Seagen Inc. - SGEN STOCK NEWS

Seagen and Astellas announced updated results from clinical trials of PADCEV for urothelial cancer. In EV-201 Cohort 2, 51% of patients had confirmed objective responses with a median overall survival of 16.1 months. The trial highlighted PADCEV's effectiveness in patients ineligible for cisplatin. In EV-103, combining PADCEV with KEYTRUDA showed a 73.3% objective response rate. Both studies revealed manageable safety profiles, with notable adverse events. The FDA is evaluating PADCEV’s supplemental application and recently granted Breakthrough Therapy designation for the combination therapy.

Seagen Inc. (Nasdaq:SGEN) reported Q1 2021 revenues of $332 million, a 42% increase from $234.5 million in Q1 2020, driven by a 52% rise in net product sales to $302.6 million. Key products ADCETRIS, PADCEV, and TUKYSA showed strong performance, with PADCEV sales growing 102%. The company expects total net product sales of approximately $1.3 billion for 2021. Despite a net loss of $121.4 million, improvements over the previous year were noted. Advances in FDA and EMA approvals for PADCEV and TUKYSA bolster market position.

Seagen Inc. (Nasdaq:SGEN) announced new data from its pipeline of therapies at the virtual ASCO Annual Meeting, held June 4-8, 2021. Key highlights include updated results from the EV-103 and EV-201 clinical trials for PADCEV® in urothelial cancer and data from the HER2CLIMB trial of TUKYSA® in HER2+ metastatic breast cancer. Chief Medical Officer Roger Dansey emphasized progress in the company's oncology portfolio, addressing a high unmet need across multiple cancers.

Astellas Pharma and Seagen announced the FDA's acceptance of two supplemental Biologics License Applications (sBLA) for PADCEV (enfortumab vedotin-ejfv) under the Real-Time Oncology Review pilot program. Both applications received Priority Review, aimed at ensuring timely access to safe treatments. The first sBLA seeks to convert accelerated approval to regular approval, while the second expands PADCEV's indication for patients with advanced urothelial cancer. Target action date for both is August 17, 2021.

Seagen and Astellas Pharma announced that the FDA filed two supplemental Biologics License Applications for PADCEV as part of the Real-Time Oncology Review pilot program. Both applications received Priority Review with a target action date of August 17, 2021. The first sBLA aims to convert PADCEV's accelerated approval to regular approval, while the second seeks to expand indications for previously treated urothelial cancer patients ineligible for cisplatin. The companies also plan regulatory submissions in Canada and Australia.

Seagen (Nasdaq: SGEN) and Genmab (Nasdaq: GMAB) announced that the FDA has accepted their Biologics License Application (BLA) for tisotumab vedotin under Priority Review. This application targets accelerated approval for treating recurrent or metastatic cervical cancer following chemotherapy. The PDUFA action date is set for October 10, 2021. The BLA is based on the innovaTV 204 pivotal trial, which evaluated tisotumab vedotin as monotherapy. The trial included 101 patients and primarily aimed to assess the objective response rate.

Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) announced the FDA's acceptance of their Biologics License Application (BLA) for tisotumab vedotin, targeting recurrent or metastatic cervical cancer. This application, filed in February 2021, is under Priority Review, with a decision expected by October 10, 2021. The BLA is based on the innovaTV 204 trial results, highlighting the need for new therapies in a field with low response rates. Both companies aim to enhance treatment options for patients with this severe condition.

Seagen Inc. (Nasdaq: SGEN) announced preclinical data for novel targeted oncology drugs to be presented at the AACR Annual Meeting from April 10-15, 2021. The data focuses on three programs: SEA-TGT, an anti-TIGIT antibody; SGN-B6A, an ADC targeting integrin beta-6; and SGN-STNV, which targets the STn carbohydrate antigen. These programs are positioned as potential best-in-class therapies for cancer, demonstrating enhanced therapeutic effects in preclinical studies. Ongoing clinical trials for these programs are highlighted, showcasing promising advancements in cancer treatment.

Seagen (Nasdaq: SGEN) will release its Q1 2021 financial results on April 29, 2021, after U.S. markets close. A conference call and webcast will follow, providing insights into the results and a business update. The event is scheduled for 1:30 p.m. PT / 4:30 p.m. ET. Interested parties can join via telephone or through the company's website. Seagen is dedicated to developing transformative cancer medicines and has operations in several regions including the U.S., Canada, and Europe.