FDA approves Omisirge, a cell therapy for patients with blood cancers

18 April 2023
gamida-cell-large

The US Food and Drug Administration yesterday approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection.

The approval for this therapy has been granted to Israel and Boston, USA-based Gamida Cell (Nasdaq: GMDA), which has struggled to get Omisirge eapproved and has been forced into recent cost-measures as funding began to run out.

The news was well received by investors, causing Gamida’s shares to leap more than 50%, and still close the day up 39% at $1.12.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Today's issue

Company Spotlight





More Features in Biotechnology