Saturday, May 09, 2020 3:14:49 PM
I think you may be right on this. The company is seeking approval upon positive data. If approval is not granted then it they will move to p3 trial.
From 10k
We are currently conducting HOPE-2, a Phase II clinical trial in the United States with our product candidate, CAP-1002, a cardiac cell derived therapy which is being used to treat patients with late-stage DMD. We plan to report final 12-month data from HOPE-2 in the second quarter of 2020. Following the receipt of this data, if positive, we plan to continue with the next stages of development towards potential registration which may include seeking approval from the FDA and, whether or not that approval is obtained following HOPE-2, pursuing a partnership to conduct a Phase III trial.
From 10k
We are currently conducting HOPE-2, a Phase II clinical trial in the United States with our product candidate, CAP-1002, a cardiac cell derived therapy which is being used to treat patients with late-stage DMD. We plan to report final 12-month data from HOPE-2 in the second quarter of 2020. Following the receipt of this data, if positive, we plan to continue with the next stages of development towards potential registration which may include seeking approval from the FDA and, whether or not that approval is obtained following HOPE-2, pursuing a partnership to conduct a Phase III trial.
Recent CAPR News
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 04/10/2026 09:17:53 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 04/10/2026 08:31:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/03/2026 09:00:07 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 04/02/2026 08:24:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/02/2026 12:00:15 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/02/2026 12:00:12 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/02/2026 12:00:11 AM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 03/31/2026 09:24:08 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/31/2026 08:23:33 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/31/2026 08:23:03 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/31/2026 08:22:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/27/2026 11:15:05 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/17/2026 09:00:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/12/2026 08:01:07 PM
- Capricor Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 03/12/2026 08:01:00 PM
- Capricor Therapeutics Announces Late-Breaking HOPE-3 Data at the 2026 MDA Conference Demonstrating Significant Functional Benefits of Deramiocel for Duchenne Muscular Dystrophy • GlobeNewswire Inc. • 03/12/2026 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/10/2026 03:01:36 PM
- Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA • GlobeNewswire Inc. • 03/10/2026 01:25:00 PM
- Capricor Therapeutics to Present Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Update on March 12 • GlobeNewswire Inc. • 03/09/2026 12:30:00 PM
- Form SCHEDULE 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 02/27/2026 12:10:54 AM
- Capricor Therapeutics Announces Late-Breaking Presentation at 2026 MDA Clinical and Scientific Conference • GlobeNewswire Inc. • 02/24/2026 02:00:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 01/30/2026 10:01:12 PM
- Form SCHEDULE 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 01/26/2026 09:15:18 PM
- Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data • GlobeNewswire Inc. • 01/20/2026 02:15:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/07/2026 09:45:17 PM
