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) has granted inducement restricted stock unit awards to two new non-executive employees. The awards, approved by the Compensation Committee on May 5, 2025, cover 12,875 shares of Puma common stock. These equity awards were granted under Puma'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 vesting commencement dates (April 1, 2025 and May 1, 2025), followed by one-sixth vesting every six months thereafter, contingent on continued employment. The awards were granted in accordance with Nasdaq Listing Rule 5635(c)(4) as an inducement for the new employees joining Puma.
Puma Biotechnology presented clinical data for neratinib at the AACR Annual Meeting 2025 in Chicago. The Phase I trial (NCI 10495) evaluated the combination of neratinib with trastuzumab deruxtecan in patients with HER2-altered solid tumors.
Key findings from the 20-patient trial:
- Most common side effects: nausea (75%), diarrhea (75%), fatigue (65%)
- 4 patients achieved partial responses, including cases of gastroesophageal, pancreatic, and ovarian cancers
- Notable results in pancreatic cancer: 3 of 5 patients showed tumor shrinkage
The study established Dose Level 3 as the recommended Phase II dose: trastuzumab deruxtecan at 5.4 mg/kg combined with neratinib starting at 120 mg (week 1), increasing to 160 mg (week 2), and 240 mg (week 3 onward). Part 2 of the study, focusing on pharmacodynamic evaluation in 12 patients, began enrollment in March 2025.
Puma Biotechnology (NASDAQ: PBYI) has announced it will host a conference call to discuss its first quarter 2025 financial results on Thursday, May 8, 2025, at 1:30 p.m. PT/4:30 p.m. ET. Investors can access the call through domestic (1-877-709-8150) or international (1-201-689-8354) dial-in numbers.
A live webcast and presentation slides will be available on the Investors section of the company's website. The call recording will be archived on Puma's website for 90 days following the event.
Puma Biotechnology (NASDAQ: PBYI) has announced the approval of inducement restricted stock unit awards for four new non-executive employees. The Compensation Committee approved grants covering 23,875 shares of Puma common stock on April 1, 2025.
The awards, granted under Puma's 2017 Employment Inducement Incentive Award Plan, will vest over three years. One-third of the shares will vest on the first anniversary (April 1, 2025), followed by one-sixth vesting every six months thereafter, contingent on continued employment. These grants were made as employment inducements in compliance with Nasdaq Listing Rule 5635(c)(4).
Puma Biotechnology (NASDAQ: PBYI) has announced the upcoming presentation of clinical data for neratinib at the AACR Annual Meeting 2025 in Chicago. The presentation will feature results from a Phase I trial investigating the combination of trastuzumab deruxtecan with neratinib in solid tumors with HER2 alterations (NCI 10495).
The poster presentation, led by Dr. Andrew Davis from Washington University School of Medicine, is scheduled for April 28, 2025, from 2:00-5:00 p.m. CT during the First-in-Human Phase I Clinical Trials session. The complete poster will be made available on Puma's website simultaneously with the live presentation.
Puma Biotechnology (NASDAQ: PBYI) has announced the approval of an inducement restricted stock unit award by its Compensation Committee. The award, covering 3,500 shares of Puma common stock, was granted to a new non-executive employee under the company's 2017 Employment Inducement Incentive Award Plan.
The restricted stock unit award features a three-year vesting schedule: one-third of shares vest on March 1, 2026 (first anniversary), followed by one-sixth of shares vesting every six months thereafter. The grant, approved on March 4, 2025, complies with Nasdaq Listing Rule 5635(c)(4) as an inducement for employment.
Puma Biotechnology (NASDAQ: PBYI) has announced its participation in the Barclays 27th Annual Global Healthcare Conference. The company's Chairman, CEO, President and Founder, Alan H. Auerbach, will deliver a corporate overview presentation at the Loews Miami Beach on Tuesday, March 11, at 2:00 p.m. ET.
Investors and interested parties can access a live webcast of the presentation through the company's website at pumabiotechnology.com. The presentation recording will remain available for replay on the website for 30 days following the event.
Puma Biotechnology (NASDAQ: PBYI) has announced its participation in the Barclays 27th Annual Global Healthcare Conference. The company's Chairman, CEO, President and Founder, Alan H. Auerbach, will deliver a corporate overview presentation at 2:00 p.m. ET on Tuesday, March 11 at the Loews Miami Beach.
The presentation will be accessible through a live webcast on the company's website at pumabiotechnology.com. For those unable to attend, the presentation will remain available for replay on the website for 30 days following the event.
Puma Biotechnology (NASDAQ: PBYI) reported its Q4 and full-year 2024 financial results, showing mixed performance. Q4 2024 product revenue from NERLYNX® sales increased to $54.4M from $53.2M in Q4 2023, while full-year product revenue decreased to $195.2M from $203.1M in 2023.
The company achieved Q4 2024 net income of $19.3M ($0.39 per share), up from $12.3M ($0.26 per share) in Q4 2023. Full-year net income rose to $30.3M ($0.62 per share) from $21.6M in 2023. The Q4 results include a $7.1M benefit from a partial release of valuation allowance.
Cash position strengthened to $101M by December 31, 2024, compared to $96M year-over-year. The company initiated the ALISCA™-Breast1 Phase II trial for alisertib in November and anticipates key clinical milestones throughout 2025.