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Financials
52W LOW $1.1552W HIGH $2.25
Volume
4.76 M
Value Traded
282.18 K
Short % Float
4.83%
+5.28%Week
-7.38%1 Month
+6.6%3 Month
+37.8%6 Month
-56.75%5 Year
-56.75%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
75.55 M
EPS (TTM)
-0.84
P/E Ratio
-
Ent. Value
78.90 M
Total Shares
46.81 M
Float Shares
43.74 M
Insiders
6.55%
Institutions
6.19%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
PoA blends historical approval base rates, trial design score and FDA review track record.
OSTX Catalyst Timeline
Dated clinical, regulatory and corporate events for OS Therapies Incorporated
Catalyst Timeline
Dated clinical, regulatory & corporate events for OS Therapies Incorporated
214Total events
30Upcoming
58Tier-1 (high impact)
2024 to 2027Coverage
Upcoming catalysts 2
Event history 50
▲INN Name AssignedHerlysticCorporate
WHO approves proprietary brand name 'Herlystic' for OST-HER2
▲Other Regulator MilestoneOST-HER2ApprovedEx-US Regulatory
OS Therapies accepts MHRA request to become sponsor representative into Project Orbis
metastatic osteosarcomasource ↗
▲FDA Feedback ReceivedOST-HER2ApprovedFDA Meeting
FDA aligns with MHRA and EMA on adaptive design for Phase 3 trial
fully-resected, pulmonary metastatic osteosarcomasource ↗
▲Interim AnalysisOST-HER2ApprovedTrial
Interim 3-year overall survival analysis shows statistically significant benefit for OST-HER2
pulmonary metastatic osteosarcomasource ↗
▲RMATOST-HER2ApprovedDesignation
Completed resubmission of RMAT request
pulmonary metastatic osteosarcomasource ↗
▲PRV GrantedOST-HER2ApprovedDesignation
CNPV letter of intent accepted by FDA
pulmonary metastatic osteosarcomasource ↗
▲Interim Efficacy DataOST-HER2ApprovedClinical Data
Interim 3-year OS analysis: 71.2% for OST-HER2 vs 45.8% historical control (p=0.002)
fully resected, pulmonary metastatic osteosarcomasource ↗
◆Type C MeetingOST-HER2ApprovedFDA Meeting
Upcoming mid-September 2026 FDA Type C Statistical Methods Meeting
osteosarcomasource ↗
◆Rolling Submission InitiatedOST-HER2ApprovedRegulatory Filing
Company intends to request Rolling Review of ongoing BLA submission
pulmonary metastatic osteosarcomasource ↗
◆Trial CompletionOST-HER2ApprovedTrial
Trial monitoring visits for two remaining patients scheduled for September 2026 and early October 2026
pulmonary metastatic osteosarcomasource ↗
●Enrollment UpdateOST-HER2ApprovedTrial
Trial monitoring visits for two remaining patients not yet at 3-year timepoint
fully resected, pulmonary metastatic osteosarcomasource ↗
◆Timing GuidanceOST-HER2ApprovedPresentation
OS Therapies expects to complete CMAA submission to MHRA in the coming weeks
Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcomasource ↗
▲Other Regulator MilestoneOST-HER2ApprovedEx-US Regulatory
U.K. waives Pediatric Investigation Plan (PIP) requirement
fully resected, pulmonary metastatic osteosarcomasource ↗
▲Debt Royalty FinancingCorporate
Up to $10 million debt financing with $5 million funded at first closing on August 10, 2026
◆FDA Feedback ReceivedOST-HER2ApprovedFDA Meeting
Accepted CDER meeting request to review OST-HER2 biomarker data under BEST program
osteosarcomasource ↗
◆Type B MeetingOST-HER2ApprovedFDA Meeting
Forthcoming Type B Statistical Methods Meeting with CBER to review 2.5-year OS data and biomarker data
osteosarcomasource ↗
◆Interim AnalysisOST-HER2ApprovedTrial
Expects to announce interim 3-year overall survival data in summer 2026
osteosarcomasource ↗
◆Pre BLA MeetingOST-HER2ApprovedFDA Meeting
Invited Type B Pre-BLA Meeting with FDA
fully resected, pulmonary metastatic osteosarcomasource ↗
▲Other Regulator MilestoneEx-US Regulatory
Formal submission for at least $4.2 million in reimbursable R&D Tax Credit by OST U.K.
