Company Overview: PBYI

Upcoming Projects (PBYI)

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Executed Projects (PBYI)

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Expired Projects (PBYI)

Discussing Puma Bio’s neratinib for HER2 (ERBB2)-mutant, metastatic cervical cancer
Ticker: PBYI
Execute By: Jan 31, 2023

Upcoming & Overdue Catalysts (PBYI)

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Occurred Catalysts (PBYI)

Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer Final Data Expected October 2017
Ticker: PBYI
Occurred on: Nov 13, 2017
Final 5-year DFS data from ExteNET expected in the second half of 2017
Ticker: PBYI
Occurred on: Sep 08, 2017
Phase 3 data of Neratinib in Third-line HER2-positive metastatic breast cancer due 1st half of 2017
Ticker: PBYI
Occurred on: Sep 08, 2017
PDUFA Date Expected in July 2017 for Puma Bio's (PBYI) Neratinib in Extended Adjuvant Treatment of Patients with Early-Stage HER2+ Breast Cancer
Ticker: PBYI
Occurred on: Jul 17, 2017
Regulatory decision in the EU on neratinib in extended adjuvant HER2 positive early stage breast cancer expected in Q3 2017
Ticker: PBYI
Occurred on: Jul 17, 2017
FDA's Oncologic Drugs Advisory Committee to Review Puma's (PBYI) New Drug Application for Neratinib in HER-2 Positive Breast Cancer
Ticker: PBYI
Occurred on: Apr 17, 2017
Phase II CONTROL trial (loperamide + budesonide) additional data expected in Q2 2017
Ticker: PBYI
Occurred on: Apr 04, 2017
Interim Phase Ib/II data fron neratinib plus Kadcyla (T-DM1) in HER2-positive metastatic breast cancer trial expected Q2 2017
Ticker: PBYI
Occurred on: Apr 02, 2017
Phase II data from SUMMIT basket trial of neratinib in patients with HER2 mutations expected Q2 2017
Ticker: PBYI
Occurred on: Apr 02, 2017
Phase 2 additional data of PB272 (Neratinib) (NSABP FB-7) in Neoadjuvant treatment for patients with HER2-positive breast cancer due 4Q 2016
Ticker: PBYI
Occurred on: Dec 07, 2016
Phase 2 data of Neratinib SUMMIT in HER2 non-amplified breast cancer that has a HER2 mutation due 4Q 2016
Ticker: PBYI
Occurred on: Dec 07, 2016
FDA Announces Acceptance of NDA for Puma Biotech's (PBYI) PB272 (Neratinib) in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
Ticker: PBYI
Occurred on: Sep 20, 2016
Puma Biotechnology Announces European Medicines Agency Validation of Marketing Authorization Application for PB272 (Neratinib) as Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in Europe
Ticker: PBYI
Occurred on: Aug 22, 2016
NDA filling of PB272 for the extended adjuvant HER2-positive early stage breast cancer due 1Q 2016
Ticker: PBYI
Occurred on: Jul 27, 2016
NDA Filing for neratinib set for mid-2016
Ticker: PBYI
Occurred on: Jul 21, 2016
Puma Biotechnology Announces Interim 5-Year Disease Free Survival Data from Phase III Trial of PB272 (Neratinib) in Extended Adjuvant HER2-Positive Early Stage Breast Cancer (ExteNET Trial)
Ticker: PBYI
Occurred on: Jul 21, 2016
Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to U.S. FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
Ticker: PBYI
Occurred on: Jul 21, 2016
Puma Biotechnology Announces I-SPY 2 Phase II Study of Neratinib Published in The New England Journal of Medicine
Ticker: PBYI
Occurred on: Jul 07, 2016
Puma Biotechnology Submits Marketing Authorization Application for PB272 (Neratinib) as Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in Europe
Ticker: PBYI
Occurred on: Jun 27, 2016
Puma Biotechnology Announces Results from ExteNET Phase III Clinical Trial of Neratinib
Ticker: PBYI
Occurred on: Feb 11, 2016
Puma to host an investor call to discuss Loperamide Prophylaxis to Reduce Neratinib-Related Diarrhea
Ticker: PBYI
Occurred on: Dec 21, 2015

Strategic Initiatives (PBYI)

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PBYI Overview