Seagen, Inc.

749 articles with Seagen, Inc.

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  Clinical Catch-Up: June 7-11

  6/14/2021

  A busy week for clinical trial news as the ASCO meeting wrapped up and the European Hematology Association 2021 Virtual Congress began. Read on for more.

• Seagen Announces Long-Term Results from TUKYSA® (tucatinib) Pivotal Trial in Patients with HER2-Positive Breast Cancer During the Virtual Scientific Program of the 2021 ASCO Annual Meeting

  6/3/2021

  Seagen Announces Long-Term Results from TUKYSA ® (tucatinib) Pivotal Trial in Patients with HER2-Positive Breast Cancer During the Virtual Scientific Program of the 2021 ASCO Annual Meeting - Updated Analysis Shows Median Overall Survival for TUKYSA Arm Extended to Two Years, with Benefit Maintained Across All Prespecified Patient Subgroups in HER2CLIMB Trial -

• Seagen and Astellas Announce Updated Results from Two Trials of PADCEV® (enfortumab vedotin-ejfv) in Patients with Locally Advanced or Metastatic Urothelial Cancer Not Eligible for Cisplatin Chemotherapy

  5/19/2021

  Durable Responses Observed in Second Cohort of Patients in Pivotal EV-201 Trial of PADCEV and in Initial First-Line Cohort of the EV-103 Trial Evaluating PADCEV in Combination with KEYTRUDA® (pembrolizumab)

• Seagen to Showcase Data from Growing Oncology Portfolio During Virtual Scientific Program of the 2021 ASCO Annual Meeting

  4/29/2021

  Seagen Inc. (Nasdaq:SGEN) today announced the presentation of new data from its growing pipeline of marketed and investigational therapies at the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held June 4-8.

• Seagen Reports First Quarter 2021 Financial Results

  4/29/2021

  Significant Regulatory Progress Across Diverse Oncology Pipeline, Including European Commission Approval of TUKYSA, Multiple Applications Under Review Globally for PADCEV, and FDA Acceptance of Tisotumab Vedotin BLA

• Seagen and Astellas Announce U.S. FDA Acceptance of Two Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

  4/19/2021

  Seagen and Astellas Announce U.S. FDA Acceptance of Two Supplemental Biologics License Applications for PADCEV ® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

•  Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

  4/9/2021

    Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

• Seagen to Highlight Data from Novel Targeted Therapies at AACR

  4/9/2021

  Seagen Inc. (Nasdaq: SGEN) today announced that preclinical data from its pipeline of novel targeted oncology drugs will be presented at the American Association for Cancer Research (AACR) Annual Meeting being held April 10-15, 2021.

• Seagen and Genmab Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

  4/9/2021

  Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin

• Seagen to Host Conference Call and Webcast Discussion of First Quarter 2021 Financial Results on April 29, 2021

  4/7/2021

  Seagen Inc. (Nasdaq: SGEN) today announced that it will report its first quarter 2021 financial results on Thursday, April 29, 2021 after the close of U.S. financial markets.

• European Medicines Agency Accepts Marketing Authorization Application for Enfortumab Vedotin

  3/26/2021

  Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer

• Pieris Announces Amendment of Existing Immuno-oncology Multi-target Collaboration with Seagen

  3/25/2021

  Seagen will supply Pieris with TUKYS to evaluate the drug in combination with cinrebafusp alfa (PRS-343) in gastric cancer Pieris co-development option for one program from existing multi-target collaboration amended to US co-promotion option with increased royalties if exercised

• Seagen Recommends Rejection Of 'Mini-Tender' Offer from TRC Capital Investment Corporation

  3/5/2021

  Seagen Inc. (Nasdaq:SGEN) today announced that it has been notified of an unsolicited “mini-tender” offer dated February 22, 2021, made by TRC Capital Investment Corporation, an Ontario, Canada corporation, to purchase up to 1,000,000 shares of Seagen's common stock. According to TRC, its “mini-tender” offer price of $151.00 per share was approximately 4.28% below the closing price of Seagen's common stock on February 19, 2021

• Seagen to Present at the Cowen 41st Annual Healthcare Conference

  2/24/2021

  Seagen to Present at the Cowen 41 st Annual Healthcare Conference

• Seagen and Astellas Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

  2/18/2021

  Seagen Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV® (enfortumab vedotin-ejfv). One submission, based on the phase 3 EV-301 trial,

• Astellas and Seagen Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

  2/18/2021

  Astellas Pharma Inc. (TSE: 4503, President and CEO:  Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq:SGEN) today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV®

• European Commission Approves Seagen’s TUKYSA® (tucatinib) for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

  2/12/2021

  European Commission Approves Seagen’s TUKYSA ® (tucatinib) for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer - Approved for Adult Patients with HER2-Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Anti-HER2 Treatment Regimens -

• Seagen and Astellas Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplatin Chemotherapy

  2/12/2021

  Seagen Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced results from the second cohort (cohort 2) of patients in the pivotal phase 2 single-arm EV-201 trial. In the trial, 52 percent of patients who received PADCEV®

• Seagen and Astellas Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer

  2/12/2021

  Seagen Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced primary results from the phase 3 EV-301 trial comparing PADCEV® (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

• Astellas and Seagen Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplatin Chemotherapy

  2/12/2021

  Astellas Pharma Inc. (TSE: 4503, President and CEO:  Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced results from the second cohort (cohort 2) of patients in the pivotal phase 2 single-arm EV-201 trial. In the trial, 52 percent of patients who received PADCEV®