ZOGENIX, INC. Form 8-K: Current report
Filings on SEC EDGAR, newest first; amendments sit with their base form. Values are as filed.
- 2020-12-21: Form 8-K; Period of report 2020-12-18; Description 8.01 Other Events; Details 8.01.
- 2020-12-08: Form 8-K; Period of report 2020-12-03; Description 1.01 Entry into a Material Definitive Agreement; Details 1.01.
- 2020-11-09: Form 8-K; Period of report 2020-11-09; Description 2.02 Results of Operations and Financial Condition; Details 2.02.
- 2020-10-16: Form 8-K; Period of report 2020-10-16; Description 8.01 Other Events; Details 8.01.
| Filed | Form | Period of report | Description | Details | Document |
|---|---|---|---|---|---|
| 2020-12-21 | 8-K | 2020-12-18 | 8.01 Other Events | 8.01 On December 18, 2020, Zogenix, Inc. (“Zogenix”) announced that the European Commission (“EC”) has granted marketing authorization for FINTEPLA® (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. | zgnx-20201218.htm |
| 2020-12-08 | 8-K | 2020-12-03 | 1.01 Entry into a Material Definitive Agreement | 1.01 Entry into a Material Definitive Agreement. | zgnx-20201203.htm |
| 2020-11-09 | 8-K | 2020-11-09 | 2.02 Results of Operations and Financial Condition | 2.02 On November 9, 2020, Zogenix, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2020. | zgnx-20201109.htm |
| 2020-10-16 | 8-K | 2020-10-16 | 8.01 Other Events | 8.01 On October 16, 2020, Zogenix, Inc. (the “Company”) announced that the Committee for Medicinal Products for Human Use (“CHMP”), a part of the European Medicines Agency, has adopted a positive opinion recommending the marketing authorization of FINTEPLA (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome, a rare and devastating infant- and childhood-onset epilepsy, as an add-on therapy to other antiepileptic medicines for patients two years of age and older. | zgnx-20201016.htm |
| 2020-10-05 | 8-K | 2020-10-05 | 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant; 3.02 Unregistered Sales of Equity Securities; 8.01 Other Events | 2.03 On October 5, 2020, Zogenix, Inc. (the “Company”) issued an additional $30,000,000 principal amount of its 2.75% Convertible Senior Notes due 2027 (the “Additional Notes”). 3.02 The disclosure set forth in Item 2.03 above is incorporated by reference into this Item 3.02. 8.01 On October 5, 2020, the Company issued a press release announcing the closing of its offering of the Additional Notes, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference. | d39257d8k.htm |
| 2020-09-28 | 8-K | 2020-09-28 | 1.01 Entry into a Material Definitive Agreement; 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant; 3.02 Unregistered Sales of Equity Securities | 1.01 On September 28, 2020, Zogenix, Inc. (the “Company”) issued $200,000,000 principal amount of its 2.75% Convertible Senior Notes due 2027 (the “Notes”). 2.03 The disclosure set forth in Item 1.01 above is incorporated by reference into this Item 2.03. 3.02 The disclosure set forth in Item 1.01 above is incorporated by reference into this Item 3.02. | d949024d8k.htm |
| 2020-09-24 | 8-K | 2020-09-23 | 8.01 Other Events | 8.01 On September 23, 2020, Zogenix, Inc. (the “Company”) issued a press release announcing that it priced its proposed private offering of $200,000,000 aggregate principal amount of convertible senior notes due 2027 (the “Notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). | d14223d8k.htm |
| 2020-09-22 | 8-K | 2020-09-22 | 8.01 Other Events | 8.01 On September 22, 2020, Zogenix, Inc. (the “Company”) provided a business update that based on written feedback from the U.S. Food and Drug Administration received in September 2020 and the Company’s clinical development plan, the Company has confirmed its plans to submit a supplemental New Drug Application in the second quarter of 2021 for Fintepla for the treatment of seizures associated with Lennox-Gastaut syndrome, which would include data from the Company’s two-year carcinogenicity study in rodents and from the Company’s Phase 1 pharmacokinetic study. | d40539d8k.htm |
| 2020-09-21 | 8-K | 2020-09-15 | 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers | 5.02 On September 15, 2020, upon recommendation of the Nominating and Corporate Governance Committee of the Board of Directors (the “Board”) of Zogenix, Inc. (the “Company”), the Board appointed Caroline M. Loewy, Mary E. Stutts and Denelle J. Waynick to fill newly-created seats on the Board, effective September 21, 2020. | d22012d8k.htm |
| 2020-09-10 | 8-K | 2020-09-10 | 8.01 Other Events | 8.01 On September 10, 2020, Zogenix, Inc. (the “Company”) reported positive top-line results from its third Phase 3 study (Study 3) of FINTEPLA (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome. | d25064d8k.htm |
| 2020-08-05 | 8-K | 2020-08-05 | 2.02 Results of Operations and Financial Condition | 2.02 On August 5, 2020, Zogenix, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2020. | zgnx-20200805.htm |
| 2020-06-26 | 8-K | 2020-06-25 | 8.01 Other Events | 8.01 On June 25, 2020, Zogenix, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) has approved FINTEPLA (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients two years of age and older. | zgnx-20200625.htm |
| 2020-05-29 | 8-K | 2020-05-29 | 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers; 5.07 Submission of Matters to a Vote of Security Holders | 5.02 On May 29, 2020, at the Annual Meeting of Stockholders of Zogenix, Inc. (the “Company”), the Company’s stockholders approved the amendment and restatement of the Company’s Employee Stock Purchase Plan (the “Restated ESPP”). 5.07 The Company’s Annual Meeting of Stockholders was held on May 29, 2020 (the “Annual Meeting”). | zgnx-20200529.htm |
| 2020-05-05 | 8-K | 2020-05-05 | 2.02 Results of Operations and Financial Condition | 2.02 On May 5, 2020, Zogenix, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2020. | zgnx-20200505.htm |
| 2020-03-04 | 8-K | 2020-03-03 | 8.01 Other Events | 8.01 On March 3, 2020, Zogenix, Inc. (“Zogenix” or the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with SVB Leerink LLC and Stifel, Nicolaus & Company, Incorporated as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale of 8,520,000 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”). | d853156d8k.htm |
| 2020-03-02 | 8-K | 2020-03-02 | 2.02 Results of Operations and Financial Condition | 2.02 On March 2, 2020, Zogenix, Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2019. | zgnx-20200302.htm |
| 2020-02-27 | 8-K | 2020-02-27 | 8.01 Other Events | 8.01 On February 27, 2020, Zogenix, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) has extended the review period for the New Drug Application (“NDA”) for FINTEPLA® for the treatment of seizures associated with Dravet syndrome. | d893184d8k.htm |
| 2020-02-13 | 8-K | 2020-02-13 | 2.02 Results of Operations and Financial Condition | 2.02 On February 13, 2020, Zogenix, Inc. (the “Company”) disclosed that its estimated, unaudited cash, cash equivalents and marketable securities as of December 31, 2019 were $251.2 million. | d888650d8k.htm |
| 2020-02-07 | 8-K | 2020-02-06 | 8.01 Other Events | 8.01 On February 6, 2020, Zogenix, Inc. (the “Company”) reported positive top-line results from its global Phase 3 clinical trial (Study 1601) of its investigational therapy, FINTEPLA (ZX008, fenfluramine oral solution) in Lennox-Gastaut syndrome (“LGS”), a severe and treatment-resistant childhood-onset epilepsy. | d880064d8k.htm |