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, Inc. (NASDAQ: PBYI) is a biopharmaceutical company focused on developing and commercializing products to enhance cancer care, and its news flow reflects this oncology focus. The company’s primary commercial product is NERLYNX (neratinib) tablets, an oral kinase inhibitor approved by the U.S. Food and Drug Administration for specific early-stage and metastatic HER2-positive breast cancer indications. NERLYNX also holds marketing authorization from the European Commission for defined early-stage hormone receptor-positive, HER2-overexpressed or amplified breast cancer settings.
News about PBYI often highlights commercial performance and financial results related to NERLYNX, including product revenue, royalty revenue, and updates on profitability and cash flow. Puma’s press releases also cover corporate developments such as inclusion in the Nasdaq Biotechnology Index, which tracks qualifying biotechnology and pharmaceutical companies listed on Nasdaq.
Another key news theme is clinical progress with alisertib, a selective, orally administered inhibitor of aurora kinase A that Puma is developing under an exclusive license. The company has launched Phase II ALISCA trials, including ALISCA-Lung1 in extensive-stage small cell lung cancer and ALISCA-Breast1 in HER2-negative, hormone receptor-positive metastatic breast cancer. Updates on these studies, including interim data and trial milestones, feature prominently in Puma’s communications.
Investors following PBYI news can also expect announcements about equity inducement awards under Puma’s 2017 Employment Inducement Incentive Award Plan, conference call schedules for quarterly results, and presentations at investor conferences. This news page aggregates those releases so readers can track how regulatory decisions, clinical trial developments, commercial trends, and corporate actions may relate to Puma Biotechnology’s stock and oncology pipeline over time.
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.
Puma Biotechnology (NASDAQ: PBYI) reported its Q3 2020 financial results, revealing a net loss of $31.5 million ($0.79 per share), compared to a loss of $16.9 million ($0.44 per share) in Q3 2019. Net revenue from NERLYNX decreased to $49.3 million from $53.5 million year-over-year. Total revenue for Q3 2020 was $50.8 million, down from $56.4 million in Q3 2019. Operating costs fell to $62.9 million from $70.8 million. As of September 30, 2020, cash and equivalents stood at $109 million. The company anticipates ongoing COVID-19 impacts but expects to release key trial data in the upcoming year.
Puma Biotechnology, Inc. (NASDAQ: PBYI) will have its CEO, Alan H. Auerbach, present at the Credit Suisse 29th Annual Healthcare Conference on November 10 at 1:15 p.m. EST. The event will be held virtually, and a live webcast can be accessed on Puma's website. The presentation will also be archived for 30 days post-event. Puma focuses on innovative cancer treatments, particularly through its FDA-approved product NERLYNX® (neratinib), used for specific breast cancer cases. More details can be found at www.pumabiotechnology.com.
Puma Biotechnology (NASDAQ: PBYI) will host a conference call on November 5, 2020, at 1:30 p.m. PST to discuss its Q3 2020 financial results. The call will be accessible via phone and a live webcast on Puma's website, with a replay available for 90 days.
Puma is focused on developing innovative cancer therapies and is known for its product NERLYNX (neratinib), approved for treating certain types of breast cancer. The company continues to seek advancements in cancer care through its product pipeline.
Puma Biotechnology (NASDAQ: PBYI) announced the publication of Phase III ExteNET trial results focusing on neratinib's efficacy in HER2-positive, hormone receptor-positive early stage breast cancer. Published in Clinical Breast Cancer, results indicate a 5.1% improvement in 5-year invasive disease-free survival (HR=0.58) in patients treated within a year of adjuvant trastuzumab. Additionally, patients at high risk of recurrence showed a 7.4% improvement (HR=0.60). Common adverse effects included diarrhea (39%) and vomiting (4%).
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