pharma's refusal to compromise on pricing would prevent patients with Medicare, Medicaid, and private insurance from obtaining the treatment. Despite the legal dispute, Capricor is continuing its commercial readiness plans for Deramiocel, which has a target FDA action date of August 22, 2026.
Capricor Therapeutics stock tumbles after suing NS Pharma
Capricor Therapeutics (NASDAQ:CAPR) shares dropped 13% after the company sued Nippon Shinyaku Co., Ltd. and its U.S. subsidiary NS Pharma Inc. The lawsuit concerns their distribution agreement for Deramiocel, an investigational therapy for Duchenne muscular dystrophy, with Capricor alleging NS Pharma failed to prepare for a commercial launch and citing a pricing mechanism that would restrict patient access. Capricor is seeking to rescind the agreement and has filed for a preliminary injunction to maintain its ability to distribute the therapy pending FDA approval.
Number of shareholders of Capricor Therapeutics, Inc. – BOATS:CAPR
This article provides information on the number of shareholders of Capricor Therapeutics, Inc. (CAPR). It highlights financial data, market overview, and various resources available through TradingView. The content focuses on company financials and general market data for the stock.
CAPR stock sinks after-hours: Capricor launches legal fight over DMD therapy rollout ahead of FDA review
Capricor Therapeutics (CAPT) shares fell significantly after hours following news that the company has initiated legal action against the Centers for Medicare & Medicaid Services (CMS). The lawsuit challenges CMS's decision not to create a new reimbursement code for Capricor's Duchenne muscular dystrophy (DMD) therapy, lenacapavir, which is currently undergoing FDA review. This move by CMS suggests potential reimbursement challenges for the therapy even before its possible approval.
CAPR Stock Sinks After-Hours: Capricor Launches Legal Fight Over DMD Therapy Rollout Ahead Of FDA Review
Capricor Therapeutics (CAPR) shares plunged after the company sued its commercial partner, NS Pharma, over the launch and commercialization agreement for its Duchenne muscular dystrophy (DMD) therapy, Deramiocel. Capricor alleges that NS Pharma failed to prepare for the commercial rollout and refused to resolve pricing flaws that could make the therapy commercially unviable under Medicare rules. This legal battle unfolds just months before a crucial FDA decision on Deramiocel.
Capricor Sues NS Pharma Over Deramiocel Launch Issues
Capricor Therapeutics has filed a lawsuit against NS Pharma, alleging that NS Pharma failed to prepare adequately for the commercial launch of Deramiocel, a Duchenne muscular dystrophy (DMD) therapy. Capricor claims that this failure, coupled with potential pricing structure problems under Medicare rules and delayed launch preparations after an FDA Complete Response Letter, has negatively impacted market access and investor confidence, causing a 13% drop in Capricor's after-hours trading. The lawsuit specifically highlights concerns about the drug's commercial viability and potential limitations on patient access due to reimbursement issues.
Capricor Sues NS Pharma Over Deramiocel U.S. Rights
Capricor Therapeutics has filed a lawsuit against Nippon Shinyaku and NS Pharma to rescind their U.S. distribution agreement for Deramiocel, an investigational Duchenne muscular dystrophy therapy. Capricor alleges fundamental pricing flaws that could limit patient access and NS Pharma's failure to adequately prepare for commercial launch. The company seeks to regain distribution rights and ensure timely market access to Deramiocel before the August 2026 FDA decision.
Responsive Playbooks and the CAPR Inflection
This article analyzes Capricor Therapeutics Inc. (NASDAQ: CAPR) using AI models, highlighting a positive near-term sentiment within a long-term bullish context, despite mid-term weakness. It identifies a significant risk-reward setup targeting a 29.7% gain with minimal risk, and outlines three distinct trading strategies: A Position Trading Strategy, a Momentum Breakout Strategy, and a Risk Hedging Strategy. The analysis also provides multi-timeframe signal analysis, showing strong support and resistance levels.
[8-K] CAPRICOR THERAPEUTICS, INC. Reports Material Event
Capricor Therapeutics, Inc. (CAPR) has filed an 8-K report detailing a material event regarding a lawsuit against Nippon Shinyaku Co., Ltd. and its U.S. subsidiary, NS Pharma. The lawsuit alleges a fundamental pricing flaw and breaches in their distribution agreement for Deramiocel, a Duchenne muscular dystrophy (DMD) therapy. Capricor seeks rescission of the agreement and the right to distribute Deramiocel independently to ensure patient access to this life-changing treatment, particularly given the approaching FDA approval target date of August 22, 2026.
Capricor Therapeutics (CAPR.US) will release its earnings report after the market closes on May 12.
Capricor Therapeutics (CAPR.US) is scheduled to release its earnings report after the market closes on May 12. Investors are advised to pay attention to this event. The article reminds investors that accounting year divisions are company-determined, and earnings calls will typically follow the report release for management to discuss financials and operations with stakeholders.
A Look At Capricor Therapeutics (CAPR) Valuation After Phase 3 Deramiocel Data And FDA Review Progress
Capricor Therapeutics (CAPR) is drawing attention after presenting promising Phase 3 data for Deramiocel, with its stock showing strong momentum. The company currently has a market value near US$1.8 billion, and analysts widely consider it to be undervalued, with a fair value estimate significantly higher than its current trading price. The valuation is driven by expectations of rapid revenue expansion and improved profit margins, though potential FDA setbacks or capital needs could alter this outlook.
