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 (NASDAQ: PBYI) disclosed interim results from the SUMMIT trial evaluating neratinib for metastatic non-small cell lung cancer patients with EGFR exon 18 mutations. Presented at WCLC 2020, the study involved 11 patients, revealing that 60% had a partial response and 80% experienced clinical benefit. The median duration of response was 7.5 months, with a progression-free survival of 9.1 months. Safety assessments indicated no severe diarrhea cases. The company continues to enroll participants, emphasizing the need for new treatments in this niche.
Puma Biotechnology (NASDAQ: PBYI) announced that CEO Alan H. Auerbach will present an overview of the company at the B. Riley Oncology Investor Conference on January 21, 2021. The presentation will be available for replay on the company’s website for 30 days starting at approximately 1:30 p.m. PST. Puma is focused on developing innovative cancer care solutions, including NERLYNX® (neratinib), which has FDA approval for treating early-stage and advanced HER2-positive breast cancer. For more information, visit www.pumabiotechnology.com.
Puma Biotechnology (NASDAQ: PBYI) presented interim results from the biliary tract cancers cohort of the SUMMIT trial at the 2021 ASCO GI Symposium. The trial evaluated neratinib's safety and efficacy in 25 patients with HER2 mutation-positive advanced biliary cancer. Results showed a 16% objective response rate, with 4 patients achieving confirmed partial responses. The treatment was deemed safe, with 56% experiencing diarrhea, mostly manageable. CEO Alan H. Auerbach expressed satisfaction with the activity seen, particularly in gallbladder and cholangiocarcinoma patients.
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.