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Seattle Genetics, Inc. (SGEN)

- NASDAQ
  • Mon, Apr. 20, 5:06 PM
    • The FDA accepts Seattle Genetics' (NASDAQ:SGEN) supplemental Biologics License Application (sBLA) seeking approval for the use of Adcetris (brentuximab vedotin) as post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression. The application is designated for Priority Review with a PDUFA date of August 18.
    • The data supporting the application was from a Phase 3 trial, AETHERA, that demonstrated that 16 cycles of Adcetris as consolidation therapy immediately following an autologous stem cell transplant (ASCT) extended progression-free survival (PFS) in HL patients at high risk of relapse or progression. The median PFS for the Adcetris cohort was 43 months compared to 24 months for placebo while the two-year PFS was 63% for the Adcetris arm versus 51% for placebo.
    • Adcetris is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached to microtubule disrupting agent, monomethyl auristatin E. It is currently cleared for the treatment of HL patients after failure of ASCT or after failure of at least two prior multi-agent chemo regimens and for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemo regimen.
    • Adcetris accounted for all of the company's 2014 product revenue of $178.2M and 62% of its total revenues of $286.8M.
    | 1 Comment
  • Wed, Feb. 18, 9:50 AM
    • Seattle Genetics (SGEN +2.4%) submits a supplemental Biologics License Application (sBLA) to the FDA for the use 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 currently cleared for the treatment of HL after failure of autologous stem cell transplant or, for HL patients who are not candidates for ASCT, after failure of at least two multi-agent chemotherapy regimens and systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemo regimen.
    • President & CEO Clay B. Siegall, Ph.D., says, "With approximately half of all Hodgkin lymphoma patients who undergo an autologous stem cell transplant experiencing disease relapse, there is a significant need to identify regimens that extend progression-free survival (PFS). Results from the AETHERA trial demonstrated that treating high risk Hodgkin lymphoma patients with Adcetris following [ASCT] resulted in a statistically significant improvement in PFS with a manageable safety profile. We believe that this is clinically meaningful and supports a label expansion for Adcetris in this setting."
    • Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
    | 1 Comment
  • Wed, Feb. 11, 7:49 AM
    • Seattle Genetics (SGEN -1.8%) Q4 results: Revenues: $74.3M (+10.2%); COGS: $5M (+31.6%); R&D Expense: $64M (+26.0%); SG&A: $29.4M (+15.3%); Operating Loss: ($27.7M) (-76.4%); Net Loss: ($26.7M) (-70.1%); Loss Per Share: ($0.22) (-69.2%).
    • FY2014 results: Revenues: $286.8M (+6.5%); COGS: $17.5M (+26.8%); R&D Expense: $230.7M (+5.5%); SG&A: $104.3M (+12.9%); Operating Loss: ($77.4M) (-23.1%); Net Loss: ($76.1M) (-21.8%); Loss Per Share: ($0.62) (-21.6%); Quick Assets: $313.4M (-16.3%).
    • 2015 guidance: ADCETRIS Product Sales: $200M - 210M; Collaboration and License Agreements Revenue: $60M - 70M; R&D expenses: $250M - 275M; SG&A expenses: $105M - 115M.
    | 1 Comment
  • Tue, Feb. 10, 4:07 PM
    • Seattle Genetics (NASDAQ:SGEN): Q4 EPS of -$0.22 beats by $0.03.
    • Revenue of $74.33M (+10.3% Y/Y) beats by $5.19M.
    • Press Release
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  • Mon, Feb. 9, 5:35 PM
  • Wed, Jan. 21, 9:45 AM
    • Seattle Genetics (SGEN +2.6%) will report Q4 and full-year results on February 10 after the close. The conference call will begin at 1:30 pm PT/4:30 pm ET.
    • Consensus views for Q4 and 2014 are losses of ($0.25) and ($0.66) on revenues of $68.4M and $280.9M, respectively.
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  • 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.
    | 2 Comments
  • 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%)
    | 1 Comment
  • 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
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  • Oct. 30, 2014, 4:15 PM
    • Seattle Genetics (NASDAQ:SGEN): Q3 EPS of -$0.13 beats by $0.11.
    • Revenue of $75.85M (+6.9% Y/Y) beats by $8.93M.
    • Shares +3.55%.
    • Press Release
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  • Oct. 14, 2014, 9:29 AM
    • Seattle Genetics (NASDAQ:SGEN) will report Q3 results on October 30 after the close. The conference call will begin at 1:30 pm PT/4:30 pm ET.
    • Consensus view is a loss of ($0.24) per share on revenues of $67M.
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  • 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.
    | 5 Comments
  • Sep. 26, 2014, 5:37 PM
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  • 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.
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  • 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.
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  • Aug. 22, 2014, 5:36 PM
    | 2 Comments
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Company Description
Seattle Genetics Inc is a biotechnology company. It develops and commercializes monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease.
Sector: Healthcare
Industry: Biotechnology
Country: United States