Core Insights - The FDA has accepted the supplemental New Drug Application (sNDA) for Zepzelca in combination with atezolizumab for first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC), with a PDUFA action date set for October 7, 2025 [1][2] - The sNDA submission is based on the Phase 3 IMforte trial results, which showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for the combination therapy compared to atezolizumab alone [2][6] - Jazz Pharmaceuticals will host an investor webcast to discuss the Zepzelca data, featuring commentary from experts in the field [3] Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on developing innovative medicines for serious diseases, including a growing portfolio of cancer treatments [25][26] - The company is headquartered in Dublin, Ireland, and is dedicated to transforming the lives of patients with limited therapeutic options [25][26] Industry Context - Small cell lung cancer (SCLC) accounts for approximately 13% of lung cancers in the U.S., with around 30,000 new cases reported annually [4] - SCLC is known for its aggressive nature and rapid spread, leading to a high unmet need for effective treatment options [4]

MAIA Biotechnology Inc (MAIA) 2025 Conference January 12, 2025 06:00 PM ET Speaker0 Therapy. Presenting for Maya is their founder and CEO, Vlad Vittok. Vlad? Thank you. Alright. Hello, everybody. So it's a pleasure to be here to present an update on, Maya biotechnology and our telomere targeting immunotherapies for cancer. So at Maya, are developing new science for cancer treatment. We are developing agents with a dual mechanism of action, telomere targeting, and immunogenicity. Our lead molecule is called ...