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Seagen Inc

Seagen Inc (SGEN)

228.74
0.00
(0.00%)
At close: March 28 04:00PM
228.74
0.00
( 0.00% )

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Key stats and details

Current Price
228.74
Bid
228.74
Ask
228.74
Volume
-
0.00 Day's Range 0.00
184.815 52 Week Range 228.96
Previous Close
228.74
Open
-
Last Trade
Last Trade Time
-
Average Volume (3m)
-
Financial Volume
-
VWAP
-

SGEN Latest News

Wall Street Highlights: HPE and Juniper Networks in Negotiations, Elliott Invests $1 Billion in Match Group, and More

U.S. index futures are registering a decline in pre-market trading this Tuesday, suggesting that the enthusiasm generated by the technology-driven recovery yesterday is losing steam. At 05:46 AM...

Form 15-12G - Securities registration termination [Section 12(g)]

    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549     FORM 15     CERTIFICATION AND NOTICE OF TERMINATION OF REGISTRATION UNDER...

Form 4 - Statement of changes in beneficial ownership of securities

SEC Form 4 FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIPFiled pursuant to Section 16(a) of the Securities Exchange...

Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend]

    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 35)   Seagen Inc...

Form 4 - Statement of changes in beneficial ownership of securities

SEC Form 4 FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIPFiled pursuant to Section 16(a) of the Securities Exchange...

Form 4 - Statement of changes in beneficial ownership of securities

SEC Form 4 FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIPFiled pursuant to Section 16(a) of the Securities Exchange...

Form 4 - Statement of changes in beneficial ownership of securities

SEC Form 4 FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIPFiled pursuant to Section 16(a) of the Securities Exchange...

Form 4 - Statement of changes in beneficial ownership of securities

SEC Form 4 FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIPFiled pursuant to Section 16(a) of the Securities Exchange...

Form 4 - Statement of changes in beneficial ownership of securities

SEC Form 4 FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIPFiled pursuant to Section 16(a) of the Securities Exchange...

Form 4 - Statement of changes in beneficial ownership of securities

SEC Form 4 FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIPFiled pursuant to Section 16(a) of the Securities Exchange...

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
10000000CS
40000000CS
120000000CS
2615.847.44011272898212.9228.962111847703219.11951021CS
5229.1414.5991983968199.6228.96184.8151504048206.93348965CS
15689.163.8069321111139.64228.96105.431157126170.41980863CS
260152.87201.48938974675.87228.9662.91116819153.61506299CS

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SGEN Discussion

View Posts
vinmantoo vinmantoo 3 months ago
Going, going, gone!
👍️0
vinmantoo vinmantoo 4 months ago
The PFE buyout of SGEN will be completed this week. The actual date is December 14th.

https://finance.yahoo.com/news/pfizer-gets-ok-43-billion-120551004.html
👍️0
Monksdream Monksdream 6 months ago
SGEN new 52 week high
👍️0
vinmantoo vinmantoo 7 months ago
Good news for SGEN shareholders as the PFE buyout is likely to be approved too.

https://www.cnbc.com/2023/09/01/ftc-allows-amgen-horizon-therapeutics-deal-to-move-forward.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
👍️0
vinmantoo vinmantoo 1 year ago
Up $18+ or >13% is my idea of a nice day.
👍️0
MiamiGent MiamiGent 1 year ago
SGEN $139.77 +$1.76 a share (+1.275%)
as of 1/26/2023 10:21AM ET

Previous Close 01/25/2023 $138.01

https://stockcharts.com/h-sc/ui?s=SGEN
👍️0
MiamiGent MiamiGent 1 year ago
Re: MiamiGent post# 631252
Wednesday, January 25, 2023 9:38:00 PM
Post# 631302

SGEN up yet again on a red day!
Quote as of 1/25/2023 4:00PM ET
$138.01 +$1.16/share (+0.848%)

Volume
733,999
90 Day Avg. Vol.
959,305

Previous Close 01/24/2023 $136.85

Today's Low $135.35 - High $138.07

Once again, end of day buying and closing near high of day. Me thinks something may be up.

https://stockcharts.com/h-sc/ui?s=SGEN

MG
👍️0
MiamiGent MiamiGent 1 year ago
Good morning Larry.

