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Theriva Biologics, Inc.

TOVX
OvervaluedPharma · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$0.23
▼ -0.01 · -2.95%

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52W LOW $0.1652W HIGH $0.86
Volume
526.78 K
Value Traded
106.31 K
Short % Float
3.52%
+0.89%Week
-8.8%1 Month
-6.12%3 Month
-1.56%6 Month
-99.76%5 Year
-100%All Time

Cash Data

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Key Stats

Market Cap
10.42 M
EPS (TTM)
-0.25
P/E Ratio
-
Ent. Value
-914.77 K
Total Shares
45.88 M
Float Shares
45.14 M
Insiders
1.63%
Institutions
4.32%

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 2a topline data readout
VCN-01
metastatic pancreatic ductal adenocarcinoma
Fast TrackOrphan
Phase 2aOncolytic VirusesOncology
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PoA blends historical approval base rates, trial design score and FDA review track record.

TOVX Catalyst Timeline

Dated clinical, regulatory and corporate events for Theriva Biologics, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Theriva Biologics, Inc.

708Total events
10Upcoming
153Tier-1 (high impact)
2007 to 2029Coverage

Upcoming catalysts 2

T2Enrollment Complete
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VCN-01Filed
T2First Patient Dosed
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VCN-01Filed

Event history 50

▲PublicationVCN-01FiledPresentation
VIRAGE Phase 2b results published in Nature Medicine
metastatic pancreatic cancersource ↗
▲First Patient DosedVCN-01FiledTrial
First patient dosed in VIRAGE2 Phase 2a trial
metastatic pancreatic ductal adenocarcinomasource ↗
▲First Patient DosedVCN-01FiledTrial
First patient treated in VIRAGE2 Phase 2a trial
metastatic pancreatic cancersource ↗
▲Trial InitiationVCN-01FiledTrial
Regulatory authorization to initiate VIRAGE2 Phase 2a trial of VCN-01 in first-line metastatic PDAC
metastatic pancreatic ductal adenocarcinomasource ↗
▲FDA Feedback ReceivedVCN-01FiledFDA Meeting
FDA recognized improved survival with 2 doses of VCN-01 and raised possibility of more frequent dosing
metastatic pancreatic ductal adenocarcinomasource ↗
▲EU MAA SubmissionVCN-01FiledEx-US Regulatory
EMA recognized improved survival with 2 doses of VCN-01 and raised possibility of more frequent dosing
metastatic pancreatic ductal adenocarcinomasource ↗
▲Topline ReadoutVCN-01FiledClinical Data
VIRAGE Phase 2b topline results: 2 doses of VCN-01 improved OS, PFS, and DOR vs 1 dose or SoC alone
metastatic pancreatic ductal adenocarcinomasource ↗
▲Full ResultsVCN-01FiledClinical Data
Results from VCN-01 Phase 1 clinical trial in HNSCC published in Clinical Cancer Research
Head & Neck Squamous Cell Carcinoma (HNSCC)source ↗
●Quarterly UpdateCorporate
First quarter 2026 financial results reported
◆Poster PresentationVCN-01FiledPresentation
Poster presentation of tumor response, biomarker, and subgroup analyses from VIRAGE Phase 2b trial at AACR 2026
metastatic pancreatic cancersource ↗
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Past FDA Catalysts and PDUFA Decisions

How TOVX actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-04-17VCN-01 (zabilugene almadenorepvec) Phase 2b data readout Phase 2b
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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

D31 / 100
Pipeline Score
$2M
Pipeline Value
Overvalued
Valuation Signal
2
Drugs Scored
0.2x
rNPV / MCap
Top 67%
Micro Cap
(rank 441 of 658)
Percentile Rank
Theriva Biologics, Inc. faces pipeline headwinds (31/100), with $250M risk-adjusted pipeline value, led by VCN-01 in Locally Advanced Solid Tumors (Phase 1).
Showing 1 of 2 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
VCN-01 Gene therapyCompletedNCT02045589Pancreatic AdenocarcinomaPhase 2 COMPLETED 120Sep 1, 2018
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Clinical Trial Results

