menu search

IBRX / ImmunityBio stock loses more than half its value after disclosing FDA can't approve the BLA for its cancer treatment in its present form

ImmunityBio stock loses more than half its value after disclosing FDA can't approve the BLA for its cancer treatment in its present form
Shares of ImmunityBio Inc. IBRX plummeted 53.7% toward a record one-day selloff in premarket trading Thursday, after the immunotherapy company disclosed it received a “complete response letter” from the U.S. Food and Drug Administration, but puts the company's Biologics License Application (BLA) for its bladder cancer treatment Anktiva (N-803) on hold. The FDA determined that it can't approve the BLA in its present form as a pre-license inspection of the company's third-party contract manufacturer found deficiencies. Read More
Posted: May 11 2023, 09:16
Author Name: Market Watch
Views: 082125

IBRX News  

ImmunityBio: The CRL Makes It Riskier Than Ever

By Seeking Alpha
October 24, 2023

ImmunityBio: The CRL Makes It Riskier Than Ever

ImmunityBio, Inc.'s drug Anktiva received a Complete Response Letter, or CRL, from the FDA, delaying its approval for the treatment of NMIBC. The CRL more_horizontal

Why Shares of ImmunityBio Jumped This Week

By The Motley Fool
September 15, 2023

Why Shares of ImmunityBio Jumped This Week

The clinical-stage biotech's lead therapy is in trials to treat bladder cancer. The sale of company stock helped raise $470 million. more_horizontal

3 Very Oversold Biotech Stocks to Buy Right Now

By InvestorPlace
August 29, 2023

3 Very Oversold Biotech Stocks to Buy Right Now

After I spent many years following Wall Street, there are a few characteristics about the “big money”  that stand out for me. One of these traits more_horizontal

Why Shares of ImmunityBio Were Up on Wednesday

By The Motley Fool
July 19, 2023

Why Shares of ImmunityBio Were Up on Wednesday

ImmunityBio is a clinical-stage biotech company. The company's lead therapy candidate is Anktiva. more_horizontal

ImmunityBio Can Recover From BLA Dip

By Seeking Alpha
June 20, 2023

ImmunityBio Can Recover From BLA Dip

The FDA rejected the Anktiva marketing application last month. Since the troubles lie with an outside organization, the company has no control over th more_horizontal

ImmunityBio: Amidst Difficulty Is Your Opportunity

By Seeking Alpha
May 17, 2023

ImmunityBio: Amidst Difficulty Is Your Opportunity

Being an extremely volatile stock, ImmunityBio, Inc. is not for all investors. Nevertheless, there are tremendous opportunities in ImmunityBio stock f more_horizontal

FDA Rejects ImmunityBio's (IBRX) Bladder Cancer Therapy Filing

By Zacks Investment Research
May 12, 2023

FDA Rejects ImmunityBio's (IBRX) Bladder Cancer Therapy Filing

FDA rejects ImmunityBio's (IBRX) filing seeking approval of Anktiva (N-803) as a combo-therapy in bladder cancer indication, citing deficiencies in an more_horizontal

ImmunityBio: Anktiva Rejection Heightens Financial Urgency

By Seeking Alpha
May 12, 2023

ImmunityBio: Anktiva Rejection Heightens Financial Urgency

ImmunityBio stock dropped over 50% after the FDA issued a CRL for Anktiva, their lead product for treating BCG-unresponsive non-muscle invasive bladde more_horizontal


Search within

Pages Search Results: