Puma Biotechnology reports developments for a biopharmaceutical company built around oncology drug commercialization and development. Company news commonly centers on NERLYNX®, its oral neratinib product for HER2-positive breast cancer, including net product revenue, cost of sales, royalty revenue and financial outlook tied to demand for the therapy.
Updates also cover alisertib, a selective, orally administered aurora kinase A inhibitor licensed for development and commercialization. Puma describes the ALISCA™-Lung1 Phase II trial in extensive-stage small cell lung cancer and the ALISCA™-Breast1 Phase II trial in HER2-negative, HR-positive metastatic breast cancer, along with employee inducement equity awards under Nasdaq Listing Rule 5635(c)(4) and investor conference activity.
Puma Biotechnology (NASDAQ: PBYI) announced an update regarding its corporate presentation, which will be discussed by CEO Alan H. Auerbach starting January 9, 2023. The presentation includes a preliminary estimate of approximately 3,323 NERLYNX® bottles sold in the U.S. during Q4 2022. This figure is subject to change pending the completion of standard closing procedures. NERLYNX® is used for treating HER2-overexpressed breast cancer and received FDA approval for various treatment regimens. For further details, the updated slides will be available on Puma’s investor website.
Puma Biotechnology, Inc. (NASDAQ: PBYI) presented updated results from the TBCRC Trial 022 at the 2022 San Antonio Breast Cancer Symposium. This Phase II study assessed the efficacy of neratinib plus T-DM1 in HER2-positive breast cancer brain metastases. Results showed CNS Objective Response Rates of 33.3% in cohort 4A, 29.4% in cohort 4B, and 28.6% in cohort 4C. Neuro-oncological activity suggests neratinib may reverse T-DM1 resistance. Diarrhea was the most common adverse effect. The findings support neratinib-based combinations for treating HER2-positive brain metastases.
Puma Biotechnology (NASDAQ: PBYI) announced the approval of inducement restricted stock unit awards for three new non-executive employees on December 3, 2022. The awards cover 20,625 shares of common stock and will vest over three years, starting December 1, 2022. This move aligns with Puma’s 2017 Employment Inducement Incentive Award Plan, designed to attract new talent. Puma is focused on advancing cancer care through products like NERLYNX® (neratinib), used in various breast cancer treatments, and is developing alisertib for small cell lung cancer and breast cancer.
Puma Biotechnology, Inc. (NASDAQ: PBYI) reported its Q3 2022 financial results, achieving a net product revenue of $54.3 million from NERLYNX, up from $43.4 million in Q3 2021. Total revenue for Q3 2022 was $57.1 million, with a net loss of $0.4 million or $0.01 per share, significantly improved from a net loss of $44.7 million or $1.09 per share in the same period last year. Puma has raised its FY 2022 revenue guidance to $194 - $196 million due to strong demand for NERLYNX.
Puma Biotechnology (NASDAQ: PBYI) announced the approval of inducement restricted stock unit awards for new non-executive employees on November 1, 2022. A total of 7,250 shares will vest over a three-year period, with one-third vesting on the first anniversary of the commencement date and subsequent one-sixth vesting every six months. These awards are part of the 2017 Employment Inducement Incentive Award Plan and comply with Nasdaq Listing Rule 5635(c)(4). Puma focuses on developing innovative cancer treatments, including its approved drug NERLYNX®.
Puma Biotechnology (NASDAQ: PBYI) presented updated results from the Phase II SUMMIT trial on neratinib for EGFR exon 18-mutant NSCLC at the EORTC/NCI/AACR Symposium in Barcelona on October 27. The trial included 29 patients, showing an overall objective response rate (ORR) of 35%, with 50% in TKI-naïve patients. Adverse events were primarily diarrhea, with no grade 4 incidents reported. The interim findings indicate neratinib may be a promising option for patients with limited treatment options. Final data will be released later.
Puma Biotechnology (NASDAQ: PBYI) will host a conference call on November 3, 2022, at 1:30 p.m. PDT to discuss its third quarter financial results. Interested parties can access the call via telephone or through a live webcast on the company’s website. Puma's NERLYNX (neratinib) has been approved for treating early-stage HER2-overexpressed breast cancer and advanced HER2-positive breast cancer. In September 2022, Puma secured an exclusive license for alisertib, aiming to develop it for small cell lung cancer and breast cancer.
Puma Biotechnology (NASDAQ: PBYI) announced on October 3, 2022, the approval of inducement restricted stock unit awards covering 26,875 shares to five new non-executive employees. These awards, granted under the 2017 Employment Inducement Incentive Award Plan, vest over three years, with one-third vesting on the first anniversary and the remainder on subsequent six-month anniversaries. The awards are intended to facilitate the hiring of new staff, in compliance with Nasdaq rules.
Puma Biotechnology (NASDAQ: PBYI) has secured a licensing agreement with Takeda for worldwide rights to alisertib, a small-molecule inhibitor targeting aurora kinase A. This agreement includes a $7 million upfront fee and potential milestone payments up to $287.3 million, alongside tiered royalties on sales. Puma aims to develop alisertib for metastatic ER-positive HER2-negative breast cancer, triple-negative breast cancer, and small cell lung cancer, with previous trials showing promising clinical activity.
Puma Biotechnology (NASDAQ: PBYI) presented updated findings from the Phase II SUMMIT trial of neratinib for HER2-mutant, metastatic cervical cancer at the 2022 ESMO Congress in Paris. The trial involved 22 patients, showing an objective response rate of 18.2% and a clinical benefit rate of 45.5%. Median progression-free survival was 5.1 months. Diarrhea was the most common adverse event (81.8%), manageable with prophylaxis. Dr. Friedman highlighted neratinib's potential as a treatment option for HER2-mutant cervical cancer, while CEO Alan Auerbach expressed satisfaction with the positive outcomes.