October: Onyx becomes an Amgen subsidiary.
Palbociclib receives FDA Breakthrough therapy designation; Pfizer initiates Phase 3 trial of Palbociclib in advanced breast cancer. Palbociclib is a Pfizer compound being developed by Pfizer. If approved, Onyx will receive an 8% royalty on global net sales.
Onyx and University of California, San Francisco (UCSF) form Oncology Innovation Alliance, a public-private partnership focusing on the discovery and development of novel cancer therapies.
Stivarga® (regorafenib) tablets receives second FDA Indication. See www.stivarga-us.com for more information. Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States. Onyx receives a 20% royalty on global net commercial sales of Stivarga in oncology in approved markets.
Pfizer announces positive
Phase 2 data for Palbociclib for the treatment of metastatic breast cancer at San Antonio Breast Cancer Symposium.
Stivarga receives first FDA Indication. See www.stivarga-us.com for more information.
Onyx receives FDA accelerated approval of Kyprolis® (carfilzomib) for Injection and launches comprehensive patient support program, Onyx Pharmaceuticals 360™ (Onyx 360).
Onyx initiates Carfilzomib ENDEAVOR study, a head-to-head comparison trial vs. Velcade in patients with relapsed multiple myeloma.
Carfilzomib receives positive vote from Oncologic Drugs Advisory Committee (ODAC).
Onyx and University of Texas MD Anderson Cancer Center announce strategic alliance in multiple myeloma and lymphoma.
Onyx Pharmaceuticals International GmbH Appoints Luigi Costa as Vice President of Europe, and opens its doors to its international headquarters in Zug, Switzerland.
Onyx and Multiple Myeloma Research Foundation announce multi-year collaboration to accelerate personalized medicine approaches for multiple myeloma.
Results from a Phase 3 study evaluating regorafenib, a Bayer owned compound, demonstrate an improvement in overall survival in patients with metastatic colorectal cancer. Bayer plans to file for approval in the United States and Europe in 2012.
Onyx expands its global oncology partnership with Bayer and enters into a new agreement for Stivarga. Stivarga® (regorafenib) is a Bayer compound being developed by Bayer. Onyx receives a 20% royalty on all global net sales in approved markets.
FDA accepts the Kyprolis® (proposed tradename for carfilzomib) New Drug Application for review under the accelerated approval pathway for potential treatment of patients with relapsed and refractory multiple myeloma.
Onyx and Multiple Myeloma Research Foundation launch Carfilzomib Myeloma Access Program (C-MAP), an expanded access program that makes Carfilzomib available to eligible patients in the United States with relapsed and refractory multiple myeloma.
U.S. FDA grants Carfilzomib Fast Track Designation for the potential treatment of patients with relapsed and refractory multiple myeloma; Onyx initiates rolling New Drug Application submission for accelerated approval.
Onyx reports positive complete results from Phase 2b study of single-agent Carfilzomib in patients with relapsed and refractory multiple myeloma.
Onyx enters into an exclusive agreement valued in excess of $300 million with Ono Pharmaceutical, giving Ono the rights to develop and commercialize Carfilzomib and Oprozomib for all oncology indications in Japan.
Phase 3 ASPIRE trial begins, evaluating Carfilzomib in combination with lenalidomide (Revlimid) and low-dose dexamethasone in patients with relapsed multiple myeloma.
Oprozomib, an oral proteasome inhibitor, enters clinical testing.
Onyx acquires Proteolix Inc., a privately held biopharmaceutical company focused on discovering and developing novel therapies that target the proteasome for the treatment of patients with cancer and autoimmune diseases.
Phase 3 DECISION trial begins, evaluating Sorafenib in patients with radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer.
Onyx and Bayer report positive results from a Phase 2 trial evaluating Sorafenib plus the chemotherapeutic agent, capecitabine, in patients with advanced breast cancer.
Hollings Renton retires as chairman and CEO of Onyx.
N. Anthony Coles, M.D., joins Onyx as president and CEO.
Nexavar® (sorafenib) Tablets pivotal liver cancer study (SHARP) published in The New England Journal of Medicine.
NEXAVAR pivotal kidney cancer study (TARGET) published in The New England Journal of Medicine.
NEXAVAR receives second FDA Indication. See www.nexavar.com for more information.
NEXAVAR receives first FDA Indication. See www.nexavar.com for more information.
PD 0332991, an oral, cell cycle inhibitor, enters clinical testing.
Onyx focuses its efforts solely on the development of sorafenib and discontinues therapeutic virus program.
Sorafenib, an oral systemic therapy, enters clinical testing.
Onyx and Warner Lambert, now Pfizer, extend collaboration in area of cell cycle regulation.
Frank McCormick leaves Onyx to become head of the University of California, San Francisco Cancer Center and Cancer Research Institute.
Onyx completes IPO and is listed on the Nasdaq under stock symbol ONXX.
Onyx and Warner Lambert, now Pfizer, form collaboration to develop therapeutics for cell cycle regulation.
Onyx and Miles Inc. (predecessor to Bayer HealthCare Pharmaceuticals, Inc.) form collaboration.
Onyx appoints Hollings Renton as the company’s first president and CEO.
Onyx Pharmaceuticals is founded by Frank McCormick to discover and develop cancer therapeutics and is spun out of the Cetus and Chiron merger as privately held company.
Cetus Corporation merges with Chiron Corporation.
Frank McCormick, Ph.D., begins cancer research program at Cetus Corporation.