StreetInsider.com News Articles

OS Therapies to report significant survival benefit for OST-HER2 in osteosarcoma

Tue, 02 Jun 2026 06:09:35 -0400

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.

The data is expected to strengthen the company's push for early market authorizations across major regulatory jurisdictions.

According to information seen by Investing.com, patients treated with OST-HER2 achieved a 75% overall survival rate at 2.5 years.

No new patient deaths were reported in the treated group between the previously reported two-year analysis and the latest 2.5-year data cut.

The updated results build on earlier

OS Therapies, Inc (OSTX) PT Lowered to $13 at Lake Street

Tue, 19 May 2026 08:56:35 -0400

Lake Street analyst Chad Messar lowered the price target on OS Therapies, Inc (NYSE: OSTX) to $13.00 (from $14.00) while maintaining a Buy rating.

OS Therapies Incorporated (OSTX) Reports Q1 Loss of $0.27

Mon, 18 May 2026 16:46:21 -0400

OS Therapies Incorporated (NYSE: OSTX) reported Q1 EPS of ($0.27).

For earnings history and earnings-related data on OS Therapies Incorporated (OSTX) click here.

Form 10-Q OS Therapies Inc For: Mar 31

Mon, 18 May 2026 06:04:00 -0400

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Form 10-Q OS Therapies Inc For: Mar 31

Mon, 18 May 2026 06:04:00 -0400

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Form 5/A OS Therapies Inc For: Dec 31 Filed by: Romness Paul A.

Fri, 15 May 2026 18:30:00 -0400

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Form 5/A OS Therapies Inc For: Dec 31 Filed by: Romness Paul A.

Fri, 15 May 2026 18:30:00 -0400

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Form NT 10-Q OS Therapies Inc For: Mar 31

Fri, 15 May 2026 16:24:00 -0400

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Form NT 10-Q OS Therapies Inc For: Mar 31

Fri, 15 May 2026 16:24:00 -0400

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Form 8-K OS Therapies Inc For: Apr 30

Thu, 30 Apr 2026 16:07:00 -0400

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Form 8-K OS Therapies Inc For: Apr 30

Thu, 30 Apr 2026 16:07:00 -0400

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EMA initiates rolling review of OS Therapies cancer treatment application

Thu, 30 Apr 2026 06:22:55 -0400

The European Medicines Agency has initiated a rolling review of OS Therapies Inc.'s (NYSE American: OSTX) conditional marketing authorization application for OST-HER2, a treatment designed to prevent recurrence in patients with fully resected pulmonary metastatic osteosarcoma.

The company announced that EMA's Committee for Advanced Therapy, working with the Committee for Medicinal Products for Human Use and Pharmacovigilance Risk Assessment Committee, began the continuous evaluation process for the OST-HER2 regulatory dossier. OS Therapies was also selected for EMA's Raw Data Pilot Programme.

Australia's Therapeutic Goods Administration has invited OS Therapies to apply for Provisional Determination, the Australian equivalent of a conditional marketing authorization.

EMA initiates rolling review of OS Therapies cancer treatment application

Thu, 30 Apr 2026 06:22:55 -0400

Australia's Therapeutic Goods Administration has invited OS Therapies to apply for Provisional Determination, the Australian equivalent of a conditional marketing authorization.

OS Therapies Announces EMA Initiates Rolling Review of Conditional Marketing Authorization Application for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected Pulmonary Metastatic Oste

Thu, 30 Apr 2026 06:00:00 -0400

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 the OST-HER2 approach. Participants will include strategic advisors Dr. Craig Eagle and Dr. Bob Langer, and Osteosarcoma key opinion leader Dr. Peter Anderson from Cleveland Clinic.

EMA and Australia TGA (ATGA) align on 3-year overall survival as the approvable clinical efficacy endpoint for Conditional Marketing Authorizations (CMAs), with alignment also achieved on confirmatory Phase 3 initiation, initially only in Australia, planned for Q3 2026 to meet regulatory requirement to support early approvals

OS Therapies Announces EMA Initiates Rolling Review of Conditional Marketing Authorization Application for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected Pulmonary Metastatic Oste

Thu, 30 Apr 2026 06:00:00 -0400

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 the OST-HER2 approach. Participants will include strategic advisors Dr. Craig Eagle and Dr. Bob Langer, and Osteosarcoma key opinion leader Dr. Peter Anderson from Cleveland Clinic.
EMA and Australia TGA (ATGA) align on 3-year overall survival as the approvable clinical efficacy endpoint for Conditional Marketing Authorizations (CMAs), with alignment also achieved on confirmatory Phase 3 initiation, initially only in Australia, planned for Q3 2026 to meet regulatory requirement to support early approvals

Form 8-K OS Therapies Inc For: Mar 31

Thu, 02 Apr 2026 17:25:00 -0400
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Form 8-K OS Therapies Inc For: Mar 31

Thu, 02 Apr 2026 17:25:00 -0400
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Form 424B5 OS Therapies Inc

Thu, 02 Apr 2026 17:01:00 -0400
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Form 424B5 OS Therapies Inc

Thu, 02 Apr 2026 17:01:00 -0400
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OS Therapies, Inc (OSTX) PT Lowered to $14 at Lake Street

Wed, 01 Apr 2026 08:51:56 -0400
Lake Street analyst Chad Messar lowered the price target on OS Therapies, Inc (NYSE: OSTX) to $14.00 (from $17.00) while maintaining a Buy rating.

Form 8-K OS Therapies Inc For: Mar 31

Tue, 31 Mar 2026 16:21:00 -0400
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Form 8-K OS Therapies Inc For: Mar 31

Tue, 31 Mar 2026 16:21:00 -0400
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Form 424B7 OS Therapies Inc

Tue, 31 Mar 2026 16:09:00 -0400
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Form 424B7 OS Therapies Inc

Tue, 31 Mar 2026 16:09:00 -0400
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Form 10-K OS Therapies Inc For: Dec 31

Tue, 31 Mar 2026 06:09:00 -0400
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