PHAT - Phathom gets FDA review for vonoprazan to treat heartburn erosive esophagitis

The U.S. Food and Drug Administration (FDA) accepted to review Phathom Pharmaceuticals' (NASDAQ:PHAT) application seeking approval of oral medicine vonoprazan to treat adults with erosive esophagitis (EE). The company's New Drug Application (NDA) for vonoprazan is for healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. The FDA is expected to make a decision by Jan. 11, 2023. The company noted that NDA was backed by data from a phase 3 trial called PHALCON-EE. In addition, Phathom said that a remaining $50M amount under a loan agreement with Hercules Capital was now available to be drawn down, as it had received an FDA approval for its vonoprazan-based therapies for H. pylori infection, and the acceptance of the filing for EE. Esophagitis is an inflammation that may damage the esophagus.

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Phathom gets FDA review for vonoprazan to treat heartburn, erosive esophagitis