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Nuvation Bio Inc.

NUVBFDA catalysts, PDUFA dates & pipeline intelligence
$4.53
▼ -0.04 · -0.87%

Financials

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R&D Expenses
Operating CF
Total Assets
Total Liabilities
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D/E Ratio
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Quarterly Cash
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52W LOW $3.9252W HIGH $9.75
Volume
1.12 M
Value Traded
31.58 M
Short % Float
23.36%
Days to Cover
13.9
+1.67%Week
-18.66%1 Month
-31.61%3 Month
-0.11%6 Month
-65.01%5 Year
-52.8%All Time

Cash Data

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  • SEC Filing

Key Stats

Market Cap
1.59 B
EPS (TTM)
-0.43
P/E Ratio
-
Ent. Value
1.43 B
Total Shares
351.08 M
Float Shares
251.98 M
Insiders
28.44%
Institutions
56.20%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 2 data readout
IBTROZI (taletrectinib)
Locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)
BreakthroughPriorityOrphan
Phase 2Small MoleculesOncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

NUVB Catalyst Timeline

Dated clinical, regulatory and corporate events for Nuvation Bio Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Nuvation Bio Inc.

224Total events
15Upcoming
53Tier-1 (high impact)
2020 to 2033Coverage

Upcoming catalysts 2

T2Oral Presentation
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IBTROZIApproved
T2Quarterly Update
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Event history 50

▲Supplemental ApprovalIBTROZIApprovedFDA Decision
FDA approves sNDA for IBTROZI (taletrectinib) with updated DOR in TKI-naïve ROS1+ NSCLC
ROS1-positive non-small cell lung cancersource ↗
▲Poster PresentationIBTROZIApprovedPresentation
New subgroup analyses from TRUST-I and TRUST-II presented at IASLC 2026 WCLC
advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)source ↗
▲Subgroup AnalysisIBTROZIApprovedClinical Data
Consistent response rates regardless of prior chemotherapy exposure in TKI-naive patients
advanced ROS1-positive (ROS1+) NSCLCsource ↗
▲Safety Data UpdateIBTROZIApprovedClinical Data
Long-term follow-up shows manageable safety profile with no new safety signals
advanced ROS1-positive (ROS1+) NSCLCsource ↗
▲Poster PresentationIBTROZIApprovedPresentation
New subgroup analyses from TRUST-I and TRUST-II presented at IASLC 2026 WCLC
advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)source ↗
▲Subgroup AnalysisIBTROZIApprovedClinical Data
Consistent efficacy between CD74 and non-CD74 ROS1 fusion partners
advanced ROS1+ NSCLCsource ↗
▲Safety Data UpdateIBTROZIApprovedClinical Data
Long-term follow-up showed manageable safety profile with no new safety signals
advanced ROS1+ NSCLCsource ↗
●Enrollment UpdateSafusidenibTrial
Pivotal Phase 3 SIGMA study enrollment underway
IDH1-mutant astrocytoma with high-risk featuressource ↗
▲Full ResultsSafusidenibClinical Data
Updated data from Phase 2 J201 study announced
IDH1-mutant gliomasource ↗
●Quarterly UpdateCorporate
Q2 2026 financial results and business update
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Past FDA Catalysts and PDUFA Decisions

How NUVB actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-09-16Ibtrozi (taletrectinib adipate) PDUFA Date ApprovedPDUFA
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

Pipeline Score
Pipeline Value
Commercial Value
Valuation Signal
2
Drugs Scored
rNPV / MCap
Top Drug
Top 22%
Micro Cap
(rank 145 of 657)
Percentile Rank
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026; product lines: last four quarters to Jun 2026 (10-K and 10-Q))
ProductRevenuePrior periodChange
IBTROZI
Showing 7 of 10 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Safusidenib Small moleculeNCT07712757Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 MutationPhase 3 NOT YET_RECRUITING 140Mar 1, 2032
Safusidenib Small moleculeNCT05303519GliomaPhase 3 RECRUITING 365Dec 1, 2030
Safusidenib Small moleculeNCT07703436Grade 2 IDH1-mutant GliomaPhase 2 RECRUITING 40Mar 1, 2032
NUV-1511 Small moleculeNCT06334432Advanced Solid TumorPhase 1 ACTIVE NOT_RECRUITING 466Oct 1, 2027
Taletrectinib Small moleculeMarketedNCT04919811Non Small Cell Lung CancerPhase 3 ACTIVE NOT_RECRUITING 764Dec 1, 2027
Multiple administration of omeprazole Single administration of AB-106 Small moleculeMarketedNCT05609929UndisclosedPhase 1 COMPLETED 24Jan 20, 2023
Taletrectinib Small moleculeMarketedNCT05357911Solid TumorPhase 1 COMPLETED 72Dec 3, 2021
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Clinical Trial Results

