Seattle Genetics: Zen And Resolve
Risk And Reward Seem Pretty Balanced At Seattle Genetics
Stephen Simpson, CFA
Stephen Simpson, CFA
Weighing Out The Seattle Genetics Barbell
Stephen Simpson, CFA • 11 Comments
Stephen Simpson, CFA • 11 Comments
Mon, Jan. 25, 6:50 AM
- Affimed N.V. (NASDAQ:AFMD) and a subsidiary of Merck (NYSE:MRK) establish a clinical trial collaboration whereby Merck will supply KEYTRUDA (pembrolizumab) to Affimed in a Phase 1b clinical trial assessing the combination of the PD-1 inhibitor and Affimed's lead product candidate AFM13 for the treatment of patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with Takeda (OTCPK:TKPHF)(OTCPK:TKPYY) and Seattle Genetics' (NASDAQ:SGEN) ADCETRIS (brentuximab vedotin). The objective of the study, to be conducted by Affimed and expected to commence in H1, is to establish a dosing regimen of the combo as well as its safety and efficacy.
- In preclinical patient derived xenograft models, the combination eradicated up to 90% of tumors. The collaboration may expand to include a Phase 3 trial if the Phase 1b is successful.
- AFM13 is a bispecific antibody that binds to a protein expressed in a range of T-cell and B-cell lymphomas called CD30 and to a protein expressed on the immune system's natural killer cells called CD16A, both of which play key roles in the activation of the immune system to detect and kill cancer cells.
- Shares are up 13% premarket on average volume.
Fri, Jan. 22, 7:43 AM
- The European Commission approves a labeling update to Takeda Pharmaceutical's (OTCPK:TKPHF)(OTCPK:TKPYY) ADCETRIS (brentuximab vedotin) to included data on the retreatment of adult patients with relapsed/refractory Hodgkin lymphoma or relapsed/refractory systemic anaplastic large cell lymphoma who previously responded to ADCETRIS but later relapsed.
- ADCETRIS was conditionally approved in the EU in 2012 for the treatment of relapsed/refractory CD30+ Hodgkin lymphoma following autologous stem cell transplantation (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and for relapsed/refractory systemic anaplastic large cell lymphoma.
- The updated labeling includes data from the Phase 2 SGN35-006 study that showed retreatment with ADCETRIS produced effective anti-tumor responses in the majority of relapsed/refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma patients.
- 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.
- ADCETRIS was co-developed with Seattle Genetics (NASDAQ:SGEN) under a December 2009 collaboration agreement. SGEN has commercialization rights in the U.S. and Canada and Takeda has rights elsewhere.
Tue, Jan. 19, 5:39 PM
Dec. 23, 2015, 9:55 AM
- Seattle Genetics (SGEN +1.2%) and clinical collaborator Bristol-Myers Squibb (BMY +0.3%) announce the initiation of a Phase 1/2 trial assessing the combination of ADCETRIS (brentuximab vedotin) and Opdivo (nivolumab) in patients with CD30-expressing relapsed/refractory B-cell or T-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and cutaneous T-cell lymphoma.
- The 120-subject study is the second of two trials under the companies' previously announced clinical trial collaboration. The Phase 1 portion will assess the optimal dose of the combination. The Phase 2 portion will expand enrollment to treat disease-specific cohorts at the recommended dose and treatment schedule. The primary endpoints are safety, tolerability and overall response rate at month 8 following the last dose.
- According to clinicaltrials.gov, the estimated final data collection date for the primary endpoints is November 2017. The estimated study completion date is November 2018.
- ADCETRIS is an antibody-drug conjugate (NYSE:ADC) 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.
- Opdivo is an programmed death receptor-1 (PD-1) immune checkpoint inhibitor that activates the immune system's T cells to detect and attack cancer cells.
Nov. 23, 2015, 9:54 AM
- Seattle Genetics (SGEN -1.2%) commences a Phase 1/2 clinical trial assessing antibody-drug conjugate (ADC) SGN-CD33A as a preconditioning regimen prior to an allogeneic stem cell transplant (alloSCT) and maintenance therapy following transplant in patients with relapsed/refractory acute myeloid leukemia (AML).
- The study will have two parts, A &B. Part A will assess SGN-CD33A as a preconditioning therapy and Part B will assess it as a maintenance therapy. Enrollment will proceed concurrently. The primary endpoints in Part A are the maximum tolerated dose and the safety and tolerability of SGN-CD33A in both pre- and post-alloSCT settings. The primary endpoints of Part B are one-year survival rates, the rate of minimal residual disease negativity and safety and tolerability of SGN-CD33A at the recommended dose.
- SGN-CD33A targets CD33, a transmembrane receptor expressed on almost all AML cells. ADCs are designed to selectively deliver cancer-killing drugs to tumor cells.
