Seagen Inc. - SGEN STOCK NEWS

Astellas Pharma and Seagen announced the acceptance of a marketing authorization application (MAA) for **enfortumab vedotin** by the **European Medicines Agency (EMA)** for treating advanced urothelial cancer. This therapy is aimed at adults who have previously undergone treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. If approved, it will be the first **antibody-drug conjugate (ADC)** available in the European Union for this condition. The MAA is based on the **global phase 3 EV-301 trial**, which showed promising results compared to chemotherapy.

Seagen Inc. (Nasdaq:SGEN) announced an unsolicited 'mini-tender' offer by TRC Capital Investment Corporation to purchase up to 1,000,000 shares at $151.00 each, approximately 4.28% below the last closing price. Seagen does not endorse this offer and advises shareholders to reject it, citing the risks associated with mini-tender offers. These offers are often below SEC thresholds, evading full disclosure requirements. The offer expires on March 23, 2021. Seagen encourages shareholders to consult their financial advisers for guidance.

Seagen announced its participation in a fireside chat at the Cowen 41st Annual Healthcare Conference on March 1, 2021, at 2:40 p.m. Eastern Time. The event will be available for live webcast and replay through Seagen's website in the Investors section. Seagen is a global biotechnology company focused on developing transformative cancer medicines, headquartered in the Seattle area with operations in California, Canada, Switzerland, and the EU. For more details about its products and pipeline, visit www.seagen.com.

Astellas Pharma and Seagen jointly announced on February 18, 2021, the submission of two supplemental Biologics License Applications (sBLAs) to the FDA for PADCEV (enfortumab vedotin-ejfv). The first application aims to convert PADCEV’s accelerated approval to regular approval based on the phase 3 EV-301 trial. The second submission seeks to expand the indication to include patients with locally advanced or metastatic urothelial cancer not suitable for cisplatin. Both applications are under the FDA's Real-Time Oncology Review program, aiming for faster access to effective treatments.

Astellas and Seagen have completed submissions for two supplemental Biologics License Applications (sBLAs) to the FDA for PADCEV (enfortumab vedotin-ejfv). One seeks to convert its accelerated approval to regular approval based on the EV-301 trial data, while the second aims for label expansion to include patients with metastatic urothelial cancer previously treated with a PD-1/L1 inhibitor. The FDA is reviewing these applications under the Real-Time Oncology Review pilot program, which aims for expedited access to effective treatments.

Astellas Pharma and Seagen announced positive primary results from the phase 3 EV-301 trial for PADCEV (enfortumab vedotin-ejfv) in advanced urothelial cancer. The trial showed that patients receiving PADCEV had a median overall survival of 12.9 months compared to 9.0 months for chemotherapy, a 3.9-month advantage (HR=0.70). Secondary endpoints also demonstrated improved progression-free survival (5.6 vs. 3.7 months) and overall response rates (40.6% vs. 17.9%). The findings highlight the significant survival benefit of PADCEV, and results will be submitted to the FDA for regular approval by March 2021.

Astellas Pharma and Seagen announced promising results from cohort 2 of the pivotal phase 2 EV-201 trial for PADCEV (enfortumab vedotin-ejfv) in patients with advanced urothelial cancer. The trial showed a 52% objective response rate, with 20% achieving complete response and a median duration of 10.9 months. Adverse events were consistent with past trials, with alopecia, peripheral sensory neuropathy, and fatigue being the most common. These findings are set to be submitted to the FDA by March for further evaluation.

Astellas Pharma and Seagen announced positive primary results from the phase 3 EV-301 trial for PADCEV in adult patients with advanced urothelial cancer. The trial showed that patients receiving PADCEV had a median overall survival of 12.9 months, 3.9 months longer than those on chemotherapy (9.0 months). Secondary endpoints also favored PADCEV, with a median progression-free survival of 5.6 months. The findings highlight PADCEV as the first therapy to significantly reduce the risk of death compared to chemotherapy in this patient demographic. Results will be submitted to the FDA and global health authorities.

Astellas Pharma and Seagen announced results from the pivotal phase 2 EV-201 trial, where 52% of patients treated with PADCEV (enfortumab vedotin-ejfv) exhibited an objective response. Among these, 20% achieved a complete response, and the median duration of response was 10.9 months. This trial focused on patients with locally advanced or metastatic urothelial cancer who were ineligible for cisplatin chemotherapy. The findings, presented at the ASCO GU symposium, will be submitted to the FDA by the end of March as part of a supplemental biologics licensing application.