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, Inc. (NASDAQ: PBYI) reported a net loss of $15 million for Q4 2020, up from $11.2 million in Q4 2019. NERLYNX product revenue declined to $50 million in Q4 2020 from $58.7 million in Q4 2019, contributing to a total annual revenue drop to $225.1 million from $272.3 million. The company recorded an adjusted net loss of $5.5 million for Q4 2020, compared to a slight adjusted profit in Q4 2019. Cash reserves decreased to $93.4 million as of December 31, 2020. The CEO highlighted ongoing impacts from COVID-19 but noted significant clinical milestones. Future clinical goals include FDA meetings for accelerated approvals in 2021.
Puma Biotechnology (PBYI) will host a conference call on February 25, 2021, at 1:30 p.m. PST/4:30 p.m. EST to discuss its fourth quarter and full-year 2020 financial results. Investors can join by calling 1-877-709-8150 for domestic or 1-201-689-8354 for international access. A live webcast and presentation slides will be available on Puma's website. The company specializes in biopharmaceuticals focused on cancer care, known for its FDA-approved drug NERLYNX (neratinib), which treats specific types of breast cancer.
Puma Biotechnology, Inc. (NASDAQ: PBYI) announced the grant of inducement restricted stock unit awards covering 11,000 shares to two new non-executive employees on February 4, 2021. These awards are issued under Puma's 2017 Employment Inducement Incentive Award Plan and vest over three years, with specific vesting milestones based on continued service. Puma Biotechnology focuses on developing and commercializing innovative cancer care products, including its FDA-approved drug NERLYNX® for certain breast cancer treatments.
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.
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