Nov. 20, 2015, 1:22 PM
- Sucampo Pharmaceuticals (SCMP -0.3%) initiated with Hold rating and $19 (10% upside) price target by Jefferies.
- BioMarin Pharmaceutical (BMRN -4.8%) initiated with Buy rating and $158 (61% upside) price target; bluebird bio (BLUE +1.2%) with a Buy rating and $165 (104% upside) price target; Incyte (INCY -3.2%) with a Buy rating and $135 (20% upside) price target; Kite Pharma (KITE -0.2%) with a Buy rating and $111 (32% upside) price target and Seattle Genetics (SGEN +0.1%) with a Sell rating and $33 (25% downside risk) price target by Goldman Sachs.
- Mylan (MYL +0.4%) initiated with Overweight rating and $62 (21% upside) price target by Morgan Stanley.
- Athenahealth (ATHN +0.4%) initiated with Overweight rating and $170 (7% upside) price target and Allscripts Healthcare Solutions (MDRX +0.5%) with an Overweight rating and $17 (14% upside) price target by J.P. Morgan.
- Genomic Health (GHDX -0.7%) upgraded to Outperform from Market Perform by Cowen & Co. Price target raised to $35 (21% upside) from $27.
- Shire plc (SHPG -0.9%) upgraded to Outperform from Market Perform by Leerink. Price target raised to $239 (12% upside) from $220.
- Cempra (CEMP -0.5%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $38 (30% upside) from $25.
- Athenahealth (ATHN +0.4%) downgraded to Underweight from Equal Weight by Barclays. Price target lowered to $110 (31% downside risk) from $140.
- Osiris Therapeutics (OSIR +1.9%) downgraded to Sell from Hold by Brean Capital. Price target is $8 (25% downside risk).
- Endo International (ENDP -0.3%) downgraded to Neutral from Buy by Mizuho. Price target lowered to $55 from $82 (7% downside risk).
- Kite Pharma (KITE -0.2%) downgraded to Hold from Buy by Standpoint Research. Price target maintained at $100 (19% upside).
Nov. 18, 2015, 7:23 AM
- Price target: $33 (implied downside 27%).
- Firm says Adcetris upside through label expansion is already baked into the stock. Says SGEN's pipeline outlook is unclear.
- Among 15 analysts, Goldman is the only firm with a Sell rating on SGEN. Street low, prior to Goldman's initiation, was $40.50 (Cowen's Dr. Boris Peaker).
- On Oct. 30, Needham ($60 price target) said it expects continued growth from Adcetris as it penetrates this market and expands its label further in the coming years, and noted SGEN is making progress with proprietary pipeline of antibody drug conjugates (ADCs). "We look for significant updates on these and other programs at ASH in December. We continue to view SGEN as one of the few mid-cap biotech companies with the ability to grow into a sustainable large cap drug developer."
- Related: Seattle Genetics: Zen And Resolve (Feb. 19 2015)
Oct. 30, 2015, 7:25 AM
- Seattle Genetics (SGEN -2%) Q3 results: Revenues: $84.1M (+10.8%); COGS: $10.1M (+32.9%); R&D Expense: $70.8M (+21.0%); SG&A: $29.7M (+17.4%); Operating Loss: ($26.5M) (-69.9%); Net Loss: ($26.4M) (-69.2%); Loss Per Share: ($0.21) (-61.5%); Quick Assets: $736.5M (+135.0%).
- No guidance given.
Oct. 29, 2015, 4:10 PM
- Seattle Genetics (NASDAQ:SGEN): Q3 EPS of -$0.21 misses by $0.01.
- Revenue of $84.1M (+10.9% Y/Y) beats by $1.43M.
- Shares +1.75%.
Oct. 29, 2015, 9:31 AM
- Seattle Genetics (NASDAQ:SGEN) initiates a randomized Phase 2 clinical trial evaluating denintuzumab mafodotin (SGN-CD19A), in combination with the second-line salvage regimen of Roche's (OTCQX:RHHBY) Rituxan (rituximab), ifosfamide, carboplatin and etoposide (RICE), for the treatment of relapse/refractory diffuse large B-cell lymphoma (DLBCL). The 150-subject, open-label study will compare the combination regimen to RICE alone. The primary endpoint is the comparison of complete remission rates between the two treatment arms.
- Denintuzumab mafodotin is an antibody-drug conjugate (ADC) targeting CD19, a protein highly expressed on the surface of malignant B cells.
