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Capricor Therapeutics Provides Regulatory Update on Deramiocel Program...
Capricor Therapeutics Provides Regulatory Update on Deramiocel Program for Duchenne Muscular Dystrophy Following Type A Meeting FDA and Capricor aligned on endpoints for HOPE-3 pivotal trialHOPE-3 pivotal trial completed; topline data expected mid-Q4 2025 to support BLA resubmissionCompany preparing to resubmit CRL response under the current BLAConference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today annou...
Capricor Therapeutics Responds to FDA Posting of Complete Response Let...
Capricor Therapeutics Responds to FDA Posting of Complete Response Letter (CRL) for Deramiocel SAN DIEGO, Sept. 09, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today issued a statement regarding the U.S. Food and Drug Administration’s (FDA) public posting of its Complete Response Letter (CRL) for the Biologics License Application (BLA) for Deramiocel, the Company’s investigational cell therapy for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The Com...
- Dave Nicoski
- Ross LaDuke
Vital Signs: Actionable charts
In this product we rank the most positive and negative domestic stocks, filter the symbols by market-cap and trading volume, and then divide the companies into sectors and groups. We then manually look through charts leadership/changes, bottoms-up/top-down ideas, short-term patterns that may have long-term significance, etc. We believe you will find this product valuable as significant price and relative moves begin in the daily charts.
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INFU MULTI UNITS LU - AMUNDI US INFLATION EXPECTATIONS 10Y
Capricor Therapeutics Announces First Subjects Dosed in Phase 1 Clinic...
Capricor Therapeutics Announces First Subjects Dosed in Phase 1 Clinical Trial of Novel Exosome-Based Vaccine First-in-human trial of Capricor’s StealthX™ vaccine initiated under HHS’s Project NextGenTrial conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID) SAN DIEGO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the first subjects have been dosed in a Phase 1 clinical trial evaluating its StealthX™ exosome-based va...
Capricor Therapeutics Reports Second Quarter 2025 Financial Results an...
Capricor Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update Type A meeting with U.S. FDA scheduled to discuss Deramiocel BLA and path toward potential approvalCapricor seeks to resubmit its BLA based on its existing dataset, with HOPE-3 data (expected in Q4 2025) potentially serving as supportive and confirmatory evidence, pending regulatory guidanceAll 483 observations noted in the Pre-License Inspection have been resolved and accepted by the FDAFDA clears IND for StealthX™ exosome-based vaccine; NIAID has initiated the Phase 1 clinical trial Cash bala...
Capricor Therapeutics Announces Type A Meeting Scheduled with U.S. FDA
Capricor Therapeutics Announces Type A Meeting Scheduled with U.S. FDA – Second Quarter 2025 Financial Results and Corporate Update Rescheduled to Monday, August 11, 2025, at 4:30 p.m. ET – SAN DIEGO, Aug. 08, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the regulatory path for its Biologics License Application (BLA) for Deramiocel, the Company’s lead cel...
Carnival Corp: 1 director
A director at Carnival Corp sold 12,500 shares at 29.753USD and the significance rating of the trade was 55/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly s...
Capricor Therapeutics to Present Second Quarter 2025 Financial Results...
Capricor Therapeutics to Present Second Quarter 2025 Financial Results and Recent Corporate Update on August 13 – Company to Host Conference Call on August 13, 2025, at 4:30 p.m. ET – SAN DIEGO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that it will release its financial results for the second quarter ended June 30, 2025, after the market close on Wednesday, August 13, 2025. Management will then host a webcast and conference call at 4:30 p.m....
Capricor Therapeutics and Parent Project Muscular Dystrophy to Host We...
Capricor Therapeutics and Parent Project Muscular Dystrophy to Host Webinar to Review Latest Developments in the Deramiocel Program for the Treatment of Duchenne Muscular Dystrophy – Webinar to be held on Tuesday, July 29, 2025, at 1:00 p.m. ET – SAN DIEGO, July 28, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that it will host a webinar in collaboration with Parent Project Muscular Dystrophy (PPMD) to review the current status of Capricor’s Biologics License Application ...
- Dave Nicoski
- Ross LaDuke
Vermilion Compass: Weekly Equity Strategy
More Breakouts and Risk-On Developments We remain near-term bullish since our 4/22/25 Compass, and our intermediate-term outlook remains bullish as well (as of our 5/14/25 Compass). We will maintain our bullish intermediate-term outlook as long as market dynamics remain healthy and the SPX is above 5700-5785, though we believe there is a low probability that this level gets tested any time soon. Short-term supports on the SPX include the 20-day MA (currently 6233), 6200, 6100-6150, and 6028-605...
