Seattle Genetics, Inc.NASDAQ
Seattle Genetics: Zen And Resolve
Sun, Dec. 4, 3:20 PM
- Results from a Phase 1b clinical trial assessing Seattle Genetics' (NASDAQ:SGEN) Orphan Drug-tagged vadastuximab talirine (SGN-CD33A) showed a treatment benefit in newly diagnosed patients with acute myeloid leukemia (AML). The data were presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- In 42 evaluable patients, 76% (n=32/42) achieved complete remission or complete remission with incomplete platelet or neutrophil recovery. 94% (n=30/32) of the remissions occurred after one cycle of therapy. In higher-risk patients, 86% (n=18/21) achieved remissions. Median overall survival has yet to be reached. 30-day mortality was 2%. Half (n=21/42) subsequently received an allogeneic stem cell transplant.
- The most common grade 3 (severe) or grade 4 (life threatening) treatment-emergent adverse events occurring in at least 20% of patients were febrile neutropenia, thrombocytopenia, anemia and neutropenia (specific incidence rates not provided).
- Vadastuximab talirine is an antibody-drug conjugate comprised of a cysteine monoclonal antibody linked to a highly potent DNA binding agent. The antibody binds to CD33, a transmembrane receptor expressed on acute myeloid leukemia cells. It is being investigated across multiple lines of therapy in patients with myeloid malignancies.
Tue, Nov. 29, 3:28 PM
- Barclays' Geoff Meacham has downgraded BioMarin Pharmaceutical (BMRN -1.4%), Johnson & Johnson (JNJ -0.5%), Seattle Genetics (SGEN -0.2%), United Therapeutics (UTHR -4.1%) and Vertex Pharmaceuticals (VRTX -0.9%) to Equal Weight from Overweight.
- He trimmed BMRN's price target to $105 (21% upside) from $125 citing "moderating growth and an overall lack of catalysts in 2017."
- J&J's price target was sliced to $125 (11% upside) from $130 due to a "less compelling risk/reward profile."
- SGEN's fair value target was lowered to $53 (21% downside risk) from $70 due to valuation.
- UTHR's price target was revised to $100 (21% downside risk) from $115 citing the likely impact of Uptravi on Orenitram uptake.
- He lowered Vertex's price target to $90 (5% upside) from $100 citing the lack of upside for Kalydeco and Orkambi.
Tue, Nov. 22, 3:31 PM
- As expected, the European Commission approves the use of Bristol-Myers Squibb's (BMY -0.7%) Opdivo (nivolumab) for the treatment of adult patients with relapsed/refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with Seattle Genetics' (SGEN -4.1%) ADCETRIS (brentuximab vedotin).
- Advisory committee CHMP adopted a positive opinion backing approval in October.
Thu, Nov. 10, 10:35 AM
- The FDA designates Seattle Genetics' (SGEN -4.6%) ADCETRIS (brentuximab vedotin) a Breakthrough Therapy for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who have received one prior line of therapy.
- MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma, accounting for more that 75% of cases.
- Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
- ADCETRIS is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached to microtubule disrupting agent, monomethyl auristatin E (MMAE). The linker system it uses is designed to be stable in the bloodstream but releases MMAE when it binds to CD30-expressing cancer cells. It is approved in the U.S. for the treatment of certain lymphomas.
Tue, Nov. 8, 9:26 AM
- A total of 452 patients have been enrolled in a global Phase 3 clinical trial, ECHELON-2, assessing Seattle Genetics (NASDAQ:SGEN) and Takeda Pharmaceutical Company's (OTCPK:TKPHF)(OTCPK:TKPYY) ADCETRIS (brentuximab vedotin), in combination with chemotherapy, in treatment-naive patients with CD30-positive mature T-cell lymphoma (MTCL).
- Participants will be randomized 1:1 to receive either ADCETRIS plus the chemo regimen CHP (cyclophosphamide, doxorubicin, prednisone) or the chemo regiment CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), the standard-of-care frontline treatment for MTCL. The primary endpoint is progression-free survival. According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is December 2017. The estimated study completion date is December 2019.
