Tag Archives: Exelixis

July, 2018

5 July
Exelixis’ Cabozantinib Significantly Improves Overall Survival in Late-Stage Hepatocellular Carcinoma Trial

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Jul. 4, 2018– Exelixis, Inc. (Nasdaq: EXEL) today announced that The New England Journal of Medicine (NEJM) published results from the CELESTIAL phase 3 pivotal trial of cabozantinib in patients with previously treated advanced hepatocellular carcinoma (HCC).1 The data, originally presented at the 2018 American Society of Clinical Oncology’s Gastrointestinal Cancers …
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31 May
FDA Accepts Exelixis’ sNDA for Cabometyx in Previously Treated Advanced Hepatocellular Carcinoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for CABOMETYX® (cabozantinib) tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma (HCC). The FDA has completed its filing review …
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3 May
Exelixis and Invenra Enter Into Collaboration to Discover and Develop Novel Biologics to Treat Cancer

SOUTH SAN FRANCISCO, Calif. & MADISON, Wis.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a collaboration with Invenra, Inc., the Madison, Wisconsin-based biotechnology firm focused on developing next-generation biologics, to discover and develop multispecific antibodies for the treatment of cancer. The partnership pairs Exelixis’ fundamental biological insights, clinical …
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8 January
Exelixis and StemSynergy Enter Exclusive Licensing Agreement for the Development of Novel Anticancer Therapies

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ: EXEL) today announced that it has entered into an exclusive collaboration and license agreement with StemSynergy Therapeutics, Inc., (StemSynergy) for the discovery and development of novel oncology compounds targeting Casein Kinase 1 alpha (CK1α), a component of the Wnt signaling pathway implicated in key …
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20 December
FDA Expands Approval of Exelixis’ Cabometyx for Previously Untreated Advanced Renal Cell Carcinoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma (RCC). RCC is the most common form of kidney cancer in adults. The FDA’s priority review and approval of CABOMETYX …
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18 October
Ipsen and Exelixis’ Cabozantinib Meets Primary Endpoint in Phase 3 Hepatocellular Carcinoma Trial

PARIS–(BUSINESS WIRE)–Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) and its partner Exelixis (NASDAQ: EXEL) today announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with …
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16 August
Exelixis Submits sNDA for Cabometyx for the Treatment of Previously Untreated Advanced Kidney Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced it has completed the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX®(cabozantinib) tablets as a treatment for patients with previously untreated advanced renal cell carcinoma (RCC). The sNDA submission is based on …
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7 March
Exelixis’ Hepatocellular Carcinoma Drug Granted Orphan Drug Designation from the FDA

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to cabozantinib for the treatment of hepatocellular carcinoma (HCC). This information was posted to FDA’s website on March 4, 2017 and can be accessed here. A pivotal …
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10 October
Exelixis’ Kidney Cancer Drug Beats Pfizer’s Sutent in Mid-Stage Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Oct. 10, 2016– Exelixis, Inc.(NASDAQ:EXEL) today announced detailed results from the CABOSUN randomized phase 2 trial of cabozantinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). Principal investigator Toni …
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7 September
Exelixis Announces Outcome of Interim Analysis of its Late-Stage Hepatocellular Carcinoma Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced the outcome from the first planned interim analysis of CELESTIAL, a randomized global phase 3 trial of cabozantinib compared with placebo in patients with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Following this interim analysis, which was …
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