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CURRENT REPORT
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Item 8.01 Other Events.
On December 6, 2023, Phathom Pharmaceuticals, Inc. (“Phathom” or the “Company”), announced that its new drug application for the use of VOQUEZNA as a daily treatment of heartburn associated with Non-Erosive gastroesophageal reflux disease (GERD) in adults has been accepted for filing by the U.S. Food and Drug Administration. The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.
The Company is also finalizing its plans to initiate an additional Phase 3 study in 2024 evaluating VOQUEZNA as an investigational As Needed treatment for episodic heartburn relief in adults with Non-Erosive GERD, a novel dosing treatment regimen for which proton pump inhibitors (PPIs) are not approved in the U.S.
Forward Looking Statements
This report contains forward-looking statements, including statements regarding initiation of a Phase 3 trial evaluating VOQUEZNA as an As Needed treatment of heartburn associated with Non-Erosive GERD. Investors are cautioned not to place undue reliance on these forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: the Company may not be able to successfully commercialize VOQUEZNA which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; future data generated from the Company’s stability program may be different from the data submitted to the FDA to date and may not demonstrate that mitigation efforts will continue to maintain the level of the nitrosamine impurity below the acceptable intake (AI) level throughout the shelf life of products containing vonoprazan, which could result in market action or shelf life reduction; risks associated with product manufacturing or formulation changes required to be made in connection with achieving the AI; the inherent risks of clinical development of vonoprazan; Phathom’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom’s ability to access additional capital under its term loan facility and royalty interest finance agreements is subject to certain conditions; Phathom’s ability to obtain and maintain intellectual property protection for vonoprazan; Phathom’s ability to comply with its license agreement with Takeda; and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| PHATHOM PHARMACEUTICALS, INC. | ||||||
| Date: December 6, 2023 | By: | /s/ Larry Miller | ||||
| Larry Miller | ||||||
| General Counsel and Secretary | ||||||