Last day in South Florida before next trip out

I want to buy more SGEN but I'll need to make some extra money.
Two options I'm considering are catching pythons in the everglades ($50 ea.) or smuggling extra large eggs from Mexico.
👍️0
MiamiGent MiamiGent 1 year ago
SGEN Steady climb now on a red day.
Someone may know something.
Merck thought to have been interested this summer.

With SGEN notching another approval on 1/20/23, it is only getting more expensive for interested suitor(s).

Just idle speculation but a promising stock, in any event.

MG
👍️0
Protocola Protocola 2 years ago
HUGE gains for $SGEN shares down the road = more people getting boosted w/MRNA vaccines...$MRK BO can't hurt either!!!
👍️0
Phosphene Phosphene 2 years ago
Astellas Pharma, Seagen Get CHMP Positive Opinion for Padcev

The CHMP recommendation is based on data from a phase 3 trial.

https://www.marketwatch.com/story/astellas-pharma-seagen-get-chmp-positive-opinion-for-padcev-271639742858

👍️0
Phosphene Phosphene 3 years ago
Seagen and Astellas’ Padcev for Urothelial Cancer

https://www.biospace.com/article/fda-action-alert-amgen-seagen-astellas-enzon-sesen-biomarin-and-axsome/
👍️0
Phosphene Phosphene 3 years ago
Seagen, RemeGen Ink $2.6B License Agreement for Anti-HER2 Drug Disitamab Vedotin

Aug 13, 2021

https://www.precisiononcologynews.com/business-news/seagen-remegen-ink-26b-license-agreement-anti-her2-drug-disitamab-vedotin#.YR2e8mjYq3A
👍️0
Phosphene Phosphene 3 years ago
EMA Committee Recommends Approval for Seagen's Tukysa in Advanced HER2-Positive Breast Cancer

https://www.precisiononcologynews.com/regulatory-news-fda-approvals/ema-committee-recommends-approval-seagens-tukysa-advanced-her2#.X9YNotHYq3A
👍️0
whytestocks whytestocks 3 years ago
BREAKING NEWS: $SGEN 3 Top Growth Stocks to Buy on the Dip

The markets are doing well in November, with the S&P 500 soaring more than 8% over the first half of this month. However, not all stocks are rising, and there are even some attractive growth stocks that have been struggling of late. Investors may want to consider buying them today w...

Read the whole news SGEN - 3 Top Growth Stocks to Buy on the Dip
👍️0
Phosphene Phosphene 3 years ago
Seattle Genetics (SGEN) to Release Earnings on 10/29/20

https://www.marketbeat.com/instant-alerts/nasdaq-sgen-earnings-date-2020-10/
👍️0
vinmantoo vinmantoo 3 years ago
As a longtime SGEN shareholder, this price rise to well over $200 is stunning and extremely satisfying.
👍️0
Phosphene Phosphene 3 years ago
Seattle Genetics shortens name to Seagen, dropping local connection as it goes global

https://www.fiercepharma.com/marketing/seattle-genetics-shortens-name-to-seagen-dropping-local-seattle-as-it-goes-global
👍️0
Phosphene Phosphene 3 years ago
Merck & Co to buy $1bn stake in Seattle Genetics

https://www.lifesciencesipreview.com/news/merck-co-to-buy-1bn-stake-in-seattle-genetics-4195
👍️0
Phosphene Phosphene 3 years ago
Seattle Genetics plans manufacturing expansion with cash from Merck deal
👍️0
Phosphene Phosphene 4 years ago
Seattle Genetics and Genmab Present Data from Tisotumab Vedotin innovaTV 204 Pivotal Trial in Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2020

https://www.businesswire.com/news/home/20200921005214/en/Seattle-Genetics-and-Genmab-Present-Data-from-Tisotumab-Vedotin-innovaTV-204-Pivotal-Trial-in-Recurrent-or-Metastatic-Cervical-Cancer-at-ESMO-Virtual-Congress-2020
👍️0
Phosphene Phosphene 4 years ago
Astellas, Seattle Genetics' Padcev bladder cancer trial stops early with 30% death risk reduction

https://www.fiercepharma.com/pharma/astellas-seattle-genetics-padcev-bladder-cancer-trial-stops-early-30-death-risk-reduction
👍️0
whytestocks whytestocks 4 years ago
Breaking News: $SGEN Merck Inks Multibillion-Dollar Deal With Seattle Genetics, Including Equity