Readouts, endpoints and source filings for every NUVB program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
IBTROZI
BreakthroughPriority
advanced ROS1-positive non-small cell lung cancer (NSCLC)2026-09-15ORR TKI naive prior chemo: 90.0%; ORR TKI naive no prior chemo: 89.8%; DOR TKI naive prior chemo: 48.3 months; DOR TKI naive no prior chemo: 54.3 months; ORR CD74 fusion: 89.5%; ORR non CD74 fusion: 88.9%Read MoreNuvation Bio Announces New Analyses Reinforcing the Durable, Consistent Efficacy of IBTROZI® (taletrectinib) Across Key Patient Subgroups in Advanced ROS1+ NSCLC at 2026 World Conference on Lung CancerRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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InsiderSideSharesPriceValueDate
Hattersley GaryOfficer (CHIEF SCIENTIFIC OFFICER)Option 100,000 100,000 held$1.87 08/19/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
TANG CAPITAL MANAGEMENT LLC 0.9 % (28.6 %) 18.74 M 3.30 M 4.76% ( 150.00 K)
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Shares held by hedge funds each quarter, and who bought or sold.

NUVB Institutional Ownership Trends

NUVB Short Interest

Shares sold short, counted twice a month.

23.36%
Short % of Float
of tradable shares sold short
58.9M
Shares Sold Short
+1.2% vs prior count
13.9 Very high
Days to Cover
trading days of normal volume to buy every short share back
4.2M
Avg Daily Volume
the average used for days to cover
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Two years of days to cover and shares sold short, with every count and its change.
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Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-11-20
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Real-Time Option Chain

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LastVolOILastVolOI
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Calls vs Puts by Expiry

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Competitive positioning

How NUVB ranks across every disease it competes in

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NUVB News

NUVB
Oct 21, 2026
NUVBConferences/Events

Nuvation Bio to Report Third Quarter 2026 Financial Results and Provide Business Update on November 4, 2026

Nuvation Bio Inc. will host a conference call on November 4, 2026, to discuss its third quarter financial results and business updates. The call will be accessible to investors and the public via a live webcast. The company aims to develop impactful cancer therapies and has a diverse pipeline.

Read more →
NUVB
Sep 17, 2026
NUVBFDA Updates
▲ +5%on this news

Nuvation Bio Announces FDA Approval of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive Non-Small Cell Lung Cancer

Nuvation Bio has received FDA approval for a supplemental New Drug Application for IBTROZI (taletrectinib), which now includes an updated median duration of response of 49.7 months for TKI-naïve patients with advanced ROS1-positive non-small cell lung cancer. The approval, which came four months early, confirms the drug's safety profile with no new safety signals identified. This update is significant for patients and physicians, providing clarity on treatment expectations.

Read more →
NUVB
Sep 15, 2026
NUVBPhases

Nuvation Bio Announces New Analyses Reinforcing the Durable, Consistent Efficacy of IBTROZI® (taletrectinib) Across Key Patient Subgroups in Advanced ROS1+ NSCLC at 2026 World Conference on Lung Cancer

Nuvation Bio presented new analyses at the 2026 World Conference on Lung Cancer, demonstrating that IBTROZI (taletrectinib) maintains consistent efficacy in advanced ROS1-positive non-small cell lung cancer (NSCLC) across various patient subgroups. The data from the TRUST-I and TRUST-II studies showed similar response rates and duration of response, regardless of prior chemotherapy exposure or ROS1 fusion partner. These findings support early biomarker testing and timely transition to targeted therapy.

