Gamida Set For Breakthrough Transplant Therapy Approval – But Cash Problems Could Hit Launch

Can Gamida Succeed On Its Own?

With a new CEO at the helm, Gamida is closing in on an FDA approval, but a lack of cash could hobble its US launch efforts for allogeneic cell therapy product omidubicel.

Stem cell
Gamida Cell believes its therapy can show superior efficacy and healthcare cost savings - but the company cash shortage is a concern. • Source: Shutterstock

Gamida Cell is nearing an expected US approval of its “breakthrough” allogeneic hematopoietic stem cell transplant (allo-HSCT) therapy omidubicel – but a lack of money could undermine its chances of a successful launch.

Omidubicel is an ex vivo expanded stem cell graft derived from umbilical cord blood (UCB), and has been developed as an enhanced option for patients with blood cancers

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 Business

Genentech, Orionis Stick Together In Second Molecular Glue Deal

 

Deal Snapshot: Orionis and Genentech signed a new partnership focused on molecular glues, on top of the one that they struck in 2023.

Finance Watch: Prime, Kyverna, Allogene And More Announce Job Cuts

 
• By 

Restructuring Edition: Prime Medicine ended its sole clinical-stage program to prioritize preclinical and partnered programs, cutting 25% of its workforce to extend its cash runway. Meanwhile, earnings season brought workforce reductions at Kyverna, Allogene, Leap and others.

End Is Nigh For 4SC After EMA’s No For Kinselby

 
• By 

The German biotech has discontinued the oral HDAC inhibitor for cutaneous T-cell lymphoma.

Japan Pharma Sees US Revenues Grow But Policy Impact Still Unclear

 
• By 

Japanese majors put in generally solid performances in the fiscal year ended 31 March, but overseas revenues and forex effects, rather than the domestic market, provided most of the growth.

More from Scrip

PureTech’s IPF Candidate Ready For Phase III After Efficacy Win

 

Coming one day after Boehringer’s underwhelming data, PureTech’s tweaked molecule, deupirfenidone, shows promise in slowing idiopathic pulmonary fibrosis.

End Is Nigh For 4SC After EMA’s No For Kinselby

 
• By 

The German biotech has discontinued the oral HDAC inhibitor for cutaneous T-cell lymphoma.

In Brief: Tourmaline Reports Positive Topline Phase II Results for Pacibekitug In CKD

 

Based on first positive results for any quarterly IL-6 inhibitor, company plans to initiate Phase III cardiovascular outcomes trial.