▲Primary Endpoint MetOST-HER2ApprovedClinical Data
Statistically significant 2.5-year Overall Survival data achieved (75% vs. 47%, p=0.003)
fully resected, pulmonary metastatic osteosarcomasource ↗
▲EMA PrimeOST-HER2ApprovedEx-US Regulatory
Advanced Therapy Medicinal Product (ATMP) designation granted by EMA
fully resected, pulmonary metastatic osteosarcomasource ↗
●Patent GrantedOST-HER2ApprovedIP / Competition
Patent filed for OST-HER2 pharmacodynamic response biomarker
▲Other Regulator MilestoneOST-HER2ApprovedEx-US Regulatory
Alignment achieved with EMA and TGA on 3-year Overall Survival data and biomarker data as approvable CMA endpoints
fully resected, pulmonary metastatic osteosarcomasource ↗
●Composition Patent FiledOST-HER2ApprovedIP / Competition
Patent filed for OST-HER2 pharmacodynamic response biomarker
fully resected, pulmonary metastatic osteosarcomasource ↗
▲Full ResultsOST-HER2ApprovedClinical Data
Publication of statistically significant 2-year Overall Survival (20% vs. 1%, p=0.00995) for OST-HER2 plus radiation in frontline unresected canine osteosarcoma
canine osteosarcomasource ↗
●PublicationOST-HER2ApprovedPresentation
Publication of four articles on OST-HER2 and osteosarcoma in Drug Discovery World
osteosarcomasource ↗
▲EU MAA SubmissionOST-HER2ApprovedEx-US Regulatory
EMA initiates rolling review of Conditional Marketing Authorization application for OST-HER2
fully resected pulmonary metastatic osteosarcomasource ↗
▲Other Regulator MilestoneOST-HER2ApprovedEx-US Regulatory
ATGA invites application for Provisional Determination
fully resected pulmonary metastatic osteosarcomasource ↗
●Oral PresentationOST-HER2ApprovedPresentation
Conference call to review OST-HER2 immune pharmacodynamic biomarker response data and regulatory successes
fully resected pulmonary metastatic osteosarcomasource ↗
●Timing GuidanceOST-HER2ApprovedPresentation
2.5-year overall survival data expected by mid-Q2 2026
fully resected pulmonary metastatic osteosarcomasource ↗
◆FDA ApprovalOST-HER2ApprovedFDA Decision
Potential UK regulatory approval for OST-HER2
recurrent, fully resected, pulmonary metastatic osteosarcomasource ↗
●Quarterly UpdateCorporate
Expects approximately $4M in non-dilutive VAT refunds and R&D reclaim funds from UK subsidiary
▲PRV GrantedOST-HER2ApprovedDesignation
Priority Review Voucher upon FDA Accelerated Approval
Human Osteosarcomasource ↗
▲Primary Endpoint MetOST-HER2ApprovedClinical Data
Statistically significant 2.5-year Overall Survival data achieved
fully resected, pulmonary metastatic osteosarcomasource ↗
▲Other Regulator MilestoneOST-HER2ApprovedEx-US Regulatory
EMA alignment achieved in the second quarter of 2026
fully resected, pulmonary metastatic osteosarcomasource ↗
▲RMATOST-HER2ApprovedDesignation
ATMP designation granted by EMA triggering Rolling Review
fully resected, pulmonary metastatic osteosarcomasource ↗
Past FDA Catalysts and PDUFA Decisions
How OSTX actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-09-30 | OST-HER2 | Approval Decision | BLA |
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
Clinical Trial Results
Readouts, endpoints and source filings for every OSTX program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| OST-HER2 Fast TrackRMATOrphan+1 | pulmonary metastatic osteosarcoma | Phase 2b | 2026-10-06 | three year overall survival rate: 72.7%; historical control rate: 45.8%; p value: 0.0006; total enrolled patients: 41; patients lost to follow up: 4Read More | OS Therapies Achieves Statistically Significant Final Three-Year Overall Survival Benefit for Herlystic(TM)-Treated Patients in Phase 2b Pulmonary Metastatic Osteosarcoma TrialRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Auerbach Shalom10% Owner | Sell | -82,000 2,664,199 held | $2.00 | 05/07/2025 |
