PHAT - Phathom Pharma resubmits vonoprazan application to FDA announces stock offering

2023-05-23 17:37:45 ET

Phathom Pharmaceuticals ( NASDAQ: PHAT ) on Tuesday said it had resubmitted its new drug application (NDA) for its acid suppressant vonoprazan to the U.S. Food and Drug Administration (FDA).

The company resubmitted the vonoprazan NDA for the treatment of erosive GERD (gastroesophageal reflux disease), also known as erosive esophagitis.

Erosive GERD is a condition in which one experiences an inflammation of the esophagus, or the tube that carries food from the mouth to the stomach.

The NDA had initially been rejected by the FDA in early February, with the regulator citing the need for additional stability data concerning levels of an impurity known as N-nitroso-vonoprazan (NVP).

PHAT subsequently in early April held a meeting with the FDA and said it expected to resubmit the NDA in Q2.

"Our resubmission includes three-months of stability data required by the FDA to reinitiate their review and demonstrates the reformulation is proving effective in limiting the presence of NVP and controlling its growth well below the FDA’s acceptable daily intake limit," PHAT CEO Terrie Curran said in Tuesday's statement.

Phathom Pharmaceuticals ( PHAT ) also separately announced a proposed public stock offering, the proceeds of which it intends to use to fund the clinical development of vonoprazan, pre-commercial activities and commercialization expenses and for working capital and general corporate purposes.

PHAT stock was down 9.3% to $11.85 after hours.

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