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Needham sees FDA’s positive CP ruling as best-case outcome for Phathom

Needham notes that Phathom Pharmaceuticals (PHAT) is trading up 95%-plus this afternoon, following the company’s announcement that the food and drug administration has approved the company’s Citizen’s Petition regarding Voquezna tablets. FDA has also communicated its intention to correct the Orange Book listing to reflect the full 10-year NCE exclusivity. This extends Voquezna’s market exclusivity through 5/3/2032. Needham notes the CP/exclusivity issue had been a massive overhang on the stock since November 2024, but it views the news as clearly a best-case scenario and a significant clearing event for the stock. The firm believes Phathom Pharmaceuticals’ shares now have a new support level, and thinks shares will move higher in the coming weeks as investors digest the news and take a fresh look at the story, which Needham believes is quite compelling given the strong Voquezna launch and TRx trends. The firm has a Buy rating on the shares with a price target of $28.

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