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Actuate Therapeutics, Inc.

ACTU
Richly ValuedPharma · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$0.68
▼ -0.05 · -7.5%

Financials

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52W LOW $0.6052W HIGH $8.49
Volume
324.46 K
Value Traded
227.75 K
Short % Float
10.73%
-17.09%Week
-46.11%1 Month
-43.88%3 Month
-60.52%6 Month
-75.91%5 Year
-75.91%All Time

Cash Data

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Key Stats

Market Cap
16.31 M
EPS (TTM)
-0.85
P/E Ratio
-
Ent. Value
11.88 M
Total Shares
24.01 M
Float Shares
10.23 M
Insiders
57.42%
Institutions
14.25%

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
Elraglusib
Metastatic pancreatic ductal adenocarcinoma
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.

ACTU Catalyst Timeline

Dated clinical, regulatory and corporate events for Actuate Therapeutics, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Actuate Therapeutics, Inc.

105Total events
5Upcoming
21Tier-1 (high impact)
2021 to 2027Coverage

Upcoming catalysts 2

T1Going Concern
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T2Trial Initiation
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Elraglusib

Event history 50

▲Preclinical PoCElraglusibPreclinical
Preclinical data show synergistic activity of elraglusib with zoldonrasib and daraxonrasib in PDAC models
pancreatic ductal adenocarcinoma (PDAC)source ↗
▲Trial InitiationElraglusibTrial
Elraglusib selected for evaluation in BEACON2 trial
high-risk pediatric neuroblastomasource ↗
▲Poster PresentationElraglusibPresentation
Post-hoc efficacy and biomarker analysis of elraglusib plus gemcitabine/nab-paclitaxel vs chemotherapy alone in mPDAC presented at ASCO 2026
metastatic pancreatic ductal adenocarcinomasource ↗
▲IND ClearanceElraglusibIND
FDA cleared IND for Phase 1/2 study of oral elraglusib in advanced cancer patients
advanced solid tumorssource ↗
▲Management ChangeCorporate
Martin Huber, MD, joins Board of Directors
◆FDA Feedback ReceivedElraglusibFDA Meeting
EMA provided guidance on trial design for potential single registration study for IV treatment of mPDAC
metastatic pancreatic ductal adenocarcinoma (mPDAC)source ↗
▲Management ChangeCorporate
Appointment of Martin Huber, MD as Independent Director
▲PublicationElraglusibPresentation
Nature Medicine publication of Phase 2 trial results for elraglusib plus GnP in metastatic pancreatic cancer
metastatic pancreatic ductal adenocarcinomasource ↗
◆Preclinical PoCElraglusibPreclinical
Preclinical results of elraglusib plus RAS inhibitor expected in mid-2026
RAS-driven cancerssource ↗
◆Oral PresentationPresentation
Actuate Therapeutics to present at Citizens Life Sciences Conference
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Past FDA Catalysts and PDUFA Decisions

How ACTU actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-06-30elraglusib plus RAS inhibitor Pre-clinical data readout Pre-clinical
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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

D27 / 100
Pipeline Score
$2M
Pipeline Value
Richly Valued
Valuation Signal
2
Drugs Scored
0.1x
rNPV / MCap
Top 76%
Micro Cap
(rank 500 of 658)
Percentile Rank
Actuate Therapeutics, Inc. faces pipeline headwinds (27/100), with $436M risk-adjusted pipeline value, led by 9-ING-41 in Cancer (Phase 2), but cash runway is a concern.
Showing 1 of 2 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
9-ING-41 Small moleculeCompletedNCT04218071MyelofibrosisPhase 2 COMPLETED 17Jan 18, 2024
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Clinical Trial Results

Readouts, endpoints and source filings for every ACTU program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
elraglusib
OrphanRare Pediatric
high-risk pediatric neuroblastomaPhase 1/22026-06-09Complete response in neuroblastoma patient achieved in Phase 1 study of elraglusib in refractory pediatric cancers; 60% of Th-MYCN mice treated with elraglusib plus temozolomide/irinotecan (TEMIRI)/14G2a, remained tumor-free at one year of age compared to 0% in the TEMIRI/14G2a only arm (P<0.0001)Read MoreActuate Therapeutics’ Elraglusib Selected for Evaluation in BEACON2 Trial for High-Risk Pediatric NeuroblastomaRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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InsiderSideSharesPriceValueDate
SCHMITT DANIEL MDirector, Officer (President, CEO and Director)Option 272,056 422,237 held$0.00 08/14/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
PROSIGHT MANAGEMENT, LP 0 % 5.00 K 885.00
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Shares held by hedge funds each quarter, and who bought or sold.

