OS Therapies Incorporated OSTX
0.87 USD -0.02 (-2.19%)
Nov 11, 2026, 2:56 PM EST
0.86 Day range 0.94
0.58 52-week range 2.25
- YTD
- -37.82%
- 1 year
- -53.94%
News
benzinga.com OS Therapies Initiates CMAA Process With UK MHRA For Herlystic In Prevention Or Delay Of Recurrence In Fully Resected, Pulmonary Metastatic Osteosarcoma; Expects To Complete CMAA Process Later In Q4 Of 2026 US Based Clinical Stage Oncology Company Begins Critical Step Following Successful September 2026 Scientific Advice MeetingSubmission expected to be accepted in the fourth quarter of 2026Potential…
newsfilecorp.com OS Therapies Initiates U.K. MHRA Conditional Marketing Authorisation Application for Herlystic (OST-HER2) in the Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma US Based Clinical Stage Oncology Company Begins Critical Step Following Successful September 2026 Scientific Advice Meeting Submission expected to be accepted in the fourth quarter of 2026 Potential…
newsfilecorp.com OS Therapies Completes Requalification of Phase 2b Herlystic (OST-HER2) Drug Substance for Confirmatory Phase 3 Trial Leading Clinical Stage Oncology Company Now Able to Complete CMMA Submission to U.K's MHRA for Early Commercial Access and Trial Authorisation Grasonville, Maryland--(Newsfile Corp. - November 5,…
benzinga.com OS Therapies' OSAH Subsidiary Receives U.S. Department Of Agriculture Guidance On Commercial Deployment Pathway For OST-HER2 To Treat Canine Osteosarcoma OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that its wholly-owned animal health…
benzinga.com OS Therapies Reports Significant Three-Year Survival Data for Bone Cancer Treatment OS Therapies reports a 72.7% three-year survival rate in its Phase 2b osteosarcoma trial, preparing for global regulatory submissions.
benzinga.com OS Therapies Announces Statistically Significant Final 3-Yr Overall Survival Benefit For OST-HER2-Treated Patients In Phase 2b Trial In Pulmonary Metastatic Osteosarcoma Compared With Combined Published Historical Control Leading Clinical Stage Oncology Company Releases Significant Findings from OST-HER2-Treated Patients72.7 percent three-year overall survival vs. 45.8 percent comparable combined historical control (p…
benzinga.com OS Therapies Appoints Frank Knuettel II As CFO OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced the appointment of Kerry Clem as Chief…
benzinga.com OS Therapies Provided an Update on Global Early Market Access Regulatory Coordination Efforts By UK's MHRA For OST-HER2 For Pulmonary Metastatic Osteosarcoma Under Project Orbis Recent U.K. MHRA Scientific Advice Meeting (SAM) that resulted in full alignment to initiate confirmatory Phase 3 trial in U.K. with existing Phase 2 drug product paved the way Conditional Marketing…
benzinga.com OS Therapies Achieves Incremental FDA Alignment Regarding Its Biologics License Application For OST-HER2 For Prevention Or Delay Of Recurrence In Fully-Resected, Pulmonary Metastatic Osteosarcoma The Company aligned with the FDA on the use of the proposed adaptive design agreed upon with the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency…- benzinga.com OS Therapies Achieves Full Alignment With UK MHRA On Its Pending Conditional Marketing Authorization Application MHRA agreed that the use of comparable historical control data – derived from a systematic evaluation of all suitable available peer-reviewed literature by independent biostatistics advisors…
benzinga.com OS Therapies Reports Strong Survival Data for Bone Cancer Treatment OS Therapies (NYSE: OSTX) interim Phase 2b trial data shows a 71.2% 3-year overall survival rate for OST-HER2 vs. 45.8% for controls.
benzinga.com OS Therapies Announces Statistically Significant Benefit For OST-HER2-Treated Patients In An Interim 3-Year Overall Survival Data Analysis Overall survival data when compared with a combined published historical control arm being used for regulatory interactions. The analysis is from the Company's Phase 2b trial for the prevention or…- benzinga.com FDA Grants OS Therapies’ Requested Type C Statistical Methods Meeting To Review 2.5-Yr Overall Survival Data From Phase 2b Trial Of OST-HER2 In Prevention Of Recurrence In Pulmonary Metastatic Osteosarcoma; Meeting To Occur In Mid-September Meeting to occur in mid-September 2026Interim 3-year Overall Survival data expected early September, 2026Decisions on appropriate comparator arm to interpret OST-HER2 clinical efficacy, RMAT…
- benzinga.com Roth Capital Initiates Coverage On OS Therapies with Buy Rating, Announces Price Target of $7 Roth Capital analyst Adam Walsh initiates coverage on OS Therapies (AMEX:OSTX) with a Buy rating and announces Price Target of $7.
