Because they achieved statistically significant results in PUL 2.0 scores and also meaningful changes in cardiac and pulmonary functions (which were both endpoints defined by FDA for success) even with such a small subset and because this is a severe unmet clinical need FDA would be positively considering using HOPE 2 as registration trial and grant them accelerated approval..whether that FDA "end of phase 2" meeting they announced recently has already taken place or about to occur is the big question but I am sure they must have some updates based on ongoing discussions with them and also KOL's
Tomorrow they might announce results of CAP1002 in the HOPE 2 trial in patients at 9 and 12 month time interval and if they have achieved any statistically significant results at 12 month interval even in a small subset of their subjects then the chances that we hear FDA has granted/is on track of granting them accelerated approval by using P2 HOPE2 trial as a registration trial are very high and if we hear any of those things there is no need to say what that will do to the stock price with such a small float..
Good Luck to all of us for tomorrow!
Recent CAPR News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/17/2024 01:15:10 PM
- Capricor Therapeutics Signs Binding Term Sheet with Nippon Shinyaku for European Expansion and Commercialization of Deramiocel for the Treatment of Duchenne Muscular Dystrophy • GlobeNewswire Inc. • 09/17/2024 01:15:00 PM
- Capricor Therapeutics to Present at Upcoming Investor and Scientific Conferences • GlobeNewswire Inc. • 09/06/2024 12:30:00 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 08/23/2024 08:02:26 PM
- Form SC 13G/A - Statement of Beneficial Ownership by Certain Investors: [Amend] • Edgar (US Regulatory) • 08/23/2024 08:01:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/09/2024 01:00:07 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/08/2024 09:00:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/07/2024 08:06:46 PM
- Capricor Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 08/07/2024 08:05:00 PM
- Capricor Therapeutics to Present Second Quarter 2024 Financial Results and Recent Corporate Update on August 7 • GlobeNewswire Inc. • 07/31/2024 01:00:00 PM
- Capricor Therapeutics Set to Join Russell 2000® and Russell 3000® Indexes • GlobeNewswire Inc. • 07/01/2024 01:00:00 PM
- Capricor Therapeutics Announces Long-Term Benefit of Deramiocel (CAP-1002) in Both Skeletal Muscle and Cardiac Function in the HOPE-2 OLE Study in Duchenne Muscular Dystrophy • GlobeNewswire Inc. • 06/28/2024 01:00:00 PM
- Capricor Therapeutics • GlobeNewswire Inc. • 06/25/2024 02:30:57 PM
- Capricor Therapeutics Announces for the Treatment of Duchenne Muscular Dystrophy • GlobeNewswire Inc. • 06/25/2024 12:30:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 06/14/2024 08:31:21 PM
- Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy with an Aim to Expedite BLA Pathway • GlobeNewswire Inc. • 06/11/2024 01:25:00 PM
- Capricor Therapeutics Announces Positive 3-Year Efficacy Results from HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy • GlobeNewswire Inc. • 06/04/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 09:05:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 09:00:50 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2024 01:00:46 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2024 08:05:49 PM
- Capricor Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 05/13/2024 08:05:00 PM
- Capricor Therapeutics to Present Exosome Platform Updates at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting • GlobeNewswire Inc. • 05/09/2024 01:15:00 PM
- Capricor Therapeutics to Present at Upcoming Scientific and Medical Conferences • GlobeNewswire Inc. • 05/08/2024 01:00:00 PM
- Capricor Therapeutics to Present First Quarter 2024 Financial Results and Recent Corporate Update on May 13 • GlobeNewswire Inc. • 05/06/2024 01:00:00 PM
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