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].

OS Therapies Announces Successful pre-Marketing Authorisation Application Meeting with UK MHRA Regarding the Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic OsteosarcomaDecember 09, 2025 7:40 AM EST | Source: OS TherapiesAlignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study designBiomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with p ...

OS Therapies Announces FDA PDUFA Waiver & EMA Grants Union Marketing Authorisation EligibilityDecember 05, 2025 8:01 AM EST | Source: OS TherapiesU.S. FDA grants waiver of application fee for BLA Filing of OST-HER2Scheduled pre-Marketing Authorisation Application meeting with United Kingdom's Medicines and Healthcare products Regulatory Agency on December 8, 2025Scheduled Type C Meeting with United States Food & Drug Administration on December 11, 2025New York, New York--(Newsfile Corp. - Dece ...

Core Insights - Sichuan Aoniu New Materials Co., Ltd. has successfully launched its Colorless Polyimide (CPI) project, marking a significant milestone in China's new materials industry [2][3][4] - The CPI project aims to enhance China's self-reliance in high-performance materials, particularly in sectors like aerospace and electronics, which have been dominated by foreign companies [4][5] - The ignition ceremony was attended by over 120 guests, indicating strong industry and governmental support for the initiative [3][4] Company Overview - Sichuan Aoniu New Materials Co., Ltd. was established in 2022 and focuses on the R&D, production, and sales of high-quality Colorless Polyimide (CPI) [7][8] - The company collaborates with the Polymer College of Sichuan University to drive the localization of CPI, assembling a team of domestic and international experts [8] - Aoniu aims to fill the domestic gap in mass production of high-performance polyimide film, providing a stable and high-quality localized solution for downstream industries [4][9] Industry Impact - The CPI film is crucial for high-end flexible displays, foldable smartphones, and aerospace applications, and its production in China is expected to break foreign monopolies [4][5] - The successful ignition and mass production ceremony signifies a shift towards "Made-in-China" CPI, accelerating the pace of domestic substitution in the materials sector [9]

OS Therapies Receives Non-Proprietary Name 'daznelimgene lisbac' for OST-HER2 from World Health OrganizationNovember 25, 2025 9:21 AM EST | Source: OS TherapiesNew York, New York--(Newsfile Corp. - November 25, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved 'daznelimgene ...

Core Insights - OS Therapies announced additional overall and event-free survival data from its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, pulmonary metastatic osteosarcoma, highlighting statistically significant positive outcomes [2][4] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with its lead asset OST-HER2 being an immunotherapy that targets the HER2 protein [4][6] - OST-HER2 has received several designations from regulatory agencies, including Rare Pediatric Disease Designation and Fast-Track status from the U.S. FDA [4] Clinical Trial Results - The Phase 2b Osteosarcoma Trial involved 41 patients, with subgroup analyses revealing: - For patients with a lung-only second or greater metastatic event, the 2-year overall survival rate was 80.0% [5] - For patients with a lung-only first metastatic event, the 2-year overall survival rate was 73.8%, significantly higher than the 30% natural history comparator (p < 0.0001) [5] - The company anticipates submitting a Biologics License Application (BLA) to the U.S. FDA for OST-HER2 in 2025 [6] Future Plans - OS Therapies is preparing for regulatory meetings with the FDA, MHRA, and EMA to discuss overall survival data and trial design for OST-HER2 [3] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [7]

