Puma Biotechnology Inc Stock Price, News & Analysis

Puma Biotechnology announced FDA approval for a labeling supplement for NERLYNX, incorporating dosing escalation based on findings from the Phase II CONTROL Trial. The new 133 count SKU aims to better meet patient needs. The CONTROL study demonstrated significant improvements, including a 60% reduction in Grade 3 diarrhea and 80% reduction in discontinuation rates, enhancing treatment tolerability. The company believes these changes will extend therapy duration and benefit more HER2-positive breast cancer patients.

Puma Biotechnology (NASDAQ: PBYI) announced on June 2, 2021, the grant of inducement restricted stock unit awards covering 30,375 shares to five new non-executive employees. This grant follows the 2017 Employment Inducement Incentive Award Plan, enabling equity awards to new hires. The shares will vest over three years, with one-third vesting on the first anniversary and one-sixth every six months thereafter, contingent on continued service. These awards are provided as an inducement for new employees, in compliance with Nasdaq Listing Rule 5635(c)(4).

Puma Biotechnology (NASDAQ: PBYI) presented interim results from the Phase II SUMMIT trial at the 2021 ASCO Annual Meeting. The trial evaluated neratinib's efficacy in patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC), particularly those with central nervous system (CNS) involvement. Among 10 evaluable patients, 60% had a partial response, with an overall clinical benefit of 80%. The median duration of response was 7.5 months, and median progression-free survival was 9.1 months. Neratinib was well tolerated, with no grade 3 diarrhea reported, suggesting its potential as a safe treatment option for challenging cases.

Puma Biotechnology (PBYI) presented findings at the 2021 ASCO Annual Meeting regarding the Phase II CONTROL trial, focusing on diarrhea management during neratinib treatment for early-stage HER2-positive breast cancer. The study compared antidiarrheal strategies, revealing that dose escalation (DE) significantly reduced grade 3 diarrhea incidence (13.3% vs. 39.9%) compared to the ExteNET trial. The DE cohort also experienced fewer treatment discontinuations due to diarrhea (3.3% vs. 14.5%) and had a longer average treatment duration. These results advocate for dose escalation as an effective diarrhea management strategy with improved tolerability.

Puma Biotechnology (NASDAQ: PBYI) presented findings from the Phase III ExteNET trial at the 2021 ASCO Annual Meeting, highlighting the positive impact of neratinib on overall survival in patients with early-stage HER2-positive breast cancer. The study involved 2,840 patients and compared outcomes of neratinib versus placebo over 11 months. Results showed improved overall survival rates: 92.2% for neratinib versus 90.2% for placebo in the intention-to-treat population. The findings suggest that extended adjuvant therapy with neratinib can reduce recurrence risk and improve survival outcomes.

Puma Biotechnology, Inc. (NASDAQ: PBYI) recently announced the publication of three abstracts on its drug neratinib, to be presented at the 2021 ASCO Annual Meeting from June 4-8. The abstracts focus on the drug's effectiveness in treating early-stage HER2+ breast cancer and non-small cell lung cancer. The presentations include findings from the ExteNET trial and the SUMMIT basket trial, highlighting treatment duration and tolerability issues related to diarrhea. The full posters will be accessible online from June 4, 2021.

Puma Biotechnology (PBYI) reported Q1 2021 financial results, with net NERLYNX revenue at $45.8 million, down from $48.6 million in Q1 2020. GAAP net income reached $16.5 million, marking a turnaround from a loss of $16.9 million the previous year. Total revenue was $98.2 million, bolstered by a $50 million licensing deal for NERLYNX in Greater China. Operating costs rose to $78 million, influenced by a one-time $20 million termination fee. Cash and marketable securities increased to $109.1 million. The company anticipates significant clinical milestones throughout 2021.

Puma Biotechnology (NASDAQ: PBYI) announced on May 3, 2021, the approval of inducement restricted stock unit awards totaling 14,500 shares for three new non-executive employees. These awards, part of the 2017 Employment Inducement Incentive Award Plan, will vest over three years, beginning with one-third on the first anniversary of May 1, 2021. The grants comply with Nasdaq Listing Rule 5635(c)(4) and are designed to incentivize new hires. Puma focuses on innovative cancer care treatments, notably the FDA-approved NERLYNX for HER2-positive breast cancer.

Puma Biotechnology will hold a conference call on May 6, 2021, at 1:30 p.m. PDT to discuss its Q1 2021 financial results. Investors can join by dialing 1-877-709-8150 domestically or 1-201-689-8354 internationally. A live webcast and presentation slides will be available on the company's website. Puma focuses on innovative cancer therapies, notably NERLYNX, an FDA-approved treatment for HER2-positive breast cancer, with additional approvals in the U.S. and Europe.