1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Ionis 12-Month FCS Data Position Olezarsen For Near-Term Filing

 
• By Joseph Haas

Showing its antisense drug can reduce triglycerides and risk of acute pancreatitis in familial chylomicronemia syndrome, Ionis plans to file olezarsen for approval soon, hoping for accelerated approval.

Ionis's 12-month data strengthen rationale for olezarsen in FCS

After reporting the full dataset from the Phase III BALANCE study of olezarsen in familial chylomicronemia syndrome (FCS) at the American College of Cardiology meeting, Ionis Pharmaceuticals, Inc. told an investor call on 8 April that it expects to file the ligand-conjugated antisense (LICA) candidate for US approval imminently, with approval possibly before the end of the year.

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
Start Free Trial

Already a subscriber?

More from Clinical Trials

Enhertu Takes The First-Line Throne In HER2 Metastatic Breast Cancer

 
• By Jessica Merrill

AstraZeneca and Daiichi’s DESTINY-Breast09 trial testing Enhertu with pertuzumab versus standard of care showed a statistically significant and meaningful PFS improvement.

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By Kevin Grogan

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

In Brief: BriaCell’s Breast Cancer Cell Therapy Boosts Survival In Phase II

 
• By Sushmita Panda

BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 
• By Dexter Jie Yan

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.

More from R&D

China’s Biotech Stocks Proved More Resilient Than US’s Amid Market Turmoil

 
• By Andrew McConaghie, Edwin Elmhirst, and Dexter Jie Yan

Start-ups from China dominated the fastest-growing share prices for mid-cap biopharma companies in Q1, while the biggest decliners were mainly US firms.

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 
• By Dexter Jie Yan

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.

AstraZeneca Logs Japan Growth Despite Price Cuts

 
• By Lisa Takagi

AstraZeneca logs growth in Japan despite a big reimbursement price cut for one of its top sellers and expects 40 approvals in the country over the next six years.