Welcome to our dedicated page for PUMA BIOTECHNOLOGY news (Ticker: PBYI), a resource for investors and traders seeking the latest updates and insights on PUMA BIOTECHNOLOGY stock.
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, a biopharmaceutical company specializing in cancer care, announced that CEO Alan H. Auerbach will present at the 39th Annual J.P. Morgan Healthcare Conference. The virtual event is scheduled for January 14, 2021, at 7:50 a.m. PST (10:50 a.m. EST). A live webcast will be accessible on Puma’s website and archived for 30 days. Puma focuses on innovative treatments like NERLYNX® (neratinib), approved for certain breast cancer patients, showcasing their commitment to advancing cancer treatment options.
Puma Biotechnology, Inc. (NASDAQ: PBYI) announced that CEO Alan H. Auerbach will present at the H.C. Wainwright VIRTUAL BioConnect Conference. The presentation will be available on demand starting January 11, 2021, at 6:00 a.m. EST, and accessible for 30 days on the company’s website.
Puma focuses on developing innovative cancer treatments, notably NERLYNX® (neratinib), approved for HER2-positive breast cancer. The FDA approved NERLYNX in 2017 for early-stage patients and in 2020 for advanced cases. For more information, visit www.pumabiotechnology.com.
Puma Biotechnology, Inc. (NASDAQ: PBYI) announced on December 10, 2020, that its Compensation Committee approved an inducement grant of 3,000 restricted stock units to a new non-executive employee. The award, part of the 2017 Employment Inducement Incentive Award Plan, vests over three years, beginning with one-third vesting on December 1, 2021. The grant aims to attract talent in line with Nasdaq Listing Rule 5635(c)(4). Puma focuses on developing innovative cancer treatments, with its flagship product NERLYNX® approved for specific breast cancer treatments.
Puma Biotechnology (NASDAQ: PBYI) presented findings at the 2020 SABCS, highlighting efficacy and safety for patients with CNS metastases from the NALA trial. The study showed that neratinib plus capecitabine (N+C) significantly improved progression-free survival (PFS) compared to lapatinib plus capecitabine (L+C), with a hazard ratio of 0.76. In the subgroup with CNS metastases, N+C demonstrated better PFS (7.8 months) versus L+C (5.5 months). The safety profile was consistent with overall results, with common adverse effects including diarrhea and nausea.
Puma Biotechnology (NASDAQ: PBYI) presented neratinib efficacy results for HER2-positive early-stage breast cancer from the Phase III ExteNET trial at the 2020 SABCS. The trial involved 2,840 patients, comparing neratinib (240 mg/day) to placebo after chemotherapy and trastuzumab. Key findings included 8-year overall survival (OS) rates of 90.1% for neratinib and 90.2% for placebo, with significant CNS metastasis reduction. Dr. Frankie Ann Holmes reported a notable OS improvement in high-risk patients not achieving a pathological complete response.
Puma Biotechnology, Inc. (Nasdaq: PBYI) presented updated results from the Phase II SUMMIT trial of neratinib at the 2020 Virtual San Antonio Breast Cancer Symposium. The trial evaluated neratinib in combination with trastuzumab and fulvestrant in patients with HER2-mutant, hormone receptor-positive metastatic breast cancer. Out of 37 evaluable patients, 45.9% achieved a confirmed objective response, with a median duration of response of 10.9 months. While the safety profile was consistent, 39.2% reported grade 3 diarrhea. The company continues patient enrollment for further study.
Puma Biotechnology, Inc. (NASDAQ: PBYI) has successfully upheld its European patent EP Patent 1848414, which pertains to irreversible EGFR inhibitors used in treating gefitinib and erlotinib-resistant cancers and T790M EGFR mutations. The European Board of Appeals announced the decision on December 1, 2023, rejecting an appeal from Boehringer Ingelheim. Originally granted in April 2011, the patent faced opposition in 2011, but the recent ruling reinstates the original claims without modification, solidifying Puma's intellectual property in this area.
Puma Biotechnology, Inc. (Nasdaq: PBYI) announced the presentation of 10 abstracts at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) from Dec 8-11, 2020. These abstracts cover the latest research on neratinib, particularly its effectiveness in treating HER2-positive breast cancer. Key presentations include findings from the SUMMIT trial, the ExteNET trial, and the NALA trial. Abstracts are publically accessible on the SABCS website, reflecting Puma's commitment to advancing cancer care through innovative therapies.
Puma Biotechnology announced on November 3, 2020, that its Board of Directors approved the grant of restricted stock unit awards covering 44,750 shares of common stock to five new non-executive employees. These awards, part of the 2017 Employment Inducement Incentive Award Plan, will vest over a three-year period. The first third vests on the anniversary of the award's commencement date, November 1, 2020, with subsequent vesting every six months. This grant is in accordance with Nasdaq Listing Rule 5635(c)(4).
Puma Biotechnology (NASDAQ: PBYI) announced interim results from the Phase II SUMMIT trial of neratinib for metastatic non-small cell lung cancer (NSCLC) patients with EGFR exon 18 mutations. Of the 10 evaluable patients previously treated with EGFR TKI, 60% achieved a partial response and 80% experienced clinical benefit. The median duration of response was 7.5 months, and median progression-free survival was 9.1 months. The study reported a manageable safety profile, with no grade 3 or higher diarrhea cases.