1. Scrip
  2. >>New Products

Day One Springs Into Commercial Action With Ojemda Approval

 
• By Alaric DeArment

The company is targeting around 200 centers that treat the vast majority of the few thousand pediatric low-grade glioma patients who are candidates for the RAF-targeting drug.

• Source: Shutterstock

Day One Biopharmaceuticals, Inc. is making an aggressive push to commercialize Ojemda (tovorafenib) following its US Food and Drug Administration accelerated approval for children with pediatric low-grade glioma (pLGG), the most common form of brain tumor in children, and intends to target the vast majority of an addressable population in the low thousands.

The FDA approved Ojemda, a type II RAF inhibitor, on 23 April for patients aged 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement...

Key Takeaways

  • The FDA granted accelerated approval to Ojemda in relapsed/refractory pLGG patients with BRAF fusions or rearrangements and with BRAF V600 mutations.

  • The company...

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 New Products

Atai/Beckley Merger Comes At A Transformative Time For Psychedelics

 
• By Kevin Grogan

All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.

Stock Watch: How GSK’s Nucala Info Drip Helped Share Price

 
• By Andy Smith

The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.

Sanofi Plays It Safer With Blueprint Buy After Bumpy 2025

 
• By Kevin Grogan

But the French major is still keen on early-stage M&A.

Pipeline Watch: Eight Approvals And Nine Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Merus Raises $300m After ASCO Success

 
• By Andrew McConaghie

The company is raising the money to fuel development of its head and neck cancer candidate, petosemtamab, on the back of promising early data. Some analysts are stopping short of declaring it the winner against a rival product from Bicara, however.

Bayer Boosted By Third FDA Approval For Nubeqa

 
• By Kevin Grogan

US green light will further expand sales of the prostate cancer blockbuster.

Degron Eyes Deals For Novel Molecular Glue Degrader Assets

 
• By Dexter Jie Yan

Pursuing first-in-class molecular glue degraders using undruggable targets could eventually help Degron Therapeutics land sizable asset-based deals, CEO Lily Zou tells Scrip.