PUMA BIOTECHNOLOGY INC - PBYI STOCK NEWS

Puma Biotechnology (NASDAQ: PBYI) announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines for Breast Cancer to include neratinib (NERLYNX^®) as a category 2B therapy for ER+/HER2- or ER-/HER2- metastatic breast cancer with activating HER2 mutations. This update highlights neratinib's use in combination with fulvestrant and trastuzumab. The decision is based on results from the Phase 2 SUMMIT and MutHER trials. Additionally, the NCCN has included a dose escalation schedule for neratinib for better tolerability. The update reflects growing recognition of neratinib's potential in treating advanced breast cancer.

Puma Biotechnology (NASDAQ: PBYI) will present an overview of its operations at the B. Riley Securities’ 3rd Annual Oncology Conference on January 19 at 11:00 a.m. PST. The presentation by CEO Alan H. Auerbach will be accessible via live webcast at this link.

Puma focuses on developing innovative cancer treatments, including NERLYNX® for HER2-positive breast cancer. Additionally, they are advancing alisertib for small cell lung cancer and breast cancer after securing a license in September 2022.

Puma Biotechnology, Inc. (NASDAQ: PBYI) announced on January 10, 2023, the grant of 22,250 inducement restricted stock unit awards to four new non-executive employees. These awards, approved by the Compensation Committee, will vest over three years, with the first third vesting one year after the commencement date for each employee. This initiative aims to attract talent under Puma's 2017 Employment Inducement Incentive Award Plan. Puma focuses on developing innovative cancer treatments, including NERLYNX® for breast cancer and alisertib for small cell lung cancer.

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.