CRL adds to ImmunityBio uncertainty

12 May 2023

ImmunityBio (Nasdaq: IBRX) lost 54% of its market value on Thursday.

The Californian company announced in a filing with the US Securities and Exchange Commission that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for its product candidate, Anktiva (N-803).

Filed in May last year, the submission requested FDA approval for Anktiva in combination with Bacillus Calmette-Guérin (BCG) as a treatment for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without Ta/T1 papillary disease.

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.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

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