OS Therapies on Tuesday said it expects to complete conditional Marketing Authorization Application (MAA) submissions to both the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) by the end of the first quarter of 2026.Additionally, the company is on track to submit the Clinical BLA module to the FDA following a Type D meeting anticipated in March 2026.The company is also preparing to release additional biomarker data from its Human Metastatic Osteosa ...

Additional forthcoming biomarker data from human trial expected to further characterize immune pathway activation and its relationship to clinical outcomesU.S., U.K. and European osteosarcoma key opinion leaders assembling to review clinical & biomarker trial data, and comment on proposed confirmatory trial designAyala Pharmaceuticals announces dissolution following liquidation of assetsNew York, New York--(Newsfile Corp. - February 17, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "th ...

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].

Core Viewpoint - Purcell & Lefkowitz LLP is investigating OS Therapies Incorporated to determine if the company's directors breached their fiduciary duties related to recent corporate actions [1]. Group 1 - The investigation is being conducted on behalf of OS Therapies's shareholders [1]. - The law firm specializes in representing shareholders who are victims of securities fraud and breaches of fiduciary duty [3]. - Shareholders interested in their rights and options can contact the firm for more information [2].

Core Insights - OS Therapies Inc. is positioned to enhance the standard of care for metastatic osteosarcoma with its lead candidate OST-HER2, with significant regulatory submissions planned for 2026 [3][4][5] Regulatory Submissions - The company plans to submit a Biologics License Application (BLA) to the U.S. FDA by the end of January 2026 under the Accelerated Approval Program [4] - Marketing Authorization Applications (MAA) for conditional approval are expected to be submitted to the U.K. MHRA and the European EMA by the end of February 2026 and March 2026, respectively [4][5] Clinical Data and Milestones - Phase 2b biomarker data from the Metastatic Osteosarcoma Program is anticipated to be released during the week of the J.P. Morgan Healthcare Conference in January 2026 [2][12] - The company expects to engage in multiple meetings with regulatory authorities in the first half of 2026 to discuss clinical efficacy endpoints and trial designs [5] Designations and Incentives - OST-HER2 has received Orphan Disease Designation (ODD), Fast Track Designation, and Rare Pediatric Disease Designation (RPDD) from the FDA, making it eligible for a Priority Review Voucher (PRV) if approved before September 30, 2026 [6][9] Future Developments - The company is advancing its OS Animal Health subsidiary towards a go-public transaction, with a confidential SEC filing expected in early January 2026 [7][12] - Additional oncology programs, including OST-503 and OST-504, are also in development, with key meetings with the FDA planned for 2026 [8][12]

Core Viewpoint - OS Therapies Inc. has made significant progress in discussions with the FDA regarding the Phase 2b clinical trial of its lead product candidate, OST-HER2, for the treatment of recurrent pulmonary metastatic osteosarcoma, with plans to submit a Biologics Licensing Application (BLA) by the end of January 2026 [1][2][7]. Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leading in listeria-based cancer immunotherapies [4]. - OST-HER2 is an innovative immunotherapy that utilizes a bioengineered form of Listeria monocytogenes to elicit a strong immune response against cancer cells expressing HER2 [2][4]. FDA Meeting Highlights - The FDA confirmed that data from single-arm studies in ultra-rare pediatric cancer osteosarcoma could support a BLA under the Accelerated Approval Program [7][8]. - The FDA suggested a confirmatory study design that includes additional osteosarcoma disease settings, such as the prevention of recurrence following primary tumor resection [7][8]. - The FDA indicated that the use of canine data to support the correlation between immune biomarker activation and clinical benefit will depend on the chosen biomarkers and their clinical validation [7][8]. Upcoming Milestones - The company expects to complete the immune activation biomarker analysis soon, with data to be released during the JP Morgan Healthcare Conference in January 2026 [2][3]. - Following the BLA submission, the company plans to hold additional meetings with the FDA to review biomarker data and confirmatory study design [2][3][7].