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Monday, June 27, 2016 5:43:35 PM
On June 27, 2016, we issued a press release announcing we received verbal notice from the U.S. Food and Drug Administration (FDA) that our Investigational New Drug (IND) for RG-101 for the treatment of chronic hepatitis C virus (HCV) infection has been placed on full clinical hold. We anticipate we will receive a formal clinical hold letter from the FDA within 30 days and plan to work diligently with the agency to seek the release of the clinical hold.
The FDA initiated the clinical hold after we reported a second serious adverse event (SAE) of jaundice. The SAE occurred in a HCV patient with end-stage renal disease on dialysis enrolled in its on-going Phase I US study 117 days after receiving a single dose of RG-101.
Timelines for our three on-going studies of RG-101 are not expected to be impacted as all patients have been enrolled and completed their dosing of RG-101 and will continue with protocol scheduled visits. We remain on track to deliver follow-up results from these studies at upcoming scientific meetings.
Recent RGLS News
- Regulus Therapeutics Advances to Cohort 4 of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) • PR Newswire (US) • 05/06/2024 12:00:00 PM
- Regulus Therapeutics to Participate in the Canaccord Genuity Genetic Medicine for Generalists Webcast Series • PR Newswire (US) • 04/30/2024 12:00:00 PM
- Regulus Therapeutics Reports Fourth Quarter and Year-End 2023 Financial Results and Recent Updates • PR Newswire (US) • 03/21/2024 08:05:00 PM
- Regulus Therapeutics Announces Oversubscribed $100 Million Private Placement of Equity • PR Newswire (US) • 03/12/2024 10:32:00 AM
- Regulus Therapeutics Announces Positive Topline Data from the Second Cohort of Patients in its Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) • PR Newswire (US) • 03/12/2024 10:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/19/2024 01:24:29 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/19/2024 01:23:30 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/17/2024 10:08:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/17/2024 10:04:34 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 01/12/2024 09:11:34 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 01/10/2024 05:15:20 AM
- Regulus Therapeutics Announces Completion of Enrollment in Third Cohort of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) • PR Newswire (US) • 01/02/2024 09:05:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 12/27/2023 09:16:06 PM
- Regulus Therapeutics to Present at the 6th Annual Evercore ISI HealthCONx Conference • PR Newswire (US) • 11/22/2023 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:39:57 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 09:15:35 PM
- Regulus Therapeutics Reports Third Quarter 2023 Financial Results and Recent Updates • PR Newswire (US) • 11/09/2023 09:05:00 PM
- Regulus Therapeutics Announces First Patient Dosed in Third Cohort of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) • PR Newswire (US) • 11/02/2023 12:00:00 PM
- Regulus Therapeutics Advances to Cohort 3 of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) • PR Newswire (US) • 10/19/2023 12:00:00 PM
- Regulus Therapeutics Announces Positive Topline Data from the First Cohort of Patients in its Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) • PR Newswire (US) • 09/20/2023 11:00:00 AM
- Regulus Therapeutics Announces Completion of Enrollment in Second Cohort of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) • PR Newswire (US) • 09/13/2023 12:00:00 PM
- Regulus Therapeutics Announces Participation at Two Healthcare Investment Conferences • PR Newswire (US) • 09/05/2023 12:00:00 PM
- Regulus Therapeutics to Host Virtual Investor Event on September 6, 2023 • PR Newswire (US) • 08/23/2023 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2023 08:40:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2023 08:36:59 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
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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