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Nuvation Bio (NUVB)
NYSE:NUVB
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Nuvation Bio
(NYSE:NUVB)
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Rating:50Neutral
Price Target:
$4.50
▲(2.27% Upside)
Action:ReiteratedDate:03/04/26
The score is primarily constrained by weak financial performance (large losses and cash burn despite improving revenue/gross margin) and a bearish technical setup (below key moving averages with negative MACD). These are partially offset by a constructive earnings-call outlook highlighting strong launch traction, supportive clinical data, and substantial cash resources.
Positive Factors
Clinical efficacy and durability
Long, durable responses (median DOR ~50 months) and high ORR in TKI‑naive patients represent a lasting clinical differentiation versus prior ROS1 TKIs. Durable efficacy supports long-term patient retention, formulary support, and reduced churn, strengthening commercial sustainability over years.
Strong U.S. launch traction & access
Rapid prescription uptake and widespread payer coverage indicate effective commercial execution and early market share capture. Broad adoption across top-tier accounts and specialty inventory alignment signal durable distribution channels and repeat prescriber behavior that underpin sustained revenue growth as mix normalizes.
Robust cash position & strategic partnerships
A >$500M cash balance plus an Eisai upfront and milestone framework materially lowers near‑term financing risk, enabling continued R&D and commercial investment. The partnership accelerates international rollout and de-risks revenue diversification beyond U.S. markets over multiple years.
Negative Factors
High cash burn and weak cash generation
Historic operating cash outflows and materially negative free cash flow reflect ongoing burn typical of a commercializing biotech. Sustained high R&D and SG&A spend without positive operating cash generation creates medium‑term funding pressure and reliance on partnerships or capital markets if performance disappoints.
Revenue mix and quality concerns
Material milestone and collaboration payments inflate reported revenue versus organic product sales. Early launch skew toward later‑line patients and rising gross‑to‑net (~25%) compress realized pricing and obscure sustainable product revenue, complicating medium‑term forecasting and margins.
Pipeline timing and program setbacks
Key pipeline catalysts are distant (SIGMA readout 2029) and a recent DDC discontinuation required resource reallocation. Long timelines and program setbacks delay diversified product drivers, increasing reliance on IBTROZI commercial execution to fund operations and heightening binary risk over the next several years.
Nuvation Bio (NUVB) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.53B
Dividend YieldN/A
Average Volume (3M)5.27M
Price to Earnings (P/E)―
Beta (1Y)1.88
Revenue Growth1137.19%
EPS Growth70.51%
CountryUS
Employees273
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.11
Shares Outstanding346,597,300
10 Day Avg. Volume6,945,427
30 Day Avg. Volume5,272,044
Financial Highlights & Ratios
PEG Ratio0.21
Price to Book (P/B)10.01
Price to Sales (P/S)48.65
P/FCF Ratio-17.61
Enterprise Value/Market Cap0.90
Enterprise Value/Revenue21.80
Enterprise Value/Gross Profit25.18
Enterprise Value/Ebitda-7.00
Forecast
1Y Price Target
$12.00Price Target Upside172.73% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
EPS Forecast (FY)-0.49
Revenue Forecast (FY)$190.96M
Nuvation Bio Business Overview & Revenue Model
Company DescriptionNuvation Bio Inc., a clinical-stage biopharmaceutical company, focuses on the development of therapeutic candidates for oncology. The company's lead product candidate is NUV-422, a small molecule inhibitor targeting cyclin-dependent kinase (CDK)2, CDK4, and CDK6. It is also developing NUV-868, a selective oral small molecule BET inhibitor that epigenetically regulates proteins that control tumor growth and differentiation; NUV-569, a differentiated oral small molecule selective inhibitor of the Wee1 kinase for DNA damage repair; NUV-1182, an adenosine receptor inhibitor; and drug-drug conjugate (DDC) platform that focuses on targeting an inhibitor of poly ADP ribose polymerase (PARP) to anti-cancer warheads of existing drugs, as well as PARP inhibitor to address ER+ breast and ovarian cancer. The company was formerly known as RePharmation Inc. and changed its name to Nuvation Bio Inc. in April 2019. Nuvation Bio Inc. was founded in 2018 and is headquartered in New York, New York.
