UNITED STATES
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FORM
CURRENT REPORT
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Emerging growth company
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| Item 8.01. | Other Events. |
On November 25, 2019, Zogenix, Inc. (the “Company”), announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing the Company’s New Drug Application (“NDA”) for FINTEPLA® (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet syndrome. The FDA granted Priority Review for the NDA for FINTEPLA, which provides for a six-month review from the date of receipt, and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of March 25, 2020.
Priority Review is granted for investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.
In its NDA filing acceptance letter, the FDA also stated that it is not currently planning to hold an advisory committee meeting to discuss the application for FINTEPLA.
The NDA is based on data from two positive pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months. The Company is also investigating FINTEPLA in Lennox-Gastaut syndrome, for which a Phase 3 trial is ongoing, with top-line data results anticipated in the first quarter of 2020.
Forward Looking Statements
The Company cautions investors that statements included in this report that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed,” and similar expressions are intended to identify forward-looking statements. These statements include the timing and results of any decision regarding the NDA from the FDA; and the potential timing of top-line data from the Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome (Study 1601). These statements are based on the Company’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the Company’s business, including, without limitation: the potential for the FDA to delay the PDUFA target action date due to the FDA’s internal resource constraints or other reasons; the FDA may later determine to hold an advisory committee meeting and risks associated therewith; the FDA may disagree that the existing safety and efficacy data is sufficient to approve the NDA; the FDA may require the Company to conduct the additional chronic toxicity studies noted in the Refusal to File letter, dated April 3, 2019, or other studies or information in connection with its review of the NDA; the timing of the data from Study 1601 of FINTEPLA in patients suffering from Lennox-Gastaut syndrome could be delayed; additional data from the Company’s ongoing studies may contradict or undermine the data submitted in the NDA for FINTEPLA; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA and MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; and other risks described in the Company’s prior public periodic filings with the U.S. Securities & Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E 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.
| THE COMPANY, INC. | ||||
| Date: November 25, 2019 |
By: |
/s/ Michael P. Smith | ||
| Name: |
Michael P. Smith | |||
| Title: |
Executive Vice President, Chief Financial Officer, Treasurer and Secretary | |||