- ADCETRIS, an antibody-drug conjugate, is being co-developed by the two companies. Seattle Genetics has commercialization rights in the U.S. and Canada and Takeda has commercialization rights elsewhere. It is currently approved in the U.S. for the treatment of certain types of lymphoma.
Thu, Oct. 27, 4:10 PM
Wed, Oct. 26, 5:35 PM
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Fri, Oct. 14, 7:17 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for the treatment of patients with relapsed/refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin [Seattle Genetics' (NASDAQ:SGEN) ADCETRIS].
- Clinical studies showed Opdivo delivered an objective response rate (ORR) of 66% in these patients.
- A final decision from the European Commission usually takes ~60 days.
Fri, Sep. 16, 12:07 PM
- C.R. Bard (NYSE:BCR) upgraded to Outperform from Market Perform by Wells Fargo.
- DexCom (NASDAQ:DXCM) upgraded to Buy from Hold by Desjardins. Downgraded to Neutral from Buy with a $92 (1% downside risk) price target by BTIG Research.
- Alimera Sciences (NASDAQ:ALIM) upgraded to Outperform from Market Perform by Cowen & Company.
- Seattle Genetics (NASDAQ:SGEN) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $47 (13% downside risk) from $30.
- Akorn (NASDAQ:AKRX) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $34 (19% upside) from $33.
- Community Health Systems (NYSE:CYH) upgraded to Positive from Neutral by Susquehanna. Price target raised to $18 (66% upside).
- AstraZeneca (NYSE:AZN) upgraded to Buy from Hold by Jefferies. Price target raised to GBX 5,800 (14% upside) from GBX 5,400. Downgraded to Neutral from Outperform with a GBX 5,200 (2% upside) price target by BNP Paribas.
- McKesson (NYSE:MCK) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $189 (15% upside) from $210.
- Cardinal Health (NYSE:CAH) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $83 (8% upside) from $90.
- Novavax (NASDAQ:NVAX) downgraded to Neutral from Outperform by Wedbush. Price target lowered to $2 (44% upside) from $14. Downgraded to Neutral from Buy by Citigroup. Price target lowered to $1.50 (8% upside) from $12. Downgraded to Neutral from Overweight by JPMorgan and Piper Jaffray.
- Raptor Pharmaceutical (NASDAQ:RPTP) downgraded to Market Perform from Outperform by Cowen & Company.
- Vitae Pharmaceuticals (NASDAQ:VTAE) downgraded to Market Perform from Outperform by BMO Capital.
- Atara Biotherapeutics (NASDAQ:ATRA) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $16 (18% downside risk) from $23.
- GlaxoSmithKline (NYSE:GSK) downgraded to Underperform from Neutral with a GBX 1,520 (6% downside risk) price target by BNP Paribas.
- Applied Genetic Technologies (NASDAQ:AGTC) downgraded to Neutral from Buy by Roth Capital. Price target lowered to $12 (34% upside) from $34. Downgraded to Hold from Buy by Cantor Fitzgerald. Price target lowered to $15 (68% upside) from $32.
- Cepheid (NASDAQ:CPHD) downgraded to Neutral from Outperform by Baird.
Fri, Sep. 9, 9:51 AM
- Quest Diagnostics (NYSE:DGX) initiated with Neutral rating and $86 (4% upside) price target by Citigroup.
- Seattle Genetics (NASDAQ:SGEN) initiated with Overweight rating and $60 (19% upside) price target by Morgan Stanley.
- Pacira Pharmaceuticals (NASDAQ:PCRX) initiated with Market Perform rating by Cowen & Company.
- Medpace Holdings (Pending:MEDP) initiated with Outperform rating and $35 (19% upside) price target by Credit Suisse. Initiated with Buy rating and $35 price target by UBS.