How the Company Makes MoneyNuvation Bio makes money primarily through the development and commercialization of its pharmaceutical products. The company generates revenue from various streams, including partnerships with other biotech and pharmaceutical companies, licensing agreements, and potential future sales of its drug candidates once they receive regulatory approval. Significant partnerships with industry players or research institutions can also provide funding and collaborative opportunities, contributing to the company's financial growth. Additionally, Nuvation Bio may engage in strategic collaborations to enhance its research and development capabilities, which can also lead to milestone payments and royalties that serve as key revenue streams.
Nuvation Bio Earnings Call Summary
Earnings Call Date:Mar 02, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 19, 2026
Earnings Call Sentiment Positive
The call highlights a number of strong clinical and commercial progress points — U.S. approval of IBTROZI, rapid new patient starts (~6x faster vs. prior launches), compelling durability data (median DOR 50 months in TKI‑naive), broad payer access, strong cash position ($529.2M), and advancing pipeline programs (safusidenib Phase III initiation and a non‑pivotal cohort with potential accelerated pathway). Offsetting these positives are near‑term commercial headwinds: a mismatch between new patient starts and net product revenue due to an early mix skewed toward later‑line patients who discontinue quickly, rising gross‑to‑net (~25%), high operating costs (R&D $115.1M; SG&A $151.6M), a discontinued DDC candidate, and long timelines for pivotal readouts (safusidenib SIGMA readout expected 2029). Overall, the call projects long‑term upside driven by clinical differentiation and international partnerships while acknowledging short‑term revenue and execution uncertainties.Q4-2025 Updates
Positive Updates
U.S. Approval and Strong Launch Momentum for IBTROZI
Received full U.S. FDA approval on June 11, 2025 for IBTROZI in advanced ROS1-positive NSCLC; 432 new patients started IBTROZI in 2025 (216 in Q4) and IQVIA shows prescriptions ~6x faster than the two prior ROS1 TKI launches over their first two full quarters.
Clinical Efficacy and Durability
Pooled analysis in TKI‑naive patients reported a median duration of response (DOR) of 50 months and previously demonstrated an 89% confirmed overall response rate (ORR); strong intracranial activity noted (example: 66% intracranial response in a second-line setting referenced).
Favorable Tolerability Enabling Broader Development
Clinical database of 337 advanced ROS1 patients showed only 1 discontinuation due to the six most common adverse events (≈0.3%); tolerability supported dosing first patient in TRUST‑IV adjuvant Phase III study and enabled global regulatory filings/approvals.
Global Regulatory and Commercial Partnerships
Approvals obtained in China and Japan; partnership with Eisai for Europe and select ex‑U.S. territories (upfront ≈$60M, $30M upon European approval, up to $140M in sales milestones, double‑digit to high‑teens royalties); combined out‑licensing and partner deal values (excluding Latin America) approach ~$520M.
Q4 and Full‑Year 2025 Revenue Highlights
Total revenue in Q4 2025 was $41.9M and total revenue for 2025 was $62.9M, which includes milestone and collaboration revenue; IBTROZI net U.S. product revenue was $15.7M in Q4 and $24.7M for full year 2025.
Strong Cash Position and Path to Profitability
Ended 2025 with $529.2M in cash, cash equivalents and marketable securities (increased by ≈$60M following Eisai upfront); management does not anticipate the need for additional external financing to reach profitability under current operating plans.
Progress on Safusidenib Clinical Program
Safusidenib Phase II in low‑grade IDH1‑mutant glioma: median PFS not reached, 12% progression at 24 months, confirmed ORR 44% (n=27); Phase I in high‑grade showed 17% ORR with durable complete responses in some patients; initiated pivotal SIGMA Phase III (300 patients, PFS primary endpoint, readout expected 2029) and a non‑pivotal grade 3 oligodendroglioma cohort (~40 patients) with a potential 2027 readout for ORR.
Operational Launch Execution and Market Access
Engaged all top‑tier target accounts; IBTROZI prescriptions written across 100% of 47 sales territories with multiple repeat prescribers; achieved broad payer coverage to label across the U.S.; specialty partners holding ~2–4 weeks of inventory, consistent with demand.
Negative Updates
Revenue Growth Lag Behind New Patient Starts
Despite 432 new patient starts in 2025, net product revenue remained modest ($24.7M full year) because a large share of early launches were later‑line patients who discontinue quickly; company highlighted the launch mix (many third‑line+) as the main reason for a gap between new patient starts and revenue recognition.
High Operating Spend
Full‑year 2025 R&D expenses were $115.1M and SG&A expenses were $151.6M, reflecting substantial ongoing investment to support commercialization and development.
