By Chris Wack


Processa Pharmaceuticals shares were up 60% to 32 cents in premarket trading after the company said it plans to expand the development of Next Generation Capecitabine, or NGC-Cap, into a treatment of advanced or metastatic breast cancer beginning with its next Phase 2 trial.

The move follows Processa's meeting with the U.S. Food and Drug Administration, with Processa deciding the next NGC-Cap trial would be a Phase 2 trial in breast cancer.

This decision was supported through discussions with the FDA where Processa agreed with the FDA that pursuing breast cancer will lead to a more efficient development program while providing a greater likelihood of FDA approval.

The FDA stated that the previously generated data in past and existing studies could be used to directly support the Phase 2 trial in breast cancer.

The company plans to begin its Phase 2 study in the third quarter of 2024.

Processa said the NGC-Cap potential market for breast, colorectal and other cancers is greater than 250,000 patients per year.


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


(END) Dow Jones Newswires

01-19-24 0824ET