Phathom Soars 95% on FDA Exclusivity for VOQUEZNA

• Phathom Pharmaceuticals Inc. (PHAT) stock soared 95% to $9.17, with an intraday high of $12.32, after the FDA approved its Citizen Petition, granting 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets until May 3, 2032.
• VOQUEZNA, a first-in-class potassium-competitive acid blocker, is marketed for heartburn relief in Non-Erosive GERD, Erosive GERD treatment, and H. pylori infection, addressing significant gastrointestinal health needs.
• The extended exclusivity strengthens Phathom’s market position, enhancing investor confidence and supporting its potential to capture a larger share of the gastrointestinal treatment market.

Phathom Pharmaceuticals Inc. (PHAT) has captured significant investor attention, with its stock price surging 95% to $9.17 in midday trading on Friday, after hitting an intraday high of $12.32. The rally follows a major regulatory win for the biopharmaceutical company, which specializes in developing innovative treatments for gastrointestinal diseases. The U.S. Food and Drug Administration (FDA) approved Phathom’s Citizen Petition, filed on December 11, 2024, and confirmed its intent to update the Orange Book to grant 10 years of New Chemical Entity (NCE) exclusivity for VOQUEZNA® (vonoprazan) tablets, extending protection through May 3, 2032. This exclusivity period ensures that no generic versions of VOQUEZNA can enter the U.S. market until that date, providing Phathom a prolonged window to capitalize on its flagship product.

VOQUEZNA, a first-in-class potassium-competitive acid blocker (PCAB), is a cornerstone of Phathom’s portfolio. The drug is marketed in the United States for multiple indications, including relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing for Erosive GERD in adults, and treatment of H. pylori infection through VOQUEZNA TRIPLE PAK (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and DUAL PAK (vonoprazan tablets, amoxicillin capsules). Unlike traditional treatments like proton pump inhibitors, PCABs like vonoprazan offer a novel mechanism to suppress acid production, providing faster and more sustained relief for acid-related conditions. This makes VOQUEZNA a significant advancement in managing gastrointestinal disorders, which affect millions of patients and represent a substantial market opportunity.

The FDA’s decision to grant 10 years of NCE exclusivity strengthens Phathom’s market position by safeguarding its intellectual property and revenue potential. The Orange Book, maintained by the FDA, lists approved drugs and their associated patents and exclusivity periods, serving as a critical reference for pharmaceutical companies and generic manufacturers. The extended exclusivity reflects the FDA’s recognition of vonoprazan as a novel compound, a designation that underscores Phathom’s innovation in addressing unmet needs in gastrointestinal care. This regulatory milestone not only boosts investor confidence but also positions Phathom to potentially expand its market share in a competitive therapeutic area.

The dramatic stock surge reflects the market’s optimism about Phathom’s growth prospects, particularly as the company leverages its exclusive rights to vonoprazan, in-licensed for the U.S. market. Gastrointestinal diseases, such as GERD and H. pylori infections, are prevalent, with GERD affecting an estimated 20% of U.S. adults and H. pylori infections linked to serious conditions like ulcers and gastric cancer. Phathom’s ability to offer differentiated treatments could drive sustained demand, especially as healthcare providers seek effective alternatives to existing therapies. However, the biopharmaceutical sector remains high-risk, with challenges like clinical trial uncertainties and market competition. Phathom’s focus on a niche but high-demand area, combined with its extended exclusivity, suggests a strong foundation for future growth, making it a compelling player in the evolving biotech landscape.

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