ACTU Institutional Ownership Trends

Options Data

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Option Volume
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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
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How ACTU ranks across every disease it competes in

Competitive Position is a premium feature
See how ACTU ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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ACTU News

ACTU
Sep 9, 2026
ACTUConferences/Events
▼ -8.7%on this news· ran to -22% by day 3

Actuate to Present at the H.C. Wainwright 28th Annual Global Investment Conference

Actuate Therapeutics, Inc. will present at the H.C. Wainwright 28th Annual Global Investment Conference from September 14-16, 2026, in New York City. The presentation is scheduled for September 14 at 4:00 PM ET. The company focuses on therapies for challenging cancers, with its lead drug elraglusib targeting key molecular pathways.

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ACTU
Sep 9, 2026
ACTUPhases
▼ -8%on this news· ran to -25% by day 3shared move

Actuate Announces Promising Preclinical Data Showing Synergistic Activity of Elraglusib in Combination with RAS Inhibitors Zoldonrasib and Daraxonrasib

Actuate Therapeutics announced promising preclinical data demonstrating the synergistic effects of elraglusib when combined with RAS inhibitors zoldonrasib and daraxonrasib in pancreatic cancer models. The studies, conducted in collaboration with Northwestern University and Mayo Clinic, showed enhanced tumor growth inhibition and potential for broader application in RAS-driven cancers. Further studies are planned for presentation at upcoming medical conferences.

Read more →
ACTU
Jun 9, 2026
ACTUPhases
▲ +10.4%on this news

Actuate Therapeutics’ Elraglusib Selected for Evaluation in BEACON2 Trial for High-Risk Pediatric Neuroblastoma

Actuate Therapeutics announced that elraglusib will be evaluated in the BEACON2 trial, targeting high-risk pediatric neuroblastoma. This Phase 1/2 trial will assess elraglusib in combination with dinutuximab beta and chemotherapy. The trial aims to confirm safety and establish dosing parameters, following promising results from earlier studies.

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ACTU
Jun 1, 2026
ACTUPhases

Actuate Therapeutics Announces ASCO Poster Presentations Demonstrating Compelling Clinical and Biomarker Data for Elraglusib in First-Line Metastatic Pancreatic Cancer

Actuate Therapeutics announced promising results from two studies presented at the 2026 ASCO Annual Meeting, highlighting the effectiveness of elraglusib in first-line treatment for metastatic pancreatic cancer. The data showed significant improvements in median overall survival for patients with KRAS and P53 wild-type genomics when elraglusib was used with established chemotherapy regimens like gemcitabine/Abraxane and FOLFIRINOX. The treatment was well tolerated, demonstrating a favorable safety profile. These findings suggest that elraglusib may serve as a differentiated therapy and contribute to improving outcomes in challenging cancer cases.

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ACTU
May 11, 2026
ACTUFDA Updates
▼ -9.8%on this news

Actuate Therapeutics Announces FDA Clearance of IND for Oral Elraglusib and Strategic Initiatives to Advance the Elraglusib Development Program

Actuate Therapeutics has received FDA clearance for an Investigational New Drug application for its oral formulation of elraglusib, aimed at treating advanced cancers. The Phase 1/2 study will focus on patients with metastatic melanoma, NSCLC, colorectal, and pancreatic cancers, with initiation planned for the second half of 2026. The company is also exploring combination therapies with RAS inhibitors and has welcomed a new board member to enhance its strategic capabilities.

