Tuesday, May 21, 2024 2:20:29 PM
Expedited development: The FDA will provide more intensive support to DURECT during the development process of larsucosterol for AH. This can help expedite clinical trials, data analysis, and regulatory filings.
Increased chances of approval: Drugs with BTD designation tend to have a higher success rate in obtaining final FDA approval. This can give investors more confidence in the drug's potential for market.
Potential for earlier commercialization: If larsucosterol receives FDA approval, BTD status may allow for an earlier launch date compared to drugs without this designation. This could mean faster revenue generation for DURECT.
Overall, BTD status can significantly improve DURECT's chances of successfully developing and commercializing larsucosterol, potentially leading to increased stock value.
Recent DRRX News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/21/2024 08:35:08 PM
- DURECT Corporation Receives FDA Breakthrough Therapy Designation for Larsucosterol in Alcohol-Associated Hepatitis • PR Newswire (US) • 05/21/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2024 08:03:39 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2024 08:17:26 PM
- DURECT Corporation Reports First Quarter 2024 Financial Results and Business Update • PR Newswire (US) • 05/13/2024 08:05:00 PM
- DURECT Corporation to Announce First Quarter 2024 Financial Results and Provide a Business Update • PR Newswire (US) • 05/07/2024 08:30:00 PM
- DURECT Corporation Announces Late-Breaking Oral Presentation at the EASL Congress 2024 to Discuss AHFIRM Phase 2b Data in Alcohol-Associated Hepatitis • PR Newswire (US) • 04/30/2024 11:00:00 AM
- DURECT Corporation Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • PR Newswire (US) • 03/27/2024 08:01:00 PM
- DURECT Corporation to Announce Fourth Quarter and Full Year 2023 Financial Results and Provide a Business Update • PR Newswire (US) • 03/20/2024 08:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/04/2024 04:37:57 PM
- DURECT and Charles River Laboratories Enter into Co-Marketing and Collaboration Agreement for ALZET® Product Line in U.S. and Canada • PR Newswire (US) • 03/04/2024 12:00:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 09:16:39 PM
- DURECT Corporation to Present at the Oppenheimer 34th Annual Healthcare Life Sciences Conference • PR Newswire (US) • 02/07/2024 11:48:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/22/2023 09:15:11 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 12/01/2023 09:28:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/13/2023 09:15:18 PM
- DURECT Corporation Reports Third Quarter 2023 Financial Results and Business Update • PR Newswire (US) • 11/13/2023 09:05:00 PM
- DURECT Corporation to Announce Third Quarter 2023 Financial Results and Provide a Business Update • PR Newswire (US) • 11/09/2023 09:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/07/2023 09:10:15 PM
- DURECT Corporation Announces Topline Results from Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated Hepatitis with Promising Effect on Mortality • PR Newswire (US) • 11/07/2023 09:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/07/2023 01:02:52 PM
- DURECT Corporation Announces Last Patient Last Visit in Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated Hepatitis • PR Newswire (US) • 09/07/2023 11:00:00 AM
- DURECT Corporation Announces Presentations in Upcoming Investor Conferences • PR Newswire (US) • 08/31/2023 08:30:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/10/2023 08:21:19 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/10/2023 08:18:32 PM
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