By Colin Kellaher


Phathom Pharmaceuticals Inc. on Wednesday said the U.S. Food and Drug Administration has accepted for review the biopharmaceutical company's application seeking approval of vonoprazan for the treatment of erosive esophagitis, a major type of gastroesophageal reflux disease.

The Florham Park, N.J., company said the agency assigned the application standard review, with a target action date of Jan. 11, 2023.

Phathom said the application covers vonoprazan as a treatment for adults for the healing of all grades of erosive esophagitis and relief of heartburn, and maintenance of healing of all grades of erosive esophagitis and relief of heartburn.

Phathom noted that the FDA's acceptance of the application, coupled with the agency's recent approval of vonoprazan-based therapies for treatment of H. pylori infection in adults, makes the remaining $50 million of its $200 million loan agreement with Hercules Capital available to be drawn down.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

05-25-22 0834ET