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
- 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
- Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy • GlobeNewswire Inc. • 04/24/2024 01:00:00 PM
- Capricor Therapeutics to Present at Upcoming Investor Conferences • GlobeNewswire Inc. • 03/21/2024 12:30:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/11/2024 12:30:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 09:06:15 PM
- Capricor Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 02/29/2024 09:05:00 PM
- 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 • GlobeNewswire Inc. • 02/27/2024 01:30:00 PM
- Capricor Therapeutics to Present Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Update on February 29 • GlobeNewswire Inc. • 02/22/2024 01:30:00 PM
- Capricor Therapeutics Announces Manufacturing Scale-Up of CAP-1002 Production at New San Diego Facility as it Continues Plans Toward Commercialization • GlobeNewswire Inc. • 02/20/2024 01:30:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 02/16/2024 10:04:29 PM
- Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine for SARS-CoV-2 • GlobeNewswire Inc. • 01/24/2024 02:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/11/2024 02:00:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:15 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 10:15:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/11/2023 09:30:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/24/2023 01:25:06 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM