Market Overview

Immunomedics Shares Crash As Breast Cancer Drug Fails To Obtain Regulatory Nod

Immunomedics Shares Crash As Breast Cancer Drug Fails To Obtain Regulatory Nod

Immunomedics, Inc. (NASDAQ: IMMU) shares were plunging Friday following an adverse regulatory development.

What Happened

Immunomedics announced Thursday after the market close the FDA issued a complete response letter for its BLA for sactuzumab govitecan, its investigational candidate for metastatic triple-negative breast cancer, or TNBC, in patients who have previously received at least two prior therapies.

"We believe in sacituzumab govitecan's potential to be a viable treatment option for these patients," CEO Michael Pehl said in a statement. 

The issues outlined by the FDA relate to chemistry, manufacturing and control, and the agency has not required new clinical or pre-clinical data, the company said.

Why It's Important

Sacituzumab govitecan is Immunomedics' lead antibody drug conjugate. The candidate has a Breakthrough Therapy Designation from the FDA for TNBC and was reviewed under the accelerated approval pathway.

The approval, which was initially expected to come through Jan. 18, will now be delayed.

The setback follows a failed licensing and collaboration deal for sacituzumab govitecan with Seattle Genetics, Inc. (NASDAQ: SGE) way back in May 2017.

In December, it was revealed that Immunomedics was taken to task by the FDA for a number of violations, including a data breach at its New Jersey manufacturing facility.

What's Next

Immunomedics said it plans to request a meeting with the FDA to get a full understanding of its requirements and timelines for approval.

Related Links:

The Daily Biotech Pulse: Regulatory Roadblock For Immunomedics, AdCom Split On Lexicon's Diabetes Drug

The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials


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