Target Action (PDUFA) Date set for October 7, 2025Application based on data from IMforte, the first Phase 3 trial demonstrating statistically significant and clinically meaningful improvements in both progression-free and overall survival in the ES-SCLC first-line maintenance settingJazz to host investor webcast on Tuesday, June 10 at 4:30 p.m. EDT / 9:30 p.m. IST to review Zepzelca dataFor U.S. media and investors onlyDUBLIN, June 10, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today annou ...

Financial Data and Key Metrics Changes - The company reported approximately $570 million in cash, providing a runway into 2028 based on the current operating plan [7] - The overall response rate in the RESILIENT-one study was 35%, with a 40% response rate in patients who progressed after chemotherapy [17][18] - The median duration of response was just under nine months across all groups [18] Business Line Data and Key Metrics Changes - The company is advancing multiple clinical-stage programs, including CLN978 for autoimmune diseases and CLN619 for non-small cell lung cancer [6] - Zipilertinib, the oral EGFR tyrosine kinase inhibitor, has shown promising results in patients with EGFR exon 20 mutations, with breakthrough therapy designation by the FDA [11][12] Market Data and Key Metrics Changes - EGFR mutated non-small cell lung cancer accounts for 16% of all non-small cell lung cancer, with exon 20 mutations representing approximately 12%, translating to an annual incidence of about 3,000 to 5,000 patients in the U.S. [67] - The company noted that patients with exon 20 mutations tend to have a poorer prognosis, highlighting the unmet need for effective therapies [68] Company Strategy and Development Direction - The company plans to pursue regulatory interactions for a potential U.S. NDA filing in the second half of the year [22][23] - There is an expansive development program for zipilertinib across multiple patient segments, including relapsed refractory disease and frontline settings [69][70] - The company retains 50% of the rights for zipilertinib in the U.S. and has a co-development and co-commercialization arrangement with partners at Tahoe [77][78] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the clinical profile of zipilertinib, noting its favorable safety profile compared to existing therapies [75] - The company anticipates significant uptake of zipilertinib once it becomes available, particularly as an oral option for patients [60][62] Other Important Information - The RESILIENT-two study will provide data on patients with active brain metastases and those with uncommon EGFR mutations in the second half of the year [79] - The RESILIENT-three study is ongoing, comparing zipilertinib plus chemotherapy to standard care [72] Q&A Session Summary Question: What is the efficacy of zipilertinib in patients with brain metastases? - The drug has shown encouraging preliminary data in patients with brain metastases, with good disease control observed [84][86] Question: What is the breakdown of patients in real-world settings? - Most patients are heavily pretreated, often having received chemotherapy and amivantamab before seeking other options [88][90] Question: Is there any data on the role of MET amplification in exon 20? - The response to this question was not directly addressed in the provided content, indicating a need for further research [94]

Puma Biotechnology (PBYI) Q4 2024 Earnings Call February 27, 2025 04:30 PM ET Company Participants Mariann Ohanesian - Senior Director of Investor RelationsAlan Auerbach - Founder, Chairman, President, CEO & SecretaryJeffrey Ludwig - Chief Commercial OfficerMaximo F. Nougues - CFO & Principal Accounting OfficerHang Hu - AVP - Biotech Equity Research Conference Call Participants Edward White - MD & Senior Biotechnology AnalystMarc Frahm - Biotechnology Equity Research Analyst Operator Good afternoon. My name ...