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) announced on June 3, 2022, the granting of inducement restricted stock unit awards covering 38,125 shares to six new non-executive employees. These awards, part of the 2017 Employment Inducement Incentive Award Plan, vest over three years. One-third will vest on the first anniversary of the June 1, 2022, commencement date, with subsequent vesting every six months. This inducement is compliant with Nasdaq Listing Rule 5635(c)(4). Puma is focused on innovative cancer care products, including NERLYNX, approved for HER2-positive breast cancer treatment.
Puma Biotechnology (NASDAQ: PBYI) presented Phase II SUMMIT trial results at ASCO, highlighting the efficacy of neratinib, fulvestrant, and trastuzumab in hormone receptor-positive, HER2-negative, HER2-mutant metastatic breast cancer. The trial showed a 35.3% objective response rate and 41.7% clinical benefit rate among patients previously treated with CDK4/6 inhibitors. The combination therapy led to a median progression-free survival of 8.2 months, indicating its potential for durable responses across various HER2 mutations.
Puma Biotechnology, Inc. (NASDAQ: PBYI) presented final results from the Phase II SUMMIT ‘basket’ trial for neratinib at the 2022 ASCO Annual Meeting. The trial focused on treatment-refractory patients with metastatic biliary tract cancers harboring somatic HER2 mutations. Out of 25 patients, the overall response rate was 16%, with a median progression-free survival of 2.8 months and overall survival of 5.4 months. Diarrhea was the most common toxicity observed (56%). While neratinib shows potential, further studies are needed for improved treatment strategies.
Puma Biotechnology, Inc. (NASDAQ: PBYI) announced the presentation of two abstracts on neratinib at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for June 3-7, 2022, in Chicago, Illinois. The abstracts focus on targeting HER2 mutation-positive advanced biliary tract cancers and the combination therapy of neratinib for hormone receptor-positive, HER2-negative metastatic breast cancer. Full details of the abstracts are accessible on the ASCO website and will be available on Puma's site post-presentation.
Puma Biotechnology, Inc. (NASDAQ: PBYI) announced the grant of inducement restricted stock unit awards for 14,500 shares to three new non-executive employees on May 9, 2022. The awards are part of Puma’s 2017 Employment Inducement Incentive Award Plan, designed to encourage new hires. Vesting occurs over three years, beginning on May 1, 2022. Puma develops innovative cancer care products and is known for its oral medication NERLYNX® (neratinib), approved for treating HER2-positive breast cancer.
Puma Biotechnology, Inc. (NASDAQ: PBYI) reported Q1 2022 financial results, showing a product revenue decrease to $40.7 million from $45.8 million in Q1 2021. The company posted a net loss of $3.4 million, compared to net income of $16.5 million in the same period last year. Total revenue fell to $45.7 million, down from $98.2 million, with significant reductions in operating costs to $46.4 million. Cash, cash equivalents, and marketable securities decreased to $73.9 million. Puma anticipates key milestones in 2022, including Phase II data from clinical trials and discussions with the FDA regarding neratinib.
Puma Biotechnology (NASDAQ: PBYI) announced the titles of abstracts for neratinib to be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 in Chicago. Key studies include the SUMMIT trial on neratinib with fulvestrant and trastuzumab for HR+, HER2-negative, HER2-mutant metastatic breast cancer, and targeting HER2 mutation-positive advanced biliary tract cancers. Full abstracts will be available online on May 26.
Puma Biotechnology (NASDAQ: PBYI) will host a conference call on May 5, 2022, at 1:30 p.m. PDT to discuss its Q1 2022 financial results. Interested parties can join the call by dialing (866) 682-6100 domestically or (862) 298-0702 internationally, and are advised to call in 10 minutes early. A live webcast will be available on the company’s website, and a replay will be archived for 90 days. Puma focuses on innovative cancer care products and is known for its oral neratinib, approved by the FDA for breast cancer treatment.
Puma Biotechnology, Inc. (NASDAQ: PBYI) announced on April 1, 2022, the grant of 31,875 inducement restricted stock unit awards to four new non-executive employees. These awards, approved by the Compensation Committee, will vest over three years, with one-third vesting after one year and the remainder in six-month intervals. This initiative is part of Puma's 2017 Employment Inducement Incentive Award Plan and complies with Nasdaq Listing Rule 5635(c)(4).
Puma focuses on innovative cancer care solutions, including the marketed product NERLYNX®.
Puma Biotechnology (Nasdaq: PBYI) announced a private placement agreement to sell 3,584,228 shares at $2.79 each, totaling around $10 million. The deal involves CEO Alan Auerbach and Athyrium Capital Management. The funds will be used for general corporate purposes and the closing is expected by March 10, 2022, pending customary conditions. The shares are not registered under the Securities Act, but Puma plans to file a registration statement for their resale.
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