Seagen Inc. - SGEN STOCK NEWS

Seagen Inc. (NASDAQ: SGEN) and Astellas Pharma announced the acceptance of a Biologics License Application (BLA) for enfortumab vedotin in China. This drug is intended for patients with locally advanced or metastatic urothelial cancer who have previously been treated with a PD-1/L1 inhibitor and platinum-based chemotherapy. The submission is based on data from the EV-203 study, which demonstrated statistical significance in objective response rates. The move aims to address the significant bladder cancer burden in China, which saw nearly 86,000 new cases in 2020. Enfortumab vedotin is now a second- and third-line treatment option for many patients worldwide.

Seagen Inc. (NASDAQ: SGEN) announced participation in a fireside chat at the Cowen 43rd Annual Health Care Conference on March 6, 2023, at 1:30 p.m. Eastern Time. The event will be webcast live, with a replay available in the investor section of Seagen's website. Seagen is recognized for its innovative cancer therapies and aims to significantly impact patients' lives. Headquartered in Seattle, Washington, the company operates in California, Canada, Switzerland, and the European Union. For more details on its products and pipeline, visit seagen.com.

Seagen (SGEN) reported total revenues of $2.0 billion in 2022, a 25% increase year-over-year, driven by a 23% rise in net product sales to $1.7 billion. Key developments include the FDA's accelerated approval of TUKYSA for HER2-positive metastatic colorectal cancer and ADCETRIS's new pediatric indication for high-risk Hodgkin lymphoma. The company anticipates multiple key milestones in 2023, including potential label expansions and significant data readouts. Despite a net loss of $610 million for the year, Seagen ended 2022 with $1.7 billion in cash and investments, positioning itself for future growth.

Seagen Inc. (NASDAQ: SGEN) has announced the presentation of new data for PADCEV (enfortumab vedotin) at the ASCO-GU symposium from February 16-18, 2023. The study focuses on patient-reported outcomes from the Phase 1b/2 EV-103 Cohort K, which evaluates PADCEV alone and with KEYTRUDA in patients with unresectable locally advanced or metastatic urothelial cancer. Additional analyses will include the confirmed objective response rate and qualitative insights from patients and caregivers, showcasing Seagen's commitment to addressing unmet clinical needs in urothelial cancer.

Seagen Inc. announced FDA's accelerated approval of TUKYSA (tucatinib) in combination with trastuzumab for adult patients with HER2-positive, RAS wild-type colorectal cancer that has progressed after standard chemotherapy. This marks the first FDA-approved treatment for this specific cancer type. Approval is based on the phase 2 MOUNTAINEER trial, demonstrating a 38% overall response rate and a median duration of response of 12.4 months. Serious adverse reactions occurred in 22% of patients, emphasizing caution in usage. Continued approval depends on confirmatory trials, with a phase 3 trial ongoing.

Seagen Inc. (NASDAQ: SGEN) is set to report its Q4 and full-year 2022 financial results on February 15, 2023, after market close. A conference call will follow at 4:30 p.m. ET for management to discuss the results and provide business updates. Seagen focuses on developing transformative cancer medicines and is headquartered near Seattle, Washington, with additional locations in California, Canada, Switzerland, and the European Union.

More details on the conference call can be found on the investor website.

Seagen Inc. (NASDAQ: SGEN) will present at the 41^st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 3:00 p.m. PT. The event will be webcast live and available for replay on the company’s investor website. Seagen is a global biotechnology firm focused on discovering, developing, and commercializing innovative cancer treatments. Headquartered in Seattle, Washington, the company has additional locations in California, Canada, Switzerland, and the European Union. For further details on its product offerings and pipeline, visit www.seagen.com.

Seagen, Astellas Pharma, and Merck announced the FDA's acceptance of supplemental Biologics License Applications for their combination therapy of PADCEV and KEYTRUDA, targeting locally advanced or metastatic urothelial cancer patients ineligible for cisplatin-based chemotherapy. The FDA granted the applications Priority Review, setting a PDUFA date of April 21, 2023. The combination therapy, previously designated as Breakthrough Therapy, is supported by clinical trial data. Continued research includes a phase 3 study to assess the treatment's efficacy and facilitate potential accelerated approval.

Astellas Pharma, Seagen, and Merck announced that the FDA has accepted their applications for Priority Review of PADCEV® and KEYTRUDA® in combination for treating locally advanced or metastatic urothelial cancer. This therapy aims to provide a new treatment option for patients who cannot receive cisplatin-based chemotherapy. The FDA set a PDUFA date of April 21, 2023, for potential accelerated approval. Supported by data from the EV-103 trial, the combination has shown promise, with additional studies ongoing to further evaluate its effectiveness.