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) announced that Alan H. Auerbach, chairman and CEO, will present an overview at the TD Cowen 46th Annual Health Care Conference on March 2, 2026 at 2:30 p.m. ET. The conference runs March 2–4 in Boston, and a live webcast and slides will be available on Puma's investor website and archived for 30 days.
Puma Biotechnology (NASDAQ: PBYI) will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET on Thursday, February 26, 2026 to discuss fourth quarter and full year 2025 financial results.
Dial-in numbers, a live webcast, presentation slides, and a replay archived for 90 days will be available via the company's Investors website.
Puma Biotechnology (NASDAQ: PBYI) announced on February 3, 2026 that its Compensation Committee approved inducement restricted stock unit awards covering 14,750 shares for two new non-executive employees.
The awards, granted under Puma’s 2017 Employment Inducement Incentive Award Plan, vest over three years beginning February 1, 2026, and comply with Nasdaq Listing Rule 5635(c)(4).
Puma Biotechnology (NASDAQ: PBYI) licensed NERLYNX® (neratinib) is now available in Thailand via Specialised Therapeutics following Thai FDA approval in December 2024.
NERLYNX is approved as a single agent for extended adjuvant treatment of early-stage HR+ HER2+ breast cancer within 12 months of completing trastuzumab, and with capecitabine for advanced/metastatic HER2+ disease after two or more prior anti-HER2 regimens.
Clinical data cited include a reduction in five-year recurrence risk by up to 42% in early-stage HR+ patients and, in advanced disease, a 2.2-month mean PFS improvement and longer response duration (8.5 vs 5.6 months) with NERLYNX+capecitabine versus lapatinib+capecitabine.
Puma Biotechnology (NASDAQ: PBYI) announced that on January 6, 2026 its Compensation Committee approved inducement restricted stock unit awards covering 10,500 shares of common stock for three new non-executive employees.
The awards were granted under Puma’s 2017 Employment Inducement Incentive Award Plan and vest over a three-year schedule: one-third vest on the first anniversary of the vesting commencement date (January 1, 2026), then one-sixth on each six-month anniversary thereafter, subject to continued service. The grants were made as inducements in accordance with Nasdaq Listing Rule 5635(c)(4).
Puma Biotechnology (NASDAQ: PBYI) was added to the Nasdaq Biotechnology Index (NBI) effective at the close of trading on December 19, 2025. The company said inclusion recognizes its commercial execution, profitability, and clinical progress, citing sustained demand for NERLYNX and advancing development of alisertib. The NBI tracks securities classified as biotechnology or pharmaceutical and requires eligibility criteria such as minimum market capitalization, average daily trading volume, and public company seasoning. The index is reviewed annually each December and is calculated using a modified capitalization-weighted methodology. Inclusion is intended to enhance visibility within the biotechnology investment community.
Puma Biotechnology (NASDAQ: PBYI) announced that on December 1, 2025 its Compensation Committee approved an inducement restricted stock unit award of 3,500 shares to one new non-executive employee under the 2017 Employment Inducement Incentive Award Plan. The RSUs vest over three years: one-third vests on the first anniversary of the vesting commencement date (December 1, 2025) and one-sixth vests every six months thereafter, subject to continued service. The grant was made as an inducement in accordance with Nasdaq Listing Rule 5635(c)(4).
Puma Biotechnology (NASDAQ: PBYI) announced that on November 5, 2025 its Compensation Committee approved inducement restricted stock unit awards covering 11,250 shares of common stock to two new non-executive employees.
The awards were granted under Puma's 2017 Employment Inducement Incentive Award Plan (adopted April 27, 2017) and vest over a three-year period: one-third vests on the first anniversary of the vesting commencement date (November 1, 2025) and one-sixth vests on each six-month anniversary thereafter, subject to continued service.
The awards were granted as an inducement under Nasdaq Listing Rule 5635(c)(4).
Puma Biotechnology (NASDAQ: PBYI) reported Q3 2025 results and raised full‑year 2025 guidance. Q3 product revenue was $51.9M versus $56.1M a year earlier; total Q3 revenue was $54.5M versus $80.5M. GAAP net income Q3 was $8.8M ($0.18 basic), and YTD net income was $17.7M ($0.35). Cash, equivalents and marketable securities totaled $94.4M at 9/30/2025. Company raised 2025 outlook: total revenue $220–$223M (from $212–$222M prior) and net income $27–$29M (from $23–$28M).
Management cited an 8% increase in U.S. NERLYNX bottles sold and upcoming interim alisertib trial data expected H1 2026.
Puma Biotechnology (NASDAQ: PBYI) will host a conference call to discuss its third quarter 2025 financial results on Thursday, Nov. 6, 2025 at 1:30 p.m. PT / 4:30 p.m. ET.
Investors can join by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international) and should dial in at least 10 minutes early, asking to join the “Puma Biotechnology Conference Call.” A live webcast and presentation slides will be available on the company Investors webpage, with a replay archived on the site for 90 days.