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FLORHAM PARK, N.J. - The U.S. Food and Drug Administration has updated its Orange Book to reflect a full 10-year period of regulatory exclusivity for Phathom Pharmaceuticals’ (NASDAQ:PHAT) VOQUEZNA tablets, the company announced Monday. The pharmaceutical company, currently valued at $741 million, has shown impressive revenue growth with a gross profit margin of 86.23% in the last twelve months.
The corrected listing confirms that VOQUEZNA, a potassium-competitive acid blocker used to treat gastrointestinal conditions, will maintain its non-patent New Chemical Entity exclusivity through May 3, 2032.
This regulatory update provides Phathom with a longer commercial runway for its first-in-class product, which is currently marketed in the United States for the treatment of various forms of gastroesophageal reflux disease (GERD) in adults. The company’s stock has responded positively to recent developments, with a notable 20.5% return over the past week, according to InvestingPro data.
VOQUEZNA is available in 10 mg and 20 mg tablets for relief of heartburn associated with Non-Erosive GERD and for healing and maintenance of Erosive GERD. The company also markets VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK for treating H. pylori infection in adults.
The extended exclusivity period aligns with statutory requirements for new chemical entities, according to the company’s press release statement.
Phathom Pharmaceuticals focuses on developing and commercializing treatments for gastrointestinal diseases and has exclusive rights to vonoprazan, the active ingredient in VOQUEZNA.
In other recent news, Phathom Pharmaceuticals has received a significant boost as the U.S. Food and Drug Administration (FDA) granted a 10-year New Chemical Entity (NCE) exclusivity for its drug VOQUEZNA (vonoprazan), extending its market protection until May 2032. This decision follows Phathom’s Citizen Petition filed in December 2024, which sought to rectify the exclusivity term for VOQUEZNA in the Orange Book. The FDA’s ruling aligns the exclusivity period for both the monotherapy and combination therapy for H. pylori, providing a unified timeline for market protection. Analysts from H.C. Wainwright, Stifel, and Guggenheim have reaffirmed their Buy ratings on Phathom’s stock, with price targets set at $20.00, $28.00, and $12.00, respectively. Goldman Sachs, however, maintained a Neutral rating while raising its price target from $10.00 to $12.00. The extended exclusivity is expected to enhance Phathom’s commercial strategy, allowing the company to focus on its goal of achieving profitability by 2026. Recent cost-reduction measures and strategic initiatives under Phathom’s new CEO aim to support long-term growth prospects. The FDA’s decision is seen as a pivotal development, potentially attracting new investor interest and providing Phathom with a more secure timeframe to maximize the commercial potential of VOQUEZNA.
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