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]

Shares of ORIC Pharmaceuticals (ORIC) surged more than 20% in the pre-market hours today after announcing potentially best-in-class preliminary efficacy and safety data from the ongoing early-stage study of its novel, once-daily candidate, ORIC-944, for prostate cancer. ORIC-944, in combination with AR inhibitors, J&J’s (JNJ) Erleada (apalutamide) and Bayer’s (BAYRY) Nubeqa (darolutamide), is being evaluated in the phase Ib study for treating patients with metastatic castration-resistant prostate cancer (mC ...

Nuvation Bio (NUVB) Q1 2025 Earnings Call May 07, 2025 04:30 PM ET Company Participants Robert DeVita - Executive Director, Corporate Development & IRDavid Hung - Founder, President & CEOColleen Sjogren - Chief Commercial OfficerPhilippe Sauvage - CFOMichael Yee - Managing Director Conference Call Participants Gregory Renza - Director & Senior Analyst of Biotechnology Equity ResearchKaveri Pohlman - Managing Director, Senior Equity Research AnalystSoumit Roy - Biotech Research AnalystYaron Werber - Managing ...

Analyst's Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. I have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech compani ...