ZOGENIX, INC. Form 8-K: Current report
Filings on SEC EDGAR, newest first; amendments sit with their base form. Values are as filed.
- 2019-12-18: Form 8-K; Period of report 2019-12-17; Description 8.01 Other Events; Details 8.01.
- 2019-12-03: Form 8-K; Period of report 2019-12-02; Description 8.01 Other Events; Details 8.01.
- 2019-11-25: Form 8-K; Period of report 2019-11-25; Description 8.01 Other Events; Details 8.01.
- 2019-11-07: Form 8-K; Period of report 2019-11-07; Description 2.02 Results of Operations and Financial Condition; Details 2.02.
| Filed | Form | Period of report | Description | Details | Document |
|---|---|---|---|---|---|
| 2019-12-18 | 8-K | 2019-12-17 | 8.01 Other Events | 8.01 On December 17, 2019, Zogenix, Inc. (the “Company”), a global pharmaceutical company developing rare disease therapies, announced that The Lancet has published the results of its Phase 3 clinical trial, Study 1, of the Company’s investigational drug, FINTEPLA® (ZX008, fenfluramine oral solution), in children and young adults with Dravet syndrome, a rare, severe infantile-onset epilepsy characterized by frequent, disabling seizures that are very difficult to treat with existing anti-epileptic drugs. | d849838d8k.htm |
| 2019-12-03 | 8-K | 2019-12-02 | 8.01 Other Events | 8.01 On December 2, 2019, Zogenix, Inc. (the “Company”), a global pharmaceutical company developing rare disease therapies, announced that JAMA Neurology published the results of the Company’s Phase 3 study (Study 1504) of the investigational drug, FINTEPLA® (ZX008, fenfluramine oral solution), in Dravet syndrome patients whose antiepileptic drug treatment regimens included stiripentol but who were still experiencing a high number of convulsive seizures. | d843060d8k.htm |
| 2019-11-25 | 8-K | 2019-11-25 | 8.01 Other Events | 8.01 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. | d822036d8k.htm |
| 2019-11-07 | 8-K | 2019-11-07 | 2.02 Results of Operations and Financial Condition | 2.02 On November 7, 2019, Zogenix, Inc. issued a press release announcing its financial results for the third quarter September 30, 2019. | zgnx-20191107.htm |
| 2019-10-07 | 8-K | 2019-10-07 | 8.01 Other Events | 8.01 On October 7, 2019, Zogenix, Inc. (the “Company”), and its wholly-owned subsidiary, Modis Therapeutics, Inc. (“Modis”) announced positive top-line results from its pivotal Phase 2 RETRO study at the recent World Muscle Society congress in Copenhagen. | d827655d8k.htm |
| 2019-09-26 | 8-K | 2019-09-26 | 8.01 Other Events | 8.01 On September 26, 2019, Zogenix, Inc. (the “Company”), a global pharmaceutical company developing rare disease therapies, announced that it has resubmitted its New Drug Application (“NDA”) for FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome to the U.S. Food and Drug Administration (“FDA”). | d811477d8k.htm |
| 2019-09-10 | 8-K | 2019-09-10 | 8.01 Other Events | 8.01 Zogenix, Inc. (the “Company”) is filing herewith the opinion of Latham & Watkins LLP as an exhibit to its Registration Statement on Form S-3 (Registration No. 333-220759) (the “Registration Statement”) in connection with the possible resale or other disposition from time to time of up to 1,595,025 shares of common stock, $0.001 par value per share, of the Company by the selling stockholders identified in the prospectus supplement dated September 10, 2019 to the prospectus dated October 2, 2017 (collectively, the “Prospectus”) forming part of the Registration Statement. | d801877d8k.htm |
| 2019-09-09 | 8-K | 2019-09-06 | 2.01 Completion of Acquisition or Disposition of Assets; 3.02 Unregistered Sales of Equity Securities; 7.01 Regulation FD Disclosure | 2.01 On September 6, 2019, Zogenix, Inc. (the “Company” or “Zogenix”) closed (the “Closing”) the previously announced acquisition of Modis Therapeutics, Inc. (“Modis”), pursuant to the Agreement and Plan of Merger, dated August 23, 2019 (the “Merger Agreement”), by and among Zogenix, Modis, Xena Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Zogenix (“Merger Sub”), and Shareholders Representative Services LLC, a Colorado limited liability company, as the shareholders’ representative. 3.02 The information set forth in Item 1.01 above with respect to the issuance of the Shares as part of the merger consideration is incorporated into this Item 3.02 by reference. 7.01 On September 9, 2019, Zogenix issued a press release announcing the Closing of the Merger, a copy of which is filed as Exhibit 99.1 hereto and incorporated herein by reference. | d757427d8k.htm |
