Puma Biotechnology Inc Stock Price, News & Analysis

Puma Biotechnology (NASDAQ: PBYI) announced that CEO Alan H. Auerbach will present at the H.C. Wainwright 23rd Annual Global Investment Conference, taking place from September 13-15, 2021. The presentation will be available on-demand starting at 7:00 a.m. EDT on September 13, 2021, and a replay can be accessed on Puma's website for 30 days thereafter. Puma specializes in developing innovative cancer care therapies, notably the oral drug NERLYNX® (neratinib), approved by the FDA for specific breast cancer treatments.

Puma Biotechnology, Inc. (NASDAQ: PBYI) announced on August 2, 2021, the grant of inducement restricted stock unit awards totaling 15,938 shares to three new non-executive employees. This award is part of Puma's 2017 Employment Inducement Incentive Award Plan, aimed at attracting new talent. The units will vest over three years, with a portion vesting annually and semi-annually. Puma specializes in developing innovative cancer care therapies, including NERLYNX® (neratinib), which is FDA-approved for treating certain types of breast cancer.

Puma Biotechnology (PBYI) reported second quarter 2021 financial results, with NERLYNX revenue at $48.9 million, a slight increase from $48.8 million in Q2 2020. Total revenue was $53.4 million, down from $70.6 million in the same period last year. The company posted a net loss of $5.1 million, or $0.13 per share, compared to a net income of $3.4 million in Q2 2020. Operating expenses rose to $70.0 million from $63.5 million. Cash reserves increased to $108.9 million as of June 30, 2021. Key milestones include upcoming data on neratinib trials and FDA discussions for accelerated approvals.

Puma Biotechnology, Inc. (NASDAQ: PBYI) has entered into a note purchase agreement with Athyrium Capital Management for the issuance of up to $125 million in notes, split into two tranches. The first tranche of $100 million was successfully closed on July 23, 2023, to retire an existing loan with Oxford Finance LLC. The second tranche of $25 million is planned for general corporate use and to support NERLYNX® initiatives. The notes will mature in July 2026, with further details to be filed with the SEC.

Puma Biotechnology (NASDAQ: PBYI) will host a conference call on August 5, 2021, at 1:30 p.m. PDT to discuss its Q2 2021 financial results. Investors can access the call via phone or through a live webcast available on the company's website.

Puma focuses on cancer care innovations, notably the oral and IV formulations of neratinib, marketed as NERLYNX®. The drug has received FDA approvals for breast cancer treatment, highlighting Puma's commitment to enhancing cancer care through its innovative products.

Puma Biotechnology announced the grant of inducement restricted stock unit awards totaling 34,375 shares to five new non-executive employees, effective July 1, 2021. These awards, part of the 2017 Inducement Plan, vest over three years. Additionally, Alvin Wong received an inducement stock option for 90,000 shares at an exercise price of $10.21 in conjunction with his appointment as Chief Scientific Officer. This award also vests over a period of time, contingent on continued employment.

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.