PHARMACYCLICS INC Form 8-K: Current report
Filings on SEC EDGAR, newest first; amendments sit with their base form. Values are as filed.
- 2013-12-11: Form 8-K; Period of report 2013-09-10; Description 7.01 Regulation FD Disclosure; Details 7.01.
- 2013-12-11: Form 8-K; Period of report 2013-12-10; Description 7.01 Regulation FD Disclosure; Details 7.01.
- 2013-12-10: Form 8-K; Period of report 2013-12-09; Description 8.01 Other Events; Details 8.01.
- 2013-11-20: Form 8-K; Period of report 2013-11-20; Description 8.01 Other Events; Details 8.01.
| Filed | Form | Period of report | Description | Details | Document |
|---|---|---|---|---|---|
| 2013-12-11 | 8-K | 2013-09-10 | 7.01 Regulation FD Disclosure | 7.01 On December 7-10, 2013, approximately 40 oral and poster, clinical and pre-clinical, presentations were made about Pharmacyclics, Inc.’s (the “Company”) product, ibrutinib, at the 2013 Annual Meeting of the American Society of Hematology (“ASH”) located in New Orleans, Louisiana. | form8k07380_12102013.htm |
| 2013-12-11 | 8-K | 2013-12-10 | 7.01 Regulation FD Disclosure | 7.01 On December 10, 2013, Pharmacyclics, Inc. (the “Company”) announced the results of 40 clinical, non-clinical and pre-clinical presentations on ibrutinib (IMBRUVICA™) at the 55TH Annual meeting of the American Society of Hematology (“ASH”) held in New Orleans, Dec 7 - 10, 2013. | form8k207380_12102013.htm |
| 2013-12-10 | 8-K | 2013-12-09 | 8.01 Other Events | 8.01 On December 9, 2013, Pharmacyclics, Inc. (the “Company”) announced that The Lancet Oncology published results of a study evaluating ibrutinib in previously untreated elderly patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). | form8k07380_12092013.htm |
| 2013-11-20 | 8-K | 2013-11-20 | 8.01 Other Events | 8.01 On November 19, 2013, Janssen-Cilag NV (“Janssen”) received a letter from the European Medicines Agency (“Agency”) confirming that the Agency has determined that Janssen’s application for IMBRUVICA™ (ibrutinib) is valid. | form8k97380_11192013.htm |
| 2013-11-19 | 8-K | 2013-11-13 | 1.01 Entry into a Material Definitive Agreement | 1.01 Entry into a Material Definitive Agreement. | form8k07380_11192013.htm |
| 2013-11-14 | 8-K | 2013-11-13 | 7.01 Regulation FD Disclosure | 7.01 On November 13, 2013, Pharmacyclics, Inc. (the “Company”) hosted a conference call to discuss the Company’s announcement that the U.S. Food and Drug Administration has approved IMBRUVICA™ (ibrutinib) as a single agent for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. | form8k307380_11132013.htm |
| 2013-11-13 | 8-K | 2013-11-13 | 8.01 Other Events | 8.01 On November 13, 2013, Pharmacyclics, Inc. (the “Company”) received approval from the U.S. Food and Drug Administration for IMBRUVICA™ (ibrutinib). | form8k207380_11132013.htm |
| 2013-11-13 | 8-K | 2013-11-13 | 8.01 Other Events | 8.01 On November 13, 2013, Pharmacyclics, Inc. (the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) as a single agent for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. | form8k07380_11132013.htm |
| 2013-11-12 | 8-K | 2013-11-08 | 7.01 Regulation FD Disclosure | 7.01 On November 7, 2013, Pharmacyclics, Inc. (the “Company”) held its quarterly earnings call and in addition to discussing the financial results from its quarter ended September 30, 2013, it discussed numerous items related to the Company’s drug product candidate, ibrutinib. | form8k07380c_11072013.htm |
| 2013-11-07 | 8-K | 2013-11-07 | 2.02 Results of Operations and Financial Condition | 2.02 On November 7, 2013, Pharmacyclics, Inc., a Delaware corporation (the “Registrant”), issued a press release regarding its financial results for its third quarter ended September 30, 2013. | form8k07380b_11072013.htm |
