1. Scrip
  2. >>Business

Juno ROCKETs On Fast Clinical Hold Resolution

 
• By Mandy Jackson

The FDA lifted a clinical hold on the Phase II ROCKET clinical trial for Juno's lead CAR-T therapy candidate JCAR015 less than a week after it was instituted, allowing the company to proceed without using fludarabine in a pre-conditioning chemotherapy regimen.

formula

Juno Therapeutics Inc. soared in after-hours trading on July 12 following the company's late-day announcement that a clinical hold on its Phase II ROCKET clinical trial for the chimeric antigen receptor T-cell (CAR-T) therapy JCAR015 has been lifted just a few business days after the US FDA instituted the hold in response to three deaths in the study.

Seattle, Washington-based Juno fell more than 27% after the stock market closed on July 7 when the company first revealed...

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 Business

Lilly Agrees To Acquire PCSK9 Base-Editing Partner Verve

 
• By Joseph Haas

Instead of opting in on Phase II-ready PCSK9-targeted VERVE-102, Lilly will buy its partner for up to $1.3bn. Analysts call the deal a bargain for Lilly, but fair to Verve.

Stock Watch: Generics Firms Trapped Between US Tariffs And European Austerity

 
• By Andy Smith

Successive annual reductions in European drug prices following the pandemic are affecting the global sales of generic pharmaceutical companies. Additionally, the imposition of US import tariffs may result in generic drug supply becoming unprofitable.

BIO Notebook: IPO Window Stays Shut, PRVs Need To Be A Priority, And Focusing On Gene Therapy Safety

 
• By Mandy Jackson and Sarah Karlin-Smith

Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.

Sarepta Market Dynamics For Elevidys Imperiled By Second Patient Death

 
• By Joseph Haas

With two deaths in non-ambulatory DMD patients, Sarepta is attempting damage control and will ask the US FDA to advise, setting up a possible confrontation with CBER director Prasad.

More from Scrip

Innovent Builds Metabolic Pipeline While Retaining Oncology Backbone

 
• By Xu Hu

Innovent presented data on multiple pipeline assets at ASCO, including promising OS results for its first-in-class anti-PD-1/IL-2α-bias bispecific. The Chinese firm is also continuing to build out its metabolic disease portfolio and consider its partnering strategies, its CEO tells Scrip.

BIO Notebook: IPO Window Stays Shut, PRVs Need To Be A Priority, And Focusing On Gene Therapy Safety

 
• By Mandy Jackson and Sarah Karlin-Smith

Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges