ZOGENIX, INC. Form 8-K: Current report
Filings on SEC EDGAR, newest first; amendments sit with their base form. Values are as filed.
- 2015-12-14: Form 8-K; Period of report 2015-12-14; Description 8.01 Other Events; Details 8.01.
- 2015-12-07: Form 8-K; Period of report 2015-12-07; Description 8.01 Other Events; Details 8.01.
- 2015-11-09: Form 8-K; Period of report 2015-11-09; Description 2.02 Results of Operations and Financial Condition; Details 2.02.
- 2015-10-19: Form 8-K; Period of report 2015-10-19; Description 8.01 Other Events; Details 8.01.
| Filed | Form | Period of report | Description | Details | Document |
|---|---|---|---|---|---|
| 2015-12-14 | 8-K | 2015-12-14 | 8.01 Other Events | 8.01 On December 14, 2015, Zogenix, Inc. (“Zogenix”) announced that the U.S. Food and Drug Administration (the “FDA”) has accepted Zogenix’s investigational new drug (“IND”) application for Zogenix’s lead product candidate, ZX008, as an adjunctive treatment of seizures in children with Dravet syndrome. | d103220d8k.htm |
| 2015-12-07 | 8-K | 2015-12-07 | 8.01 Other Events | 8.01 On December 7, 2015, Zogenix, Inc. (“Zogenix”) announced new data demonstrating sustained effectiveness and cardiovascular-related safety for patients treated with ZX008 (low-dose fenfluramine) as an adjunctive therapy for seizures associated with Dravet syndrome. | d100508d8k.htm |
| 2015-11-09 | 8-K | 2015-11-09 | 2.02 Results of Operations and Financial Condition | 2.02 On November 9, 2015, Zogenix, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2015. | d45908d8k.htm |
| 2015-10-19 | 8-K | 2015-10-19 | 8.01 Other Events | 8.01 On October 19, 2015, Zogenix, Inc. (“Zogenix”) announced the recent receipt of a request from the U.S. Food and Drug Administration (“FDA”) for additional information related to Zogenix’s proposed Phase 3 program for ZX008 prior to the FDA declaring Zogenix’s Investigational New Drug Application effective. | d71466d8k.htm |
| 2015-09-30 | 8-K | 2015-09-30 | 8.01 Other Events | 8.01 On September 30, 2015, Zogenix, Inc. (the “Company” or “Zogenix”) announced positive top-line pharmacokinetic results from its Phase 1b multi-dose clinical trial of Relday™, a proprietary, once-monthly subcutaneous investigational formulation of risperidone for the treatment of schizophrenia. | d100231d8k.htm |
| 2015-09-29 | 8-K | 2015-09-29 | 7.01 Regulation FD Disclosure | 7.01 Beginning on September 29, 2015, representatives of Zogenix, Inc. (“Zogenix”) will be attending meetings with investors and others in connection with Leerink Partners’ Fourth Annual Rare Disease Roundtable in New York City, New York. | d61724d8k.htm |
| 2015-08-18 | 8-K/A | 2015-04-23 | 9.01 Financial Statements and Exhibits | d161559d8ka.htm | |
| 2015-08-10 | 8-K | 2015-08-10 | 2.02 Results of Operations and Financial Condition | 2.02 On August 10, 2015, Zogenix, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2015. | d163205d8k.htm |
| 2015-07-30 | 8-K | 2015-07-28 | 8.01 Other Events | 8.01 On July 29, 2015, Zogenix, Inc. (“Zogenix” or the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Leerink Partners LLC and Stifel, Nicolaus & Company, Incorporated, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale of 4,750,000 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”). | d52531d8k.htm |
| 2015-07-28 | 8-K | 2015-07-28 | 1.02 Termination of a Material Definitive Agreement; 2.02 Results of Operations and Financial Condition; 8.01 Other Events | 1.02 On July 28, 2015, Zogenix, Inc. (the “Company” or “Zogenix”) gave notice to Cantor Fitzgerald & Co. that it was terminating its Controlled Equity OfferingSM Sales Agreement, dated November 6, 2014 (the “Cantor Agreement”), pursuant to Section 12(b) of the Cantor Agreement. 2.02 We estimate that our cash and cash equivalents were approximately $77.4 million as of June 30, 2015. 8.01 We are filing certain information for the purpose of updating various aspects of our risk factors contained in our other filings with the SEC. | d20592d8k.htm |
| 2015-07-21 | 8-K | 2015-07-20 | 1.01 Entry into a Material Definitive Agreement | 1.01 On July 20, 2015, Zogenix, Inc. (the “Company”) entered into a Third Amendment to Office Lease (the “Lease Amendment”) with Emery Station Joint Venture, LLC (“Emery Station”), amending the Office Lease by and between the Company and Emery Station dated October 31, 2006 (as amended, the “Original Lease”). | d21143d8k.htm |
