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• | Positive ECHELON-2 Phase 3 Results: Seattle Genetics and its partner Takeda Pharmaceutical Company Limited (Takeda) reported positive top-line results from the ECHELON-2 phase 3 clinical trial in frontline CD30-expressing peripheral T-cell lymphoma (PTCL). The trial demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS) of ADCETRIS in combination with CHP (cyclophosphamide, doxorubicin, prednisone) versus the control arm, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). The ADCETRIS plus CHP arm also demonstrated superior overall survival, a key secondary endpoint, compared to CHOP. The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with chemotherapy. Additional data will be presented at the 60th Annual Meeting of the American Society of Hematology (ASH), taking place December 1-4, 2018, in San Diego, Calif. |
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Seattle Genetics Inc Wa's Definitive Proxy Statement (Form DEF 14A) filed after their 2018 10-K Annual Report includes:
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Net loss for the nine months ended September 30, 2018 was favorably impacted by a net gain of $62.9 million resulting from the change in the fair value of our equity securities.
The significant estimates in the discounted cash flow model primarily include the discount rate, rates of future revenue growth and/or profitability of the acquired business, and working capital effects.
For the nine months ended September 30, 2018, total costs and expenses increased to $649.9 million, compared to $503.4 million for the same period in 2017.
Additionally, selling, general and administrative expenses increased for the nine months ended September 30, 2018 due to costs associated with the Cascadian Acquisition.
We anticipate that our total research and development expenses in 2018 will increase compared to 2017 due primarily to higher costs for the development of our product candidates, primarily enfortumab vedotin, tucatinib, tisotumab vedotin, and ladiratuzumab vedotin, the operation of the North Creek manufacturing facility that we acquired in October 2017, and upfront in-license payments.
While we expect continued growth...Read more
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In particular: Obtaining and maintaining...Read more
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Investment and other income (loss),...Read more
Selling, general and administrative Selling,...Read more
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Third-party costs for SGN-CD33A decreased...Read more
The competition ADCETRIS faces from...Read more
Royalty revenues increased for the...Read more
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Such factors include the approval...Read more
Research and development Research and...Read more
Although we reported positive top-line...Read more
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Specific to in-process research and...Read more
Tucatinib is currently being evaluated...Read more
Tucatinib is currently being evaluated...Read more
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Collaboration revenues from Takeda decreased...Read more
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Ticker: SGEN
CIK: 1060736
Form Type: 10-Q Quarterly Report
Accession Number: 0001060736-18-000021
Submitted to the SEC: Fri Oct 26 2018 12:21:09 PM EST
Accepted by the SEC: Fri Oct 26 2018
Period: Sunday, September 30, 2018
Industry: Biological Products No Disgnostic Substances