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Astellas Pharma and Seagen announce that the CHMP of the EMA has reaffirmed its positive opinion for PADCEV (enfortumab vedotin) as a monotherapy for adults with locally advanced or metastatic urothelial cancer previously treated with platinum chemotherapy and a PD-1/L1 inhibitor. This endorsement follows a review of updated safety data and could lead to PADCEV being the first antibody-drug conjugate authorized in the EU for this cancer type. The final decision from the European Commission is awaited.
Genmab A/S (NASDAQ: GMAB) and Seagen Inc. (NASDAQ: SGEN) announced preliminary results from the innovaTV 207 phase 2 trial of tisotumab vedotin (TIVDAK®) for squamous cell carcinoma of the head and neck. Of 31 patients treated, a 16% objective response rate was observed. Secondary endpoints showed a disease control rate of 58.1% and median progression-free survival of 4.2 months. Safety data indicated a manageable profile, with 67.7% experiencing Grade ≥3 adverse events. The findings will be presented at the ASTRO 2022 symposium on February 25.
Seagen and Genmab will present preliminary data from the innovaTV 207 phase 2 trial of tisotumab vedotin (TIVDAK) for patients with squamous cell carcinoma of the head and neck at the ASTRO 2022 symposium. Results indicate a 16% confirmed objective response rate, with 58.1% disease control rate and a median progression-free survival of 4.2 months. Noteworthy adverse events included Grade ≥3 treatment-emergent adverse events in 67.7% of patients. The data underscores the potential of tisotumab vedotin in treating this high-need patient group, with ongoing trials planned.
Seagen and Astellas Pharma announced results from the EV-103 trial evaluating enfortumab vedotin for muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin therapy. Data presented at the 2022 ASCO Genitourinary Cancers Symposium showed that 36.4% of the 22 patients achieved a pathologic complete response, with 50% experiencing tumor downstaging. All patients proceeded to surgery without delays. Adverse events included fatigue (45.5%) and alopecia (36.4%). Ongoing phase 3 trials will further investigate the drug's efficacy in combination with pembrolizumab.
Astellas Pharma and Seagen reported initial results from Cohort H of the EV-103 trial on PADCEV® (enfortumab vedotin-ejfv) for muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin chemotherapy. Of 22 patients analyzed, 36.4% achieved a pathologic complete response, with 50% showing tumor size reduction. All patients proceeded to surgery without delays. Adverse events included fatigue (45.5%) and alopecia (36.4%). The results will be presented at the ASCO Genitourinary Cancers Symposium on February 18, 2022.
Seagen reported total revenues of $1.6 billion in 2021, marking a 38% increase in net product sales to $1.4 billion. The company highlighted growth across its oncology portfolio, driven by ADCETRIS, PADCEV, TUKYSA, and TIVDAK. Significant clinical trial results for ADCETRIS were announced, demonstrating improved overall survival rates in Hodgkin lymphoma patients. Seagen expects multiple milestones in 2022, aiming for continued growth despite a net loss of $674.5 million for the year. The company has $2.2 billion in cash and investments to support future initiatives.
Seagen Inc. (Nasdaq: SGEN) will participate in a virtual fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 2:20 p.m. Eastern Time. The event will be webcast live, and recordings will be accessible on Seagen's investor relations website. Based in the Seattle area, Seagen is a biotechnology company focused on developing transformative cancer medicines. For more details on their products and pipeline, visit www.seagen.com.
Seagen announced that its Phase 3 ECHELON-1 clinical trial for ADCETRIS achieved a statistically significant improvement in overall survival (OS) for patients with advanced classical Hodgkin lymphoma (cHL), showing a 41% reduction in risk of death. After six years of median follow-up, results indicated a hazard ratio of 0.59 (p=0.009) compared to traditional chemotherapy. The safety profile was consistent with prior studies, with no new safety signals. The data is set for presentation at an upcoming medical meeting, showcasing potential advancements in cHL treatment.
Seagen Inc. has appointed Lee Heeson as Executive Vice President of Commercial International. Heeson, who has nearly 30 years of experience, will lead the company’s expansion in Europe, Canada, and other global markets. He succeeds Tuomo Pätsi, who retires on February 4, 2022. Dr. Clay Siegall, CEO, expressed confidence in Heeson’s capabilities to drive the company’s initiatives, including TUKYSA launches in Europe and ongoing efforts in Canada. Heeson previously served as President of International at Vifor Pharma.
ShouTi Inc., a clinical-stage biopharmaceutical firm, has appointed Daniel Welch as Chairman of its board. Welch brings over 40 years of experience in the pharmaceutical industry, having led companies like InterMune and Triangle Pharmaceuticals. His extensive background in drug development is expected to bolster ShouTi's mission to deliver innovative, small molecule medicines addressing chronic diseases. CEO Raymond Stevens emphasized Welch's invaluable leadership as the company seeks to enhance its impact on patients awaiting life-changing treatments.