Readouts, endpoints and source filings for every TOVX program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
VCN-01
Fast TrackOrphanRare Pediatric
metastatic pancreatic cancerPhase 2b2026-09-30improved overall survival; progression free survival; duration of responseRead MoreTheriva™ Biologics Announces Publication of the Results from the VIRAGE Phase 2b Clinical Trial of VCN-01 in Metastatic Pancreatic Cancer Published in Nature MedicineRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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InsiderSideSharesPriceValueDate
SHALLCROSS STEVEN ADirector, Officer (CEO and CFO)Buy 14,000 250,000 held$0.69 06/07/2023
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
Ikarian Capital, LLC 0 % 28.00 K 112.08 K
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TOVX Institutional Ownership Trends

Options Data

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Real-Time Option Chain

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Competitive positioning

How TOVX ranks across every disease it competes in

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See how TOVX ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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TOVX News

TOVX
Sep 30, 2026
TOVXPhases
▲ +7.1%on this news

Theriva™ Biologics Announces Publication of the Results from the VIRAGE Phase 2b Clinical Trial of VCN-01 in Metastatic Pancreatic Cancer Published in Nature Medicine

Theriva Biologics announced the publication of results from the VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic cancer in Nature Medicine. The study demonstrated improved overall and progression-free survival in patients receiving VCN-01 alongside standard chemotherapy. The company is now evaluating more frequent dosing in the ongoing VIRAGE2 trial, which aims to enhance clinical outcomes.

Read more →
TOVX
Aug 11, 2026
TOVXPhases

Theriva™ Biologics Reports Second Quarter 2026 Operational Highlights and Financial Results

Theriva Biologics reported operational highlights and financial results for Q2 2026, including the dosing of first patients in the VIRAGE2 Phase 2a trial for VCN-01 in metastatic PDAC. The company has a cash runway extending into Q1 2027 and noted a significant reduction in general and administrative expenses. However, it also reported a net loss and paused enrollment for another trial, indicating financial pressures.

Read more →
TOVX
Aug 6, 2026
TOVXPhases

Theriva™ Biologics Announces First Patient Dosed in VIRAGE2 Phase 2a Clinical Trial to Evaluate More Frequent Dosing of VCN-01 (zabilugene almadenorepvec) in First-Line Patients with Metastatic Pancreatic Ductal Adenocarcinoma

Theriva Biologics has announced the dosing of the first patient in the VIRAGE2 Phase 2a clinical trial, which aims to evaluate more frequent dosing of VCN-01 in patients with metastatic pancreatic ductal adenocarcinoma. This trial builds on encouraging results from the VIRAGE Phase 2b study and aims to refine the dosing regimen for future pivotal trials. Initial results are expected by Q3 2027.

Read more →
TOVX
Jul 7, 2026
TOVXPhases
▼ -7.1%on this news

Theriva™ Biologics Announces Regulatory Authorization to Proceed with a VIRAGE2 Phase 2a Clinical Trial to Evaluate More Frequent Dosing of VCN-01 (zabilugene almadenorepvec) in First-Line Patients with Metastatic Pancreatic Ductal Adenocarcinoma

Theriva Biologics has received regulatory approval from the Spanish Agency of Medicines to initiate the VIRAGE2 Phase 2a clinical trial. This trial will explore more frequent dosing of VCN-01 in combination with standard chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma. The study aims to refine the dosing regimen based on positive outcomes from earlier trials.

Read more →
TOVX
Jun 11, 2026
TOVXPhases
▲ +26.1%on this news

Theriva™ Biologics Announces Results from VCN-01 Phase 1 Clinical Trial in Head and Neck Cancer Published in Clinical Cancer Research

Theriva Biologics announced positive results from its Phase 1 trial of VCN-01 in patients with refractory Head & Neck Squamous Cell Carcinoma (HNSCC). The study demonstrated prolonged overall survival and enhanced immune responses when VCN-01 was administered prior to durvalumab. Key findings include increased levels of PD-L1 positive T-cells and significant pharmacokinetic results supporting VCN-01's mode of action.

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TOVX
Jun 11, 2026
TOVXPhases
▲ +26.1%on this news

Theriva™ Biologics anuncia los resultados del ensayo clínico de Fase I con VCN-01 para el cáncer de cabeza y cuello, publicados en la revista *Clinical Cancer Research*

Theriva™ Biologics announced positive results from its Phase I trial of VCN-01 for refractory head and neck squamous cell carcinoma (HNSCC). The study demonstrated prolonged overall survival and supported the drug's mechanisms of action, including immune response enhancement. The findings have been published in *Clinical Cancer Research*, highlighting the potential for VCN-01 in combination with immune checkpoint inhibitors.

