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Tobira Therapeutics, Inc. (TBRA) Create: Alert

All | News | Filings
Date FiledTypeDescription
11/01/2016 8-K Quarterly results
09/20/2016 8-K Entry into a Material Definitive Agreement, Departure of Directors or Certain Officers; Election of Directors; Appointment of...
Docs: "Agreement and Plan of Merger, by and among Allergan Holdco US, Inc., Sapphire Acquisition Corp. and Tobira Therapeutics, Inc",
"Tender and Support Agreement, by and among Allergan Holdco US, Inc., Sapphire Acquisition Corp. and certain directors and stockholders of Tobira Therapeutics, Inc",
"Allergan to Acquire Tobira Therapeutics Expanding Global GI R&D Pipeline and Taking a Leading R&D Position in NASH"
08/09/2016 8-K Form 8-K - Current report
07/25/2016 8-K Form 8-K - Current report
05/09/2016 8-K Quarterly results
Docs: "Tobira Therapeutics Reports First Quarter 2016 Financial and Business Results Conference Call to be Held Today at 4:30 p.m. Eastern Time"
04/11/2016 8-K Form 8-K - Current report
03/03/2016 8-K Quarterly results
Docs: "Exhibit 99.1 Tobira Therapeutics Reports Fourth Quarter 2015 Financial and Year-End Business Results Cash Balance of $62.8 million On Track to Report CENTAUR NASH Phase 2b Study Primary Endpoint in Third Quarter Conference Call to be Held Today at 4:30 p.m. Eastern Time SOUTH SAN FRANCISCO, Calif., March 3, 2016 /PRNewswire/ -- Tobira Therapeutics, Inc. , a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis and other serious immuno-inflammatory and fibrotic diseases, today reported business highlights and financial results for the three and 12 months ended December 31, 2015. "We had an excellent finish to the year with the presentation of patient demographic data from our CENTAUR Phase 2b study, showing that the population enrolled in this study is ..."
11/10/2015 8-K Quarterly results
Docs: "Exhibit 99.1 Tobira Therapeutics Reports Third Quarter 2015 Financial Results Conference Call to be Held Today at 4:30 p.m. Eastern Time SOUTH SAN FRANCISCO, Calif., Nov. 10, 2015 /PRNewswire/ -- Tobira Therapeutics, Inc. , a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis and other serious immuno-inflammatory and fibrotic diseases, today reported business highlights and financial results for the third quarter of 2015. "We are making excellent progress on CENTAUR, our Phase 2b study of cenicriviroc for the treatment of NASH and liver fibrosis. CENTAUR is a well-powered large Phase 2b NASH study that has completed enrollment and exclusively enrolled patients at greater risk of progression to cirrhosis. The study was designed to include key seconda..."
08/17/2015 8-K Other Events, Financial Statements and Exhibits
Docs: "Tobira Therapeutics Announces Initiation of ORION, a Phase 2a Study of Cenicriviroc in Obese Patients with Suspected Fatty Liver Disease SOUTH SAN FRANCISCO, Calif. - August 17, 2015 - Tobira Therapeutics, Inc. , a clinical-stage biopharmaceutical company focused on the development and commercialization of novel treatments for liver and inflammatory diseases, announced today the enrollment of the first patient into the Phase 2a ORION study. ORION is a randomized, double-blind, placebo-controlled study evaluating the treatment effects of cenicriviroc in approximately 50 obese adults with prediabetes or diabetes and suspected non-alcoholic fatty liver disease . The primary outcome of ORION will measure changes in insulin sensitivity in peripheral and adipose tissue over a 24-week period and ..."
08/11/2015 8-K Quarterly results
Docs: "Tobira Therapeutics Reports Second Quarter 2015 Financial Results"
07/14/2015 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
06/18/2015 8-K Entry into a Material Definitive Agreement, Financial Statements and Exhibits
Docs: "License Agreement by and between Takeda Pharmaceutical Company Limited and Tobira Therapeutics, Inc. Dated August 1st, 2007 Confidential [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.",
"Amendment"
06/08/2015 8-K Other Events, Financial Statements and Exhibits
Docs: "Tobira Therapeutics Completes Patient Recruitment for CENTAUR Phase 2b Study of Cenicriviroc in NASH with Liver Fibrosis SOUTH SAN FRANCISCO, June 8, 2015 - Tobira Therapeutics, Inc. , a clinical-stage biopharmaceutical company focused on the development and commercialization of novel treatments for liver and inflammatory diseases, announced today that it has completed recruitment for the Phase 2b CENTAUR study. CENTAUR is a global, double blind, placebo controlled, Phase 2b clinical trial evaluating the treatment effects of cenicriviroc versus placebo in patients with non-alcoholic steatohepatitis and liver fibrosis at high risk of progressive disease. NASH is a severe form of non-alcoholic fatty liver disease. Patients with NASH and risk factors such as liver fibrosis and type 2 diabetes..."
