FDA grants VOQUEZNA extended market exclusivity to 2032

FLORHAM PARK, N.J. - Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a pharmaceutical company with a market capitalization of $711 million, today announced a favorable decision by the U.S. Food and Drug Administration (FDA) regarding its drug VOQUEZNA® (vonoprazan) tablets. The FDA has approved Phathom’s Citizen Petition filed last December to acknowledge a full 10 years of New Chemical Entity exclusivity for the drug, effectively extending its market exclusivity through May 3, 2032.

VOQUEZNA®, a novel treatment developed by Phathom Pharmaceuticals, is a potassium-competitive acid blocker (PCAB) used primarily for the treatment of gastrointestinal diseases. It is marketed in the United States for conditions such as Non-Erosive GERD and Erosive GERD in adults, as well as for the treatment of H. pylori infection in conjunction with VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK®.

This FDA decision comes as a significant boost for Phathom, ensuring that VOQUEZNA® will not face generic competition for a longer period, which may positively impact the company’s market position and revenue prospects. The extended exclusivity is particularly crucial as InvestingPro data shows the company achieved remarkable revenue growth of over 3,000% in the last twelve months, though it remains unprofitable with a net loss of $346 million. The extended exclusivity is a critical factor for Phathom as it continues to navigate the commercial landscape of gastrointestinal treatments.

The company has been focused on the development and commercialization of vonoprazan, which has been recognized for its therapeutic benefits in the management of acid-related disorders. The extension of exclusivity rights is expected to provide Phathom with a more secure timeframe to maximize the commercial potential of VOQUEZNA® without the immediate threat of generic alternatives.

Investors and industry observers note that the extended exclusivity could also enhance Phathom’s ability to invest in further research and development. According to InvestingPro analysis, while the company maintains strong liquidity with a current ratio of 3.58, it carries a significant debt burden of $565 million. The company’s success in commercializing VOQUEZNA®, along with its other products, will depend on various factors, including market acceptance, coverage, and reimbursement levels from health insurers. InvestingPro subscribers have access to 10 additional key insights about PHAT, including detailed financial health scores and comprehensive valuation metrics.

Phathom’s forward-looking statements caution that actual results may differ due to inherent risks and uncertainties in the business. These include regulatory developments, potential adverse effects or inadequate efficacy of the drug, and challenges in obtaining and maintaining intellectual property protection. InvestingPro’s detailed research report, available for over 1,400 US stocks including PHAT, provides comprehensive analysis of these risks and opportunities, helping investors make more informed decisions.

The information about the FDA’s approval of the Citizen Petition and the extended exclusivity for VOQUEZNA® is based on a press release statement from Phathom Pharmaceuticals.

In other recent news, Phathom Pharmaceuticals reported a strong financial performance for the first quarter of 2025, surpassing earnings expectations with an earnings per share (EPS) of -1.07 USD, compared to the forecasted -1.11 USD. Revenue also exceeded projections, coming in at 28.5 million USD against an anticipated 27.75 million USD. The company maintained a robust gross margin of 87%, reflecting effective cost management. Phathom Pharmaceuticals is implementing cost-cutting measures to achieve profitability by 2026, aligning with their strategic goal of not requiring additional financing. In related developments, H.C. Wainwright adjusted its price target for Phathom Pharmaceuticals, lowering it to 20 USD from 28 USD, while maintaining a Buy rating on the stock. This adjustment follows the company’s strategic decision to reduce direct-to-consumer marketing efforts and focus on leveraging its salesforce through gastrointestinal specialists and primary care channels. Analysts at H.C. Wainwright remain confident in the unique value of Phathom’s VOQUEZNA™, anticipating that the company’s commercial initiatives will evolve positively in the near term.

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