PUMA BIOTECHNOLOGY, INC.
PBYI evidence brief
What we can confirm
- BioSniper Score:
- 5.1 / 10
- Market Cap:
- $473.4M
- Lead Asset:
- alisertib (Phase 2)
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. (PBYI) is a biopharmaceutical company that commercializes NERLYNX (neratinib) for HER2-positive breast cancer and is developing alisertib, an Aurora Kinase A inhibitor, for multiple cancer types.
Key risk: Single product reliance
BioSniper Score
Based on 5 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 2 pipeline candidates · 20 clinical trials · 1 catalyst · 1 FDA decision for PUMA BIOTECHNOLOGY, INC..
Puma Biotechnology, Inc. (PBYI) is a biopharmaceutical company that commercializes NERLYNX (neratinib) for HER2-positive breast cancer and is developing alisertib, an Aurora Kinase A inhibitor, for multiple cancer types.
- Cash & equivalents of $36.5M as of 2026-06-30 [sec].
- Total revenue of $56.5M and net income of $8.2M for the period ending 2026-06-30 [sec].
- NERLYNX approved in over 60 countries outside the U.S. for HER2-positive breast cancer [sec_mda · as of 2026-08-06].
- Alisertib Phase II trials ongoing: ALISCA-Lung1 (small cell lung cancer) started Feb 2024 and ALISCA-Breast1 (breast cancer) started Nov 2024 [sec_mda · as of 2026-08-06].
- Shareholders' equity of $138.5M as of 2026-06-30 [sec].
What works
- NERLYNX has achieved regulatory approval in over 60 countries, indicating broad international market access [sec_mda · as of 2026-08-06].
- Alisertib has a large clinical safety database from over 1,300 patients across 22 prior trials, supporting its development [sec_mda · as of 2026-08-06].
- The company has positive net income ($8.2M) and substantial shareholders' equity ($138.5M) as of 2026-06-30 [sec].
What to weigh
- The company relies on a single product (NERLYNX) for the vast majority of revenue, creating concentration risk [sec_mda · as of 2026-05-07].
- Puma expects to continue incurring losses for the foreseeable future and may need additional funding to sustain operations and develop alisertib [sec · filed 2026-04-28] [sec_mda · as of 2026-08-06].
- Future financing is uncertain and could be adversely impacted by market conditions and commercial success of neratinib [sec_mda · as of 2026-08-06].
From the filings
Quoted directly from source documents.
Cash position as of 2026-06-30
“cash and cash equivalents totaling approximately $36.5 million and approximately $57.4 million in marketable securities available at June 30, 2026”
SEC MD&A · August 6, 2026
NERLYNX approval in over 60 countries
“NERLYNX has received approval for the treatment of certain patients with extended adjuvant or metastatic HER2-positive breast cancer in over 60 countries outside the United States”
SEC MD&A · August 6, 2026
Alisertib Phase II trial start dates
“We initiated the ALISertib in CAncer (ALISCA ® -Lung1) Phase II trial (PUMA-ALI-4201) of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer in February 2024, and we commenced the ALISCA™ -Breast1 Phase II trial (PUMA-ALI-1201) in November 2024”
SEC MD&A · August 6, 2026
Single product reliance
“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 MD&A · May 7, 2026
Catalyst timeline
- 2031-07-18 · Patent_Expiry · NERATINIB MALEATE — Expiration of NDA208051 for neratinib maleate; may open door for generic competition.
Risks & what to watch (4)›
Key risks
- Single product reliance — NERLYNX is the sole marketed product; any setback would severely impact revenue [sec_mda · as of 2026-05-07].
- Continued operating losses — Company expects to incur losses for the foreseeable future, requiring additional funding [sec · filed 2026-04-28].
- Alisertib development costs — Significant expenses anticipated for alisertib development; funding beyond current cash may be needed [sec_mda · as of 2026-08-06].
- Financing uncertainty — Ability to raise future financing is uncertain and may be affected by market conditions and product success [sec_mda · as of 2026-08-06].
What to watch
- Progress of alisertib Phase II trials (ALISCA-Lung1 and ALISCA-Breast1) [sec_mda · as of 2026-08-06].
- NERLYNX revenue trends and expansion in approved countries [sec_mda · as of 2026-08-06].
- Cash runway and any new financing or partnership announcements [sec_mda · as of 2026-08-06].
- Patent expiry for neratinib maleate on 2031-07-18, which could affect future exclusivity [catalyst].
Sources: SEC filings · SEC MD&A · Generated October 13, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.39 · 3% dilution
Lead: Approved
2 candidates
1 upcoming, next in ~1738d
0 buys · 8 sells (180d)
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
156
Total value held
$220.8M
| Holder | Shares | Value |
|---|---|---|
| acorn capital advisors, llc | 4,131,299 | $26.4M |
| 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 capital management llc | 1,817,681 | $11.6M |
| 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 156 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. (PBYI) is a biopharmaceutical company that commercializes NERLYNX (neratinib) for HER2-positive breast cancer and is developing alisertib, an Aurora Kinase A inhibitor, for multiple cancer types.
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 Patent_Expiry event — "Patent_Expiry: NDA208051" — expected July 18, 2031.
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.