- benzinga.com OS Therapies Accepts New FDA Meeting Request For Review Of Pharmacodynamic Response Biomarker Data OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that it has accepted a new Meeting Request…
benzinga.com OS Therapies Expects Phase 3 Study For The OST-HER2 Metastatic Osteosarcoma Program To Begin Near End Of Q3 2026 OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today provides a third quarter 2026 corporate outlook. The- benzinga.com OS Therapies Requests FDA Type B Meeting To Review Its 2.5-Year OST-HER2 Overall Survival Data And To Confirm Alignment That 3-year Overall Survival Data Is A Clinical Endpoint OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today provided regulatory update on the Company's
- benzinga.com OS Therapies Announces Peer-Reviewed Publication Of Data From Its Phase 2 Clinical Trial Of OST-HER2 With Palliative Radiation Therapy To Prevent Amputation In Frontline Canine Osteosarcoma 20% of OST-HER2 treated dogs survived 2-year vs. 1% in control group (p = 0.00995)Over 15,000 dogs per year diagnosed with osteosarcomaCompany expects to submit U.S. Department of Agriculture meeting…
benzinga.com 12 Health Care Stocks Moving In Thursday's After-Market Session - benzinga.com OS Therapies Achieves FDA And UK MHRA Alignment On Design Of Its Pending Phase 3 Study Of OST-HER2 For Prevention Or Delay Of Recurrence In Fully Resected, Pulmonary Metastatic Osteosarcoma Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA in the U.K., Europe and AustraliaPatent pending pharmacodynamic response…
benzinga.com OS Therapies Says New Bone Cancer Data Strengthens Case For Regulatory Filings OS Therapies shares rise after OST-HER2 Phase 2b data showed a 75% survival rate and progress toward FDA, EMA and TGA regulatory filings.- benzinga.com OS Therapies Announces Its Phase 2b Trial Of OST-HER2 In The Prevention Or Delay Of Recurrence In Fully Resected, Pulmonary Metastatic Osteosarcoma Achieved Statistically Significant Benefit For OST-HER2 Treated Patients In Overall Survival At The 2.5-Year Mark 75% 2.5-year overall survival for OST-HER2 vs. 47% pooled historical control (p = 0.003), with no new patient deaths reported since the 2-year overall survival data (75% vs. 60%, p = 0.034)Updated…
- benzinga.com Lake Street Maintains Buy on OS Therapies, Lowers Price Target to $13 Lake Street analyst Chad Messer maintains OS Therapies (AMEX:OSTX) with a Buy and lowers the price target from $14 to $13.
benzinga.com Earnings Scheduled For May 18, 2026 - benzinga.com OS Therapies Q1 EPS $(0.27) Misses $(0.18) Estimate OS Therapies (AMEX:OSTX) reported quarterly losses of $(0.27) per share which missed the analyst consensus estimate of $(0.18) by 50 percent. This is a 50 percent decrease over losses of $(0.18) per…
- benzinga.com OS Therapies Says EMA's CAT Initiates Continuous Evaluation Of OST-HER2 CMA Request Regulatory Dossier For Prevention Of Recurrence In Fully Resected, Pulmonary Metastatic Osteosarcoma Conference call scheduled for Thursday, April 30, 2026, at 8:30 am ET to review new OST-HER2 immune pharmacodynamic biomarker response (seroconversion) data and review regulatory successes validating…
- benzinga.com OS Therapies Files New Patent Application Covering Immune Signature In Response Therapeutic Candidates Developed Using Listeria Monocytogenes Platform New patent application covers treatment-emergent immune signature related to 'turning cold tumors hot' and the activation of targeted cytotoxic cellular immune responsesCompany to host conference…
- benzinga.com OS Therapies Q4 EPS $(0.41) Misses $(0.13) Estimate OS Therapies (AMEX:OSTX) reported quarterly losses of $(0.41) per share which missed the analyst consensus estimate of $(0.13) by 228 percent. This is a 70.83 percent decrease over losses of $(0.24)…
benzinga.com OS Therapies Completes Filing On Clinical, Biomarker Data From Its Phase 2b Clinical Study Of OST-HER2 To FDA OS Therapies, Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it has completed the submission on clinical and…- benzinga.com OS Therapies Engages Four Global Regulators In Q2 2026 Ahead Of Phase 3 Osteosarcoma Trial Enrollment Expected To Begin In Australia Meetings with all four regulatory agencies scheduled to occur in the second quarter of 2026, with expected Phase 3 commencement in the third quarter of 2026 initially in AustraliaCommencing the Phase…
benzinga.com 12 Health Care Stocks Moving In Thursday's After-Market Session - benzinga.com OS Therapies Advances OST‑HER2 Toward BLA; FDA Elevates Meeting To Type B Pre‑BLA FDA's elevated meeting status signals transition from biomarker data discussions to Accelerated Approval discussionsOS Therapies on track to complete clinical data submission by the end of Q1 2026New…
benzinga.com OS Therapies Discloses 2026 Timeline For Lead Drug Regulatory Filings OS Therapies shares climb after new regulatory plans for OST-HER2 osteosarcoma treatment in the UK, EU, and U.S.- benzinga.com D. Boral Capital Maintains Buy on OS Therapies, Maintains $20 Price Target D. Boral Capital analyst Jason Kolbert maintains OS Therapies (AMEX:OSTX) with a Buy and maintains $20 price target.
- benzinga.com OS Therapies Begins FDA Filing for Experimental Cancer Treatment Aimed at Osteosarcoma Recurrence OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it has formally initiated a Biologics License…
benzinga.com OS Therapies Bone Cancer Trial Data Strengthens FDA Case OS Therapies releases trial data supporting FDA approval, U.K. and U.S. timelines, and potential eligibility for a valuable priority review voucher.- benzinga.com OS Therapies Announces Biomarker Data From Phase 2b Clinical Trial Of OST-HER2 In Prevention Or Delay Of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Activation of immune blood biomarkers from interferon gamma pathway distinguished long term survivors (>=2 years) from short-term survivors (<1year)Pre-specified pathway analysis strategy developed…
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