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ACTU
May 6, 2026
ACTUGeneral

Actuate Therapeutics Announces Key Appointment of Industry Veteran to Board of Directors

Actuate Therapeutics has appointed Martin Huber, MD, as an Independent Director to its Board of Directors, effective immediately. Dr. Huber brings significant experience in oncology drug development, having previously held leadership roles at Mersana Therapeutics, Xilio Therapeutics, and TESARO. This strategic appointment is expected to strengthen Actuate's efforts in advancing their lead investigational drug, elraglusib, through various cancer indications. Elraglusib specifically targets a well-established pathway that may improve outcomes for patients with difficult-to-treat cancers.

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ACTU
Apr 14, 2026
ACTUPhases
▲ +14.3%on this news· ran to +27% by day 3shared move

Actuate Therapeutics Announces Nature Medicine Publication of Clinical Trial Results Showing Doubling of the Rate of Survival with Elraglusib Plus Chemotherapy in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Actuate Therapeutics announced promising results from a Phase 2 clinical trial of elraglusib combined with chemotherapy for metastatic pancreatic cancer. The study demonstrated a 40% increase in median overall survival and a one-year survival rate of 44% compared to 22% with standard treatment. The findings suggest elraglusib's potential as a first-line therapy, especially in high-risk patient groups.

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ACTU
Mar 9, 2026
ACTUPhases

Actuate Therapeutics Launches Strategic Research Initiative to Combine Elraglusib with RAS Inhibitors

Actuate Therapeutics has launched a strategic research initiative to evaluate the combination of its GSK-3β inhibitor elraglusib with RAS-targeted therapies. This initiative aims to enhance treatment efficacy for difficult-to-treat cancers, particularly pancreatic cancer. Initial preclinical results are anticipated in the second half of 2026, with the potential to improve clinical outcomes in RAS-driven cancers.

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ACTU
Mar 5, 2026
ACTUConferences/Events

Actuate Therapeutics to Present at The Citizens Life Sciences Conference

Actuate Therapeutics, a clinical-stage biopharmaceutical company, will present at the Citizens Life Sciences Conference on March 10, 2026. CEO Dan Schmitt will discuss the company's focus on therapies for difficult-to-treat cancers, particularly their lead drug, elraglusib. The presentation will be available via webcast, and the management team will hold one-on-one meetings with attendees.

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ACTU
Feb 24, 2026
ACTUConferences/Events
▲ +10.6%on this news

Actuate Therapeutics to Present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference

Actuate Therapeutics will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026. CEO Dan Schmitt will discuss the company's focus on therapies for challenging cancers, particularly their lead drug, elraglusib. The presentation will be available via webcast, and one-on-one meetings with investors are scheduled during the event.

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ACTU
Jan 22, 2026
ACTUPhases
▼ -7%on this news

Actuate Therapeutics Announces Plans to Expand Clinical Pipeline, Advancing Elraglusib Tablet into a Phase 1/2 Clinical Program in Refractory Cancers

Actuate Therapeutics announced plans to initiate a Phase 1/2 clinical program for elraglusib, an oral tablet aimed at treating refractory cancers. The Phase 1 trial will focus on determining the maximum tolerated dose and assessing preliminary anti-tumor activity. The Phase 2 portion will target specific indications, including refractory melanoma, building on previous encouraging results. The company aims to explore additional cancer indications with this formulation.

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ACTU
Jan 13, 2026
ACTUPhases

Actuate Therapeutics Reports Positive Follow-Up Data from its Randomized Controlled Phase 2 Trial Demonstrating Extended Long-Term Overall Survival Benefit with Elraglusib Plus Chemotherapy for Metastatic Pancreatic Cancer in Oral Presentation at ASCO GI 2026

Actuate Therapeutics has reported promising follow-up data from its Phase 2 trial of elraglusib combined with chemotherapy for metastatic pancreatic cancer. The study indicates that this combination may significantly improve overall survival compared to standard chemotherapy alone. The findings were presented at the ASCO GI 2026, highlighting the potential of elraglusib in addressing the high unmet medical need in this patient population.