| 2015-07-14 | 8-K | 2015-07-14 | 7.01 Regulation FD Disclosure; 8.01 Other Events | 7.01 On July 14, 2015, Zogenix, Inc. ( “Zogenix”) plans to host a meeting featuring presentations by members of Zogenix’s management team and key opinion leaders in the field related to Dravet syndrome. 8.01 Based on a recent meeting with the U.S. Food and Drug Administration (the “FDA”), Zogenix has revised its clinical trial plans for ZX008, Zogenix’s investigational proprietary pediatric formulation of fenfluramine for the treatment of Dravet syndrome. | d57715d8k.htm |
| 2015-07-06 | 8-K | 2015-06-29 | 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers | 5.02 On July 6, 2015, Zogenix, Inc. (“Zogenix” or the “Company”) announced the appointment of Gail M. Farfel, Ph.D. as Executive Vice President and Chief Development Officer, effective as of June 29, 2015. | d76404d8k.htm |
| 2015-06-18 | 8-K | 2015-06-18 | 5.07 Submission of Matters to a Vote of Security Holders | 5.07 Zogenix, Inc. (the “Company”) held its annual meeting of stockholders on June 18, 2015. | d944760d8k.htm |
| 2015-06-12 | 8-K | 2015-06-12 | 1.02 Termination of a Material Definitive Agreement | 1.02 On June 12, 2015 Zogenix, Inc. (the “Company”) and Valeant Pharmaceuticals North America LLC (“Valeant”) entered into a Termination and Mutual Release Agreement (the “Termination Agreement”), which terminates the Co-Promotion Agreement dated June 27, 2013, by and between the Company and Valeant (the “Co-Promotion Agreement”). | d938984d8k.htm |
| 2015-05-27 | 8-K | 2015-05-27 | 8.01 Other Events | 8.01 On May 27, 2015, Zogenix, Inc. (the “Company” or “Zogenix”) announced new data demonstrating sustained efficacy and tolerability for patients treated with low-dose fenfluramine as an adjunctive therapy for Dravet syndrome. | d932920d8k.htm |
| 2015-05-11 | 8-K | 2015-05-11 | 2.02 Results of Operations and Financial Condition | 2.02 On May 11, 2015, Zogenix, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2015. | d923700d8k.htm |
| 2015-04-28 | 8-K | 2015-04-23 | 1.01 Entry into a Material Definitive Agreement; 2.01 Completion of Acquisition or Disposition of Assets; 2.05 Costs Associated with Exit or Disposal Activities | 1.01 Entry into a Material Definitive Agreement. 2.01 On April 24, 2015, the Company closed the previously announced sale of its Zohydro ER business to Ferrimill (the substitute purchaser appointed by Pernix) pursuant to the Asset Purchase Agreement. 2.05 On April 24, 2015, the Company committed to a restructuring plan in conjunction with the sale of the Zohydro ER business in which approximately 100 employees will transition employment to Pernix. | d914478d8k.htm |
| 2015-04-27 | 8-K | 2015-04-23 | 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers | 5.02 On April 23, 2015, Roger L. Hawley, the Chief Executive Officer of Zogenix, Inc. (the “Company”), announced his resignation, effective April 27, 2015. | d915473d8k.htm |
| 2015-03-10 | 8-K | 2015-03-10 | 1.01 Entry into a Material Definitive Agreement; 2.02 Results of Operations and Financial Condition | 1.01 On March 10, 2015, Zogenix, Inc. (the “Company” or “Zogenix”) entered into an asset purchase agreement (“Asset Purchase Agreement”) with Pernix Ireland Limited (“Pernix Limited”) and Pernix Therapeutics Holdings, Inc., as guarantor (“Pernix Therapeutics” and, together with Pernix Limited, “Pernix” or the “Buyers”), pursuant to which, and on the terms and subject to the conditions thereof, among other things, the Company agreed to sell its Zohydro ER business to the Buyers, including the registered patents and trademarks, certain contracts, the new drug application and other regulatory approvals, documentation and authorizations, the books and records, marketing materials and product data relating to Zohydro ER. 2.02 On March 10, 2015, Zogenix, Inc. issued a press release announcing its financial results for the fourth quarter and full-year ended December 31, 2014. | d885850d8k.htm |
| 2015-02-10 | 8-K | 2015-02-06 | 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers | 5.02 On February 6, 2015, Renee Tannenbaum, Pharm.D. accepted an appointment to fill a newly-created seat on the Board of Directors (the “Board”) of Zogenix, Inc. (the “Company”), effective immediately. | d870331d8k.htm |
| 2015-02-02 | 8-K | 2015-01-30 | 8.01 Other Events | 8.01 On January 30, 2015, the U.S. Food and Drug Administration (“FDA”) approved a new formulation of ZohydroTM ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek™. | d861798d8k.htm |
| 2015-01-12 | 8-K | 2015-01-12 | 2.02 Results of Operations and Financial Condition | 2.02 On January 12, 2015, Zogenix, Inc. (the “Company” or “Zogenix”) announced that its preliminary unaudited cash and cash equivalents as of December 31, 2014 were approximately $42.2 million, including $21.5 million in cash from a term loan and a revolving line of credit with Oxford Finance LLC and Silicon Valley Bank. | d850346d8k.htm |