Gross‑to‑Net and Pricing Pressure
Gross‑to‑net is approximately 25% as of Q4 2025 and is expected to increase slightly before stabilizing, which will pressure net realized pricing as access expands and additional contracts are signed.
Clinical and Safety Uncertainties for Safusidenib
Safusidenib showed dermatologic adverse events (alopecia, arthralgia, skin hyperpigmentation) and a drug‑related discontinuation rate of ~8% in the Phase II pivotal dose cohort; Phase III SIGMA is a PFS trial with a long timeline (readout expected 2029) and no planned interim analysis.
Program Setback in DDC Modality
Discontinued development of first DDC (NUV‑1511) in Q4 2025; although learnings will be applied to new preclinical candidates, this represents a pipeline setback and reallocation of resources.
Visibility and Seasonality / Market Risks
Limited visibility into full patient mix (many patients not captured via hub data), seasonal variability in Q4 historically, and potential competitor entries later in 2026 create uncertainty in short‑term uptake and revenue cadence.
Revenue Composition Includes Milestones
Q4 and 2025 revenues include material milestone and collaboration payments (e.g., $25M Japan milestone, $60M Eisai upfront), which inflate reported revenue relative to pure product sales and may obscure organic product revenue trends in early launch phases.
Company Guidance
The company provided no formal 2026 revenue guide but gave clear operational and development milestones: commercial metrics include 432 new IBTROZI patient starts by year‑end 2025 (216 in Q4, 204 in Q3), an observed >200 new patient starts/quarter run rate to date, IQVIA showing prescription uptake ~6x faster than the two prior ROS1 TKI launches over their first two quarters, 70% of new starts from academic/IDN centers vs 30% community, specialty inventory of ~2–4 weeks, and Innovation Connect data showing ~75% of discontinuations coming from later‑line patients; clinical metrics include a pooled median DOR of 50 months and 89% confirmed ORR in TKI‑naive IBTROZI patients (clinical database of 337 with only 1 discontinuation for common AEs), ROS1 disease CNS burden (36% present with brain mets, brain is first site of progression in ~50% of cases), safusidenib Phase II (n=27) with median PFS not reached, ~12% progression at 24 months and 44% ORR, Phase I safusidenib ORR 17% (n=35) in high‑grade, ~8% drug‑related discontinuation at 250 mg BID, SIGMA Phase III sized at ~300 patients with a 2029 readout (no interim planned), and a non‑pivotal grade‑3 oligodendroglioma cohort ~40 patients (31 U.S. sites activated) targeting a 2027 readout; financial metrics/guidance include Q4 revenue $41.9M and FY2025 revenue $62.9M (IBTROZI net U.S. product revenue $15.7M Q4 / $24.7M FY), gross‑to‑net ≈25% (expected to tick up then stabilize), year‑end cash ~$529.2M with an additional $50M term loan available through June 30, 2026, Eisai upfront ~$60M (+ ~$30M on EU approval and up to ~$140M in sales milestones, plus double‑digit to high‑teens royalties) and a combined ex‑U.S. deal value of ~ $520M (ex‑LatAm), and the company expects no need for additional external financing to reach profitability under its current plan.Nuvation Bio Financial Statement Overview
Summary
Revenue and gross margin improved sharply in 2025, but profitability remains very weak with a large net loss and historically heavy cash burn. The balance sheet shows low leverage, yet equity has declined materially, reflecting ongoing capital consumption.Income Statement
Revenue has inflected meaningfully, rising to ~$62.9M in 2025 (annual) from ~$7.9M in 2024 (135% growth), and gross margin expanded sharply to ~86.6% (vs. ~10.1% in 2024), indicating improved revenue mix/quality. However, profitability remains very weak: 2025 net loss was ~$204.6M with a deeply negative net margin (~-325%), and losses have been highly volatile year-to-year (e.g., 2024 net loss ~$567.9M vs. 2023 ~$75.8M). Overall, strong top-line momentum but still far from operating leverage.22
Negative
Balance Sheet
The balance sheet is a relative strength: leverage is low with total debt of ~$10.1M against ~$305.7M of equity in 2025 (debt-to-equity ~0.03). That said, equity has declined meaningfully from ~$605.1M in 2023 to ~$305.7M in 2025, consistent with sustained losses and potential dilution/valuation pressure. Returns remain negative (2025 return on equity ~-67%), underscoring that the company is still consuming capital rather than compounding it.62