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ACTU
Jan 6, 2026
ACTUPhases
▲ +5%on this news

Actuate Therapeutics Announces Positive Patient Outcomes from Phase 1 Trial in Difficult-to-Treat Refractory Pediatric Cancers

Actuate Therapeutics announced positive outcomes from its Phase 1 trial of elraglusib in pediatric cancers, showcasing significant clinical responses in patients with refractory Ewing sarcoma and neuroblastoma. Specifically, two complete metabolic responses and one complete response were observed among the participants. The results support the potential of elraglusib, both as a monotherapy and in combination therapies, leading to further clinical development plans scheduled for 2026. The company has also received Rare Pediatric Designations from the FDA for these indications.

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ACTU
Dec 18, 2025
ACTUPhases

Actuate Therapeutics Phase 2 Metastatic Pancreatic Cancer Data Selected for Oral and Poster Presentation at ASCO GI 2026

Actuate Therapeutics announced that data from its Phase 2 study of elraglusib in metastatic pancreatic cancer will be presented at the ASCO GI Cancers Symposium in January 2026. The study investigates elraglusib in combination with gemcitabine/nab-paclitaxel, a first-line chemotherapy regimen. This acknowledgment at a prestigious conference highlights the importance and potential of the treatment in addressing a critical health issue. Additionally, Actuate aims to explore mutational analyses and biomarkers associated with treatment outcomes.

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ACTU
Dec 15, 2025
ACTUPhases
▼ -8.8%on this newsshared move

Actuate Therapeutics Announces Publication of Positive Phase II Clinical Data for Elraglusib Combined with Platinum Chemotherapy and Sequential Immunotherapy in Recurrent, Metastatic Salivary Gland Carcinoma

Actuate Therapeutics has published positive Phase II clinical data for elraglusib, a GSK-3β inhibitor, combined with platinum chemotherapy in patients with recurrent, metastatic salivary gland carcinoma. The study showed a median overall survival of 18.6 months and identified nuclear GSK-3β expression as a potential biomarker for treatment response. These findings could pave the way for future clinical studies in this challenging cancer type.

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ACTU
Sep 22, 2025
ACTUFDA Updates
▲ +6.8%on this news

Actuate Therapeutics Provides FDA with Updated Clinical Data Package to Support Planned Regulatory Interactions with FDA and EMA Over the Coming Months

Actuate Therapeutics has updated its IND application with new clinical data supporting elraglusib for metastatic pancreatic cancer. The Phase 2 trial demonstrated significant improvements in overall survival with elraglusib combined with chemotherapy. The company is preparing for regulatory submissions to the FDA and EMA, bolstered by a recent financing round. However, challenges remain regarding regulatory approval and potential side effects.

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ACTU
Sep 11, 2025
ACTUGeneral

Actuate Therapeutics Announces Closing of $17.25 Million Public Offering of Common Stock, Including Full Exercise of Over-Allotment Option

Actuate Therapeutics has successfully closed a $17.25 million public offering of common stock, including the full exercise of an over-allotment option. The offering consisted of 2,464,286 shares priced at $7.00 each. The proceeds will be used for working capital and general corporate purposes. Lucid Capital Markets acted as the sole book-running manager for the offering.

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ACTU
Sep 10, 2025
ACTUGeneral
▼ -19.2%on this newsshared move

Actuate Therapeutics Announces Pricing of $15.0 Million Public Offering of Common Stock

Actuate Therapeutics has announced the pricing of a public offering of 2,142,858 shares at $7.00 per share, aiming to raise approximately $15 million. The offering is set to close on September 11, 2025, and will be used for working capital and corporate purposes. Lucid Capital Markets is the sole book-running manager for this offering.

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ACTU
Sep 9, 2025
ACTUGeneral
▼ -19.2%on this newsshared move

Actuate Therapeutics Announces Proposed Public Offering of Common Stock

Actuate Therapeutics, Inc. has announced a proposed public offering of its common stock to raise funds for working capital and corporate purposes. The offering is underwritten and includes a 30-day option for underwriters to purchase additional shares. The company is focused on developing therapies for challenging cancers, but the offering's completion is subject to market conditions.

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About Actuate Therapeutics, Inc.

Fort Worth, TX 12 employees actuatetherapeutics.com
Headquarters1751 RIVER RUN, FORT WORTH, TX, 76107
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