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 Australia Commencing the Phase 3 confirmatory study is a pre-requisite to being granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisations (CMAs) in the U.K. & EuropeNew York, New York--(Newsfile Corp. - March 27, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ...

ATMP benefits include access to the Conditional Marketing Authorisation accelerated market access pathway in Europe, significantly reduced user fees for small and medium-sized enterprises (SMEs), tailored regulatory assessment via Committee for Advanced Therapies (CAT) and increased pricing power New York, New York--(Newsfile Corp. - March 25, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that t ...

Core Viewpoint - OS Therapies Inc. is advancing its Biologics License Application (BLA) for OST-HER2, a listeria-based cancer immunotherapy, aimed at preventing or delaying recurrent pulmonary metastatic osteosarcoma, with an expected submission of clinical data by the end of Q1 2026 [1][2]. Group 1: FDA Engagement and Designations - The FDA has elevated OS Therapies' Type D Biomarker Meeting to a Type B pre-BLA Meeting, indicating progress in discussions regarding Accelerated Approval for OST-HER2 [1]. - OST-HER2 has received multiple designations from the FDA, including Orphan Drug Designation (ODD), Fast Track Designation, and Rare Pediatric Disease Designation (RPDD) [2][3]. - If OST-HER2 receives Accelerated Approval, the company will be eligible for a Priority Review Voucher (PRV), which could be sold; the last reported PRV transaction was valued at $205 million [2]. Group 2: Clinical Trials and Efficacy - The company reported positive results from its Phase 2b clinical trial of OST-HER2, showing statistically significant benefits in the 12-month event-free survival (EFS) primary endpoint [3]. - A confirmatory randomized Phase 3 trial is planned to commence before the company can be granted Accelerated Approval in the U.S. [2]. Group 3: Future Developments - OS Therapies is also working on next-generation Antibody Drug Conjugates (ADC) and Drug Conjugates (DC), utilizing proprietary technology for tailored treatment options [4]. - The company anticipates reading out data from a Phase 1b study of OST-504 in castration-resistant prostate cancer in the first half of 2026 [3].

Core Insights - The company expects to complete conditional Marketing Authorization Application submissions to the U.K. and European regulatory agencies by the end of Q1 2026 [1] - Additional biomarker data from the Human Metastatic Osteosarcoma Program is set to be released in Q1 2026, which aims to support the use of biomarkers as surrogate endpoints for clinical efficacy [2] - The company acquired listeria-based assets from Ayala Pharmaceuticals in April 2025, and Ayala has since liquidated its shares in the company [3] Technical Analysis - The stock is currently trading 8.0% below its 20-day simple moving average and 15.0% below its 100-day simple moving average, indicating short-term weakness [4] - Over the past 12 months, shares have decreased by 38.07%, reflecting ongoing challenges for the company [4] - The RSI is at a neutral level, and MACD is also neutral, suggesting mixed momentum for the stock [5] Analyst Consensus & Recent Actions - The stock carries a Buy Rating with an average price target of $18.25, with recent analyst moves maintaining a target of $20 [6] - OS Therapies shares were up 2.46% at $1.25 during premarket trading [6] - Key resistance is identified at $1.50 and key support at $1.12 [6]

Core Viewpoint - OS Therapies Inc. is advancing its regulatory strategy for OST-HER2, a listeria-based cancer immunotherapy, with significant upcoming data releases and regulatory submissions aimed at preventing recurrent pulmonary metastatic osteosarcoma [1][2][3][4]. Regulatory Updates - The company submitted the Non-Clinical and Chemistry, Manufacturing & Controls (CMC) modules of its Biologics License Application (BLA) to the FDA at the end of January 2026 and plans to release additional biomarker data in Q1 2026 [2]. - Conditional Marketing Authorisation Applications (MAAs) are expected to be submitted to the U.K. MHRA and the EMA by the end of Q1 2026, with a Clinical BLA module submission to the FDA anticipated after a Type D meeting in March 2026 [3]. Biomarker Data and Clinical Trials - OS Therapies is conducting follow-on biomarker analyses to further understand the drug's treatment effects and their relationship to clinical outcomes, with data expected to be shared soon [4]. - The company is assembling a meeting with key opinion leaders in osteosarcoma to review clinical and biomarker data and discuss confirmatory trial designs, with plans to initiate a confirmatory trial in Q3 2026 [4][11]. Designations and Financial Implications - OST-HER2 has received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA, making it eligible for a Priority Review Voucher (PRV) upon Accelerated Approval, which could be sold for significant value [5]. - The most recent PRV transaction was valued at $200 million [5]. Acquisition and Corporate Developments - OS Therapies acquired listeria-based assets from Ayala Pharmaceuticals in April 2025, and Ayala has since announced its dissolution following the liquidation of its assets [6].