Hedge Fund 13F Activity
Hedge Funds invested in OSTX
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in OSTX for Q2 2026. | ||||
OSTX Institutional Ownership Trends
Options Data
Option Volume
Open Interest
Call OI
Put OI
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OI 30-day avg
Today vs avg
Option Volume
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Put Vol
Put-Call Ratio
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Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
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Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How OSTX ranks across every disease it competes in
Competitive Position is a premium feature
See how OSTX ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialOSTX News
OSTXOS Therapies Achieves Statistically Significant Final Three-Year Overall Survival Benefit for Herlystic(TM)-Treated Patients in Phase 2b Pulmonary Metastatic Osteosarcoma Trial
OS Therapies announced significant findings from its Phase 2b trial of OST-HER2 in pulmonary metastatic osteosarcoma, showing a three-year overall survival rate of 72.7% compared to 45.8% in historical controls. The company is preparing regulatory submissions for early market access in the U.S., U.K., Europe, and Australia. The proprietary brand name Herlystic™ has been accepted by the WHO.
Read more →OSTXOS Therapies Appoints Kerry Clem as Chief Commercial Officer and Frank Knuettel II as Chief Financial Officer
OS Therapies has appointed Kerry Clem as Chief Commercial Officer and Frank Knuettel II as Chief Financial Officer to lead the commercialization of their lead product, Herlystic. The company is preparing for potential market entry in the U.S., U.K., and Europe, pending regulatory approvals. The appointments come as OS Therapies aims to leverage recent positive clinical trial results and secure necessary funding for further development.
Read more →OSTXOS Therapies Announces Brand Name 'Herlystic' Approved by World Health Organization for OST-HER2 (daznelimgene lisbac)
OS Therapies has received approval from the World Health Organization for the brand name 'Herlystic' for its product OST-HER2, a gene-edited cancer immunotherapy. With both the proprietary and nonproprietary names approved, the company plans to start regulatory submissions in the U.K. and expand to the U.S., Europe, and Australia. The CEO expressed optimism about the potential benefits for patients with pulmonary metastatic osteosarcoma as they move forward with market access filings.
Read more →OSTXOS Therapies Completes FDA Type C Statistical Methods Meeting and Provides Update on Global Regulatory Coordination for OST-HER2 Under Project Orbis
OS Therapies has completed a Type C Statistical Methods Meeting with the FDA, aligning on the Phase 3 study design for OST-HER2. The company is set to initiate a confirmatory Phase 3 trial in the U.K. following a recent Scientific Advice Meeting with the MHRA. This collaboration aims to enhance global regulatory coordination under Project Orbis, facilitating early market access for OST-HER2 in treating metastatic osteosarcoma.
Read more →OSTXOS Therapies Achieves Incremental Alignment With FDA and Accepts Project Orbis Invitation From MHRA on OST-HER2 Metastatic Osteosarcoma Program
OS Therapies has aligned with the FDA on the adaptive design for its upcoming Phase 3 trial of OST-HER2, targeting metastatic osteosarcoma. The company has also accepted an invitation from the MHRA to participate in Project Orbis, which aims to harmonize regulatory reviews across multiple countries. The Phase 3 trial is expected to commence in late 2026, following a Type B Pre-BLA meeting with the FDA.
