By Chris Wack

 

Erytech Pharma SA shares were down 19%, to $1 after the company said it is no longer seeking approval for Graspa in hypersensitive acute lymphoblastic leukemia following feedback from the Food and Drug Administration.

The stock hit its 52-week low of 95 cents earlier in the session, and is down 57% year to date.

Erytech said it has been in discussions with the FDA following positive results of a Phase 2 trial.

A meeting to discuss the submission of a biologics license application took place in June 2021, after which the company confirmed its intention to submit a BLA, subject to the submission of additional requested information to the FDA and agreement on an initial pediatric study plan.

The company recently received feedback from the FDA on its iPSP, submitted in July. After thorough evaluation of this feedback, which included a new request for additional data, and taking into account the changing competitive landscape in the treatment of hypersensitive ALL, Erytech determined that it is in the best interests of the company and its shareholders to no longer seek approval for Graspa in ALL and to focus its resources on its preclinical programs and strategic partnering activities.

Following the sale of its production facility in Princeton, N.J., for $44.5 million in April, the company appointed a specialized adviser to evaluate strategic options to see its Erycaps platform with complementary assets and/or a broader corporate transaction.

Erytech said multiple options are under review, and it expects to give further updates on these strategic initiatives in the fourth quarter.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

August 25, 2022 13:06 ET (17:06 GMT)

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