Merck & Co   (NYSE: MRK)  and Seattle Genetics (NASDAQ: SGEN) have agreed to terms in a licensing and equity-investment deal that could be worth $4.2 billion to Seattle Genetics. Specifically, Merck's paying $600 million upfront and up to $2.6 billion in progress-determined...

Find out more SGEN - Merck Inks Multibillion-Dollar Deal With Seattle Genetics, Including Equity
👍️0
whytestocks whytestocks 4 years ago
NEWS: $SGEN Seattle Genetics and Merck Announce Two Strategic Oncology Collaborations

Companies to Co-Develop and Co-Commercialize Seattle Genetics’ Antibody-Drug Conjugate Ladiratuzumab Vedotin Globally; Merck to Acquire $1 Billion Equity Stake in Seattle Genetics Common Stock Companies Enter Exclusive License and Co-Development Agreement to Accelerate Global Re...

In case you are interested SGEN - Seattle Genetics and Merck Announce Two Strategic Oncology Collaborations
👍️0
Phosphene Phosphene 4 years ago
The Baker Brothers have 27% ownership.

https://whalewisdom.com/filer/baker-bros-advisors-llc#tabholdings_tab_link
👍️0
Phosphene Phosphene 4 years ago
Seattle Genetics to Receive Milestone Payment Under ADC Collaboration with GlaxoSmithKline Following European Commission Approval of BLENREP (belantamab mafodotin)

https://www.businesswire.com/news/home/20200827005212/en/Seattle-Genetics-Receive-Milestone-Payment-ADC-Collaboration
👍️0
Phosphene Phosphene 4 years ago
Seattle Genetics Appoints Ted W. Love, M.D., to Board of Directors

https://www.businesswire.com/news/home/20200818005140/en/Seattle-Genetics-Appoints-Ted-W.-Love-M.D.
👍️0
T695 T695 4 years ago
Hmmm maybe US deny for now
👍️0
Phosphene Phosphene 4 years ago
Seattle Genetics gets FDA approval for breast cancer treatment drug Tukysa

https://www.geekwire.com/2020/seattle-genetics-gets-fda-approval-breast-cancer-treatment-drug-tukysa/
👍️0
Phosphene Phosphene 4 years ago
How a Seattle Genetics cancer drug could help lupus patients with kidney damage

https://www.fiercebiotech.com/research/how-a-seattle-genetics-cancer-drug-could-help-lupus-patients-kidney-damage
👍️0
mellow fellow mellow fellow 4 years ago
https://mobile.twitter.com/SeattleGenetics/status/1220436036997660672
👍️0
mellow fellow mellow fellow 4 years ago

Seattle Genetics Achieves Milestone Following European Commission Approval of Roche’s Polivy® (Polatuzumab Vedotin)

Business WireJanuary 21, 2020, 8:00 AM EST

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that it will receive a milestone payment from Roche triggered by European Commission conditional marketing authorisation for Polivy® (polatuzumab vedotin). Polivy is an antibody-drug conjugate (ADC) that utilizes Seattle Genetics’ technology. It was developed and is commercialized by Roche/Genentech. Polivy was approved in combination with bendamustine plus MabThera® (rituximab) (BR) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a haematopoietic stem cell transplant. Polivy was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of people with R/R DLBCL in 2017.

"In addition to our two marketed ADC products ADCETRIS® (brentuximab vedotin) and the recently FDA-approved PADCEV™ (enfortumab vedotin-ejfv), the European Commission approval of Polivy highlights the increasing importance of ADCs in the treatment of cancer," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Across our internal and collaborator pipelines, there are more than ten ADCs in clinical development employing our proprietary technology. We continue to lead in the field of ADCs with our novel linker systems, cell-killing payloads and conjugation technologies."