A Look At Capricor Therapeutics (CAPR) Valuation After Phase 3 Deramiocel Data And FDA Review Progress
Capricor Therapeutics (CAPR) is currently undervalued at $33.50 compared to an analyst consensus target of $54.67, following positive Phase 3 Deramiocel data for Duchenne muscular dystrophy. The company, with a market value near $1.8 billion, shows strong momentum in its stock performance. The valuation narrative highlights rapid revenue expansion and margin improvement, though potential FDA setbacks and capital needs for R&D pose risks.
Capricor Therapeutics (CAPR) Is Down 12.4% After New HOPE-3 Deramiocel Phase 3 Data Release - What's Changed
Capricor Therapeutics (CAPR) experienced a 12.4% stock drop following the release of new Phase 3 HOPE-3 data for its Duchenne muscular dystrophy therapy, Deramiocel, despite the data showing positive results in slowing disease progression. The company is awaiting an FDA decision on its Biologics License Application, with a PDUFA target action date of August 22, 2026. The article suggests that while the new data is directionally helpful, regulatory uncertainty and potential cash burn remain significant risks for investors.
Capricor (NASDAQ: CAPR) CFO exercises options, sells 25,000 shares under 10b5-1 plan
Capricor Therapeutics CFO Anthony Bergmann exercised options to acquire 25,000 shares at $3.18 per share and subsequently sold all 25,000 shares at a weighted average price of $31.7016 per share. This transaction was conducted under a pre-arranged Rule 10b5-1 trading plan adopted in December 2025. Following these transactions, Bergmann directly holds 8,223 shares of common stock and retains 116,980 stock options.
Biotech Capricor pairs Q1 results with a corporate update May 12
Capricor Therapeutics announced it will release its first quarter 2026 financial results after market close on May 12, 2026, followed by a conference call and webcast. The company plans to provide a corporate update on its lead candidate, Deramiocel, for Duchenne muscular dystrophy, and its StealthX exosome platform. Investors are encouraged to monitor the call for updates on regulatory progress, commercialization plans, and cash flow.
Capricor (NASDAQ: CAPR) EVP sells 25K shares under 10b5-1 plan
Capricor Therapeutics, Inc.'s EVP and General Counsel Karen Krasney sold 25,000 shares of common stock at a weighted average price of $31.7019 per share on May 1, 2026, under a pre-arranged Rule 10b5-1 trading plan. On the same day, she exercised stock options to acquire 25,000 shares at an exercise price of $3.18 per share. Following these transactions, Krasney directly holds 30,547 shares of Capricor common stock.
Capricor Therapeutics to Report First Quarter 2026 Financial Results and Provide Recent Corporate Update on May 12
Capricor Therapeutics will announce its first-quarter 2026 financial results after market close on Tuesday, May 12, 2026. The company will also host a conference call and webcast on the same day at 4:30 p.m. ET to discuss the results and provide a corporate update. Capricor Therapeutics is a biotechnology company focused on developing cell and exosome-based therapies for rare diseases, with Deramiocel for Duchenne muscular dystrophy as its lead product candidate.
Capricor Therapeutics to Report First Quarter 2026 Financial Results and Provide Recent Corporate Update on May 12
Capricor Therapeutics announced it will release its first-quarter 2026 financial results on Tuesday, May 12, 2026, after market close. The company will host a conference call and webcast at 4:30 p.m. ET on the same day to discuss the results and provide a corporate update. Capricor Therapeutics is a biotechnology company developing cell and exosome-based therapies for rare diseases, with Deramiocel (for Duchenne muscular dystrophy) being its lead product candidate.
CAPR Stock In Focus: Ex-Exec Eyed For FDA Role Says Drug Approvals Are Not ‘Best-In-Class’ Signals
Former Capricor executive Houman David Hemmati, who is being considered for a leadership role at the FDA, stated that FDA approval should be viewed merely as a "building permit" for a drug, not a certification of it being the best option. This comes as Capricor Therapeutics (CAPR) awaits an FDA decision on its Duchenne muscular dystrophy therapy, Deramiocel, by August 22nd. Hemmati's comments emphasize that approval only confirms safety and efficacy, leaving final choices to patients, doctors, and insurers.
Capricor Therapeutics (CAPR) Is Down 12.4% After New HOPE-3 Deramiocel Phase 3 Data Release - What's Changed
Capricor Therapeutics recently presented Phase 3 HOPE-3 data for its Duchenne muscular dystrophy therapy, Deramiocel, showing a significant slowing of disease progression in upper limb function. This data comes as Deramiocel's Biologics License Application is already under FDA review with a PDUFA target action date of August 22, 2026. The article discusses how these results and the upcoming FDA decision could impact Capricor's investment outlook, highlighting both the potential for addressing a severe pediatric disease and the risks associated with regulatory uncertainty and continued cash burn if approval is delayed.
Capricor Therapeutics (NASDAQ:CAPR) Stock Price Down 6.5% - What's Next?
Capricor Therapeutics (NASDAQ:CAPR) saw its stock price drop 6.5% during mid-day trading due to missing quarterly EPS estimates and significant insider selling. Despite this, analysts largely maintain positive ratings, with a "Moderate Buy" consensus and an average price target of $46.09. The company is actively developing cell and exosome-based therapies for cardiovascular and rare diseases.
Moody Aldrich Partners LLC Takes Position in Capricor Therapeutics, Inc. $CAPR
Moody Aldrich Partners LLC initiated a new position in Capricor Therapeutics, Inc. (NASDAQ:CAPR) during the fourth quarter, acquiring 208,755 shares valued at approximately $6.03 million. This investment makes Capricor Therapeutics 1.1% of their portfolio, with the firm now holding 0.46% ownership. Other institutional investors like Vanguard and Goldman Sachs also increased their stakes, bringing total institutional ownership to 21.68%.
