Alisertib

Puma Biotechnology initiates Phase II trial of alisertib with endocrine therapy for HR+/HER2- recurrent/metastatic breast cancer, previously treated with CDK 4/6 inhibitors. The ALISCA-Breast1 trial will randomize up to 150 patients to receive alisertib at 30 mg, 40 mg, or 50 mg twice daily in a 28-day cycle, combined with endocrine therapy. Primary endpoints include response rate, duration, disease control, progression-free survival, and overall survival. Puma will analyze biomarkers and perform an interim safety/efficacy analysis, aiming for FDA approval and a pivotal trial.

Puma Biotechnology initiates Phase II trial of alisertib with endocrine therapy for HR+, HER2-negative metastatic breast cancer, aiming to identify optimal dose and explore FDA approval pathway.

Puma Biotechnology initiates ALISCA™-Breast1 Phase II trial of alisertib with endocrine therapy for hormone receptor-positive, HER2-negative metastatic breast cancer. The trial will enroll up to 150 patients previously treated with CDK 4/6 inhibitors and at least two endocrine therapies, randomized to receive alisertib at 30mg, 40mg, or 50mg doses. Primary endpoints include objective response rate, duration of response, disease control rate, progression-free survival, and overall survival. Initial data expected in 2025, with plans to discuss potential approval pathways with the FDA.

Puma Biotechnology initiated a Phase II trial of alisertib in combination with endocrine therapy for HR+/HER2-negative metastatic breast cancer patients previously treated with CDK 4/6 inhibitors. The trial aims to identify the optimal alisertib dose, with primary endpoints including response rate and survival. Puma plans to engage with regulatory agencies for a pivotal Phase III trial based on trial outcomes.

Puma Biotechnology initiates Phase II ALISCA™-Breast1 trial of alisertib in combination with endocrine therapy for HR+, HER2-negative metastatic breast cancer patients previously treated with CDK 4/6 inhibitors and at least two prior lines of endocrine therapy. The trial aims to identify the optimal alisertib dose, with primary endpoints including response rate, duration, and survival. Puma plans to engage with global regulatory agencies for a pivotal Phase III trial based on trial outcomes.

Puma Biotechnology reported Q3 2024 revenue of $80.5 million, up from $51.6 million in Q3 2023, driven by NERLYNX sales and royalty revenue from China. The company discussed ongoing clinical trials, including Phase 2 studies of alisertib, and provided financial forecasts for Q4 and fiscal year 2024.

Puma Biotechnology Inc (PBYI) reported Q3 2024 revenue of $80.5M, with product revenue at $56.1M and royalty revenue at $24.4M. The company achieved a net income of $20.3M, exploring new business opportunities. Challenges include flat Neuralink prescriptions, higher gross to net adjustments, and lumpy China sales. Q&A highlights focus on sales strategies, business development, and trial timelines.

Puma Biotechnology Inc reported Q3 2024 revenue of $80.5 million, with product revenue net at $56.1 million and royalty revenue at $24.4 million. Net income was $20.3 million or $0.41 per share (GAAP) and $22.4 million or $0.45 per diluted share (Non-GAAP). The company anticipates challenges in expanding Alisertib's dose range and expects lumpy sales to China.

Puma Biotechnology reported Q3 2024 revenue of $80.5M, including $56.1M from NERLYNX® and $24.4M in royalties, with net income of $20.3M ($0.41 per share). The company updated its 2024 guidance to $187-190M in net product revenue and $15-17M in net income.