Read more →OSTXOS Therapies Announces Full Alignment with UK MHRA and EU EMA for Conditional Marketing Authorisation Application Filing
OS Therapies has announced full alignment with the UK MHRA and EU EMA regarding its Conditional Marketing Authorisation Application (CMAA) for OST-HER2, a treatment for pulmonary metastatic osteosarcoma. The company plans to submit the CMAA in the coming weeks and initiate a confirmatory Phase 3 trial in Q4 2026. This alignment is seen as a significant achievement, paving the way for potential regulatory approvals.
Read more →OSTXOS Therapies Achieves Statistically Significant Benefit for OST-HER2-Treated Patients in Interim 3-Year Overall Survival Analysis of Phase 2b Pulmonary Metastatic Osteosarcoma Trial
OS Therapies announced a statistically significant overall survival benefit for patients treated with OST-HER2 in a Phase 2b trial for pulmonary metastatic osteosarcoma. The interim analysis showed a 71.2% survival rate compared to 45.8% in historical controls. The company is preparing for regulatory submissions to the FDA and other agencies, aiming for market access in 2027.
Read more →OSTXOS Therapies Provides OST-HER2 Metastatic Osteosarcoma Program Update and Announces Upcoming Conference Attendance
OS Therapies, Inc. has announced updates on its OST-HER2 program for metastatic osteosarcoma, including participation in several upcoming healthcare conferences. The company anticipates key regulatory meetings and submissions in late 2026, aiming for early market access in the U.S., U.K., Europe, and Australia. OST-HER2 has received multiple designations from regulatory authorities, indicating its potential in the oncology market.
Read more →OSTX▼ -9.3%on this news
OS Therapies Reports Second Quarter 2026 Financials and Provides Business and Regulatory Updates
OS Therapies reported its financial results for Q2 2026, highlighting significant progress in its regulatory submissions for OST-HER2, a treatment for pulmonary metastatic osteosarcoma. The company is preparing for key FDA and MHRA meetings to align on trial designs and statistical methods. Financially, they secured up to $10 million in debt financing, supported by VAT refunds and R&D tax credits.
Read more →OSTXOS Therapies Granted U.S. FDA Type C Statistical Methods Meeting to Review 2.5-Year Overall Survival Data for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma
OS Therapies has received FDA approval for a Type C Statistical Methods meeting to review 2.5-year overall survival data for OST-HER2 in osteosarcoma. The meeting is scheduled for mid-September 2026, where the company will discuss the appropriateness of using historical control data. The company anticipates announcing interim 3-year survival data shortly before this meeting.
Read more →OSTX▼ -8.2%on this news
OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program
OS Therapies has accepted a meeting request from the FDA's CDER to review its OST-HER2 biomarker data as part of the BEST Program. This meeting will occur alongside a Type B Statistical Methods Meeting with CBER. The company is preparing for a Biologics License Application submission expected in early Fall 2026, following positive results from its clinical trials.
Read more →OSTX▼ -14.8%on this newsshared move
OS Therapies Third Quarter 2026 Corporate Outlook
OS Therapies provided a corporate outlook for Q3 2026, highlighting key milestones for its OST-HER2 program targeting metastatic osteosarcoma. The company has aligned with regulatory bodies in Europe and Australia for Conditional Marketing Authorisation Applications, with a Phase 3 study expected to start soon. Positive survival data strengthens its case for early market access in the U.S. and abroad.
Read more →OSTXOS Therapies Appoints Dr. Craig Eagle to Board of Directors
OS Therapies has appointed Dr. Craig Eagle to its Board of Directors, enhancing its leadership. The company secured a $10 million line of credit, which will support the commercial manufacturing of its lead asset, OST-HER2. Positive results from a Phase 2b trial bolster the company's confidence as it prepares for regulatory submissions in the U.S. and Europe.
