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) has announced it will host a conference call to discuss its fourth quarter and full year 2024 financial results on Thursday, February 27, 2025, at 1:30 p.m. PT/4:30 p.m. ET. Investors can access the call via phone using 1-877-709-8150 (domestic) or 1-201-689-8354 (international) numbers.
A live webcast and presentation slides will be available on the Investors section of Puma's website. The call recording will be archived on the company's website for 90 days after the event.
Puma Biotechnology (NASDAQ: PBYI) has announced the approval of inducement restricted stock unit awards for two new non-executive employees. The Compensation Committee of Puma's Board of Directors approved the grant of 7,250 shares of common stock on February 4, 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 February 1, 2026 (first anniversary), and one-sixth vesting every six months thereafter, contingent on continued employment. These awards were granted as employment inducements in compliance with Nasdaq Listing Rule 5635(c)(4).
Puma Biotechnology (NASDAQ: PBYI) announced the approval of inducement restricted stock unit awards for two new non-executive employees. The Compensation Committee approved grants covering 24,375 shares of Puma common stock under the company's 2017 Employment Inducement Incentive Award Plan.
The restricted stock units will vest over three years, with one-third vesting on January 1, 2026 (first anniversary), and one-sixth vesting every six months thereafter, contingent on continued employment. These awards were granted as employment inducements in compliance with Nasdaq Listing Rule 5635(c)(4).
Puma Biotechnology (NASDAQ: PBYI) announced that NERLYNX® (neratinib) has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Cervical Cancer. The drug is now listed as a second-line or subsequent therapy option for recurrent or metastatic cervical cancer patients with HER2-mutated tumors, receiving a Category 2A designation. The inclusion was based on results from the Phase II SUMMIT trial, which studied patients with histologically confirmed recurrent/metastatic cervical cancer and documented evidence of somatic, activating HER2 mutations.
Puma Biotechnology (NASDAQ: PBYI) announced the approval of an inducement restricted stock unit award for a new non-executive employee. The award, covering 7,500 shares of Puma common stock, was granted under the company's 2017 Employment Inducement Incentive Award Plan. The stock units will vest over three years, with one-third vesting on December 1, 2025, and one-sixth vesting every six months thereafter, contingent on continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4) as an employment inducement.
Puma Biotechnology (NASDAQ: PBYI) has initiated the ALISCA™-Breast1 Phase II trial of alisertib combined with endocrine therapy for hormone receptor-positive, HER2-negative metastatic breast cancer patients. The study will enroll up to 150 patients who have previously received CDK 4/6 inhibitors and at least two prior endocrine therapies. Patients will be randomized to receive alisertib at 30mg, 40mg, or 50mg doses. The trial's primary endpoints include objective response rate, duration of response, disease control rate, progression-free survival, and overall survival. Initial data is expected in 2025, with plans to discuss potential approval pathways with the FDA following trial outcomes.
Puma Biotechnology (NASDAQ: PBYI) reported strong Q3 2024 financial results with total revenue of $80.5 million, including $56.1 million in product revenue from NERLYNX® and $24.4 million in royalty revenue. The company posted a net income of $20.3 million ($0.41 per share), up from $5.8 million in Q3 2023. Operating cash flow was $11.0 million, with cash and equivalents of $97 million. The company updated its full-year 2024 guidance, projecting net product revenue of $187-190 million and net income of $15-17 million.
Puma Biotechnology (NASDAQ: PBYI) announced the approval of an inducement restricted stock unit award of 5,625 shares to a new non-executive employee. The award, granted under the company's 2017 Employment Inducement Incentive Award Plan, will vest over three years, with one-third vesting after the first year and one-sixth every six months thereafter, starting from November 1, 2024. This grant was made in accordance with Nasdaq Listing Rule 5635(c)(4) as an employment inducement.
Puma Biotechnology (NASDAQ:PBYI) announced it will host a conference call on Thursday, November 7, 2024, at 1:30 p.m. PST/4:30 p.m. EST to discuss its third quarter 2024 financial results. Participants can join via phone using 1-877-709-8150 (domestic) or 1-201-689-8354 (international). A live webcast and presentation slides will be available on the company's website, with a replay accessible for 90 days.
Puma Biotechnology (NASDAQ: PBYI) has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, at the Lotte New York Palace Hotel in New York City. Alan H. Auerbach, the company's Chairman, CEO, President, and Founder, will present an overview of Puma Biotechnology on Monday, September 9, at 3:00 p.m. EDT.
Investors and interested parties can access a live webcast of the presentation through the company's website at pumabiotechnology.com. The presentation will remain available on the website for 30 days after the event, providing an opportunity for those unable to attend the conference to gain insights into Puma Biotechnology's current status and future plans.