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Phathom Pharmaceuticals Inc. (NASDAQ:PHAT) shares are trading higher Friday after the company announced a major regulatory win.
What To Know: The FDA has granted 10-year new chemical entity exclusivity for its drug Voquezna, extending full market protection through May 3 2032. The FDA also updated the Orange Book listings for the 10 mg and 20 mg Voquezna tablets to reflect this extended exclusivity.
This move came in response to a citizen petition from Phathom arguing that Voquezna, which contains the same active moiety vonoprazan as the previously approved Voquezna Triple Pak and Dual Pak, qualifies for the same new chemical entity plus GAIN Act-based exclusivity period. The Voquezna Paks had previously been granted Qualified Infectious Disease Product designation and received a total of 10 years of exclusivity under the FDA's umbrella policy. That policy allows later products containing the same new active moiety to benefit from the same exclusivity period, even if those later products aren't independently designated as Qualified Infectious Disease Products.
The FDA reviewed the petition and agreed with Phathom's interpretation, concluding that the 10-year NCE+GAIN exclusivity granted to the Voquezna Paks must also apply to Voquezna. The agency cited longstanding legal and regulatory precedent supporting its decision and committed to updating the Orange Book accordingly.
Investors responded strongly to the news, as the 10-year exclusivity effectively blocks generic competition until 2032. The ruling secures Phathom's market position for Voquezna and enhances the commercial value of the drug. The move in the stock reflects renewed confidence in the company's long-term revenue prospects tied to its acid-suppressing product line.
PHAT Price Action: Phathom shares were down 95.0% at $9.16 at the time of writing, according to Benzinga Pro.
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Posted In: PHAT
