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EXEL

Exelixis

$15.87 /

+0.5 (+3.25%)

, TAK

Takeda Pharmaceutical

$13.89 /

+0.545 (+4.09%)

05:18
03/25/20
03/25
05:18
03/25/20
05:18

Exelixis says Takeda Pharmaceutical receives approval in Japan for CABOMETYX

Exelixis (EXEL) announced that Takeda Pharmaceutical (TAK), its partner responsible for the clinical development and commercialization of CABOMETYX in Japan, received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market CABOMETYX as a treatment for patients with curatively unresectable or metastatic renal cell carcinoma, or RCC. The approval is based on the results of three clinical trials: METEOR, the Exelixis-sponsored phase 3 pivotal trial of cabozantinib versus everolimus in patients with advanced RCC that experienced disease progression following treatment with at least one prior VEGF receptor tyrosine kinase inhibitor, or VEGFR-TKI; CABOSUN, the Alliance for Clinical Trials in Oncology-sponsored phase 2 trial comparing cabozantinib with sunitinib in patients with previously untreated advanced RCC with intermediate- or poor-risk disease; and Cabozantinib-2001, a Takeda-sponsored phase 2 trial in 35 Japanese patients with advanced RCC who had progressed after prior VEGFR-TKI therapy. Per the terms of Exelixis and Takeda's collaboration and license agreement, Exelixis is eligible to receive a $31 million milestone payment from Takeda upon the first commercial sale of CABOMETYX for unresectable or metastatic RCC. In January 2020, Takeda applied for approval to manufacture and sell cabozantinib as a treatment for patients with unresectable hepatocellular carcinoma, or HCC, that had progressed after prior systemic therapy in Japan, which triggered a $10 million milestone payment. Exelixis will also be eligible to receive further development, regulatory and first-sale milestone payments of up to $45 million from Takeda related both to previously treated and untreated RCC and previously treated HCC. Exelixis continues to be eligible to receive additional development, regulatory and first-sale milestones for potential future cabozantinib indications and is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan. Takeda fully funds cabozantinib development activities that are exclusively for the benefit of Japan and is responsible for 20% of the costs associated with global cabozantinib clinical trials, providing the company opts into those trials.

EXEL

Exelixis

$15.87 /

+0.5 (+3.25%)

TAK

Takeda Pharmaceutical

$13.89 /

+0.545 (+4.09%)

EXEL Exelixis
$15.87 /

+0.5 (+3.25%)

03/04/20 Barclays
Barclays starts small, mid cap Biotechnology sector with Positive view
03/04/20 Barclays
Exelixis initiated with an Overweight at Barclays
02/27/20 Piper Sandler
Exelixis price target lowered to $23 from $35 at Piper Sandler
02/11/20 Piper Sandler
Exelixis data 'impressive,' support accelerated approval, says Piper Sandler
TAK Takeda Pharmaceutical
$13.89 /

+0.545 (+4.09%)

02/25/20 Stifel
Iovance among 'more interesting' cell therapy takeout candidates, says Stifel
02/12/20 Wells Fargo
Fate Therapeutics price target raised to $34 from $24 at Wells Fargo
11/19/19 Needham
Phathom Pharmaceuticals initiated with a Buy at Needham
11/01/19 Cowen
Takeda Pharmaceutical initiated with a Market Perform at Cowen

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