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Wednesday, December 10, 2014 2:24:34 PM
rNAPc2 Previously Demonstrated Post-Exposure Efficacy in NHP Models of Ebola HFV
rNAPc2 Previously Tested in Over 700 Human Patients in Nine Phase 1 and 2 Cardiovascular Disease Clinical Trials
rNAPc2 Potentially Inhibits the Human Body’s Catastrophic Response to Hemorrhagic Fever Viruses Like Ebola
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted orphan drug designation to rNAPc2 as a potential treatment of viral hemorrhagic fever post-exposure to Ebola virus. The drug candidate has previously demonstrated post-exposure efficacy in non-human primate models of Ebola hemorrhagic fever virus (HFV). rNAPc2 was originally developed as a cardiovascular therapy for thrombosis and other indications. As a result, it has an extensive human clinical record, and has been safely tested in over 700 human patients in nine Phase 1 and 2 clinical trials for cardiovascular disease.
Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 individuals in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon marketing approval, as well as certain financial incentives that can help support its development.
$ABIO
Recent ABIO News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/30/2024 09:57:33 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 08/23/2024 08:35:36 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 06:23:17 PM
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 08/16/2024 08:27:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/16/2024 08:25:22 PM
- ARCA biopharma Declares Special Dividend in Connection with the Proposed Merger with Oruka Therapeutics • GlobeNewswire Inc. • 08/16/2024 08:15:00 PM
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 08/15/2024 08:17:16 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/15/2024 08:15:35 PM
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 08/09/2024 12:35:20 PM
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 08/01/2024 08:30:02 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/01/2024 08:25:09 PM
- ARCA biopharma Announces Second Quarter 2024 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 08/01/2024 08:15:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 08/01/2024 08:10:17 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/01/2024 08:05:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/26/2024 02:50:20 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 07/25/2024 04:15:10 AM
- Form S-4/A - Registration of securities, business combinations: [Amend] • Edgar (US Regulatory) • 07/22/2024 09:17:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 11:38:10 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 11:10:32 PM
- Form S-4/A - Registration of securities, business combinations: [Amend] • Edgar (US Regulatory) • 07/09/2024 09:29:01 PM
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 07/09/2024 09:04:50 PM
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