06/02/2015 8-K/A Financial Statements and Exhibits
Docs: "Consent of Independent Registered Public Accounting Firm",
"Unaudited Interim Financial Statements of Tobira Therapeutics, Inc",
"Audited Financial Statements of Tobira Therapeutics, Inc",
"Unaudited Pro Forma Combined Financial Statements of Tobira Therapeutics, Inc"
05/20/2015 8-K Changes in Registrant's Certifying Accountant, Departure of Directors or Certain Officers; Election of Directors; Appointment...
Docs: "Management Cash Incentive Plan",
"Tobira Therapeutics, Inc. 2010 Stock Plan and form of Stock Option Agreement thereunder",
"Letter from Grant Thornton LLP to the Securities and Exchange Commission"
05/07/2015 8-K Entry into a Material Definitive Agreement, Completion of Acquisition or Disposition of Assets, Unregistered Sales of Equity ...
Docs: "Amended and Restated Certificate of Incorporation of Regado Biosciences, Inc",
"Certificate of Amendment of Seventh Amended and Restated Certificate of Incorporation of Regado Biosciences, Inc. (which name was changed to Tobira Therapeutics, Inc. upon the closing of the Merger)",
"Registration Rights Agreement, by and among Regado Biosciences, Inc. (which name was changed to Tobira Therapeutics, Inc. upon the closing of the Merger) and the Investors (as defined therein)",
"Purchase Agreement, by and among Regado Biosciences, Inc. (which name was changed to Tobira Therapeutics, Inc. upon the closing of the Merger) and the Investors (as defined therein)",
"Tobira Therapeutics Completes Financing and Merger with Regado Biosciences"
03/02/2015 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
01/23/2015 8-K Entry into a Material Definitive Agreement, Financial Statements and Exhibits
Docs: "Amendment No. 1 to Agreement and Plan of Merger and Reorganization, by and among Regado Biosciences, Inc., Landmark Merger Sub, Inc., Tobira Therapeutics, Inc. and Brent Ahrens as the Company Stockholders' Agent"
01/20/2015 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "Transcript of Conference Call"
01/14/2015 8-K Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Changes in Control of Registrant, Depart...
Docs: "Agreement and Plan of Merger and Reorganization, by and among Regado Biosciences, Inc., Tobira Therapeutics, Inc., Landmark Merger Sub Inc. and Brent Ahrens, as the Tobira stockholders' Agent",
"Form of Parent Support Agreement, by and between Tobira Therapeutics and each of the parties named in each agreement therein",
"Form of Company Support Agreement, by and between Regado Biosciences, Inc. and each of the parties named in each agreement therein",
"Form of Lock-Up Agreement, by and among Regado Biosciences, Inc. and each of the parties named in each agreement therein",
"Equity Commitment Letter, by and among Regado Biosciences, Inc. and the parties named therein"
01/14/2015 8-K Other Events, Financial Statements and Exhibits
Docs: "Regado Biosciences and Tobira Therapeutics Announce Merger Agreement to Create Leading NASH Company"
01/08/2015 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
12/24/2014 8-K Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing
12/05/2014 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "Amended and Restated Employment Agreement by and between Regado Biosciences, Inc. and Michael A. Metzger"
11/05/2014 8-K Quarterly results
Docs: "Regado Biosciences Announces Third Quarter 2014 Financial Results and Provides Corporate Update"
10/16/2014 8-K Appointed a new director
Docs: "Regado Biosciences Appoints Michael A. Metzger CEO"
09/24/2014 8-K Cost Associated with Exit or Disposal Activities, Financial Statements and Exhibits
Docs: "Regado Biosciences Announces Workforce Reduction and Provides Update on Strategic Direction"
08/25/2014 8-K Other Events, Financial Statements and Exhibits
Docs: "Regado Biosciences Permanently Halts REGULATE-PCI Clinical Trial Safety Stops Phase 3 Study for Revolixys™ Kit August 25, 2014 - Regado Biosciences, Inc. today announced the permanent termination of enrollment in its REGULATE-PCI phase 3 trial for its lead program, Revolixys™ Kit. The decision was made based on a recommendation from the trial's Data and Safety Monitoring Board following their analysis of the data from the first approximately 3250 patients enrolled in what was intended to be a 13,200-patient trial comparing the safety and efficacy of Revolixys Kit with bivalirudin. “The DSMB indicated that the level of serious allergic adverse events associated with Revolixys was of a frequency and severity such that they recommended that we do not enroll any further patients in the REGULAT..."
