The FDA will question the added value each combination brings to the existing HCV market. First generation oral therapy was safe, tolerable, and clearly more efficacious than interferon-based therapy. Open-label studies were guaranteed since there was no approved all-oral comparator. The landscape is changing.
There's a lot of speculation here. I'm not sure if the FDA will release written industry guidance for these changes (if they do come to bear). Another possibility is a large time gap between the release of a individual sponsor's Phase-2 data and the introduction of their Phase-3 design. An indication discussions with the FDA aren't going well.
Recent ENTA News
- Enanta Pharmaceuticals Announces Positive Topline Results for EDP-323 in a Phase 2a Human Challenge Study of Healthy Adults Infected With Respiratory Syncytial Virus (RSV) • Business Wire • 09/26/2024 10:00:00 AM
- Enanta Pharmaceuticals to Participate in Investor Conferences in September • Business Wire • 09/03/2024 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/09/2024 09:24:47 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/07/2024 08:00:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/05/2024 08:05:10 PM
- Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter • Business Wire • 08/05/2024 08:01:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/15/2024 09:29:25 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/11/2024 09:30:41 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/18/2024 12:38:39 AM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/17/2024 08:15:05 PM
- Enanta Pharmaceuticals to Participate at the Jefferies Global Healthcare Conference • Business Wire • 05/29/2024 11:00:00 AM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 05/08/2024 08:37:27 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/08/2024 08:00:34 PM
- Enanta Pharmaceuticals to Participate at the JMP Securities Life Sciences Conference • Business Wire • 05/07/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 08:05:14 PM
- Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter with Webcast and Conference Call Today at 4:30 p.m. ET • Business Wire • 05/06/2024 08:01:00 PM
- Enanta Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 04/30/2024 11:10:00 AM
- Enanta Pharmaceuticals Announces the Appointment of Matthew P. Kowalsky as Chief Legal Officer • Business Wire • 04/30/2024 11:00:00 AM
- Enanta Pharmaceuticals to Host Conference Call on May 6 at 4:30 p.m. ET to Discuss its Financial Results for its Fiscal Second Quarter Ended March 31, 2024 • Business Wire • 04/29/2024 11:00:00 AM
- Enanta Pharmaceuticals Announces Data Presentation at ESCMID Global 2024 • Business Wire • 04/17/2024 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:30:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:27:40 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:23:55 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:19:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 10:15:54 PM
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