PUMA BIOTECHNOLOGY, INC.
PBYINext catalyst
Neratinib
Advanced Breast Cancer
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Track PUMA BIOTECHNOLOGY (PBYI) and we email you when an FDA date moves, 7 days and 1 day before the decision when the exact day is known, and when it is announced. Free account, no card.
Plus 1 more upcoming event in our data (earnings).See the timeline
2 upcoming, 0 past
PBYI Earnings Report
Date estimated from past reporting pattern, not yet confirmed by the company | EPS Est: $0.06 | FQ end Sep/2026 | Call: amc
Neratinib Phase 2 Est. Readout
Estimated primary completion for Neratinib trial (NCT04886531) in Breast Cancer. Topline data typically follows completion by weeks to months.
SourceMarket Overview
Stock performance and key metrics
Puma Biotechnology is a publicly traded biopharmaceutical company (NASDAQ: PBYI) headquartered in Los Angeles, CA.
WebsiteNeratinib
Advanced Breast Cancer
HKI-272
Carcinoma, Non-Small-Cell Lung
Alisertib
Hormone Receptor Positive HER-2 Negative Breast Cancer
Loperamide
HER2 Amplified Breast Cancer
Colesevelam
Early-stage Breast Cancer
Letrozole (L) or Anastrozole (A)
Breast Cancer
5-Fluorouracil + leucovorin
GastroEsophageal Cancer
Colestipol
Early Stage HER2+ Breast Cancer
Crofelemer
HER2-positive Breast Cancer
Temsirolimus
Breast Cancer
Diphenoxylate/Atropine
HER2-positive Breast Cancer
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Neratinib | Phase 3 | Advanced Breast Cancer | - | - |
HKI-272 | Phase 2 | Carcinoma, Non-Small-Cell Lung | - | - |
Alisertib | Phase 2 | Hormone Receptor Positive HER-2 Negative Breast Cancer | - | - |
Loperamide | Phase 2 | HER2 Amplified Breast Cancer | - | - |
Colesevelam | Phase 2 | Early-stage Breast Cancer | - | - |
Letrozole (L) or Anastrozole (A) | Phase 2 | Breast Cancer | - | - |
5-Fluorouracil + leucovorin | Phase 2 | GastroEsophageal Cancer | - | - |
Colestipol | Phase 2 | Early Stage HER2+ Breast Cancer | - | - |
Crofelemer | Phase 2 | HER2-positive Breast Cancer | - | - |
Temsirolimus | Phase 2 | Breast Cancer | - | Patent 2032 |
Diphenoxylate/Atropine | Phase 2 | HER2-positive Breast Cancer | - | - |
Advanced Breast Cancer
1 drug in this indication
Breast Cancer
1 drug in this indication
Carcinoma, Non-Small-Cell Lung
1 drug in this indication
Hormone Receptor Positive HER-2 Negative Breast Cancer
1 drug in this indication
Source: CatalystAlert database (ClinicalTrials.gov, SEC EDGAR)
Frequently asked questions
What is in PUMA BIOTECHNOLOGY, INC.'s drug pipeline?β
CatalystAlert tracks 11 drug candidates in PUMA BIOTECHNOLOGY, INC.'s (PBYI) pipeline across Phase 3, Phase 2. Its lead program is Neratinib (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is PUMA BIOTECHNOLOGY, INC.'s next FDA catalyst?β
PUMA BIOTECHNOLOGY, INC.'s (PBYI) next tracked catalyst is a Phase 2 readout expected December 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track PBYI biotech catalysts?β
Add PBYI to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow PUMA BIOTECHNOLOGY, INC.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page β sourced from ClinicalTrials.gov, FDA and SEC filings.
