Wed, Jan. 21, 9:45 AM| Comment!
Mon, Jan. 12, 1:44 PM
- Seattle Genetics (SGEN +5.4%) and Bristol-Myers Squibb (BMY +4.4%) enter into a clinical trial collaboration to evaluate the combination of SGEN's Adcetris (brentuximab vedotin) and BMY's Opdivo (nivolumab) in two Phase 1/2 trials, one in patients with relapsed or refractory Hodgkin lymphoma (HL) and the other in patients with relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL), including diffuse large B-cell lymphoma (DLBCL).
- The trials will commence this year. Additional details about the partnership are undisclosed.
Dec. 8, 2014, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
Oct. 30, 2014, 6:29 PM
- Seattle Genetics (NASDAQ:SGEN) now expects full-year U.S./Canada Adcetris net product sales of $172M-$177M, better than prior guidance of $160M-$170M. Collaboration revenue (also better than expected) is now forecast to total $64M-$68M.
- Q3 Adcetris net sales +32% Y/Y to $48.2M. Collaboration revenue -33% to $19.5M. Costs/expenses -3% to $91.5M.
- SGEN +3.4% AH. Q3 results, PR
Oct. 30, 2014, 4:15 PM
Oct. 14, 2014, 9:29 AM
Sep. 29, 2014, 8:08 AM
- Seattle Genetics (NASDAQ:SGEN) and Takeda Pharmaceutical Co. announce positive results from a 329-patient Phase 3 clinical trial evaluating the safety and efficacy of Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplantation (ASCT) in patients with Hodgkin lymphoma (HL).
- The study met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) compared to placebo. PFS improved 75% as assessed after a minimum of two years post initiation of treatment by an independent central review committee.
- A pre-specified interim analysis of overall survival (OS) showed no statistically significant difference between the treatment arms. Patients in both cohorts with HL progression received a variety of subsequent therapies. Most in the placebo group received Adcetris after progression. A further analysis of OS is planned for 2016.
- Adcetris is approved in over 45 countries for the treatment of relapsed HL and systemic anaplastic large cell lymphoma.
Sep. 26, 2014, 5:37 PM
Sep. 26, 2014, 4:44 PM
- Seattle Genetics (NASDAQ:SGEN) will hold a conference call and webcast on Monday, September 29, 2014 at 5:30 am PT to discuss top-line results from the AETHERA Phase 3 clinical trial evaluating the safety and efficacy of Adcetris (brentuximab vedotin) in patients with Hodgkin lymphoma at risk of relapse following autologous stem cell transplant.
Sep. 10, 2014, 10:21 AM
- Seattle Genetics (SGEN +1.8%) and Denmark-based Genmab A/S collaborate on an antibody-drug conjugate for the potential treatment of solid tumors. Under the terms of the agreement, Genmab will pay SGEN an upfront fee of $11M for the exclusive rights to use its auristatin-based ADC technology with Genmab's HuMax-AXL antibody (expressed in multiple types of solid cancers). SGEN is eligible to receive up to $200M in potential milestone payments and mid-to-high single-digit royalties on net worldwide sales of any resulting products.
- Prior to the start of a Phase 3 clinical trial, SGEN has the option of increasing the royalties to double digits in exchange for a reduction in milestone payments.
- Genmab fully controls development and commercialization activities.
Aug. 22, 2014, 5:36 PM
Aug. 4, 2014, 12:05 PM
- The FDA and the EMA designate AbbVie's anti-epidermal growth factor receptor antibody drug conjugate, ABT-414, an orphan drug for glioblastoma multiforme. The company presented Phase 1 data at ASCO earlier this year.
- The anti-EGFR mAb drug conjugate includes components in-licensed from LIfe Science Pharmaceuticals and Seattle Genetics (SGEN -0.2%).
Jul. 31, 2014, 4:53 PM
- Seattle Genetics (SGEN -1.9%) Q2 results: Total Revenues: $68.3M (-7.2%); Operating Expenses: $86.0M (+6.7%); Operating Loss: ($17.6M) (-151.4%); Net Loss: ($17.6M) (-155.1%); Loss Per Share: ($0.14) (-133.3%); Quick Assets: $349.2M (-6.7%).
- 2014 Guidance: Adcetris product sales in U.S. and Canada: $160M - 170M; R&D expenses: $235M - 250M.
Jul. 31, 2014, 4:06 PM
Jul. 3, 2014, 3:07 PM
May. 1, 2014, 9:29 PM
- Total revenues: $68.3M (+19.2%): product sales: $38.7M (+14.2%), collab/license: $16.9M (-19.5%), royalties: $12.7M (+429%).
- Loss from operations: $16.4M.
- Net loss: $16.3M.
- Quick assets (ex-A/R) at quarter end: $355.4M (-5%).
- Q2 revenue estimate: $64.5M.
- 2014 and 2015 revenue estimates are $263.2M and $331M, respectively.
- (SGEN +1%)
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