Phathom Pharmaceuticals, Inc. (NASDAQ: PHAT) extended its surge in post-market trading on Wednesday, registering a remarkable 5.62% increase, reaching $10.15. During the standard trading session, Phathom Pharmaceuticals saw a 3.33% ascent, culminating at $9.61. This surge in PHAT stock price was catalyzed by a regulatory green light.
Yesterday, Phathom Pharmaceuticals (PHAT) unveiled a significant development: the U.S. Food and Drug Administration (FDA) has granted its approval for VOQUEZNA (vonoprazan) tablets in 10 mg and 20 mg variants. VOQUEZNA, a pioneering potassium-competitive acid blocker (PCAB), has been sanctioned by the FDA as a novel treatment for adults seeking relief from all degrees of Erosive Esophagitis, colloquially referred to as Erosive GERD (gastroesophageal reflux disease).
This FDA authorization underscores Phathom Pharmaceuticals’ unwavering dedication to revolutionizing the landscape of gastrointestinal treatments for both patients and healthcare practitioners. It signifies a groundbreaking shift in the U.S. Erosive GERD market, an area that had not witnessed any major innovation for over three decades. Erosive GERD, known for its excruciating nature, frequently exerts a substantial toll on afflicted individuals.
The FDA’s green light was the outcome of favorable findings from the Phase 3 PHALCON-EE study, a pivotal trial encompassing 1,024 Erosive GERD patients from the United States and Europe. This rigorous study, characterized by randomization and double-blind methodology, compared VOQUEZNA against the commonly prescribed PPI, lansoprazole, in terms of its effectiveness in healing Erosive GERD and alleviating associated heartburn symptoms.
For numerous GERD patients afflicted with Erosive Esophagitis, current treatment protocols have yielded suboptimal results, often failing to achieve complete healing and symptom mitigation. The FDA’s blessing of VOQUEZNA ushers in a new first-in-class therapeutic option for healthcare providers, one that has demonstrated expedited healing in the more challenging cases of GERD patients with Erosive Esophagitis.
Furthermore, VOQUEZNA has demonstrated superior durability in maintaining healing across all Erosive Esophagitis grades when compared to lansoprazole. In the clinical trial, it also delivered 24-hour relief from heartburn on most days. VOQUEZNA is anticipated to be accessible to the U.S. market in December 2023 and will be exclusively marketed by Phathom Pharmaceuticals.
