Phathom surges 125% after FDA grants petition on Voquezna exclusivity

June 06, 2025 09:27 AM PDT | By EODHD

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Phathom surges 125% after FDA grants petition on Voquezna exclusivity — Image source: Kalkine Media

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[Going Up] Richard Drury Phathom Pharmaceuticals has shot up ~125% in Friday trading after the U.S. FDA granted their Citizen Petition regarding the expiration date of new chemical entity exclusivity for their drug Voquezna (vonoprazan). Trading in the stock was briefly halted from 1211p-1221p ET. In the document, filed in December 2024, the pharma argued [https://seekingalpha.com/pr/19943607-phathom-pharmaceuticals-submits-citizen-petition-to-fda-seeking-correction-of-orange-book] that the Orange Book listings for Voquezna didn't properly reflect the full 10-year NCE exclusivity period that lasts through May 3, 2032. Phathom said it wanted Voquezna's NCE exclusivity to be the same as that granted to Voquezna Triple Pak and Voquezna Double Pak.

The former is made of vonoprazan, amoxicillin, and clarithromycin; the latter, vonoprazan and amoxicillin. The two products benefitted from the Generating Antibiotic Incentives Now (NCE*GAIN) exclusivity which provided them an extra five years of exclusivity protection. "As Voquezna tablet products contain the same drug substance with the active moiety, vonoprazan, they should be entitled to the same protection," the company argued in its petition. "We agree that Voquezna benefits from the NCE*GAIN exclusivity recognized for the Voquezna Paks," FDA Center for Drug Evaluation and Research Acting Director Jacqueline Corrigan-Curay wrote in the letter [https://www.regulations.gov/document/FDA-2024-P-5703-0013]. "Recognition of NCE*GAIN exclusivity for Voquezna is consistent with the statutory text of the GAIN provisions and the Agency’s longstanding umbrella policy interpretation of NCE exclusivity and gives full effect to the NCE*GAIN exclusivity recognized for the QIDP-designated Voquezna Paks." Voquezna is approved for erosive esophagitis and gastroesophageal reflux disease.

MORE ON PHATHOM PHARMACEUTICALS * Phathom Pharmaceuticals, Inc. 2025 Q1 - Results - Earnings Call Presentation [https://seekingalpha.com/article/4780540-phathom-pharmaceuticals-inc-2025-q1-results-earnings-call-presentation] * Phathom Pharmaceuticals, Inc. (PHAT) Q1 2025 Earnings Call Transcript [https://seekingalpha.com/article/4780539-phathom-pharmaceuticals-inc-phat-q1-2025-earnings-call-transcript] * Phathom Pharmaceuticals: The Clock Is Ticking On Voquezna (Downgrade) [https://seekingalpha.com/article/4772792-phathom-pharmaceuticals-clock-ticking-on-voquezna-downgrade] * Phathom Pharmaceuticals surges 50% following large insider purchase [https://seekingalpha.com/news/4445858-phathom-pharmaceuticals-surges-50-following-large-insider-purchase] * Phathom pharmaceuticals outlines VOQUEZNA expansion targets and cost-saving measures for profitability by 2026 [https://seekingalpha.com/news/4439224-phathom-pharmaceuticals-outlines-voquezna-expansion-targets-and-cost-saving-measures-for]

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