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STRL STERLING CONSTRUCTION COMPANY INC.
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FLR FLUOR CORPORATION
MYRG MYR GROUP INC.
AGX ARGAN INC.
ROAD CONSTRUCTION PARTNERS
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SNEX STONEX GROUP INC
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PRIM PRIME ENERGY P.E. LTD
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Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of cardiomyopathy associated with Duchenne muscular dystrophyFDA advised Capricor to request a meeting to determine next steps toward potential approvalConference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, July 11, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company dev...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy FDA has indicated that an Advisory Committee meeting is not required at this timeIn-person late-cycle review meeting scheduled for mid-July Biologics License Application (BLA) remains under Priority Review with PDUFA target action date of August 31, 2025Four-year data presented at PPMD 2025 Conference demonstrate sustained cardiac function SAN DIEGO, June 24, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for r...
Capricor Therapeutics Announces Positive 4-Year Data from HOPE-2 Open-...
Capricor Therapeutics Announces Positive 4-Year Data from HOPE-2 Open-Label Extension Study of Deramiocel in Duchenne Muscular Dystrophy Four-year data show preservation of cardiac function, including LVEFSkeletal muscle disease progression continues to slow with extended treatment (PUL v2.0)Deramiocel’s long-term safety profile remains favorableResults presented at PPMD’s 2025 Annual Conference SAN DIEGO, June 20, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced positive fou...
Capricor Therapeutics Announces Orphan Drug Designation for Becker Mus...
Capricor Therapeutics Announces Orphan Drug Designation for Becker Muscular Dystrophy and Regulatory Progress for Duchenne Muscular Dystrophy Program U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseasesCapricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-base...
Capricor Therapeutics Announces Key Regulatory Updates for its Duchenn...
Capricor Therapeutics Announces Key Regulatory Updates for its Duchenne Muscular Dystrophy Program U.S. FDA successfully completed Pre-License Inspection; Company expects facility will meet all requirements to support licensureAdvisory Committee meeting scheduled for July 30, 2025Mid-cycle meeting recently completed with no significant issues or major deficiencies; late-cycle meeting planned for mid-JulyBiologics License Application remains under priority review with PDUFA target action date of August 31, 2025 SAN DIEGO, June 11, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnolog...
Capricor Therapeutics Reports First Quarter 2025 Financial Results and...
Capricor Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update Biologics License Application (BLA) for deramiocel in the treatment of Duchenne muscular dystrophy (DMD) remains under priority review by the U.S. FDA, with a target Prescription Drug User Fee Act (PDUFA) date slated for August 31, 2025Recently completed mid-cycle review meeting with FDA with no significant deficiencies identified; late cycle meeting scheduled for June FDA has indicated intent to convene advisory committee meetingAppointed Dr. Michael Binks as Chief Medical Officer, bringing dee...
Capricor Therapeutics Appoints Michael Binks, M.D. as Chief Medical Of...
Capricor Therapeutics Appoints Michael Binks, M.D. as Chief Medical Officer — Dr. Binks joins Capricor in anticipation of potential approval of deramiocel in Q3 2025, bringing extensive experience in neuromuscular and rare diseases — SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced the appointment of Michael Binks, M.D., as Chief Medical Officer, effective immediately. Dr. Binks brings 25 years of experience leading global clinical development and translat...
Capricor Therapeutics to Present First Quarter 2025 Financial Results ...
Capricor Therapeutics to Present First Quarter 2025 Financial Results and Recent Corporate Update on May 13 Company to Host Conference Call, May 13, 2025 at 4:30 p.m. ET SAN DIEGO, May 06, 2025 (GLOBE NEWSWIRE) -- (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, 2025, after the market close on Tuesday, May 13, 2025. Management will then host a webcast and conference call at 4:30 p.m. ET on May 13. Title:Capricor Therapeutics ...
Capricor Therapeutics Announces Completion of Mid-Cycle Review Meeting...
Capricor Therapeutics Announces Completion of Mid-Cycle Review Meeting with FDA on Deramiocel for the Treatment of Duchenne Muscular Dystrophy Cardiomyopathy -Company remains on track for PDUFA target action date of August 31, 2025- -Advisory committee meeting to be held in advance of target action date- SAN DIEGO, May 05, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of a mid-cycle review meeting with the U.S. Food and Drug Admi...
- Jonathan Moreland
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