Phathom Pharmaceuticals reports Q4 EPS ($1.33), consensus ($1.35)

"Over the past year, our teams made significant progress to advance the development and commercial potential of vonoprazan. We obtained FDA approval of our first products, aligned with the FDA on a near final label for erosive GERD, and delivered our third positive Phase 3 trial for vonoprazan in a third potential indication," said Terrie Curran, President and Chief Executive Officer of Phathom. "While our anticipated commercial launch is on hold pending resolution of the previously announced nitrosamine impurity issue, we are confident in the progress we have made in generating additional stability data, and based on initial testing results, we believe the mitigation measures put in place are achieving their intended effects. We have a meeting scheduled with the FDA in March to discuss our proposed resubmission plan and align on potential review timelines to help make vonoprazan available to patients as soon as possible. We look forward to meeting with the FDA and expect to share more details about our progress once we have obtained additional clarity."