Exelixis is on a Mission to Help Cancer Patients Recover Stronger and Live Longer
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model genetic systems, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. We discovered our three commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib) and COTELLIC® (cobimetinib), and have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery – all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. In July 2018, Exelixis was added to the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.
The Exelixis Credo
We drive for results, so patients can survive and thrive.
We are resilient in the face of adversity, and tireless in advancing our science.
We celebrate our long history of prolific drug discovery and rigorous drug development.
We unite to launch innovative medicines for difficult-to-treat cancers.
We exist to give people hope – one drug, one patient at a time.
We are Exelixis.
Exelixis, from the Greek word for evolution, is founded in Cambridge, Massachusetts initially focused on the model system platform of genetics and genomics, with a strategy to transition to drug discovery.
Exelixis moves its headquarters to South San Francisco, California.
Exelixis acquires the assets of Metaxen, including its facilities, equipment, and employees — an important early step in our evolution into an integrated drug discovery company.
Exelixis goes public, raising $127.5 million, and is listed on NASDAQ as EXEL.
Exelixis forms a broad alliance with GlaxoSmithKline to discover, develop and commercialize novel therapeutics in oncology.
Exelixis purchases X-Ceptor Therapeutics, a leader in the discovery and development of small molecules that modulate nuclear hormone receptors.
Exelixis initiates the first phase 1 clinical trial of XL184 (later known as cabozantinib), a potent inhibitor of various receptor tyrosine kinases.
Exelixis presents data from phase 1 trial of cabozantinib in patients with advanced malignancies.
Exelixis enters into a partnership with Daiichi Sankyo Company to discover, develop and commercialize novel therapies targeting the mineralocorticoid receptor.
Exelixis establishes a partnership with Genentech focused on the development of XL518 (later known as cobimetinib), a reversible and potent inhibitor of MEK.
Initiation of the first phase 1 clinical trial of XL518.
Responsibility for development of XL518 transferred to Genentech.
Between the years of 2004 and 2010, Exelixis filed 17 investigational new drug applications with the FDA for compounds arising from its internal discovery programs.
Cabozantinib meets primary endpoint of progression-free survival in a phase 3 clinical trial in medullary thyroid cancer.
At ASCO 2012, Exelixis presents results from the phase 1b study evaluating cabozantinib in patients with advanced renal cell carcinoma (RCC).
Exelixis expands the cabozantinib development program in collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP), enabling the NCI to study cabozantinib in a variety of tumor types.
The FDA approves COMETRIQ® (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer.
Exelixis initiates METEOR, the phase 3 pivotal trial of cabozantinib in patients with advanced RCC.
- COMETRIQ® is approved in the European Union for the treatment of progressive, unresectable locally advanced MTC.
- Following negative data from the COMET program studying cabozantinib in patients with metastatic castration-resistant prostate cancer, Exelixis refocuses its development efforts on the METEOR trial and opportunity for cabozantinib in advanced RCC.
- Exelixis announces positive top-line results from METEOR: the trial met its primary endpoint of demonstrating a statistically significant increase in progression-free survival.
- COTELLIC® (cobimetinib) receives approval in the U.S. and European Union for use in combination with vemurafenib for patients with unresectable or metastatic melanoma.
- Exelixis partners with Ipsen Pharma SAS, awarding Ipsen exclusive rights to commercialize cabozantinib throughout the world, excluding the United States and Japan.
- CABOMETYX® (cabozantinib tablets) receives approval in the U.S. as a treatment for patients with advanced RCC who have received prior anti-angiogenic therapy.
- European Commission approves CABOMETYX® tablets for the treatment of advanced RCC.
- Exelixis’ partner Genentech presents data from a phase 1b trial evaluating cobimetinib and atezolizumab in patients with metastatic colorectal cancer, forming the basis of the Genentech-sponsored IMblaze370 pivotal trial.
- Exelixis collaborator Daiichi Sankyo initiates phase 3 clinical development for CS-3150, a selective mineralocorticoid receptor blocker.
- Exelixis reports positive results from the phase 2 CABOSUN trial of cabozantinib versus sunitinib in previously untreated advanced RCC.
- Exelixis partners with Takeda, granting Takeda clinical development and commercial rights for cabozantinib in Japan.
- Exelixis posts its first quarter of profitability based on operations in Q1 ‘17.
- Exelixis initiates a phase 1b clinical trial of cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic urothelial carcinoma or RCC.
- Exelixis and Bristol-Myers Squibb initiate the phase 3 CheckMate 9ER trial of CABOMETYX® in combination with Opdivo® (nivolumab) plus or minus Yervoy® (ipilimumab), the first late-stage trial to pair cabozantinib with immune checkpoint inhibitors.
- Exelixis files for regulatory approval in the U.S. for CABOMETYX® tablets as a treatment for patients with previously untreated advanced RCC.
- FDA approves sNDA, expanding the indication for CABOMETYX® tablets in the U.S. to include patients with previously untreated advanced RCC.
- Exelixis enters into exclusive collaboration with StemSynergy Therapeutics to conduct studies with compounds from their CK1α Activator Program.
- Exelixis reports positive phase 3 CELESTIAL study results of cabozantinib in patients with previously treated advanced hepatocellular carcinoma (HCC).
- Exelixis enters into collaboration with Invenra to discover and develop novel biologics to treat cancer, moving beyond small molecule drug discovery for the first time in the company’s history.
- Exelixis files for regulatory approval in the U.S. for CABOMETYX® tablets as a treatment for patients with previously treated advanced HCC.
- European Commission approves CABOMETYX® for previously untreated intermediate- or poor-risk advanced RCC.
- Exelixis further expands its COSMIC-021 study (cabozantinib+atezolizumab), bringing the total number of planned expansion cohorts to 18.
- Exelixis moves its headquarters across the San Francisco Bay to Alameda’s Waterfront, providing a foundation for future growth.
- Health Canada approves CABOMETYX® for adults with advanced RCC who have received prior vascular endothelial growth factor targeted therapy.
- European Commission approves CABOMETYX® for HCC in adults who have previously been treated with sorafenib.
- CABOMETYX® tablets receive approval by the FDA in the U.S. as a treatment for patients with HCC who have been previously treated with sorafenib.