OS Therapies Incorporated OSTX

Experienced biotech leaders to focus on preparations for U.S., U.K., and European commercial launch of the Company's lead product candidate Herlystic™(OST-HER2; daznelimgene lisbac)Grasonville, Maryland--(Newsfile Corp. - October 1, 2026) - OS Therapies, Inc. (NYSE American: 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 Commercial Officer (CCO) and Frank Knuettel II as Chief.

New York, New York and Rockville, Maryland--(Newsfile Corp. - September 24, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announce that the World Health Organization has approved the proprietary name 'Herlystic'™ was approved by the World Health Organization (WHO) as the brand name for OST-HER2. The nonproprietary name daznelimgene lisbac for the ingredients in OST-HER2 was...

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 Authorisation Application (CMAA) submission in the coming weeks and Phase 3 trial initiation in mid Q4/'26 following Phase 2b drug product requalificationMHRA's SAM participants' recommendation to Project Orbis U.K. leadership to take the global regulatory leadership mantle with U.S. FDA and EMA,...

FDA aligns with MHRA and EMA on adaptive design for Phase 3 trialAfter successful Scientific Advice Meeting, OS Therapies accepts MHRA request to become the Company's sponsor into Project Orbis to harmonize regulatory review with FDA and EMACBER recently re-opened Project Orbis to foreign-sponsored U.S. companies onlyNew York, New York and Rockville, Maryland--(Newsfile Corp. - September 17, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in..

Overall Survival (OS) historical-control data gains HMRA and EMA support for pending CMAA submissionsFull alignment achieved on confirmatory Phase 3 trial designComplete CMAA submission expected in coming weeksNew York, New York and Rockville, Maryland--(Newsfile Corp. - September 15, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that it has achieved full alignment with..

71.2% 3-year overall survival for OST-HER2-treated patients vs. 45.8% comparable combined historical control (p = 0.002)The two remaining patients who have not yet reached the 3-year timepoint from enrollment have trial monitoring visits scheduled for September 2026 and early October 2026Company receives $3.15 million in VAT refunds into OS Therapies UK, Ltd. subsidiary, with an additional $7.2 million in refundable VAT and R&D Tax Credits pendingNew York, New York and Rockville,...

Management will participate at Jefferies Global Healthcare Conference, H.C. Wainwright Global Investment Conference, ROTH Healthcare Opportunities Conference Management and business development advisors will attend BioJapan Interim 3-year overall survival data, U.S. FDA Type C Statistical Methods meeting and U.K. MHRA Statistical Methods Scientific Advice Meeting expected in September 2026RMAT and Rolling Review decisions expected to follow U.S. FDA meetingFinal 3-year overall survival data,...

Up to $10 million debt financing supported by U.K. subsidiary VAT refunds and reimbursable R&D tax credits, including $5 million funded at the August 10, 2026 first closingFDA Type C Statistical Methods Meeting mid-September 2026 meeting to review 2.5-year Overall Survival data and confirmatory Phase 3 trial design to gain alignment on statistical analysis plan for BLA submission under the Accelerated Approval ProgramInterim 3-year Overall Survival data expected in early September 2026 ahead of.

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 designation and Rolling Review expected following this meetingSustained overall survival benefit observed between 2-year and 2.5-year timepointsU.K. MHRA Statistical Methods Scientific Advice Meeting granted in parallelNew York, New York and Rockville, Maryland--(Newsfile Corp. - August 13, 2026) - OS...

CDER meeting expected to take place in the summer of 2026 in parallel with CBER's Type B Statistical Methods MeetingNew York, New York and Rockville, Maryland--(Newsfile Corp. - July 8, 2026) - OS Therapies, Inc. (NYSE American: 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 from the U.S. Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER)..

Upcoming Type B Statistical Methods Meeting expected to set stage for FDA to align with EMA and MHRA on use of Fall 2026 3-year overall survival data combined with biomarkers to support early market accessNew York, New York and Rockville, Maryland--(Newsfile Corp. - July 6, 2026) - OS Therapies, Inc. (NYSE American: 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 outlook...

Company secures $10 million line of credit supported by OS Therapies UK tax creditsNew York, New York and Rockville, Maryland--(Newsfile Corp. - July 2, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that it has appointed Dr. Craig Eagle to the Company's Board of Directors. Dr. Eagle currently serves as the Company's Chief Medical Advisor. The Company also thanks Karim...

Type B Meeting requested to follow up on September 2025 End of Phase 2 FDA Meeting guidance on statistical methods to be used for BLA SubmissionSeeking to align FDA with MHRA & EMA on 3-year overall survival as approval endpointBiomarker data submitted to FDA BEST program as surrogate clinical efficacy dataSynthetic historical control arm OST-400 recruitment potentially adds comparator for BLA submission under the Accelerated ApprovalReview of Rolling Review, RMAT & Breakthrough Therapy...

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 request to gain alignment on regulatory path towards conditional approval in the third quarter of 2026OS Therapies reiterates plan to distribute OS Animal Health shares to shareholdersOS Animal Health plans crowdfunding to expand shareholder base to meet U.S. national exchange initial listing...

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 biomarker accepted as surrogate clinical efficacy endpointTGA and MHRA agree to allow utilization of remaining Phase 2b drug product for initiation of confirmatory Phase 3FDA and EMA fully align with Company on Chemistry, Manufacturing and Controls (CMC)Market access process initiated with UK NICE and

Investing.com -- OS Therapies is expected to report today that its lead immunotherapy candidate, OST-HER2, has achieved a statistically significant overall survival benefit at 2.5 years in patients with fully resected pulmonary metastatic osteosarcoma, Investing.com has learned.

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 clinical efficacy data being added to regulatory dossiers as Company seeks early market authorizations in U.S., U.K., Europe and Australia in 2nd half of 2026EMA and Australia TGA (TGA) alignment achieved on early Q4-2026 3-year overall survival data, supported by biomarker data, as key...

The Company confirms that it will release 2.5 year overall survival data from Phase 2b clinical trial OST-HER2 in the prevention or delay of recurrence in fully-resected pulmonary metastatic osteosarcoma during the 2026 American Society of Clinical Oncologists (ASCO) Annual Meeting being held from May 28, 2026 to June 2, 2026.New York, New York and Rockville, Maryland--(Newsfile Corp. - May 29, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader..

ASCO 2026: 2.5-Year Overall Survival DataJefferies Healthcare Conference: Partnering & Investor meetingsBIO International Convention: Panel ParticipationMIB Agents Factor Osteosarcoma Conference: Data PresentationNew York, New York and Rockville, Maryland--(Newsfile Corp. - May 26, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced that it will attend upcoming medical, financial and

$5.5 million financing that closed on April 2, 2026 together with $5.7 million in capital raised in Q1-2026, expected to provide Company with cash runway into 2027$4.5 million of accrued VAT refunds and R&D refundable tax credits from UK subsidiary begin maturing, including $1.9 million VAT cash refund expected in June 2026Successful EMA and Australia TGA (ATGA) meetings aligned around use of existing biomarker and pending release of 3-year overall survival data to support Conditional Marketing.