Read more →OSTX▼ -15.2%on this news· ran to -28% by day 3shared move
OS Therapies Provides U.S. Regulatory Update
OS Therapies provided a regulatory update regarding its Biologics License Application for OST-HER2. The company is seeking alignment with the FDA on overall survival data as an approval endpoint, following positive interactions with the MHRA and EMA. Additionally, they are incorporating data from the OST-400 study as a synthetic control for their application under the Accelerated Approval Program.
Read more →OSTXOS Animal Health Announces Peer-Reviewed Publication of Clinical Trial Data for OST-HER2 Plus Palliative Radiation as Frontline Treatment in Canine Osteosarcoma
OS Animal Health announced the publication of Phase 2 clinical trial data for OST-HER2 combined with palliative radiation therapy in treating canine osteosarcoma. The results showed a significant improvement in survival rates, with 20% of treated dogs surviving two years compared to just 1% in the control group. The company plans to seek regulatory alignment with the USDA for conditional approval by Q3 2026.
Read more →OSTXOS Therapies Achieves Global Regulatory Alignment on Design of Phase 3 Trial of OST-HER2 in Fully Resected, Pulmonary Metastatic Osteosarcoma
OS Therapies has secured regulatory alignment for its Phase 3 trial of OST-HER2 in pulmonary metastatic osteosarcoma. The trial will utilize the drug product from the Phase 2b study and is expected to commence in Australia by late Q3 2026. This alignment with the FDA, MHRA, EMA, and TGA positions the company for potential regulatory decisions by year-end 2026.
Read more →OSTXOS Therapies Achieves Statistically Significant 2.5-Year Overall Survival in Phase 2b Trial of OST-HER2 in Fully Resected Pulmonary Metastatic Osteosarcoma
OS Therapies announced that its Phase 2b trial of OST-HER2 for pulmonary metastatic osteosarcoma achieved a statistically significant overall survival rate of 75% at the 2.5-year mark, compared to 47% in historical controls. The company is preparing to submit updated clinical efficacy data to regulatory agencies in the U.S., U.K., Europe, and Australia, aiming for early market access by late 2026. Upcoming meetings with regulatory bodies are set to align on critical data for market authorization.
Read more →OSTX▲ +8.1%on this newsshared move
OS Therapies Announces the Publication of Four Articles on OST-HER2 and Osteosarcoma in Drug Discovery World
OS Therapies has announced the upcoming release of four articles related to OST-HER2 and osteosarcoma. Notably, they will present 2.5-year overall survival data from their Phase 2b clinical trial at the 2026 ASCO Annual Meeting. The articles cover various aspects of osteosarcoma treatment, including regulatory science and the potential for accelerated approval.
Read more →OSTXOS Therapies to Attend Upcoming Medical, Financial and Industry Conferences
OS Therapies, Inc. will participate in several upcoming medical and financial conferences, including the ASCO 2026 and Jefferies Healthcare Conference. The company is focused on advancing its lead asset, OST-HER2, which has shown promising results in clinical trials for osteosarcoma. They expect to submit a Biologics License Application to the FDA in 2026.
Read more →OSTXOS Therapies Announces EMA Initiates Rolling Review of Conditional Marketing Authorization Application for OST-HER2 in the Prevention or Delay of Recurrence
OS Therapies has announced that the European Medicines Agency (EMA) has initiated a Rolling Review of its Conditional Marketing Authorization application for OST-HER2, aimed at preventing recurrence in pulmonary metastatic osteosarcoma. The review process is expected to extend into late 2026, when the company anticipates receiving a decision. Alongside this, OS Therapies is also pursuing market authorization in the UK and Australia. These developments underscore the company's focus on advancing OST-HER2's regulatory progress while preparing for a confirmatory Phase 3 trial.
Read more →About OS Therapies Incorporated
Headquarters15825 SHADY GROVE ROAD, ROCKVILLE, MD, 20850
Founded2024
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