Core Insights - OS Therapies announced statistically significant positive final 2-year overall survival data from the Phase 2b trial of OST-HER2, showing 75% of treated patients achieved 2-year overall survival compared to 40% in historical controls [1][4] - The company is on track to file for conditional marketing authorization in the UK, the US, and the EU, with key regulatory meetings planned for December 2025 [3][6] Group 1: Clinical Trial Results - 75% of OST-HER2 treated patients achieved 2-year overall survival, significantly higher than the 40% in historical controls (p < 0.0001) [1][4] - Subgroup analysis indicated that 100% of patients who achieved 12-month Event Free Survival (EFS) also achieved 2-year overall survival [1][4] Group 2: Regulatory Path and Future Plans - The company plans to submit a conditional Marketing Authorization Application (MAA) to the MHRA in December 2025 and a Biologics Licensing Application (BLA) to the FDA in January 2026 [3][6] - OS Therapies is analyzing patient samples to confirm correlations between clinical outcomes and immune system biomarker activation, with results expected in November 2025 [3] Group 3: Company Overview and Product Pipeline - OS Therapies focuses on developing treatments for Osteosarcoma and other solid tumors, with OST-HER2 as its lead asset, which has received multiple designations from regulatory agencies [6][7] - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [7]

Core Viewpoint - OS Therapies is advancing its regulatory submissions for OST-HER2, focusing on obtaining marketing authorizations in the UK and US for the treatment of pulmonary metastatic osteosarcoma, with submissions expected in late 2025 and early 2026 [3][7]. Regulatory Update - The company has updated its regulatory filing sequence to prioritize the UK MHRA conditional Marketing Authorisation Application (MAA) submission, which is expected to be completed in December 2025, followed by the US FDA Biologics Licensing Application (BLA) submission in January 2026 [3][7]. - A conditional MAA Pre-Submission Request has been submitted to the MHRA, and the company anticipates receiving formal acceptance for a rolling review request soon [4]. Clinical Trial Insights - The information in the MHRA conditional MAA submission aligns closely with the planned US FDA BLA submission, with the exception of the acceptable comparator arm for efficacy data [5]. - The company aims to use immune activation biomarker data as a surrogate marker correlated with overall survival to support its Accelerated Approval request [5][7]. Company Background - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with OST-HER2 being its lead asset [8]. - OST-HER2 has received several designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track designation, and has shown statistically significant benefits in its Phase 2b clinical trial [8]. Future Developments - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [9].

Core Insights - OS Therapies has completed the last patient visit in its Phase 1b clinical trial for OST-504, focusing on biochemically recurrent prostate cancer, with a total of 7 patients enrolled [1][2] - The company is optimistic about the potential of OST-504 in various prostate cancer settings and plans to report study results in Q4 2025 [2] - Prostate cancer represents a significant market opportunity, with 1 in 8 men diagnosed and 1 in 44 men dying from the disease, making it the second leading cause of cancer death among men [2] - The company is also preparing for a rolling submission for a Biologics Licensing Application (BLA) for OST-HER2 in osteosarcoma, which could lead to accelerated market access for OST-504 if successful [2][5] - Updated 2-year overall survival data from the Phase 2b trial of OST-HER2 will be released on October 10, 2025 [4] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with OST-HER2 as its lead asset [3][5] - OST-HER2 has received multiple designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status, and has shown positive results in its Phase 2b clinical trial [3][5] - 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 [6]

Core Insights - The analysis emphasizes the importance of reviewing both successful and unsuccessful stock picks to learn from mistakes and successes [1][2] - Ostin Technology (OST) experienced a significant decline in price due to a lack of due diligence and ignoring negative trends in revenue, earnings, and cash flow [2][3] - Bloom Energy (BE) demonstrated a positive performance with a 22.61% gain in six trading days, attributed to thorough research and favorable analyst projections [4][5] Summary of Ostin Technology - The company faced declining revenue, earnings, and cash flow over several years, which was overlooked during the initial analysis [3] - The price increase prior to the decline had no fundamental support, leading to a significant loss for investors who did not conduct proper due diligence [2][3] Summary of Bloom Energy - Bloom Energy was highlighted for its consistent revenue growth and positive analyst projections for both revenue and earnings [4][5] - The stock closed at $51.35 on September 2 and rose to $62.96 by September 10, marking a 22.61% increase [5] - The analysis stresses the necessity of examining multi-year revenue and earnings trends to avoid costly investment mistakes [5]