Oct. 28, 2015, 5:35 PM
- ARAY, ARI, ATEN, ATR, AUY, AXTI, AZPN, BCOR, BCOV, BGG, BIDU, BMRN, BVN, BXP, CALX, CATM, CENX, CLW, COLM, CPSI, CPT, CRAY, CTRL, CXP, DCT, DECK, DGI, DGII, DLR, EA, ECOL, EHTH, EMN, EPAY, ESS, EXPE, EXTR, EYES, FE, FLDM, FLR, FLS, FRGI, FSLR, FWM, GB, GNW, HWAY, IM, IMMR, IMPV, ISBC, IXYS, KAMN, KRG, LC, LEG, LNKD, LSCC, MEP, MOBL, MOD, MOH, MTSN, MXWL, NANO, NBIX, NR, NSR, NUS, OIS, OMCL, ON, OSIS, OUTR, PCCC, PDFS, PRMW, PSMT, QTM, RGA, RKUS, RSG, SAAS, SAM, SBUX, SCTY, SEM, SGEN, SHO, TMST, TNAV, TNDM, TRMB, TSRO, TSYS, TUES, VR, WRI, WU, WWWW, YRCW
Oct. 27, 2015, 11:32 AM
- Seattle Genetics (SGEN +3.1%) and development partner Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) announce the completion of enrollment in a Phase 3 study, called ECHELON-1, evaluating ADCETRIS (brentuximab vedotin) as part of a first-line chemotherapy regimen for treatment-naive Hodgkin lymphoma (HL) patients. The ~1,300 participants have been randomized to receive standard-of-care frontline treatment of ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) or the combination of ADCETRIS and AVD (bleomycin removed).
- Data readout is expected in 2017 or 2018. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is December 2019. The estimated study completion date is March 2020.
- ADCETRIS is an antibody-drug conjugate (ADC) 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.
Oct. 19, 2015, 9:32 AM
- Seattle Genetics (NASDAQ:SGEN) initiates a 110-subject, randomized, open-label, multi-center Phase 2 clinical trial assessing ADCETRIS (brentuximab vedotin), in combination with Roche's (OTCQX:RHHBY) Rituxan (rituximab) and bendamustine, in relapsed/refractory patients with CD30-expressing diffuse large B-cell lymphoma (DLBCL). Participants will receive Rituxan and bendamustine, agents commonly used to treat DLBCL, with or without ADCETRIS every three weeks for six cycles. The primary endpoint is the comparison of objective response rates between the treatment arms. Secondary endpoints include progression-free survival, complete remission rate, duration of response and overall survival. The trial is being conducted in ~50 sites across North America and Europe.
- Previously presented data from a Phase 2 study assessing ADCETRIS alone or with Rituxan every three weeks in relapsed/refractory CD30-positive non-Hodgkin lymphoma patients showed an objective response rate of 44% (19% complete remissions) in the ADCETRIS arm and an objective response rate of 46% (15% complete remissions) in the combination arm. The most common treatment-emergent adverse event at least Grade 3 was neutropenia (abnormally low neutrophil [type of white blood cell] count).
- ADCETRIS, an antibody-drug conjugate, is being evaluated in more than 30 ongoing clinical trials.
Oct. 7, 2015, 8:32 AM
- Seattle Genetics (NASDAQ:SGEN) commences a Phase 1/2 clinical trial evaluating the combination of ADCETRIS (brentuximab vedotin) and Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) in patients with relapsed/refractory Hodgkin lymphoma (HL) who have failed first-line treatment. The trial, which will enroll ~60 subjects, is being conducted to see if patient outcomes can be improved by combining ADCETRIS with a checkpoint inhibitor.
- The study is being under the companies' clinical trial collaboration announced in January 2015.
- 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.
- Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is approved in the U.S. for the treatment of metastatic squamous non-small cell lung cancer and metastatic melanoma.
- Previously: Seattle Genetics and Bristol-Myers team up in blood cancer trials (Jan. 12)
Sep. 11, 2015, 6:53 AM
- Seattle Genetics (NASDAQ:SGEN) prices its public offering of 11,707,318 shares of common stock at $41 per share. Gross proceeds of ~$480M is upsized about 20% from the original plan of ~$400M.
- Underwriters over-allotment is an additional 1,756,097 shares. Closing date is September 16.
- Net proceeds will fund the ongoing commercialization of ADCETRIS (brentuximab vedotin) in the U.S. and Canada, R&D to expand ADCETRIS' label, the advancement of product candidates and general corporate purposes.
- Yesterday's close was $41.58.
Sep. 9, 2015, 4:25 PM
- Seattle Genetics (NASDAQ:SGEN) commences a $400M public offering of common stock. Price, volume and terms have yet to be announced.
Seattle Genetics, Inc. is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for cancer. Its product ADCETRIS or brentuximab vedotin has been approved by both U.S. Food and Drug Association and Health Canada in U.S. and Canada... More
Country: United States
Other News & PR