PUMA BIOTECHNOLOGY, INC.
PBYI evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for PBYI—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · PBYI
Puma Biotechnology, Inc. is a biopharmaceutical company focused on the acquisition, development, and commercialization of innovative cancer treatments, with its sole marketed product NERLYNX (neratinib) and a pipeline including alisertib for small cell lung cancer.
Key risk: Single product dependency
BioSniper Score
Based on 6 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 2 pipeline candidates · 21 clinical trials · 2 catalysts · 1 FDA decision for PUMA BIOTECHNOLOGY, INC..
Puma Biotechnology, Inc. is a biopharmaceutical company focused on the acquisition, development, and commercialization of innovative cancer treatments, with its sole marketed product NERLYNX (neratinib) and a pipeline including alisertib for small cell lung cancer.
- As of 2026-06-30, Puma reported cash & equivalents of $36.5M, total revenue of $56.5M, net income of $8.2M, shareholders' equity of $130.3M, and total debt of $102.0M [sec].
- The company's sole marketed product is NERLYNX (neratinib), which constitutes the vast majority of product revenue and is commercialized in the U.S. and several other countries [sec · filed 2021-11-04].
- Puma has a history of operating losses and expects to continue incurring losses for the foreseeable future, relying on external funding to sustain operations [sec · filed 2021-11-04].
- The company is initiating a Phase 2 study of alisertib in combination with paclitaxel for small cell lung cancer, with a start date of 2026-09-30 [upcoming catalysts].
What works
- Puma has achieved product revenue since 2017 and reported net income of $8.2M as of 2026-06-30, indicating a period of profitability [sec].
- The company has a global commercialization strategy for NERLYNX, with approvals in multiple countries including Canada, China, and South Korea [sec · filed 2022-05-05].
- Puma is advancing its pipeline with a Phase 2 study of alisertib, a potential new treatment for small cell lung cancer, set to start in 2026-09-30 [upcoming catalysts].
What to weigh
- Puma is heavily dependent on the commercial success of a single product, NERLYNX, which makes it vulnerable to market and regulatory risks [sec · filed 2021-11-04].
- The company has a history of operating losses and expects to continue incurring losses for the foreseeable future, requiring additional funding to sustain operations [sec · filed 2021-11-04].
- Puma relies exclusively on third parties to formulate and manufacture NERLYNX and its drug candidates, creating supply chain risks [sec · filed 2021-11-04].
- The company has $102.0M in total debt as of 2026-06-30, which may constrain financial flexibility [sec].
From the filings
Quoted directly from source documents.
Puma's success depends on NERLYNX commercialization
“'s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product and limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth.”
SEC filings · November 4, 2021
Puma has a history of operating losses
“the Company's history of operating losses and its expectation that it will continue to incur losses for the foreseeable future”
SEC filings · April 28, 2026
Puma relies on third parties for manufacturing
“The Company relies exclusively on third parties to formulate and manufacture NERLYNX and its drug candidates.”
SEC filings · November 4, 2021
Puma has debt of $102.0M
“31, 2022 there were $102.0 million in term loans outstanding under the Athyrium Notes, representing all of our long-term debt outstanding as of that date”
SEC filings · May 5, 2022
Catalyst timeline
- 2026-09-30 · Phase2_Start · alisertib — Phase 2 Start: A Phase 2 Study of Alisertib in Combination With Paclitaxel in Patients With Small Cell Lung Cancer — Initiation of a Phase 2 trial evaluating alisertib plus paclitaxel in small cell lung cancer, a key pipeline milestone.
- 2031-07-18 · Patent_Expiry · NERLYNX — Patent/Exclusivity Expiry: NERLYNX — Expiration of NERLYNX patent/exclusivity, which could open the market to generic competition.
Risks & what to watch (4)›
Key risks
- Single product dependency — Puma's revenue is almost entirely from NERLYNX; any setback in its commercialization could severely impact the company [sec · filed 2021-11-04].
- History of operating losses — The company has incurred negative cash flow since inception and expects to continue losing money, requiring external funding [sec · filed 2021-11-04].
- Third-party manufacturing reliance — Puma depends on external manufacturers for NERLYNX and pipeline candidates, introducing supply and quality risks [sec · filed 2021-11-04].
- Significant debt burden — Total debt of $102.0M as of 2026-06-30 may limit financial flexibility and increase refinancing risk [sec].
What to watch
- Initiation and enrollment progress of the Phase 2 alisertib study in small cell lung cancer, expected to start 2026-09-30 [upcoming catalysts].
- Commercial performance of NERLYNX, including revenue trends and market expansion in new countries [sec · filed 2022-05-05].
- Puma's ability to secure additional funding to support operations and pipeline development, given its history of losses [sec · filed 2021-11-04].
- Patent exclusivity for NERLYNX, which expires on 2031-07-18, potentially impacting long-term revenue [upcoming catalysts].
Sources: SEC filings · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
Profitable (positive operating cash flow)
D/E 0.39 · 3% dilution
Lead: Approved
2 candidates
2 upcoming, next in ~31d
0 buys · 8 sells (180d)
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
157
Total value held
$233.2M
| Holder | Shares | Value |
|---|---|---|
| acorn capital advisors, llc | 4,131,299 | $26.4M |
| vanguard capital management llc | 3,635,362 | $23.2M |
| blackrock, inc. | 3,598,952 | $23.0M |
| renaissance technologies llc | 1,942,413 | $12.4M |
| american century companies inc | 1,916,346 | $12.2M |
| vanguard portfolio management llc | 1,734,649 | $11.1M |
| millennium management llc | 1,477,519 | $9.4M |
| dimensional fund advisors lp | 1,436,106 | $9.2M |
| o'shaughnessy asset management, llc | 1,138,169 | $7.3M |
| geode capital management, llc | 1,017,342 | $6.5M |
Showing top 10 of 157 institutional holders of PUMA BIOTECHNOLOGY, INC.. Open the full 13F history after sign-in.
Short Interest
as of May 22, 2026- % of float
- 9.5%
- Days to cover
- 15.2
- Shares short
- 4,105,615
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
PBYI short interestGovernance
Frequently asked questions
What is the AI investment thesis for PUMA BIOTECHNOLOGY, INC.?
Puma Biotechnology, Inc. is a biopharmaceutical company focused on the acquisition, development, and commercialization of innovative cancer treatments, with its sole marketed product NERLYNX (neratinib) and a pipeline including alisertib for small cell lung cancer.
What is PUMA BIOTECHNOLOGY, INC.'s lead drug candidate?
PUMA BIOTECHNOLOGY, INC.'s most advanced tracked candidate is alisertib (Phase 2) for Small Cell Lung Cancer ( SCLC ); Hormone Receptor Positive HER-2 Negative Breast Cancer; Small Cell Lung Cancer.
What is PUMA BIOTECHNOLOGY, INC.'s next catalyst?
PUMA BIOTECHNOLOGY, INC.'s next tracked catalyst is a Phase2_Start event — "Phase 2 Start: A Phase 2 Study of Alisertib in Combination With Paclitaxel in Patients With Small Cell Lung Cancer" — expected September 30, 2026.
Who is the CEO of PUMA BIOTECHNOLOGY, INC.?
Mr. Alan H. Auerbach is the chief executive officer of PUMA BIOTECHNOLOGY, INC. (PBYI).
Where is PUMA BIOTECHNOLOGY, INC. headquartered?
PUMA BIOTECHNOLOGY, INC. (PBYI) is headquartered in Los Angeles, CA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.