CTI BioPharma’s Pacritinib Meets One Co-Primary Endpoint, Just Misses Another, In PERSIST-2

The US company is encouraged by top-line efficacy Phase III results showing pacritinib was effective in high-risk myelofibrosis patients with low platelet counts, and has said it is working with the FDA to lift the clinical hold imposed earlier this year because of side-effect concerns.

CTI BioPharma Corp. has been able to analyze top-line efficacy results from around a third of patients with myelofibrosis and thrombocytopenia enrolled in the PERSIST-2 Phase III study, treated before the FDA-imposed clinical hold came into effect in February, that show pacritinib met one of the co-primary endpoints of the study, and narrowly missed meeting the second.

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 R&D

MetaVia’s ‘Safe’ Obesity Drug Resonates With Analysts, But Not Investors

 
• By 

The biotech reported Phase I multiple-ascending dose data for its obesity drug for the second time in a week, but its safety and tolerability do not offset concerns about relatively unimpressive weight reduction.

Roche US Exports To Exceed Imports After New $50bn Investment

 

A brand new R&D center in Massachusetts and a giant manufacturing site for its future obesity drugs are among the key investments in the US.

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

 

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 

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

More from Scrip

Stock Watch: Dollar Weakness, Tariffs, Biosimilars In J&J’s Q1 Mix

 
• By 

Announcing increased full-year earnings guidance and another dividend increase, Johnson & Johnson’s stock price weakened, outweighed by concerns about the replacement of Stelara revenues and possible drug import tariffs.

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Roche US Exports To Exceed Imports After New $50bn Investment

 

A brand new R&D center in Massachusetts and a giant manufacturing site for its future obesity drugs are among the key investments in the US.