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Puma Biotechnology Inc (PBYI) is a pioneering biopharmaceutical company dedicated to developing and commercializing innovative treatments for cancer. Specializing in the in-licensing of drug candidates, Puma focuses on therapies that have undergone initial clinical testing, aiming to advance these candidates for commercial use. The company's core mission is to enhance cancer care and improve patient outcomes through cutting-edge treatments.
One of Puma Biotechnology's flagship products is NERLYNX, an oral version of neratinib. This drug is specifically designed for the treatment of HER2-positive breast cancer. NERLYNX works by inhibiting the HER2 receptor, which plays a key role in the growth and spread of breast cancer cells. The effectiveness and commercial success of NERLYNX highlight Puma's commitment to providing innovative solutions in oncology.
In addition to NERLYNX, Puma is developing alisertib, a selective inhibitor of aurora kinase A. This small-molecule drug disrupts mitosis, leading to the apoptosis of rapidly proliferating tumor cells. Alisertib is targeted at various forms of cancer, making it a versatile addition to Puma's portfolio.
Puma Biotechnology's strategy involves collaboration and partnerships to bring their innovations to market. The company has a robust financial foundation, enabling it to invest in research and development while pursuing effective commercialization strategies. Puma's ongoing projects and recent achievements demonstrate its role as a significant player in the biopharmaceutical industry, consistently pushing the boundaries of cancer treatment.
For investors and stakeholders, Puma Biotechnology's focus on innovative cancer therapies and its strategic development pipeline offer promising opportunities. The company's commitment to enhancing treatment outcomes ensures it remains at the forefront of the biopharmaceutical sector.
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.
Celcuity announced a Phase 2 clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology to evaluate NERLYNX (neratinib) combined with XELODA (capecitabine) in patients with metastatic HER2-negative breast cancer with brain metastases. The trial, utilizing Celcuity's CELsignia HER2 Activity Test to select patients, aims to find effective treatment options for this underserved group. Interim results are expected within 12-15 months post-enrollment.
Puma Biotechnology (NASDAQ: PBYI) announced on October 1, 2021, that its Compensation Committee approved the grant of inducement restricted stock unit awards totaling 49,625 shares to six new non-executive employees. The awards are part of Puma's 2017 Employment Inducement Incentive Award Plan, vesting over three years. The awards are granted as incentives for new hires, in line with Nasdaq Listing Rule 5635(c)(4). Puma focuses on developing innovative cancer care products, including NERLYNX® (neratinib), which is approved for treating certain breast cancer cases.
Puma Biotechnology, Inc. (NASDAQ: PBYI) announced that Alan H. Auerbach, the company's Chairman and CEO, will present at the 2021 Cantor Virtual Global Healthcare Conference on September 28 at 8:00 a.m. EDT. The presentation will be available as a webcast on Puma's website and archived for 30 days post-event. Puma specializes in innovative cancer care products, notably NERLYNX® (neratinib), approved by the FDA for treating HER2-positive breast cancer.
Puma Biotechnology, Inc. (Nasdaq: PBYI) announced the approval of inducement restricted stock unit awards covering 16,375 shares to three new non-executive employees as of September 1, 2021. This grant, made under the 2017 Employment Inducement Incentive Award Plan, vests over three years, with one-third vesting on the first anniversary and the remainder vesting bi-annually. This move aligns with Nasdaq Listing Rule 5635(c)(4), aimed at attracting talent to enhance the company's operations in cancer care development and commercialization.
Puma Biotechnology (NASDAQ: PBYI) announced that CEO Alan H. Auerbach will present at the H.C. Wainwright 23rd Annual Global Investment Conference, taking place from September 13-15, 2021. The presentation will be available on-demand starting at 7:00 a.m. EDT on September 13, 2021, and a replay can be accessed on Puma's website for 30 days thereafter. Puma specializes in developing innovative cancer care therapies, notably the oral drug NERLYNX® (neratinib), approved by the FDA for specific breast cancer treatments.
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