| 2013-11-07 | 8-K | 2013-11-07 | 7.01 Regulation FD Disclosure | 7.01 At the American Society of Hematology’s (“ASH”) 55th Annual Meeting located in New Orleans, Louisiana from December 7 through 10, 2013, ten (10) oral presentation abstracts and eleven (11) poster presentation abstracts with respect to Pharmacyclics, Inc.’s (the “Company”) product, Ibrutinib, were accepted for presentation. | form8k07380a_11072013.htm |
| 2013-09-10 | 8-K | 2013-09-10 | 7.01 Regulation FD Disclosure | 7.01 On September 10, 2013, a presentation entitled “The Bruton Tyrosine Kinase (BTK) Inhibitor Ibrutinib Promotes a High Frequency of Durable Response in Relapsed/ Refractory and Older Treatment-Naïve CLL Patients: Final Results of a Phase Ib/II Study” related to Pharmacyclics, Inc.’s study PCYC 1102 CA was made at the 15th biennial international workshop on CLL in Cologne, Germany. | form8k07380_09102013.htm |
| 2013-08-29 | 8-K | 2013-08-29 | 8.01 Other Events | 8.01 On August 29, 2013, Pharmacyclics, Inc., a Delaware corporation (the “Company”), announced that the U.S. Food and Drug Administration (the “FDA”) has accepted for filing the Company's New Drug Application (the “NDA”) for the investigational oral Bruton’s tyrosine kinase (“BTK”) inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma (“MCL”) and previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (“CLL/SLL”). | form8k07380_08292013.htm |
| 2013-08-20 | 8-K | 2013-08-14 | 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers | 5.02 Effective August 16, 2013, Manmeet Soni, Pharmacyclics, Inc.’s (the “Company”) Vice President, Corporate Controller, was promoted to Senior Vice President, Finance, and will serve as the Company’s Principal Financial Officer, Principal Accounting Officer and Treasurer. | form8k07380_08202013.htm |
| 2013-07-31 | 8-K | 2013-07-31 | 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers | 5.02 Dr. Lori Anne Kunkel, who served as Pharmacyclics, Inc.’s (the “Company” or “Pharmacyclics”) Chief Medical Officer tendered her resignation from the Company to pursue other interests, effective August 2, 2013. | form8k207380_07312013.htm |
| 2013-07-31 | 8-K | 2013-07-31 | 2.02 Results of Operations and Financial Condition | 2.02 On July 31, 2013, Pharmacyclics, Inc., a Delaware corporation (the “Company”), issued a press release regarding its financial results for its three and six months ended June 30, 2013. | form8k07380_07312013.htm |
| 2013-07-10 | 8-K | 2013-07-10 | 8.01 Other Events | 8.01 On July 10, 2013, Pharmacyclics, Inc., a Delaware corporation (the “Company”), announced that it has submitted a New Drug Application (the “NDA”) to the U.S. Food and Drug Administration (the “FDA”) for the investigational oral Bruton’s tyrosine kinase (“BTK”) inhibitor, ibrutinib, for two B-cell malignancy indications; mantle cell lymphoma (“MCL”) and chronic lymphocytic leukemia/small lymphocytic lymphoma (“CLL/SLL”). | form8k07380_07102013.htm |
| 2013-07-10 | 8-K | 2013-07-10 | 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers | 5.02 On July 9, 2013, Pharmacyclics, Inc. (the “Company”) made the following promotions: Jesse McGreivy, MD, to Chief Medical Officer; Darrin Beaupre, MD, to Vice President of Clinical Medicine and Early Development; Thorsten Graef, MD, to Vice President of Clinical Science; and Betty Chang, Ph.D., to Vice President of Research/Biology. | form8k207380_07102013.htm |
| 2013-06-21 | 8-K | 2013-06-21 | 7.01 Regulation FD Disclosure | 7.01 On June 21, 2013, a presentation entitled “The Histone Deacetylase Inhibitor (HDACi) Abexinostat (PCI-24781): Significant Activity in Relapsed/Refractory Follicular Lymphoma (FL)” related to Pharmacyclics, Inc.’s product drug candidate Ibrutinib was made at the 12th International Conference on Malignant Lymphoma. | form8k07380_06212013.htm |
| 2013-06-20 | 8-K | 2013-06-20 | 7.01 Regulation FD Disclosure | 7.01 On June 20, 2013, a presentation entitled “A Prospective, Multicenter, Phase II Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Patients with Relapsed and Refractory Waldenstrom's Macroglobulinemia” related to Pharmacyclics, Inc.’s product drug candidate Ibrutinib was made at the 12th International Conference on Malignant Lymphoma. | form8k07380_06202013.htm |
