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) 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.
Puma Biotechnology (NASDAQ: PBYI) announced that on October 1, 2025 its Compensation Committee approved an inducement restricted stock unit (RSU) award of 9,375 shares to one new non-executive employee under the 2017 Employment Inducement Incentive Award Plan. The RSU award vests over a three-year schedule: one-third on the first anniversary of the vesting commencement date (October 1, 2025) and one-sixth on each subsequent six-month anniversary, subject to continued service. The grant was made pursuant to Nasdaq Listing Rule 5635(c)(4) as an inducement to employment.
Puma Biotechnology (Nasdaq: PBYI) announced the approval of inducement restricted stock unit awards for four new non-executive employees. The Compensation Committee approved grants totaling 25,750 shares of Puma common stock on September 2, 2025, under the company's 2017 Employment Inducement Incentive Award Plan.
The restricted stock units will vest over three years, with one-third vesting on the first anniversary of the August 1 and September 1, 2025 commencement dates, followed by one-sixth vesting every six months thereafter, contingent on continued employment. These awards were granted in accordance with Nasdaq Listing Rule 5635(c)(4) as employment inducements.
Puma Biotechnology (NASDAQ: PBYI) announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference. Alan H. Auerbach, the company's Chairman, CEO, President and Founder, will present a company overview on September 8, 2025 at 1:00 p.m. EDT at the Lotte New York Palace Hotel.
The presentation will be accessible through a live webcast on Puma's website and will remain available for 30 days following the event.