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Seattle Genetics Inc (SGEN.O)

SGEN.O on Nasdaq

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Latest Key Developments (Source: Significant Developments)

FDA accepts supplemental biologics license application and grants priority review for adcetris in cutaneous t-cell lymphoma
Wednesday, 16 Aug 2017 08:00am EDT 

Aug 16 (Reuters) - Seattle Genetics Inc ::FDA accepts supplemental biologics license application and grants priority review for adcetris® (brentuximab vedotin) in cutaneous t-cell lymphoma.Says ‍FDA granted priority review for application and pdufa target action date is december 16, 2017​.Says ‍adcetris is currently not approved for treatment of ctcl​.  Full Article

Seattle Genetics to buy Bothell plant from Bristol-Myers Squibb
Tuesday, 1 Aug 2017 04:00pm EDT 

Aug 1 (Reuters) - Bristol-Myers Squibb Co :Seattle Genetics announces purchase of Bothell manufacturing facility from Bristol-Myers Squibb.Seattle Genetics - ‍signed definitive agreements to purchase Bristol-Myers Squibb's pharmaceutical manufacturing facility in Bothell, Washington​.Seattle Genetics - ‍intends to offer employment to manufacturing facility's current employees​.Seattle Genetics - plans to utilize facility primarily for antibody production for current and future pipeline programs​.Seattle Genetics - ‍company intends to offer employment to manufacturing facility's current employees​.  Full Article

Seattle Genetics Q2 loss per share $0.39
Thursday, 27 Jul 2017 04:02pm EDT 

July 27 (Reuters) - Seattle Genetics Inc :Seattle Genetics reports second quarter 2017 financial results.Q2 loss per share $0.39.Q2 earnings per share view $-0.42 -- Thomson Reuters I/B/E/S.Q2 revenue $108.2 million versus i/b/e/s view $108.8 million.Seattle Genetics Inc - increased its expectations for 2017 adcetris net product sales in U.S and Canada to a range of $290 million to $310 million.Seattle genetics inc - as of june 30, 2017, Seattle Genetics had $473.0 million in cash, cash equivalents and investments..  Full Article

Seattle Genetics announces clinical collaboration to expand the therapeutic evaluation of sgn-liv1a
Monday, 24 Jul 2017 08:00am EDT 

July 24 (Reuters) - Seattle Genetics Inc ::Seattle Genetics announces clinical collaboration to expand the therapeutic evaluation of sgn-liv1a in triple negative breast cancer.Seattle Genetics Inc - ‍genentech will manage study operations for phase 1b/2 trial​.Seattle Genetics Inc - ‍seattle Genetics will retain global development and commercialization rights to sgn-liv1a​.  Full Article

Seattle Genetics reports 8.2 percent stake in Immunomedics as of June 29, 2017
Friday, 7 Jul 2017 05:20pm EDT 

July 7 (Reuters) - Seattle Genetics Inc : :Seattle genetics inc reports a 8.2 percent stake in immunomedics inc as of June 29, 2017 - sec filing.Seattle Genetics- acquired common stock, warrant in connection with development, license agreement with issuer to acquire strategic interest in Immunomedics.  Full Article

Takeda and Seattle Genetics announce positive results from phase 3 ECHELON-1 clinical trial
Monday, 26 Jun 2017 06:45am EDT 

June 26 (Reuters) - Seattle Genetics Inc :Takeda and Seattle Genetics announce positive results from phase 3 ECHELON-1 clinical trial evaluating Adcetris in frontline advanced hodgkin lymphoma.Says interim analysis of overall survival, key secondary endpoint, also trended in favor of Adcetris+AVD arm.Says safety profile of Adcetris+AVD in trial was consistent with that known for single-agent components of regimen.Says there was an increased incidence of febrile neutropenia and peripheral neuropathy in the Adcetris+AVD arm.Takeda and Seattle Genetics plan to submit trial results to regulatory authorities for approval in respective territories.phase 3 clinical trial met primary endpoint of statistically significant improvement in modified progression-free survival versus control arm.  Full Article

FDA notifies Seattle Genetics that IND for vadastuximab talirine placed on hold
Thursday, 22 Jun 2017 06:13am EDT 

June 22 (Reuters) - Seattle Genetics Inc ::Seattle Genetics Inc - fda notified co on June 21, IND for vadastuximab talirine has been placed on hold - SEC filing.Seattle Genetics Inc - FDA notified co that no clinical trials may resume under IND until FDA lifts clinical hold for vadastuximab talirine.  Full Article

Seattle Genetics submits supplemental biologics license application to fda for Adcetris
Tuesday, 20 Jun 2017 08:00am EDT 

June 20 (Reuters) - Seattle Genetics Inc ::Seattle Genetics submits supplemental biologics license application to FDA for Adcetris® (brentuximab vedotin) in cutaneous t-cell lymphoma.Seattle Genetics Inc - adcetris is currently not approved for treatment of ctcl.Seattle Genetics- trial achieved primary endpoint with adcetris treatment arm demonstrating highly statistically significant improvement for adcetris.Seattle Genetics- bla based on trial results from phase 3 alcanza,phase 2 investigator-sponsored studies in cutaneous t-cell lymphoma for adcetris.  Full Article

Seattle Genetics discontinues Phase 3 trial of vadastuximab talirine
Monday, 19 Jun 2017 06:45am EDT 

June 19 (Reuters) - Seattle Genetics Inc ::Seattle Genetics discontinues Phase 3 cascade trial of vadastuximab talirine (SGN-CD33A) in frontline acute myeloid leukemia.Seattle Genetics discontinues Phase 3 cascade trial of vadastuximab talirine (SGN-CD33A) in frontline acute myeloid leukemia.Seattle Genetics Inc - will closely review data and consult with FDA to determine future plans for vadastuximab talirine development program.Seattle Genetics - data indicated higher rate of deaths, including fatal infections in vadastuximab talirine-containing arm versus control arm of trial.Says ‍based on available data, safety concerns in this trial do not appear related to hepatotoxicity​.Seattle Genetics Inc - suspending patient enrollment and treatment in all of its vadastuximab talirine clinical trials.Seattle Genetics - on track to advance enfortumab vedotin into a pivotal trial in metastatic urothelial cancer in H2 2017 under collaboration with Astellas.  Full Article

Takeda, Seattle Genetics announce Lancet publication
Wednesday, 7 Jun 2017 08:00am EDT 

June 7 (Reuters) - Takeda Pharmaceutical Co Ltd <4502.T>: :Takeda and Seattle Genetics announce Lancet publication of phase 3 alcanza clinical trial data of adcetris (brentuximab vedotin) for CD30-positive cutaneous t-cell lymphoma.Takeda - ‍takeda plans to begin to submit data from alcanza trial to regulatory agencies in its territories in 2017​.Takeda - ‍Seattle Genetics plans to submit these data as part of a supplemental biologics license application to FDA in mid-2017​.  Full Article