Puma Biotechnology

258 articles with Puma Biotechnology

• Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - Oct. 3, 2019

  10/3/2019

  Puma Biotechnology, Inc., a biopharmaceutical company, announced that on October 1, 2019 the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering an aggregate of 79,375 shares of Puma common stock to eleven new non-executive employees.

• FDA Approves Labeling Supplement for Puma Biotechnology’s NERLYNX® (neratinib) for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

  10/2/2019

  Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the rate of discontinuation due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.

• Puma Biotechnology to Present at Cantor Global Healthcare Conference

  9/25/2019

  Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 2:25 p.m. EDT on Thursday, October 3, at the Cantor Global Healthcare Conference.

• Puma Biotechnology Announces U.S. FDA Acceptance of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

  9/11/2019

  The FDA confirmed that the review will have an action date of late April, 2020.

• Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - Sept. 5, 2019

  9/5/2019

  Puma Biotechnology, Inc., a biopharmaceutical company, announced that on September 4, 2019 the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering an aggregate of 48,750 shares of Puma common stock to five new non-executive employees.

• Puma Biotechnology Licensing Partner Pint Pharma Receives Marketing Authorization for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage Hormone Receptor Positive, HER2-Positive Breast Cancer

  9/4/2019

  First regulatory approval of NERLYNX in Latin America.

• Puma Biotechnology to Present at the H.C. Wainwright 21st Annual Global Investment Conference

  9/3/2019

  Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 9:35 a.m. EDT on Tuesday, September 10,

• FDA Grants Orphan Drug Designation to Puma Biotechnology’s NERLYNX® for the Treatment of Breast Cancer Patients with Brain Metastases

  9/3/2019

  Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases.

• Puma Biotechnology Reports Second Quarter 2019 Financial Results

  8/8/2019

  All comparisons are for the second quarter 2019 compared to the second quarter of 2018.

• Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - Aug. 6, 2019

  8/6/2019

  Puma Biotechnology, Inc., a biopharmaceutical company, announced that on July 23, 2019 the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering an aggregate of 52,501 shares of Puma common stock to seven new non-executive employees.

• Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - July 25, 2019

  7/25/2019

  Puma Biotechnology, Inc., a biopharmaceutical company, announced that on July 23, 2019 the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering an aggregate of 9,125 shares of Puma common stock to two new non-executive employees.

• Puma Biotechnology to Host Conference Call to Discuss Second Quarter Financial Results 2019

  7/24/2019

  Puma Biotechnology, Inc., a biopharmaceutical company, will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 8, 2019 following release of its second quarter 2019 financial results.

• Puma Biotechnology’s Licensing Partner Knight Therapeutics Receives Regulatory Approval from Health Canada to Commercialize NERLYNX® for Extended Adjuvant Treatment of Hormone Receptor Positive, HER2-Positive Early Stage Breast Cancer

  7/16/2019

  Puma Biotechnology, Inc. announced that its licensing partner Knight Therapeutics Inc. has received marketing authorization from Health Canada to commercialize NERLYNX® in Canada for the extended adjuvant treatment of women with early stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.

• Puma Biotechnology Presents Interim Results from the Biliary Tract Cohort of its Phase II SUMMIT Basket Trial of Neratinib at the ESMO World Congress on Gastrointestinal Cancer 2019

  7/3/2019

  Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, presented updated interim results from the biliary cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the efficacy of neratinib in HER2-mutated cancers, at the European Society for Medical Oncology (ESMO) 21st World Congress on Gastrointestinal Cancer 2019, currently taking place in Barcelona, Spain

• Puma Biotechnology Submits a Supplemental New Drug Application to U.S. FDA for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

  7/1/2019

  Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease).

• Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - June 5, 2019

  6/5/2019

  Puma Biotechnology, Inc., a biopharmaceutical company, announced that on June 3, 2019 the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering an aggregate of 82,063 shares of Puma common stock to 15 new non-executive employees.

• CORRECTING and REPLACING GRAPHIC Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the ASCO 2019 Annual Meeting

  6/4/2019

  Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, will present updated interim results from a Phase II clinical trial of Puma’s drug neratinib at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting in Chicago.

• Puma Biotechnology Presents Results from Phase III NALA Trial of Neratinib in Patients with HER2-Positive Metastatic Breast Cancer at the ASCO 2019 Annual Meeting

  6/4/2019

  Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that results from the Phase III NALA trial of PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease, were presented at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting in Chicago.

• Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the ASCO 2019 Annual Meeting

  6/2/2019

  Puma Biotechnology, Inc., a biopharmaceutical company, will present updated interim results from a Phase II clinical trial of Puma’s drug neratinib at the American Society of Clinical Oncology 2019 Annual Meeting in Chicago.

• Puma Biotechnology to Present at Jefferies 2019 Global Healthcare Conference

  5/29/2019

  Puma Biotechnology, Inc. announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 3:30 p.m. EDT on Thursday, June 6, at the Jefferies 2019 Global Healthcare Conference.