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TOVX
May 5, 2026
TOVXPhases

Theriva™ Biologics Reports First Quarter 2026 Operational Highlights and Financial Results

Theriva Biologics reported positive operational highlights for Q1 2026, including FDA alignment on the Phase 3 trial design for VCN-01 in metastatic PDAC. Data from the VIRAGE Phase 2b trial suggests improved patient outcomes, particularly in those with liver metastases. The company is also exploring compassionate use of VCN-01 for retinoblastoma patients, aiming to initiate a Phase 2/3 trial soon.

Read more →
TOVX
Apr 20, 2026
TOVXPhases
▲ +59.4%on this news

Theriva Biologics Announces Upcoming Presentation of Additional Data from the VIRAGE Phase 2b Clinical Trial of VCN-01 in Metastatic Pancreatic Cancer at AACR 2026 Annual

Theriva Biologics has announced an upcoming presentation of new data from its VIRAGE Phase 2b clinical trial for VCN-01 in metastatic pancreatic cancer, to be held at the AACR Annual Meeting in April 2026. The data indicates improved outcomes across several patient subgroups, including those with liver metastases. This presentation will emphasize an immune-mediated mode of action for VCN-01, reinforcing confidence in its potential when combined with chemotherapy. The company has also secured alignment with regulatory agencies on plans for a pivotal Phase 3 trial to evaluate VCN-01 further.

Read more →
TOVX
Apr 17, 2026
TOVXPhases

Theriva™ Biologics Announces Upcoming Presentation of Additional Data from the VIRAGE Phase 2b Clinical Trial of VCN-01 in Metastatic Pancreatic Cancer at AACR 2026 Annual Meeting

Theriva™ Biologics has announced the upcoming presentation of additional data from the VIRAGE Phase 2b clinical trial evaluating VCN-01 for metastatic pancreatic cancer at the AACR 2026 Annual Meeting. The data indicates improved outcomes in patients treated with VCN-01 alongside chemotherapy, reinforcing the drug's immune-mediated action. The company has also confirmed alignment with regulatory bodies on a planned Phase 3 trial, while contemplating a smaller study to boost treatment efficacy. The results could significantly impact future treatment options for this patient population.

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TOVX
Mar 23, 2026
TOVXPhases
▲ +8.4%on this news

Theriva™ Biologics Announces Positive End-of-Phase 2 Meeting with U.S. FDA Regarding the Design of a Phase 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma

Theriva Biologics has successfully concluded an End-of-Phase 2 meeting with the FDA, receiving approval for the design of a Phase 3 trial for VCN-01 in combination with chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC). The trial aims to build on positive results from the VIRAGE Phase 2 trial, which showed improved survival rates. The FDA's feedback allows Theriva to finalize the trial protocol and seek funding opportunities.

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TOVX
Mar 13, 2026
TOVXGeneral

Theriva™ Biologics presenta los aspectos operativos más destacados y los resultados financieros del ejercicio 2025

Theriva Biologics reported its financial results for the year ending December 31, 2025, highlighting advancements in its clinical pipeline, particularly for VCN-01 targeting pancreatic cancer and retinoblastoma. The company successfully licensed SYN-020 to Rasayana Therapeutics, which could yield up to $38 million in milestones. Financially, Theriva holds $15.2 million in cash, ensuring liquidity until early 2027.

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TOVX
Mar 12, 2026
TOVXFDA Updates

Theriva™ Biologics Reports Full-Year 2025 Operational Highlights and Financial Results

Theriva Biologics reported its full-year 2025 operational highlights and financial results, showcasing advancements in its oncology pipeline, particularly with VCN-01 for pancreatic ductal adenocarcinoma and retinoblastoma. The company successfully licensed SYN-020 to Rasayana Therapeutics, which could yield up to $38 million in milestones. Financially, Theriva has increased its cash reserves to $15.2 million, ensuring operational funding into Q1 2027.

Read more →
TOVX
Feb 18, 2026
TOVXPhases
▲ +6.3%on this news

Theriva™ Biologics Licenses SYN-020 to Rasayana Therapeutics for Multiple Indications

Theriva Biologics has licensed SYN-020 to Rasayana Therapeutics, receiving an upfront payment of $300,000 and the potential for up to $38 million in milestones. Rasayana will take on all development and commercialization responsibilities for SYN-020, which has shown promise in addressing gastrointestinal dysfunction and related health issues. The drug is set to enter Phase 2 clinical testing.