Seattle Genetics’ ADC technology combines the specificity of monoclonal antibodies, innovative linker systems and potent cell-killing agents to treat cancer. The technology has been licensed to several companies, including Roche/Genentech and GlaxoSmithKline. Under the terms of these agreements, each licensee company has rights to use the technology with antibodies against specified targets. The licensee is responsible for research, product development, manufacturing and commercialization. Seattle Genetics is entitled to receive fees, progress-dependent milestone payments and royalties on worldwide net sales of any resulting ADC products.

👍️0
whytestocks whytestocks 4 years ago
$SGEN bears are running Seattle Genetics Inc Nasdaq Sgen Short Squeeze
👍️0
Phosphene Phosphene 4 years ago
Seattle Genetics will receive an upfront payment and is eligible to receive progress-dependent milestones for a total deal value of up to $160 million and tiered royalties on any product sales.

https://pipelinereview.com/index.php/2019110672784/More-News/Seattle-Genetics-and-BeiGene-Announce-Global-License-Agreement-for-Advanced-Preclinical-Product-Candidate.html
👍️0
whytestocks whytestocks 4 years ago
News: $SGEN Seattle Genetics Announces Positive Topline Results from Pivotal Trial of Tucatinib in Locally Advanced or Metastatic HER2-Positive Breast Cancer

-HER2CLIMB Trial Met Primary Endpoint and Both Key Secondary Endpoints- -Global Regulatory Strategy Includes NDA Submission to U.S. FDA Planned for First Quarter of 2020- -Data to be Presented at the 2019 San Antonio Breast Cancer Symposium- -Company to Host Conference Call ...

Find out more SGEN - Seattle Genetics Announces Positive Topline Results from Pivotal Trial of Tucatinib in Locally Advanced or Metastatic HER2-Positive Breast Cancer
👍️0
whytestocks whytestocks 4 years ago
News: $SGEN Here's Why Seattle Genetics Stock Jumped Higher Today

Shares of Seattle Genetics (NASDAQ: SGEN) are up 12% at 12:05 p.m. EDT after the biotech presented a pair of positive clinical trial results at the 2019 European Society for Medical Oncology (ESMO) Congress. In a phase 2 clinical trial testing Seattle Genetics' tucatinib with Roche 's Herc...

Read the whole news SGEN - Here's Why Seattle Genetics Stock Jumped Higher Today
👍️0
whytestocks whytestocks 4 years ago
News: $SGEN Initial Results from MOUNTAINEER Trial Show Antitumor Activity of Tucatinib Combination in HER2-Positive Metastatic Colorectal Cancer

- First Presentation of Tucatinib With Trastuzumab in Metastatic Colorectal Cancer - - Findings Presented Today at the European Society for Medical Oncology (ESMO) 2019 Congress - Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that initial data were presented from the si...

Got this from SGEN - Initial Results from MOUNTAINEER Trial Show Antitumor Activity of Tucatinib Combination in HER2-Positive Metastatic Colorectal Cancer
👍️0
whytestocks whytestocks 4 years ago
News: $SGEN Seattle Genetics and Astellas Announce Results from Phase 1 Trial of Investigational Agent Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Bladder Cancer

- Study Met Outcomes for Safety and 71 Percent of Patients with Locally Advanced or Metastatic Urothelial (Bladder) Cancer Had a Confirmed Response - - Findings Presented Today at an Oral Session at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona - ...

Find out more SGEN - Seattle Genetics and Astellas Announce Results from Phase 1 Trial of Investigational Agent Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Bladder Cancer
👍️0
PennyStock Alert PennyStock Alert 5 years ago
SGEN DAY
👍️0
crudeoil24 crudeoil24 5 years ago
“The current standard of care for initial treatment of peripheral T-cell lymphoma is multi-agent chemotherapy. That treatment has not significantly changed in decades and is too often unsuccessful in leading to long-term remissions, underscoring the need for new treatments,” said Steven Horwitz, M.D., Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York. “The ECHELON-2 clinical trial demonstrated ADCETRIS plus CHP was superior to the current standard of care, CHOP, for both progression-free survival and all other key secondary endpoints, including, most importantly, overall survival. With this approval, clinicians have the opportunity to transform the way newly diagnosed CD30-expressing PTCL patients are treated.”

