Investing.com -- Shares of Phathom Pharmaceuticals Inc. (NASDAQ: PHAT) soared 128% after the FDA granted the company’s petition for exclusivity in the Orange Book listing for its drug Voquezna (vonoprazan fumarate). The decision by the Food and Drug Administration to extend the exclusivity period to a full 10 years for Voquezna, under the umbrella of the Generating Antibiotic Incentives Now (GAIN) provisions, has been a significant catalyst for the stock’s movement.
The FDA’s response to Phathom’s citizen petition, which was received on December 11, 2024, allows the company to benefit from the extended exclusivity initially granted to Voquezna Triple Pak and Voquezna Dual Pak. These packages, which contain the new chemical entity (NCE) vonoprazan, were designated as qualified infectious disease products (QIDPs) and received an additional 5 years of exclusivity, totaling 10 years under the GAIN provisions. The FDA’s decision is in line with its umbrella policy, which aims to encourage the development and improvement of drugs containing the NCE without compromising the innovator’s exclusivity period.
This FDA ruling is pivotal for Phathom as it ensures that Voquezna will benefit from the remainder of the NCE exclusivity recognized for the Voquezna Paks. The Orange Book will be updated to accurately reflect this extended period of exclusivity, which is a substantial win for the company. This exclusivity extension is particularly important as it protects Voquezna from generic competition and allows Phathom to capitalize on the market potential of its product without immediate threats.