Read more →
NUVB
Sep 2, 2026
NUVBConferences/Events

Nuvation Bio to Participate in Upcoming Investor Conferences

Nuvation Bio Inc. will participate in upcoming investor conferences, including the Citi's 2026 Biopharma Back to School Conference and the 2026 Cantor Global Healthcare Conference. CEO David Hung and CFO Philippe Sauvage will lead discussions and one-on-one meetings. Live webcasts will be available on their website.

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NUVB
Aug 20, 2026
NUVBFDA Updates
▼ -5.9%on this news

Nuvation Bio Granted FDA Fast Track Designation for Safusidenib for Treatment of IDH1-Mutant Glioma

Nuvation Bio has received FDA Fast Track Designation for safusidenib, an oral inhibitor targeting IDH1-mutant glioma. This designation aims to expedite the regulatory review process, contingent on positive clinical data. The ongoing Phase 3 SIGMA study is expected to evaluate safusidenib's effectiveness as a maintenance therapy. The drug has shown encouraging results in earlier studies, indicating its potential to meet critical patient needs.

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NUVB
Aug 6, 2026
NUVBGeneral

Nuvation Bio Reports Second Quarter 2026 Financial Results and Provides Business Update

Nuvation Bio reported strong financial results for Q2 2026, achieving $31.7 million in total revenue, with $23.2 million from IBTROZI. The drug is now the most prescribed ROS1 TKI, showing a 30% growth in TKI-naïve patients. Additionally, positive long-term data for safusidenib was announced, expanding its clinical program. Despite a net loss of $62.8 million, the company maintains a robust balance sheet.

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NUVB
Aug 4, 2026
NUVBConferences/Events

Nuvation Bio to Present New Subgroup Analyses of Pivotal Data for IBTROZI® (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at WCLC and ESMO Annual Congresses

Nuvation Bio announced that it will present new subgroup analyses of long-term data from its Phase 2 TRUST-I and TRUST-II studies for IBTROZI (taletrectinib) at the upcoming WCLC and ESMO congresses. These analyses will focus on the efficacy and safety of IBTROZI in patients with advanced ROS1-positive non-small cell lung cancer. The findings aim to reinforce the drug's potential as a standard treatment option across various patient subgroups.

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NUVB
Jul 22, 2026
NUVBConferences/Events

Nuvation Bio to Report Second Quarter 2026 Financial Results and Provide Business Update on August 6, 2026

Nuvation Bio Inc. will host a conference call on August 6, 2026, to discuss its financial results for Q2 2026 and provide business updates. Investors and the public can access the live webcast and participate via a conference call. The company, founded in 2018, focuses on developing impactful cancer therapies.

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NUVB
Jul 20, 2026
NUVBPhases
▲ +7.9%on this newsshared move

Nuvation Bio Announces Positive Updated Phase 2 Data and Expansion of Safusidenib Clinical Program with Two New Studies to Explore Broad Spectrum of IDH1-Mutant Glioma

Nuvation Bio has announced positive updated Phase 2 data for safusidenib, showing a confirmed objective response rate of 52% and a 36-month progression-free survival rate of 79%. The company is expanding its clinical program with two new studies: a Phase 3 study for newly diagnosed grade 2 glioma patients outside the U.S. and a Phase 2 study for patients whose glioma has progressed after treatment with vorasidenib in the U.S. The long-term data supports the efficacy and safety of safusidenib.

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NUVB
Jul 6, 2026
NUVBGeneral

Nuvation Bio Inc. Announces Full Exercise of Greenshoe Option in $287.5 Million Convertible Senior Notes Offering

Nuvation Bio Inc. announced the full exercise of its Greenshoe option, raising an additional $37.5 million in a convertible senior notes offering, totaling $287.5 million. The company plans to use the net proceeds of approximately $277.6 million for general corporate purposes, including working capital and operating expenses. The offering was conducted under a registration statement with the SEC.

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NUVB
Jun 29, 2026
NUVBFDA Updates

Nuvation Bio Announces Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated in the United Kingdom

Nuvation Bio announced that the Medicines and Healthcare products Regulatory Agency in the U.K. has validated the Marketing Authorisation Application for taletrectinib, an oral treatment for advanced ROS1-positive non-small cell lung cancer. This follows a similar validation by the European Medicines Agency. Taletrectinib has already been approved in the U.S., China, and Japan, and aims to expand access for patients in the U.K.