Positive
Cash Flow
Cash generation is weak and inconsistent. Operating and free cash flow were materially negative in prior years (e.g., 2024 operating cash flow about -$130.4M; 2023 about -$68.0M), reflecting ongoing cash burn typical of development-stage biotech. In 2025, operating and free cash flow are reported as 0, which does not demonstrate positive cash generation and creates uncertainty around true cash burn for the period; free cash flow growth is shown as -100%, reinforcing deterioration versus prior reporting.18
Very Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 62.90M | 7.87M | 0.00 | 0.00 | 0.00 |
| Gross Profit | 54.46M | 795.00K | 0.00 | 0.00 | 0.00 |
| EBITDA | -190.94M | -566.91M | -75.58M | -119.53M | -93.13M |
| Net Income | -204.63M | -567.94M | -75.80M | -104.20M | -86.85M |
Balance Sheet | |||||
| Total Assets | 594.82M | 540.63M | 621.48M | 672.14M | 776.15M |
| Cash, Cash Equivalents and Short-Term Investments | 529.21M | 502.69M | 611.21M | 661.01M | 765.39M |
| Total Debt | 10.15M | 8.91M | 4.01M | 4.26M | 3.06M |
| Total Liabilities | 289.11M | 76.84M | 16.36M | 17.07M | 30.15M |
| Stockholders Equity | 305.72M | 463.79M | 605.12M | 655.08M | 746.00M |
Cash Flow | |||||
| Free Cash Flow | -173.78M | -130.57M | -68.07M | -96.48M | -68.47M |
| Operating Cash Flow | -173.43M | -130.41M | -68.00M | -96.11M | -68.19M |
| Investing Cash Flow | 99.52M | 122.70M | 8.92M | 63.46M | -454.67M |
| Financing Cash Flow | 202.53M | 331.00K | 628.00K | 1.33M | 625.53M |
Nuvation Bio Technical Analysis
Negative
4.40
Price Trends
5.77
Negative
6.38
Negative
4.56
Negative
Market Momentum
-0.41
Positive
33.86
Neutral
34.31
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For NUVB, the sentiment is Negative. The current price of 4.4 is below the 20-day moving average (MA) of 5.04, below the 50-day MA of 5.77, and below the 200-day MA of 4.56, indicating a bearish trend. The MACD of -0.41 indicates Positive momentum. The RSI at 33.86 is Neutral, neither overbought nor oversold. The STOCH value of 34.31 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for NUVB.
Nuvation Bio Risk Analysis
Nuvation Bio disclosed 91 risk factors in its most recent earnings report. Nuvation Bio reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Nuvation Bio Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
67 Neutral | $8.45B | -21.87 | -58.74% | ― | 364.98% | -25.33% | |
61 Neutral | $1.66B | -8.42 | -24.22% | ― | ― | 3.18% | |
59 Neutral | $1.25B | -1.67 | -3342.58% | ― | 59.20% | -155.65% | |
57 Neutral | $2.15B | -5.95 | -399.10% | ― | -32.79% | 36.87% | |
56 Neutral | $2.35B | -14.03 | -84.99% | ― | 103.75% | 33.84% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $1.53B | -14.96 | -57.48% | ― | 1137.19% | 70.51% |
* Healthcare Sector Average
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Nuvation Bio Corporate Events
Business Operations and StrategyFinancial Disclosures
Nuvation Bio Expands Global Reach with Eisai Partnership
Positive
Jan 12, 2026
On January 11, 2026, Nuvation Bio entered into an exclusive license and collaboration agreement with Eisai granting Eisai rights to develop and commercialize taletrectinib (IBTROZI) across Europe, a wide swath of the Middle East and North Africa, Russia, Turkey, Canada, Australia, New Zealand and key Asia‑Pacific markets, in return for an upfront €50 million payment, a near-term €25 million regulatory milestone, up to €120 million in sales milestones, and tiered royalties on net sales. The deal, announced publicly on January 12, 2026, strengthens Nuvation Bio’s financial position and global reach for IBTROZI, complementing strong early U.S. commercial traction in 2025—432 new patient starts since the mid‑June FDA approval and preliminary net product revenue of $24.7 million for the year—while supporting continued investment in its pipeline, including a pivotal phase 3 trial of safusidenib and further development of its drug‑drug conjugate platform.
The most recent analyst rating on (NUVB) stock is a Hold with a $10.00 price target. To see the full list of analyst forecasts on Nuvation Bio stock, see the NUVB Stock Forecast page.
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.