Core Insights - OS Therapies Inc. celebrates the passage of the Mikaela Naylon Give Kids A Chance Act, which aims to enhance research and therapeutic access for pediatric cancer patients, particularly those with osteosarcoma [1][5] - Pediatric cancers are the leading cause of disease-based death among children in the U.S., highlighting the urgent need for innovative treatments [2] - The reauthorization of the Rare Pediatric Disease Designation (RPDD) Priority Review Voucher (PRV) program allows OS Therapies to extend its timeline for submitting a Biologics License Application (BLA) for its lead product, OST-HER2, until September 30, 2029 [3][6] Company Developments - OS Therapies is focused on developing listeria-based cancer immunotherapies, with OST-HER2 being its lead asset, which has shown positive results in clinical trials for recurrent pulmonary metastatic osteosarcoma [7] - The company is also evaluating other pipeline products for potential PRV opportunities and benefits under the FDA Platform Technology Designation Program [4] - OST-HER2 has received multiple designations from regulatory bodies, including Orphan Disease Designation and Fast Track Designation, which facilitate its development and potential market entry [6][7] Future Prospects - The company is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [8] - OS Therapies is committed to transforming the lives of children and teens affected by osteosarcoma and other rare cancers, building on the legacy of patients like Mikaela Naylon [5]

Core Viewpoint - OS Therapies Inc. has initiated a Biologics License Application (BLA) submission to the FDA for OST-HER2, targeting the prevention or delay of recurrent pulmonary metastatic osteosarcoma, with expectations for approval by September 30, 2026 [1][5]. Company Developments - The company has submitted the Non-Clinical and Chemistry, Manufacturing, and Controls (CMC) modules of the BLA to the FDA and requested a Rolling Review [1][5]. - A Type D Meeting is anticipated in March 2026 to discuss new Comparative Oncology biomarker data from the Phase 2b clinical trial in humans and a similar trial in canines [1][5]. - The final clinical BLA module is expected to be submitted by the end of March 2026 [5]. Designations and Approvals - OST-HER2 has received Orphan Disease Designation (ODD), Fast Track Designation from the FDA and EMA, and Rare Pediatric Disease Designation (RPDD) from the FDA [3][4]. - If Accelerated Approval is granted before September 30, 2026, the company will be eligible for a Priority Review Voucher (PRV), which it intends to sell [3][4]. Clinical Trial Results - Positive data from the Phase 2b clinical trial of OST-HER2 demonstrated statistically significant benefits in the 12-month event-free survival (EFS) primary endpoint [4]. Future Developments - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [6].