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NUVB
Jun 26, 2026
NUVBGeneral

Nuvation Bio Announces Pricing of Upsized Offering of $250.0 million of Convertible Senior Notes

Nuvation Bio has announced the pricing of an upsized offering of $250 million in convertible senior notes due in 2032. The offering, initially set at $200 million, is expected to close on June 30, 2026. Proceeds will be used to repay existing debt and for general corporate purposes. The notes will have a 0.75% interest rate and are convertible under specific conditions.

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NUVB
Jun 25, 2026
NUVBGeneral
▼ -10.1%on this newsshared move

Nuvation Bio Announces Proposed Convertible Senior Notes Offering

Nuvation Bio has announced a proposed offering of $200 million in Convertible Senior Notes due in 2032, with an option for underwriters to purchase an additional $30 million. The proceeds will be used for various corporate purposes, including repaying existing loans. The offering is subject to market conditions and will include capped call transactions to mitigate potential dilution.

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NUVB
May 27, 2026
NUVBConferences/Events

Nuvation Bio to Present at the Jefferies Global Healthcare Conference

Nuvation Bio Inc. will present at the Jefferies Global Healthcare Conference on June 3, 2026. CEO David Hung and CFO Philippe Sauvage will participate in a fireside chat, which will be available via live webcast. The company aims to address major challenges in cancer treatment with its diverse pipeline of therapies.

Read more →
NUVB
May 4, 2026
NUVBGeneral

Nuvation Bio Reports First Quarter 2026 Financial Results and Provides Business Update

Nuvation Bio reported strong financial results for the first quarter of 2026, with $18.5 million in net product revenues from IBTROZI, their ROS1 inhibitor. The company noted continued adoption in TKI-naïve patients and impressive long-term response durability exceeding four years. Additionally, Nuvation secured exclusive global rights to safusidenib, which is intended to advance the treatment options for IDH1-mutant glioma. Despite rising research and administrative costs, the company remains on a solid financial footing, with over $533 million in cash and assets.

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NUVB
Apr 27, 2026
NUVBFDA Updates
▼ -6.7%on this news

Nuvation Bio Announces National Comprehensive Cancer Network® Adds Taletrectinib (IBTROZI®) as Recommended Option to Clinical Practice Guidelines in Oncology for Central Nervous System Cancers

Nuvation Bio announced that taletrectinib (IBTROZI) has been included in the NCCN Guidelines for CNS cancers as a recommended systemic therapy for ROS1-positive non-small cell lung cancer patients with brain metastases. This addition follows its previous recognition as a preferred agent for NSCLC. The drug has shown significant efficacy in treating brain metastases, highlighting its importance in addressing the needs of this patient population.

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NUVB
Apr 20, 2026
NUVBConferences/Events

Nuvation Bio to Report First Quarter 2026 Financial Results and Provide Business Update on May 4, 2026

Nuvation Bio Inc. will host a conference call on May 4, 2026, to discuss its Q1 financial results and business updates. The event will be accessible via a live webcast and phone call. Nuvation Bio is dedicated to developing impactful cancer therapies, with a pipeline that includes several innovative treatments.

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NUVB
Mar 27, 2026
NUVBFDA Updates

Eisai and Nuvation Bio Announce Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated by the European Medicines Agency

Eisai and Nuvation Bio have announced that the European Medicines Agency has validated their Marketing Authorisation Application for taletrectinib, a treatment for advanced ROS1-positive non-small cell lung cancer. This application follows approvals in the U.S., China, and Japan, with plans for additional filings in other regions. The companies aim to make this therapy available to patients in Europe, pending the review process.

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NUVB
Mar 3, 2026
NUVBGeneral
▼ -25.3%on this news

Nuvation Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Nuvation Bio reported strong financial results for Q4 and full year 2025, highlighting the successful launch of IBTROZI, which has rapidly gained adoption. The company also announced positive Phase 2 results for safusidenib in treating IDH1-mutant glioma. Despite a net loss of $36.6 million in Q4, Nuvation maintains a robust cash position of $529.2 million and is expanding its collaboration with Eisai to enhance global access to IBTROZI.

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About Nuvation Bio Inc.

New York, NY 305 employees nuvationbio.com
Headquarters1500 BROADWAY, NEW YORK, NY, 10036
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