PUMA BIOTECHNOLOGY INC - PBYI STOCK NEWS

Puma Biotechnology (NASDAQ: PBYI) presented findings from a Phase I/Ib study of alisertib in advanced osimertinib-resistant EGFR-mutated non-small cell lung cancer (NSCLC) at the ASCO Annual Meeting. The study, involving 21 patients, found that intermittent dosing of alisertib (30 mg BID) with osimertinib (80 mg daily) was well-tolerated. The overall response rate was 9.5%, and the disease control rate was 81%. Median progression-free survival (PFS) was 5.5 months, and overall survival (OS) was 23.5 months. Notably, TP53 wild type patients showed a higher response rate (25%) and longer PFS (8.0 months) compared to those with TP53 mutations. Adverse events included neutropenia, anemia, diarrhea, and lymphopenia, mostly manageable. The study will now focus on enrolling TP53 wild type patients.

Puma Biotechnology (NASDAQ: PBYI) presented promising findings from a Phase II study of alisertib for endocrine and CDK4/6 inhibitor-resistant, HER2-negative, hormone receptor-positive metastatic breast cancer at the 2024 ASCO Annual Meeting.

The study compared alisertib alone versus alisertib plus fulvestrant, showing overall response rates of 19.6% and 20.0%, respectively. Median progression-free survival was 5.6 months for alisertib and 5.4 months for the combination therapy, both indicating tolerable safety profiles.

Key biomarker findings include decreased progression-free survival in patients with PIK3CA mutations and longer progression-free survival associated with lower circulating tumor cell counts and lower methylated tumor fraction percentages. Ongoing analyses aim to identify patients who may benefit most from alisertib.

Puma Biotechnology (NASDAQ: PBYI) will join the Russell 3000 Index starting July 1, following the annual reconstitution of Russell Investments' equity indexes. This inclusion is based on market-capitalization rankings as of the end of April.

Membership in the Russell 3000 will also mean automatic inclusion in either the Russell 1000 Index or Russell 2000 Index, and relevant growth and value style indexes. It offers increased liquidity and broader exposure to institutional investors, benefiting stockholders.

The Russell indexes, utilized by investment managers and institutional investors, benchmark over $10 trillion in assets. This is a significant development for Puma Biotechnology, aligning them with major U.S. and global equity performance metrics.

Puma Biotechnology announced the release of abstracts on its drug alisertib, which will be presented at the 2024 ASCO Annual Meeting. The event, scheduled from May 31 to June 4 in Chicago and online, will feature two key studies involving alisertib. The first, Abstract 1037, is a phase II study on alisertib in treating endocrine-resistant metastatic breast cancer, with findings presented by Dr. Karthik Giridhar from Mayo Clinic. The second, Abstract 8572, explores a phase I/Ib study of alisertib combined with osimertinib for osimertinib-resistant EGFR-mutated lung cancer, presented by Dr. Turja Chakrabarti from the University of California, San Francisco. Full abstracts are available online.

Puma Biotechnology, Inc. (NASDAQ: PBYI) reported its first quarter financial results for 2024, with $40.3 million in product revenue, a net loss of $4.8 million, and $107.2 million in cash reserves. Key milestones include clinical trials for lung and breast cancer treatments. Total revenue was $43.8 million, with operating costs of $46.1 million. Second quarter and full-year 2024 financial outlook projects net product revenue of $43-45 million and $183-190 million, respectively.

Puma Biotechnology, Inc. (NASDAQ: PBYI) will host a conference call to discuss its first quarter 2024 financial results on May 2, 2024. The call will be accessible via phone or webcast, with a replay available on the company's website. Investors and analysts can participate to learn about the latest financial performance and strategic updates.

Puma Biotechnology, Inc. granted an inducement restricted stock unit award of 7,500 shares of common stock to a new non-executive employee. The award vests over three years, with gradual vesting periods, as part of the 2017 Employment Inducement Incentive Award Plan.

Puma Biotechnology, Inc. (PBYI) receives FDA notification to proceed with the clinical development of alisertib for HER2-negative, hormone receptor-positive metastatic breast cancer. The Phase II ALISCA-Breast1 trial will investigate alisertib in combination with endocrine treatment, targeting patients previously treated with CDK 4/6 inhibitors. The trial aims to identify optimal dosing, biomarker evaluation, and efficacy endpoints to potentially enhance alisertib's efficacy. Puma plans to initiate the trial in the second half of 2024.

Puma Biotechnology (PBYI) reported positive financial results for Q4 and full year 2023, with net income of $12.3 million for Q4 and $21.6 million for the full year. Product revenue was $53.2 million for Q4 and $203.1 million for the year. Non-GAAP adjusted net income was $14.8 million for Q4 and $31.8 million for the year. Cash, cash equivalents, and marketable securities stood at $96.0 million as of December 31, 2023.