- Gemphire Therapeutics (Pending:GEMP) initiated with Buy rating and $20 (61% upside) price target by Laidlaw.
- DaVita Healthcare (NYSE:DVA) initiated with Neutral rating and $71 (11% upside) price target by Citigroup.
- AbbVie (NYSE:ABBV) initiated with Outperform rating and $82 (29% upside) price target by Raymond James.
- Spark Therapeutics (NASDAQ:ONCE) initiated with Buy rating and $73 (23% upside) price target by Stifel Nicolaus.
Tue, Jul. 26, 4:03 PM
Mon, Jul. 25, 5:35 PM
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Tue, Jul. 19, 10:50 AM
- Prompted by moderating growth from traditional drug sales, large cap drug/biotech firms have their sights set on developers of cancer therapies, in particular immunotherapies, to boost both their top and bottom lines. Roche (OTCQX:RHHBY -1.5%), Amgen (AMGN +0.1%), Sanofi (SNY -1.3%) and Gilead Sciences (GILD -1.2%) are all actively on the prowl for acquisitions.
- Medivation (MDVN +0.1%), with its prostate cancer drug Xtandi (enzalutamide), is currently in play. Sanofi has been the most aggressive with two unsuccessful bids, but Pfizer (PFE) and Celgene (CELG -0.6%) are supposedly interested.
- Analysts say Incyte (INCY -0.4%), with polycythemia vera and myelofibrosis drug Jakafi (ruxolitinib), and Seattle Genetics (SGEN -0.8%), with lymphoma drug Adcetris (brentuximab vedotin), are the most attractive takeover targets.
- Recent transactions include AbbVie's (ABBV -0.3%) buyout of Stemcentryx, Jazz Pharmaceuticals' (JAZZ -0.8%) takeout of Celator Pharmaceuticals and Bristol-Myers Squibb's (BMY -0.2%) acquisition of Cormorant Pharmaceuticals.
Wed, Jul. 6, 9:11 AM
- Takeda Pharmaceutical (OTCPK:TKPHF) announces that the European Commission (EC) has extended the current conditional marketing authorization of ADCETRIS (brentuximab vedotin) and approved ADCETRIS for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT).
- The approval was based on the Phase 3 AETHERA study which demonstrated a 75% improvement in progression-free survival (PFS) for patients treated with ADCETRIS as consolidation therapy immediately following ASCT.
- ADCETRIS, an antibody-drug conjugate, was co-developed with Seattle Genetics (SGEN) who has commercialization rights in the U.S. and Canada. Takeda has commercialization rights elsewhere.
Fri, May 27, 10:27 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending the extension of the current conditional approval of Takeda Pharmaceutical's (OTCPK:TKPHF)(OTCPK:TKPYY) ADCETRIS (brentuximab) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation (ASCT), an approval first granted in October 2012.
- ADCETRIS, an antibody-drug conjugate, was co-developed with Seattle Genetics (SGEN +1.3%) who has commercialization rights in the U.S. and Canada. Takeda has commercialization rights elsewhere.
- A final decision from the European Commission usually takes ~60 days.
Wed, May 18, 6:58 AM
- The FDA approves Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin [Seattle Genetics' (NASDAQ:SGEN) Adcetris].
- The approval, the first for a PD-1 inhibitor for any type of blood cancer, was based on results from the Phase 1 CheckMate-039 and Phase 2 CheckMate-205 studies. which showed an overall response rate of 65% with a median duration of response of 8.7 months. Full results from -205 will be presented at ASCO in June.
- In the safety population (n=263), 4.2% of patients discontinued treatment due to adverse reactions (AEs) while 23% had a dose delay for an AE. In the efficacy population (n=95), serious AEs occurred in 27% of patients. The most common AEs in -205 and -039 were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (high fever) (24% and 35%), diarrhea (23% and 30%) and cough (22% and 35%).
- Opdivo was previously approved for the treatment of certain types of melanoma, non-small cell lung cancer and kidney cancer.