Regulus HCV Candidate On Clinical Hold After Second Jaundice Report

First jaundice adverse event was deemed unlikely to be connected to treatment with RG-101, and the second patient presents similar profile of overall health and co-morbidities.

Although the issue seems unlikely to be related to the study drug, Regulus Therapeutics Inc.'s mid-stage hepatitis C candidate RG-101 has been placed on clinical hold by FDA after a second patient presented a serious adverse event of jaundice.

It's a potentially serious setback for the clinical-stage microRNA specialist, which is trying to elbow into the competitive HCV space...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Sanofi Revels In More Positive Rilzabrutinib Data

 
• By 

The oral BTK inhibitor impresses in a Phase II trial for IgG4-related disease.

How AstraZeneca Aims To Stay Ahead In Lupus As New Competition Looms

 

The company has established the efficacy of its biologic Saphenlo in systemic lupus erythematosus but is now investing across modalities to stay ahead of rivals.

Biogen Lays Out Cadence For Felzartamab Data In Kidney Diseases

 

The first Phase III data for the CD38-targeting antibody is expected in 2027 in antibody-mediated rejection in kidney transplant patients, followed by other indications.

In Brief: Gilead HIV Trials On Hold Over Safety Signal

 

The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.

More from R&D

In Brief: Gilead HIV Trials On Hold Over Safety Signal

 

The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.

Pharma’s Space Trails Entering Transformative Era - Keytruda’s Been There

 

Merck and Lilly are among the leading pharma players using space-based research to power drug development. From reusable satellites to process drugs in low earth orbit to biomanufacturing labs experts discuss R&D opportunities in the starry canvas above.

Spain’s SpliceBio Secures Sanofi and Roche Support In $135m Financing

 
• By 

Series B cash will be used to advance its Stargardt disease gene therapy.