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seattle genetics inc (SGEN) Key Developments

Seattle Genetics, Inc. Submits Supplemental Biologics License Application to the FDA Based on Data from Phase 3 AETHERA Trial of ADCETRIS

Seattle Genetics Inc. announced that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) based on data from the phase 3 AETHERA trial of ADCETRIS (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin lymphoma (HL) patients at high risk of relapse. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is approved in relapsed HL and sALCL but is currently not approved for consolidation therapy in HL patients immediately after ASCT. The supplemental BLA is based on positive results from a phase 3 clinical trial called AETHERA that were presented at the 56thAmerican Society of Hematology (ASH) Annual Meeting in December 2014. Results from the AETHERA trial in 329 HL patients at high risk of relapse included: the trial achieved its primary endpoint and demonstrated a significant increase in progression-free survival (PFS) per independent review facility, with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS was 43 months for patients who received ADCETRIS versus 24 months for patients who received placebo. The two-year PFS rate was 63% in the ADCETRIS arm compared to 51% in the placebo arm; the PFS benefit was consistent across all pre-specified subgroups, including primary refractory patients, patients who relapsed within twelve months of frontline therapy and patients who relapsed after twelve months with extranodal disease; the most common adverse events in the ADCETRIS arm were peripheral sensory neuropathy (56%), neutropenia (35%), upper respiratory tract infection (26%), fatigue (24%) and peripheral motor neuropathy (23%). The most common adverse events in the placebo arm were upper respiratory tract infection (23%), fatigue (18%), peripheral sensory neuropathy (16%), cough (16%) and neutropenia (12%). 85% of patients with peripheral neuropathy on the ADCETRIS arm had resolution or improvement in symptoms with a median time to improvement of 23.4 weeks. Submission of safety data from the AETHERA trial to the FDA is a post-marketing requirement that Seattle Genetics will fulfill with this submission of the supplemental BLA.

Seattle Genetics, Inc. Announces Initiation of Phase 1 Clinical Trial of SEA-CD40 for Multiple Types of Advanced Solid Tumors

Seattle Genetics Inc. announced initiation of a phase 1 clinical trial of SEA-CD40 for multiple types of advanced solid tumors. SEA-CD40 is a novel investigational immuno-oncology agent targeted to CD40, a widely expressed stimulatory receptor found on antigen-presenting cells (APCs) which play a role in immune cell activation. SEA-CD40 utilizes Seattle Genetics' proprietary sugar-engineered antibody (SEA) technology to produce a non-fucosylated antibody targeting CD40. Preclinical data show that SEA-CD40 stimulates the immune system to fight cancer. The study is a phase 1, open-label, multi-center, dose-escalation clinical trial of SEA-CD40 in patients with advanced solid tumors who have failed current standard of care treatments. Expansion cohorts are planned to evaluate SEA-CD40 across up to three cancer indications that will be determined based on data from the dose escalation portion of the study. The primary endpoints are determination of the maximum tolerated dose (MTD) and safety profile of SEA-CD40. In addition, the trial will evaluate antitumor activity, pharmacokinetics and immunological pharmacodynamic effects. The phase 1 trial will enroll approximately 50 patients during dose escalation and up to 90 patients in the expansion cohorts at multiple centers in the United States.

Seattle Genetics Inc. Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2014; Provides Revenue Guidance for the Year 2015

Seattle Genetics Inc. reported unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2014. For the quarter, the company reported total revenues of $74,326,000 compared to $67,409,000 a year ago. Loss from operations was $27,724,000 compared to $15,681,000 a year ago. Net loss was $26,684,000 or $0.22 per basic and diluted share compared to $15,671,000 or $0.13 per basic and diluted share a year ago. The company generated cash inflows in excess of $250 million, which came primarily from ADCETRIS sales, collaborations and royalties. For the year, the company reported total revenues of $286,758,000 compared to $269,264,000 a year ago. Loss from operations was $77,363,000 compared to $62,861,000 a year ago. Net loss was $76,141,000 or $0.62 per basic and diluted share compared to $62,520,000 or $0.51 per basic and diluted share a year ago. The company provided revenue guidance for the year 2015. The company anticipates 2015 revenues from ADCETRIS net product sales to be in the range of $200 million to $210 million and 2015 revenues from collaboration and license agreements to be in the range of $60 million to $70 million. Collaboration revenues will be generated from fees, milestones and reimbursements earned through the company’s ADCETRIS and ADC collaborations.

Seattle Genetics Inc. Presents at Leerink's Global Healthcare Conference, Feb-12-2015 11:35 AM

Seattle Genetics Inc. Presents at Leerink's Global Healthcare Conference, Feb-12-2015 11:35 AM. Venue: Waldorf Astoria New York, New York, New York, United States. Speakers: Clay B. Siegall, Co-Founder, Chairman, Chief Executive Officer and President.

Seattle Genetics Inc. to Report Q4, 2014 Results on Feb 10, 2015

Seattle Genetics Inc. announced that they will report Q4, 2014 results at 4:30 PM, US Eastern Standard Time on Feb 10, 2015

 

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