08/11/2014 8-K Quarterly results
Docs: "Regado Biosciences Announces Second Quarter 2014 Financial Results and Corporate Highlights Conference Call and Webcast, August 12, 2014, at 8:30 a.m. EDT Basking Ridge, N.J. - August 11, 2014 - Regado Biosciences, Inc. , a biopharmaceutical company focused on the Phase 3 clinical development of Revolixys™ Kit , its first-in-class, actively controllable antithrombotic drug system, today announced its second quarter 2014 corporate highlights and financial results. A conference call and webcast to discuss the results will be held, August 12, 2014, at 8:30 a.m. EDT. SECOND QUARTER 2014 FINANCIAL SUMMARY Cash and cash equivalents at June 30, 2014, totaled $72.7 million compared to $30.7 million at December 31, 2013. Regado's net loss for the quarter ended June 30, 2014, was $21.4 million or a ..."
07/09/2014 8-K Other Events, Financial Statements and Exhibits
Docs: "REGADO BIOSCIENCES ANNOUNCES CLINICAL HOLD OF REGULATE-PCI TRIAL FOLLOWING VOLUNTARY HALT OF TRIAL BY REGADO"
07/02/2014 8-K Other Events, Financial Statements and Exhibits
Docs: "REGADO ANNOUNCES INITIATION OF DSMB REVIEW OF REGULATE-PCI DATA BASKING RIDGE, N.J., July 2, 2014 /PRNewswire/ — Regado Biosciences, Inc. , a biopharmaceutical company focused on the Phase 3 clinical development of Revolixys™ Kit , its first-in-class, actively controllable antithrombotic drug system, today announced that the Data Safety Monitoring Board has initiated an unplanned review of data from the REGULATE-PCI trial. Patient enrollment has been paused until the DSMB has completed its analysis and communicated its recommendations, which are anticipated within the next 8 weeks. The DSMB will conduct a full analysis of safety and treatment benefit-risk ratio of all patients enrolled to date with a focus on serious adverse events related to allergic reactions. Regado and the trial's acad..."
06/17/2014 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "Regado Biosciences, Inc. 2013 Equity Compensation Plan, as amended to include the Inducement Award Subplan"
05/23/2014 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "Employment Agreement by and between Regado Biosciences, Inc. and Nicholas J. Pelliccione, Ph.D.",
"Regado Biosciences Appoints Nicholas Pelliccione, Ph.D., Senior Vice President of Regulatory Affairs and Quality Assurance and Reports Inducement Grant under NASDAQ Listing Rule 5635 Basking Ridge, N.J. - May 19, 2014 — Regado Biosciences, Inc. , a biopharmaceutical company focused on the Phase 3 clinical development of Revolixys™ Kit , its first-in-class, actively controllable antithrombotic drug system, today announced the appointment of Nicholas Pelliccione, Ph.D., as Senior Vice President of Regulatory Affairs and Quality Assurance. He succeeds Alexander Giaquinto, Ph.D., who has served as Regado's Senior Vice President of Regulatory Affairs and Quality Assurance and Chief Compliance Officer since 2008 and who is retiring from full-time employment. However, Dr. Giaquinto will remain a ..."
05/14/2014 8-K Quarterly results
Docs: "Regado Biosciences Announces First Quarter 2014 Financial Results and Corporate Highlights Conference Call and Webcast, May 14, 2014, at 8:30 a.m. EDT Basking Ridge, N.J. - May 14, 2014 — Regado Biosciences, Inc. , a biopharmaceutical company focused on the late-stage, Phase 3 clinical development of the Revolixys™ Kit , its first-in-class, actively controllable antithrombotic drug system, today announced its first quarter 2014 corporate highlights and financial results. A conference call and webcast to discuss the results will be held, May 14, 2014, at 8:30 a.m. EDT. “As announced in April, we were very pleased to reach the first enrollment milestone in our global REGULATE-PCI trial, which allowed us to expand our efforts and enroll ‘all comers' into the trial, and include NSTEMI pat..."
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