This is the sixth FDA-approved indication for ADCETRIS, which also has approval for adult patients with: (1) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine (AVD), (2) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (3) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (4) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

“By participating in the FDA’s Real-Time Oncology Review process and working closely with the FDA, we are now able to make the ADCETRIS regimen available to previously untreated patients with CD30-expressing PTCL in an unprecedented less than two weeks after submission of our supplemental BLA,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The ECHELON-2 clinical trial demonstrated ADCETRIS plus CHP results in a superior outcome for patients when compared to current standard of care, CHOP. We want to thank the patients, physicians and their staff who participated in the ECHELON-2 trial, which supported this FDA approval.”

The ECHELON-2 data will be presented at the American Society of Hematology (ASH) 2018 Annual Meeting, on Monday, December 3, 2018, at 6:15 pm PT at the San Diego Convention Center in Room 6F in San Diego, Calif. Patients in ECHELON-2 were randomized to receive either a combination of ADCETRIS plus CHP or CHOP, a recognized standard of care for frontline PTCL. Results from the trial demonstrated that combination treatment with ADCETRIS plus CHP was superior to CHOP for progression free survival (PFS) as assessed by a Blinded Independent Central Review facility (BICR; hazard ratio=0.71; 95% CI, 0.54–0.93; p-value=0.011). This corresponds to a 29 percent reduction in the risk of progression, death, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease. The ADCETRIS plus CHP arm also demonstrated superior overall survival (OS), a key secondary endpoint, compared to CHOP (hazard ratio=0.66; 95% CI, 0.46-0.95; p-value=0.024). All other key secondary endpoints, including PFS in patients with sALCL (hazard ratio=0.59; 95% CI, 0.42-0.84; p-value=0.003), complete remission rate (68% vs 56%; p-value=0.007) and objective response rate (83% vs 72%; p-value=0.003) were statistically significant in favor of the ADCETRIS plus CHP arm.

The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with AVD. The most common adverse events of any grade that occurred in at least 20 percent of patients in the ADCETRIS plus CHP arm were peripheral neuropathy, nausea, diarrhea, neutropenia, lymphopenia, fatigue, mucositis, constipation, alopecia, pyrexia, vomiting and anemia. Serious adverse reactions occurring in at least two percent of ADCETRIS plus CHP-treated patients included febrile neutropenia, pneumonia, pyrexia and sepsis. Based on ECHELON-2 clinical trial results, prophylactic growth factors (G-CSF) should be administered starting at cycle one for patients receiving ADCETRIS plus CHP for previously untreated PTCL.

ECHELON-2 Phase 3 Clinical Trial Design

The multi-center, randomized, double-blind, placebo-controlled phase 3 trial is investigating ADCETRIS plus CHP (cyclophosphamide, doxorubicin, prednisone) versus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) as frontline therapy in patients with CD30-expressing peripheral T-cell lymphoma, also known as mature T-cell lymphoma. The primary endpoint is progression-free survival (PFS) per BICR facility assessment, with events defined as progression, death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease. Secondary endpoints include PFS in patients with systemic anaplastic large cell lymphoma (sALCL), complete remission rate, overall survival and objective response rate, in addition to safety. The trial was conducted at sites across North America, Europe and Asia and was designed to enroll 450 patients, approximately 75 percent of whom were to be diagnosed with sALCL. The ECHELON-2 trial was conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and the trial also received European Medicines Agency (EMA) scientific advice.

Please see Important Safety Information, including Boxed Warning, at the end of this press release.