Core Insights - OS Therapies Incorporated (NYSE:OSTX) shares experienced a decline following the announcement of positive biomarker data from its Phase 2b clinical trial of OST-HER2, an immunotherapy for recurrent, fully resected lung metastatic osteosarcoma [1][2] Clinical Trial and Regulatory Path - The clinical trial data indicated that activation of immune blood biomarkers in the interferon gamma pathway could differentiate long-term survivors from short-term survivors [1] - The company is preparing a Biologics License Application (BLA) submission to the U.S. FDA, with regulatory approval anticipated in the U.K. by the end of Q2 2026, in the U.S. by Q3 2026, and in Europe by the end of 2026 [2] - If the company receives Accelerated Approval before September 30, 2026, it will be eligible for a Priority Review Voucher, which it plans to sell [2] Stock Performance and Market Position - OSTX shares are currently trading 2.5% below the 20-day simple moving average (SMA) and 12.8% below the 50-day SMA, indicating bearish momentum, with a 12-month share decrease of approximately 66.17% [3] - The stock is closer to its 52-week lows than highs, with a neutral RSI of 47.78 and a bullish MACD above its signal line, suggesting mixed momentum [3][4] - The Benzinga Edge scorecard indicates a challenging environment for OS Therapies as it navigates clinical trials and market expectations, advising investors to remain cautious [5] Price Action and Technical Analysis - At the time of publication, OS Therapies shares were down 4.52% at $1.48, with key resistance at $1.69 and key support at $1.12 [6] - The stock is showing mixed signals in terms of momentum, quality, and value, appearing to trade at a premium relative to its peers [6]

Company Overview - OS Therapies Inc. is a leader in listeria-based cancer immunotherapies, focusing on treatments for osteosarcoma and other solid tumors [8] - The company is preparing for an Initial Public Offering (IPO) for its subsidiary OS Animal Health Corp (OSAH) in the first half of 2026 [1][5] - OSAH aims to commercialize OST-HER2, an immunotherapy for canine osteosarcoma and HER2-positive cancers in animals [5][7] Research and Development - A 2023 study highlighted similarities between human and canine osteosarcoma, indicating that a robust immune response improves clinical outcomes [2] - Data from canine studies of OST-HER2 showed upregulation of immune activation biomarkers that correlate with better outcomes [2][3] - OST-HER2 has demonstrated potential in improving patient outcomes in canine osteosarcoma, including preventing metastatic disease and amputation [4] Market Opportunity - The veterinary oncology market is projected to grow from $1.58 billion in 2024 to $4.77 billion by 2034, primarily driven by North America [3] - The canine cancer segment is expected to grow at a rate of 12.56% from 2025 to 2030, attributed to rising cancer prevalence and increased awareness of treatment options [3] Regulatory and Approval Status - OS Therapies is pursuing a Biologics Licensing Application (BLA) for OST-HER2 under the Accelerated Approval Program for human osteosarcoma [3][8] - OST-HER2 has received conditional approval from the USDA for treating canine osteosarcoma and is part of the National Cancer Institute's Comparative Oncology Program [6][8]

Core Viewpoint - OS Therapies Inc. has launched a warrant exercise inducement and exchange offer to nine accredited investors, raising a total of $7.53 million in gross proceeds to support its ongoing projects and regulatory filings [1][3]. Group 1: Financial Details - The gross proceeds of $7.53 million will provide the company with a financial runway into 2027 [3]. - All nine investors who were offered the inducement have agreed to participate in the exercise of their existing warrants [7]. Group 2: Regulatory and Development Plans - The company plans to use the net proceeds to support regulatory filings and commercial preparation activities for its lead asset, OST-HER2, aimed at treating pulmonary metastatic osteosarcoma [3]. - OS Therapies intends to file a Biologics Licensing Application (BLA) with the U.S. FDA by the end of January 2026 and expects to submit Marketing Authorisation Applications (MAA) to the UK and EU regulatory bodies by February and March 2026, respectively [4][5]. - The company is hopeful for regulatory approval for OST-HER2 in the UK by Q2 2026, in the U.S. by Q3 2026, and in Europe by Q4 2026 [4]. Group 3: Product Designations and Market Potential - OST-HER2 has received Orphan Disease Designation and Fast Track Designation from the FDA, as well as Rare Pediatric Disease Designation, which may allow the company to receive a Priority Review Voucher (PRV) if it gains Accelerated Approval before September 30, 2026 [5]. - The most recent PRV sale was valued at $160 million, indicating significant market potential for the company if it successfully monetizes a future PRV [5]. Group 4: Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leveraging listeria-based cancer immunotherapies [9]. - The company reported positive data from its Phase 2b clinical trial of OST-HER2, demonstrating significant benefits in the primary endpoint of 12-month event-free survival [9].