| 2013-06-19 | 8-K | 2013-06-19 | 7.01 Regulation FD Disclosure | 7.01 On June 19, 2013, a presentation entitled “Single Agent Ibrutinib (PCI-32765) is Highly Effective in Chronic Lymphocytic Leukemia (CLL) Patients with 17p Deletion” related to Pharmacyclics, Inc.’s product drug candidate Ibrutinib was made at the 12th International Conference on Malignant Lymphoma. | form8k207380_06182013.htm |
| 2013-06-18 | 8-K | 2013-06-18 | 7.01 Regulation FD Disclosure | form8k07380_06182013.htm | |
| 2013-06-17 | 8-K | 2013-06-16 | 8.01 Other Events | 8.01 On June 16, 2013, at the European Hematology Association 18th Annual Congress in Stockholm, Sweden, Pharmacyclics, Inc., a Delaware corporation (the “Registrant”), issued a press release announcing the results of two separate Phase 2 studies suggesting that ibrutinib, an investigational oral Bruton's tyrosine kinase (BTK) inhibitor, showed efficacy when used as a monotherapy in patients with relapsed/refractory mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL). | form8k207380_06162013.htm |
| 2013-06-17 | 8-K | 2013-06-16 | 7.01 Regulation FD Disclosure | 7.01 On June 16, 2013, presentations entitled “The Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765), has Preferential Activity in the Activated B-cell-like (ABC) Subtype of Relapsed/Refractory (R/R) DLBCL: Interim Phase 2 Results” and “Updated Interim Results of an International, Multicenter, Phase 2 Study of Ibrutinib in Relapsed or Refractory Mantle Cell Lymphoma” relating to Pharmacyclics, Inc.’s product drug candidate Ibrutinib were made at the 18th Congress of European Hematology Association. | form8k07380_06162013.htm |
| 2013-06-03 | 8-K | 2013-06-02 | 7.01 Regulation FD Disclosure | 7.01 On June 2, 2013, a presentation entitled “Phase 1b Study Combining Ibrutinib with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients with CD20-Positive B-Cell Non-Hodgkin Lymphoma (NHL)” related to Pharmacyclics, Inc.’s product drug candidate Ibrutinib was made at the American Society of Clinical Oncology Annual Meeting (“ASCO”). | q1101127_8k-pharmacyclics.htm |
| 2013-05-23 | 8-K | 2013-05-21 | 5.05 Amendments to the Registrant's Code of Ethics, or Waiver of a Provision of the Code of Ethics | 5.05 On May 21, 2013, the Board of Directors of Pharmacyclics, Inc. (the “Company”) amended and restated the Company’s Code of Business Conduct and Ethics (as amended and restated, the “Amended and Restated Code”) that applies to all of the Company’s directors, officers and employees. | form28k07380_05212013.htm |
| 2013-05-21 | 8-K | 2013-05-21 | 7.01 Regulation FD Disclosure | form8k07380_05212013.htm | |
| 2013-05-16 | 8-K | 2013-05-15 | 7.01 Regulation FD Disclosure | form8k07380_05152013.htm | |
| 2013-05-15 | 8-K | 2013-05-09 | 1.01 Entry into a Material Definitive Agreement; 5.07 Submission of Matters to a Vote of Security Holders | 1.01 Entry into a Material Definitive Agreement. 5.07 At the Annual Meeting the following four matters were put forth to the stockholders to be voted on: (1) the election of seven (7) directors to serve until the 2014 annual meeting and until their successors are duly elected and qualified; (2) an amendment of the Company’s Employee Stock Purchase Plan to increase the maximum number of shares available for issuance under the Employee Stock Purchase Plan by an additional 300,000 shares; (3) a proposal to consider and approve an advisory resolution regarding the compensation of the Company’s named executive officers; and (4) the ratification of the appointment of PricewaterhouseCoopers LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2013. | form8k07380_05092013.htm |
