Puma Biotechnology Inc Stock Price, News & Analysis

Puma Biotechnology (NASDAQ: PBYI) provided an update on its corporate presentation at the H.C. Wainwright BioConnect Conference on January 10, 2022. The company estimated selling about 3,454 bottles of NERLYNX® in the U.S. during Q4 2021. This figure is preliminary and may be subject to adjustments. NERLYNX, which is used for treating specific breast cancer types, was approved by the FDA in 2017 and 2020 for various applications, including adjuvant and metastatic settings. Additional details regarding the presentation are available on Puma's Investor Relations website.

Puma Biotechnology (NASDAQ: PBYI) will present at the H.C. Wainwright BioConnect Virtual Conference, with CEO Alan H. Auerbach speaking on January 10, 2022, at 7:00 a.m. EST. The presentation will be available on the company’s website for 30 days. Puma focuses on developing innovative cancer therapies, including NERLYNX® (neratinib), approved for specific HER2-positive breast cancer treatments. NERLYNX is also indicated for advanced cases after prior therapies. Further details can be found on www.pumabiotechnology.com.

Puma Biotechnology presented promising results from the Phase II SUMMIT trial at the 2021 San Antonio Breast Cancer Symposium. The trial evaluated neratinib combined with fulvestrant and trastuzumab for patients with hormone receptor-positive, HER2-mutant metastatic breast cancer previously treated with CDK4/6 inhibitors. The non-randomized cohort showed a 46.2% confirmed objective response rate. In triple-negative breast cancer cohorts, a 33.3% confirmed objective response rate was observed. Safety results indicated diarrhea as the most frequent adverse event, with 45.5% reporting grade 3 diarrhea in HR-positive patients.

Puma Biotechnology, Inc. (Nasdaq: PBYI) announced the grant of inducement restricted stock units covering 13,125 shares to two new non-executive employees on December 1, 2021. The awards, part of Puma’s 2017 Employment Inducement Incentive Award Plan, vest over three years, with one-third vesting on the first anniversary and one-sixth every six months thereafter. This move is in accordance with Nasdaq Listing Rule 5635(c)(4) to incentivize new hires.

Puma Biotechnology (PBYI) announced a five-year extension of U.S. Patent No. 7,399,865 for NERLYNX^®, now set to expire on December 29, 2030. This extension, granted by the USPTO under the Hatch-Waxman Amendments, allows Puma to invest further in NERLYNX as a treatment for HER2-positive breast cancer. CEO Alan H. Auerbach expressed satisfaction with the extension, emphasizing its potential to benefit cancer patients. NERLYNX has received FDA approval for early-stage and advanced HER2-positive breast cancer treatments.

Puma Biotechnology (PBYI) presented results from the neratinib arm of the Phase II INSIGhT Trial at the Society for Neuro-Oncology Annual Meeting. The trial involved 149 patients with newly diagnosed glioblastoma. Results showed a median progression-free survival (PFS) of 6.0 months for neratinib compared to 4.7 months for the control, but this was not statistically significant (HR 0.75; p=0.12). Overall survival (OS) was similar: 13.8 months for neratinib versus 14.7 months for control (HR 1.01; p=0.75). Neratinib was well-tolerated, with manageable toxicity. The trial showed promise in patients with activated EGFR pathways, suggesting potential for further investigation.

Puma Biotechnology (NASDAQ: PBYI) announced the presentation of 9 abstracts at the 2021 San Antonio Breast Cancer Symposium (SABCS) from December 7-10, 2021. Highlights include an oral presentation on the SUMMIT trial, focusing on neratinib for hormone receptor-positive and HER2-mutant metastatic breast cancer. The event will be held at the Henry B. Gonzalez Convention Center, San Antonio, Texas. Details of the abstracts are available on the SABCS website.

Puma Biotechnology, Inc. (PBYI) reported a net loss of $44.7 million, or $1.09 per share, for Q3 2021, compared to a net loss of $31.5 million, or $0.79 per share, in Q3 2020. Product revenue fell to $43.4 million from $49.3 million year-over-year. Total revenue for Q3 2021 was $46.2 million, down from $50.8 million in Q3 2020. Despite challenges from COVID-19, the company noted a positive uptake in its product NERLYNX due to recent label expansions. Cash and marketable securities totaled $87.5 million as of September 30, 2021, down from $93.4 million at year-end 2020.

Puma Biotechnology (NASDAQ: PBYI) has announced a conference call scheduled for November 4, 2021, at 1:30 p.m. PDT/ 4:30 p.m. EDT to discuss its Q3 2021 financial results. Investors can access the call by dialing 1-888-437-3179 (domestic) or 1-862-298-0702 (international) and are encouraged to join 10 minutes early. A live webcast is available on Puma's website, along with a replay after the event. Puma focuses on developing innovative cancer treatments, including its FDA-approved drug NERLYNX® (neratinib) for certain HER2-positive breast cancer patients.