About T-Cell Lymphomas

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of the estimated 74,680 people diagnosed with non-Hodgkin lymphoma in the U.S. in 2018.1

About ADCETRIS (brentuximab vedotin)

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include the recently completed phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed phase 3 ECHELON-1 trial in previously untreated Hodgkin lymphoma, the completed phase 3 ALCANZA trial in cutaneous T-cell lymphoma, and the ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 72 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

About Seattle Genetics

Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) utilizes the company’s industry-leading antibody-drug conjugate (ADC) technology and is currently approved for the treatment of multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer utilize our proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visit www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

ADCETRIS (brentuximab vedotin) Important Safety Information

BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML):

JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Institute dose modifications accordingly.
Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.
Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS. Start primary prophylaxis with G-CSF beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III or IV classical HL or previously untreated PTCL. Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent ADCETRIS doses.
Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for bacterial, fungal, or viral infections.
Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor and high tumor burden.
Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment compared to patients with normal renal function. Avoid use in patients with severe renal impairment.
Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment compared to patients with normal hepatic function. Avoid use in patients with moderate or severe hepatic impairment.
Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.
PML: Fatal cases of JC virus infection resulting in PML and death have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS therapy, with some cases occurring within 3 months of initial exposure. Other possible contributory factors other than ADCETRIS include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.
Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement.
Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.
Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with preexisting GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, perform a prompt diagnostic evaluation and treat appropriately.
Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus, and to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.
Most Common (≥20% in any study) Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia and mucositis

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

For additional Important Safety Information, including BOXED WARNING, please see the full Prescribing Information for ADCETRIS at www.seattlegenetics.com or http://www.ADCETRIS.com.

Forward-Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the utilization of and therapeutic potential of ADCETRIS (brentuximab vedotin) as a treatment for adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, the possibility that the approved regimen could transform the way newly diagnosed CD30-expressing PTCL patients are treated, and the anticipated presentation of data from the ECHELON-2 clinical trial at ASH in 2018. Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to factors such as utilization and adoption of the approved treatment regimen by prescribing physicians, the availability and extent of reimbursement, the risk of adverse events and adverse regulatory action. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.

References:

1 American Cancer Society, Key Statistics for Non-Hodgkin Lymphoma. Available at https://www.cancer.org/cancer/non-hodgkin-lymphoma.html. Accessed November 2018.



View source version on businesswire.com: https://www.businesswire.com/news/home/20181116005332/en/

Media:
Tricia Larson
(425) 527-4180
tlarson@seagen.com
Investors:
Peggy Pinkston
(425) 527-4160
ppinkston@seagen.com

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crudeoil24 crudeoil24 5 years ago
SGEN is a great $$$$$ opportunity.
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crudeoil24 crudeoil24 5 years ago
Also, Seattle pounded the Packers last night!
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crudeoil24 crudeoil24 5 years ago
Agree!

SGEN is looking to bust $70. I think something is brewing.
© 2018 InvestorsHub.com, Inc.
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crudeoil24 crudeoil24 5 years ago

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626079.htm
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crudeoil24 crudeoil24 5 years ago
Boom! > FDA approves Adcetris > SGEN

The FDA granted this application Priority Review and Breakthrough Therapy designation.

The FDA granted the approval of Adcetris to Seattle Genetics.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626079.htm
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46er 46er 6 years ago
SGEN is looking to bust $70. I think something is brewing.
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BottomBounce BottomBounce 6 years ago
$SGEN OVER BOUGHT. RETRACE TO $20 imo coming
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shub shub 6 years ago
There's a whole little flock of new collaborations and clinical trials either in process or about to launch.
As is proper, we are up 7%!
While my other little bios just squat there, SG roars into the future.
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shub shub 6 years ago
It sure is an incoherent and dispersed bunch of properties.
I've avoided Twitter and FB between the tracking and the level of ambiguous BS.
Back in the '60s when i was in the local salt water aquarium business, we used ozone generators to control bacteria, etc. It's old tech now..Harsh but effective. The pot industry is growing fast , but is tumultuous.
The patio/snow services looks like it could be solid. The game pub stuff looks vulnerable to fad gusts.
The stock , basically, is a low end penny stock with several earmarks that'd invite the seasoned investor to run like crazy!
If management is very talented, it might do very well.
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cdaniel394 cdaniel394 6 years ago
Thanks for the tips. I'll sure take a look. Take a look at the history on Amfil's twitter page. Audits should be done by the 15th and another Snakes opening very soon.
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