Read more →
TOVX
Feb 3, 2026
TOVXPhases

Theriva™ Biologics Announces Upcoming Presentation of Data from VCN-01 Retinoblastoma Phase 1 Clinical Trial at APAO 2026

Theriva Biologics announced that it will present data from its Phase 1 clinical trial of VCN-01 for refractory retinoblastoma at the APAO Congress in February 2026. The study evaluates the safety and efficacy of VCN-01 in pediatric patients who have not responded to standard treatments. Additionally, preclinical data will showcase the potential benefits of combining VCN-01 with topotecan, a standard chemotherapy.

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TOVX
Jan 12, 2026
TOVXPhases

Unique Oncolytic Virus Therapies for Multiple Solid Tumors January 2026 2 FORWARD LOOKING STATEMENTS This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform

Theriva Biologics is preparing for a Phase 3 clinical trial of its lead candidate, VCN-01, which targets pancreatic cancer and has demonstrated potential in treatment alongside chemotherapy. The company aims to leverage unique oncolytic virus therapy to achieve improved clinical outcomes for various solid tumors. However, the path forward includes potential risks, such as regulatory approval challenges and the need to meet patient enrollment and trial milestones on time. Overall, there exists optimism regarding VCN-01's capabilities, especially in the context of its promising early clinical data.

Read more →
TOVX
Dec 29, 2025
TOVXPhases

Theriva™ Biologics Announces Positive Scientific Advice from the European Medicines Agency (EMA) on the Design of a Phase 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Theriva Biologics has received positive scientific advice from the EMA regarding the design of a Phase 3 trial for VCN-01 in combination with gemcitabine/nab-paclitaxel for treating metastatic pancreatic ductal adenocarcinoma. The EMA agreed on key trial aspects, including sample size and adaptive design. The company plans to finalize the trial protocol and has sufficient funding until Q1 2027 to support its regulatory activities.

Read more →
TOVX
Nov 12, 2025
TOVXPhases
▲ +8%on this newsshared move

Theriva™ Biologics Reports Third Quarter 2025 Operational Highlights and Financial Results

Theriva Biologics reported operational highlights and financial results for Q3 2025, emphasizing progress in its oncology pipeline, particularly with VCN-01 in metastatic pancreatic cancer. The company successfully completed the VIRAGE Phase 2b trial and is pursuing regulatory discussions for a Phase 3 study. Financially, cash reserves have increased to $15.5 million, extending their operational runway into early 2027.

Read more →
TOVX
Oct 24, 2025
TOVXGeneral
▼ -35.7%on this news

Theriva Biologics Provides Response to Unusual Market Action

Theriva Biologics has reported unusual trading activity in its stock but believes no corrective actions are needed. The company confirmed that there are no undisclosed material developments. Recently, it presented expanded data from its VIRAGE trial at the ESMO 2025 Annual Congress, highlighting its ongoing research efforts.

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TOVX
Oct 20, 2025
TOVXPhases
▼ -20.9%on this news

Content of this presentation is copyright and responsibility of the author. Permission is required for re - use. R.Garcia - Carbonero VIRAGE trial: randomized Phase IIb, open - label, study of Nab - Paclitaxel and Gemcit

The VIRAGE trial is a randomized Phase IIb study evaluating VCN-01 in combination with nab-paclitaxel and gemcitabine for patients with metastatic pancreatic cancer. The trial aims to determine overall survival and other effectiveness measures compared to standard care alone. Results from a Phase 1 study indicated an acceptable safety profile and encouraging activity, suggesting VCN-01 could enhance treatment outcomes. The study will enroll 92 patients to assess its efficacy and safety further.

Read more →
TOVX
Oct 16, 2025
TOVXGeneral

Theriva™ Biologics anuncia una operación de incentivo de warrants por un importe bruto de 4 millones de dólares

Theriva Biologics has announced a warrant incentive operation to raise approximately $4 million by allowing current institutional investors to exercise warrants at a reduced price. The operation aims to bolster working capital and will close around October 17, 2025. Investors will receive new warrants in exchange for exercising their current warrants, enhancing the company's financial position.

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About Theriva Biologics, Inc.

Rockville, MD 16 employees therivabio.com
Headquarters9605 MEDICAL CENTER DRIVE, ROCKVILLE, MD, 20850
Founded2006
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