| 2013-05-01 | 8-K | 2013-05-01 | 2.02 Results of Operations and Financial Condition | 2.02 On May 1, 2013, Pharmacyclics, Inc., a Delaware corporation (the “Registrant”), issued a press release regarding its financial results for its first quarter ended March 31, 2013. | form8k07380_05012013.htm |
| 2013-04-19 | 8-K | 2013-04-18 | 8.01 Other Events | 8.01 On April 18, 2013, Pharmacyclics, Inc. (the “Company”) announced that the enrollment target of 350 patients for its Phase III study using ibrutinib monotherapy versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL), (RESONATE™) was achieved on April 3, 2013. | form8k07380_04182013.htm |
| 2013-04-11 | 8-K | 2013-04-11 | 8.01 Other Events | 8.01 On April 11, 2013, Pharmacyclics, Inc. (the “Company”) announced that the Phase III clinical trial (RESONATE™-2), a monotherapy trial using ibrutinib versus chlorambucil in elderly patients with newly diagnosed chronic lymphocytic leukemia / small lymphocyctic lymphoma (CLL/SLL) has enrolled its fifth patient. | form8k07380_04112013.htm |
| 2013-04-08 | 8-K | 2013-04-08 | 7.01 Regulation FD Disclosure | 7.01 On April 8, 2013, Pharmacyclics, Inc. (the “Company”) announced results from a Phase II trial of the investigational oral agent ibrutinib which demonstrated rapid and sustained disease control as a monotherapy in untreated, relapsed and refractory chronic lymphocytic leukemia (CLL) patients, irrespective of characteristics that predict poor outcomes to chemoimmunotherapy. | form8k207380_04082013.htm |
| 2013-04-08 | 8-K | 2013-04-08 | 8.01 Other Events | 8.01 On April 8, 2013, Pharmacyclics, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients with deletion of the short arm of chromosome 17 (deletion 17p). | form8k07380_04082013.htm |
| 2013-03-14 | 8-K | 2013-03-14 | 8.01 Other Events | 8.01 Pharmacyclics, Inc. (the “Company”) will hold its 2013 Annual Meeting of Stockholders on Thursday, May 9, 2013 at 1:00 p.m. local time at the Company’s headquarters, 999 E. Arques Avenue, Sunnyvale, California 94085. | form8k07380_03142013.htm |
| 2013-03-08 | 8-K | 2013-03-08 | 1.01 Entry into a Material Definitive Agreement; 8.01 Other Events | 1.01 On March 8, 2013, Pharmacyclics, Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with J.P. Morgan Securities LLC (the “Underwriter”) relating to an underwritten public offering of 2,200,000 shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (the “Common Stock”). 8.01 The Company issued a press release on March 8, 2013 announcing the pricing of the public offering. | d499404d8k.htm |
| 2013-02-14 | 8-K | 2013-02-14 | 2.02 Results of Operations and Financial Condition | 2.02 On February 14, 2013, Pharmacyclics, Inc., a Delaware corporation (the “Company”), issued a press release regarding its financial results for its three and six months ended December 31, 2012. | form8k07380_0214203.htm |
| 2013-02-13 | 8-K | 2013-02-12 | 8.01 Other Events | 8.01 On February 12, 2013, Pharmacyclics, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the Company’s investigational oral agent ibrutinib monotherapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) and to ibrutinib monotherapy for the treatment of patients with Waldenström's macroglobulinemia (WM), both of which are B-cell malignancies. | form8k07380_02122013.htm |
| 2013-02-07 | 8-K | 2013-02-07 | 8.01 Other Events | 8.01 On February 7, 2013, Pharmacyclics, Inc., a Delaware corporation (the “Registrant”), issued a press release announcing that it intends to report its financial results for the three and sixth months ended December 31, 2012, after the NASDAQ Market closes on Thursday, February 14, 2013. | form8k07380_02072013.htm |
| 2013-01-10 | 8-K | 2013-01-09 | 7.01 Regulation FD Disclosure | 7.01 On January 9, 2013 at the 31st Annual J.P. Morgan Healthcare Conference, Pharmacyclics, Inc. presented the presentation attached hereto as exhibit 99.1. | form8k07380_01092013.htm |