Seagen Inc. - SGEN STOCK NEWS

Seagen, Astellas, and Merck announced promising results from the phase 1b/2 EV-103 trial, showcasing a 64.5% confirmed objective response rate (ORR) in patients with unresectable locally advanced or metastatic urothelial cancer treated with enfortumab vedotin and pembrolizumab. The primary endpoint was met with significant responses including 10.5% complete responses. The median overall survival (OS) was 22.3 months. The trial highlights the potential of this combination therapy for patients ineligible for cisplatin chemotherapy. Discussions with regulatory authorities are planned.

Astellas, Seagen, and Merck announced significant findings from the phase 1b/2 EV-103 trial, highlighting a 64.5% confirmed objective response rate in unresectable advanced urothelial cancer patients treated with enfortumab vedotin and pembrolizumab. This combination demonstrated promising efficacy as a first-line treatment, with 10.5% achieving complete response. Additionally, median overall survival reached 22.3 months for the combination group. Adverse events mainly included skin reactions and neuropathy. The companies plan to discuss results with regulatory authorities and pursue further studies.

Seagen Inc. (NASDAQ:SGEN) will showcase significant findings from its EV-103 trial involving PADCEV® at the ESMO Congress on September 12. This trial assesses PADCEV, alone or with KEYTRUDA®, for patients with advanced urothelial cancer. Additionally, data from the Phase 2 MOUNTAINEER trial will be presented, focusing on TUKYSA® for HER2-positive metastatic colorectal cancer. The FDA recently granted Breakthrough Therapy Designation for TUKYSA's combination with trastuzumab.

Seagen Inc. (NASDAQ: SGEN) announced participation in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on September 14, 2022, at 12:55 p.m. Eastern Time. The event will be webcast live and available for replay on Seagen's investor website. Seagen, based in Seattle, Washington, focuses on discovering and commercializing transformative cancer medicines. More details on their products and pipeline can be found on their website.

Seagen Inc. announced the outcome of an arbitration ruling in favor of Daiichi Sankyo regarding their 2008 collaboration on antibody-drug conjugate technology. The arbitrator cited statute of limitations and contract interpretation disagreements. Interim CEO Roger Dansey expressed disappointment but emphasized that this decision does not affect their existing business operations. Seagen continues to focus on innovation and growth with four commercial products and a robust pipeline aimed at improving cancer treatment outcomes.

Seagen Inc. (NASDAQ:SGEN) reported Q2 2022 revenues of $498 million, including $432 million in net product sales, a 24% increase year-over-year. Key highlights include positive clinical trial results for PADCEV and TUKYSA, leading to potential new indications. The company received EU approval for PADCEV and reported a net loss of $134.8 million, with $1.9 billion in cash. Seagen also expects total revenues of $1.710 billion to $1.795 billion for 2022.

Seagen and Astellas announce positive topline results from the phase 1b/2 EV-103 trial evaluating PADCEV combined with KEYTRUDA for treatment of unresectable locally advanced or metastatic urothelial cancer. The trial showed a confirmed objective response rate (ORR) of 64.5% among patients who are ineligible for cisplatin-based chemotherapy. The combination therapy's safety profile aligns with previous studies, prompting plans to discuss these findings with regulatory authorities. Further results will be presented at an upcoming conference.

Astellas Pharma and Seagen announced positive topline results from the phase 1b/2 EV-103 trial evaluating PADCEV (enfortumab vedotin) combined with KEYTRUDA (pembrolizumab) for unresectable locally advanced or metastatic urothelial cancer. The trial reported a 64.5% confirmed objective response rate (ORR) per independent review. While results align with previous findings, the trial's secondary endpoints will also be assessed. Discussions with regulatory authorities are planned to explore this combination as a new first-line treatment for patients unable to receive cisplatin-based chemotherapy.

Seagen Inc. (NASDAQ: SGEN) will release its second quarter 2022 financial results on July 28, 2022, after U.S. market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and business updates. Investors can access the call via telephone or through a webcast available at investor.seagen.com. Seagen is a biotechnology company focused on developing transformative cancer therapies.