Phathom Pharmaceuticals (NASDAQ: PHAT) Shares Surge 128%
Shares of Phathom Pharmaceuticals Inc. (NASDAQ: PHAT) experienced a dramatic increase of 128% after the FDA granted the company’s petition for exclusivity concerning its medication, Voquezna (vonoprazan fumarate). This pivotal decision by the Food and Drug Administration extends the exclusivity period to a full 10 years under the Generating Antibiotic Incentives Now (GAIN) provisions, propelling the stock's upward movement.
The FDA's approval, responding to Phathom’s citizen petition submitted on December 11, 2024, allows the company to enjoy the extended exclusivity that was initially granted to the Voquezna Triple Pak and Voquezna Dual Pak. These products, which include the new chemical entity (NCE) vonoprazan, were designated as Qualified Infectious Disease Products (QIDPs) and have received an additional five years of exclusivity. This totals a decade of protection under the GAIN provisions.
This decision is crucial for Phathom, as it ensures that Voquezna can capitalize on the remaining NCE exclusivity associated with the Voquezna Paks. The Orange Book will be updated to reflect this extended exclusivity period, marking a significant victory for the company. This extension is especially vital as it shields Voquezna from generic competition, enabling Phathom to maximize its product's market potential without imminent threats.
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