ADDED
false --12-31 FY 2025 true true true false true true false false false false true 0 362 0.0001 0.0001 100,000,000 100,000,000 50,408,023 50,408,023 49,105,834 49,105,834 5 10.6 4 4 15.2 2.1 3 3 7 0 9.7 9.7 9.7 0.4 0.4 5.417 5 5 2.0 0 3 1.6 1.6 14.9 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 State taxes in Kentucky and Indiana comprise the majority (greater than 50%) of the tax effect in this category.
Other research and development expense include regulatory affairs, pharmacovigilance, quality assurance, chemical manufacturing and other costs.
As of February 23, 2026, there were 50,876,487 shar es of the registrant s common stock outstanding.
These risks include, among others, the following: While we have reported net income in recent years, we cannot assure that we will continue to do so and may not be able to maintain profitability.
We are currently commercializing NERLYNX, an oral version of neratinib, for the treatment of certain HER2-positive breast cancers.
Prior to our licensing alisertib from a subsidiary of Takeda Pharmaceutical Company Limited ( Takeda ), alisertib was tested in over 1,300 patients who were treated across 22 company-sponsored trials resulting in a large, well-characterized clinical safety database.
Based on information in this database, we believe alisertib has potential application in the treatment of a range of different cancer types, including hormone receptor-positive breast cancer, triple negative breast cancer and small cell lung cancer.
We intend to pursue development of alisertib initially in small cell lung cancer and hormone receptor-positive breast cancer.
* EBC: Early breast cancer ** MBC: Metastatic breast cancer *** HRc+: Hormone receptor-positive **** NSCLC: Non-small cell lung cancer Neratinib Breast cancer is the leading cause of cancer death among women worldwide, with approximately 2.3 million new cases reported each year and more than 670,000 deaths globally per year.
NERLYNX, the commercial name for neratinib, is currently approved in the United States for two indications: the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy and for use in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
REMOVED
false --12-31 FY 2024 true true true false true true false false false false 362 881 0.0001 0.0001 100,000,000 100,000,000 49,105,834 49,105,834 47,646,787 47,646,787 0 0 0 200 4 2.1 3 3 7 9.7 9.7 9.7 9.7 5 4.9 4.9 2 2,000 0 0 3 Other research and development expense include regulatory affairs, pharmacovigilance, quality assurance, chemical manufacturing and other costs.
As of February 24, 2025 , there were 49,610,799 shar es of the registrant s common stock outstanding.
These risks include, among others, the following: While we have reported net income in the years ended December 31, 2024, 2023 and 2022, we cannot assure that we will continue to do so and may not be able to maintain profitability.
We are currently commercializing NERLYNX, an oral version of neratinib, for the treatment of HER2-positive breast cancer.
Based on information in this database, we believe alisertib has potential application in the treatment of range of different cancer types, including hormone receptor positive breast cancer, triple negative breast cancer, small cell lung cancer and head and neck cancer.
We intend to pursue development of alisertib initially in small cell lung cancer and hormone receptor positive breast cancer.
* EBC: Early breast cancer ** MBC: Metastatic breast cancer *** HRc+: Hormone receptor positive **** NSCLC: Non-small cell lung cancer Neratinib Breast cancer is the leading cause of cancer death among women worldwide, with approximately one million new cases reported each year and more than 400,000 deaths per year.
Neratinib is a potent irreversible tyrosine kinase inhibitor ( TKI ) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.
Alisertib In September 2022, we entered into an exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited ( Takeda ) to license the worldwide research and development and commercial rights to alisertib.
Women with breast cancer that over-expresses HER2 are at greater risk for disease recurrence, progression and death than women whose tumors do not over-express HER2.