| 2019-08-26 | 8-K | 2019-08-23 | 1.01 Entry into a Material Definitive Agreement; 3.02 Unregistered Sales of Equity Securities; 7.01 Regulation FD Disclosure; 8.01 Other Events | 1.01 Entry into a Material Definitive Agreement. 3.02 The information set forth in Item 1.01 above with respect to the issuance of the Shares as part of the merger consideration is incorporated into this Item 3.02 by reference. 7.01 On August 26, 2019, Zogenix issued a press release announcing the execution of the Merger Agreement, a copy of which is filed as Exhibit 99.1 hereto and incorporated herein by reference. 8.01 Modis’ lead product candidate, MT1621, is an investigational deoxynucleoside substrate enhancement therapy, is in late-stage development for the treatment of TK2d, an inherited mitochondrial DNA depletion disorder that predominantly affects children and is often fatal. | d794121d8k.htm |
| 2019-08-06 | 8-K | 2019-08-06 | 2.02 Results of Operations and Financial Condition | 2.02 On August 6, 2019, Zogenix, Inc. issued a press release announcing its financial results for the second quarter June 30, 2019. | a201906308-k.htm |
| 2019-07-23 | 8-K | 2019-07-17 | 1.01 Entry into a Material Definitive Agreement | 1.01 Entry into a Material Definitive Agreement. | zgnx-20190717x8k.htm |
| 2019-06-27 | 8-K | 2019-06-27 | 8.01 Other Events | 8.01 On June 27, 2019, Zogenix, Inc. (the “Company”) announced that, based on its receipt of final minutes from the U.S. Food and Drug Administration (“FDA”) from the Type A meeting held on May 30, 2019, the Company intends to resubmit its New Drug Application (“NDA”) for FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in the third quarter of this year. | d646769d8k.htm |
| 2019-05-22 | 8-K | 2019-05-22 | 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 22, 2019, at the Annual Meeting of Stockholders of Zogenix, Inc. (the “Company”), the Company’s stockholders approved the amendment and restatement of the Company’s 2010 Equity Incentive Award Plan (the “Restated Plan”). 5.07 The Company’s Annual Meeting of Stockholders was held on May 22, 2019. | zgnx-2019proxyresults8xk.htm |
| 2019-05-08 | 8-K | 2019-05-08 | 2.02 Results of Operations and Financial Condition | 2.02 On May 8, 2019, Zogenix, Inc. issued a press release announcing its financial results for the first quarter March 31, 2019. | a201903318-k.htm |
| 2019-04-08 | 8-K | 2019-04-08 | 8.01 Other Events | 8.01 On April 8, 2019, Zogenix, Inc. (the “Company”), announced that it received a Refusal to File (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application (“NDA”) for FINTEPLA (ZX0008, fenfluramine hydrochloride) for the treatment of seizures associated with Dravet syndrome. | d658273d8k.htm |
| 2019-03-28 | 8-K | 2019-03-25 | 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers; 8.01 Other Events | 5.02 On March 25, 2019, Roger L. Hawley notified the Board of Directors (the “Board”) of Zogenix, Inc. (the “Company”) that he plans to retire from the Board effective as of March 31, 2019 and will not stand for re-election at the Company’s 2019 annual meeting of stockholders (the “Annual Meeting”). 8.01 Amendment to the Zogenix, Inc. Employment Inducement Equity Incentive Award Plan. | d713437d8k.htm |
| 2019-03-19 | 8-K | 2019-03-18 | 1.01 Entry into a Material Definitive Agreement | 1.01 Entry into a Material Definitive Agreement. | zgnx-20190319x8k.htm |
| 2019-02-28 | 8-K | 2019-02-28 | 2.02 Results of Operations and Financial Condition | 2.02 On February 28, 2019, Zogenix, Inc. issued a press release announcing its financial results for the fourth quarter and full-year ended December 31, 2018. | a20181231er8-k.htm |
| 2019-02-12 | 8-K | 2019-02-06 | 1.01 Entry into a Material Definitive Agreement | 1.01 Entry into a Material Definitive Agreement. | zgnx-20190206x8k.htm |
| 2019-02-06 | 8-K | 2019-02-06 | 8.01 Other Events | 8.01 On February 6, 2019, Zogenix, Inc. (the “Company”), issued a press release announcing that it has completed its rolling submission of a New Drug Application (“NDA”) to the U.S. Food & Drug Administration (“FDA”) and submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) for FINTEPLA (ZX008, low-dose fenfluramine) for the treatment of seizures associated with Dravet syndrome. | d681167d8k.htm |