Puma Biotechnology, Inc. PBYI
Puma Biotechnology, Inc. (Nasdaq: PBYI) is an oncology drug developer. Its lead program, NERLYNX (neratinib), is in Phase 2 for HER2-positive breast cancer (extended adjuvant and metastatic). Its next catalyst on record is alisertib: Puma will present updated data from ALISCA-Breast1 Phase II trial in metastatic breast cancer at the San Antonio Breast Cancer Symposium in December 2026. (December 2026).
Upcoming catalysts
- December 2026alisertib — Puma will present updated data from ALISCA-Breast1 Phase II trial in metastatic breast cancer at the San Antonio Breast Cancer Symposium in December 2026.
presentation of updated data from ALISCA®-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (San Antonio Breast Cancer Symposium, December 2026)
Next further out: alisertib — Puma plans to initiate discussions with global regulatory agencies regarding Phase III trial design for alisertib in metastatic breast cancer in H1 2027. (H1 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| NERLYNX (neratinib) | HER2-positive breast cancer | small molecule | Approved |
| alisertib | extensive stage small cell lung cancer (ALISCA-Lung1) | small molecule | Phase 2 |
| alisertib | HR+/HER2- breast cancer (ALISCA-Breast1) | small molecule | Phase 2 |
Recent results and decisions
- started Puma initiated ALISCA-Lung2, a Phase II trial evaluating alisertib in combination with paclitaxel in patients with advanced small cell lung cancer.
During the quarter, we initiated ALISCA®-Lung2, a Phase II trial evaluating alisertib in combination with paclitaxel in patients with advanced small cell lung cancer, further expanding our clinical development program in this area.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.