Core Insights - Biotech stocks experienced significant gains in after-hours trading, with Inhibrx Biosciences leading the surge due to positive trial results [1][2] Company Summaries - **Inhibrx Biosciences (INBX)**: Shares surged over 81% to $51.52 following positive topline results from the ChonDRAgon study, which evaluated ozekibart as a monotherapy for advanced chondrosarcoma. The company also reported progress on expansion cohorts for colorectal cancer and Ewing sarcoma [2] - **Femasys Inc. (FEMY)**: Stock increased by more than 18% to $0.7227 after launching a post-market surveillance clinical study for its FemBloc Permanent Birth Control, complying with EU Medical Device Regulation [3] - **Cingulate Inc. (CING)**: Shares rose over 6% to $3.80 after announcing that data from its ADHD candidate CTx-1301 was selected for presentation at the AACAP Annual Meeting, highlighting its potential in ADHD treatment [4] - **Community Health Systems, Inc. (CYH)**: Stock increased over 4% to $3.41 following positive Q3 results [5] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares climbed over 10% to $0.6295 in after-hours trading [6] - **Ascendis Pharma A/S (ASND)**: Stock gained more than 4%, reaching $210.68 post-market [6] - **ADC Therapeutics SA (ADCT)**: Shares rose over 5% to $4.2887 in after-hours trading [6] - **Zura Bio Limited (ZURA)**: Stock increased more than 5% to $3.55 post-market [6] - **Foghorn Therapeutics Inc. (FHTX)**: Shares gained more than 5%, closing at $4.11 after hours [6]

Core Insights - Femasys Inc. has initiated a post-market surveillance clinical study for its FemBloc Permanent Birth Control, marking a significant step in its European commercialization strategy under the EU Medical Device Regulation [1][2][3] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [4] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including the FemBloc and FemaSeed [4] Product Details - FemBloc is a non-surgical solution for permanent birth control that uses a patented delivery system to occlude fallopian tubes without the need for anesthesia or incisions, thus avoiding surgical risks [3][5] - The product has received full regulatory approval in Europe, the UK, and New Zealand, and is positioned to meet the strong demand for safe and accessible permanent birth control options among women [5] Clinical Study and Compliance - The post-market surveillance study aims to monitor the safety and performance of FemBloc in real-world settings, complying with the rigorous requirements of the EU MDR [2][3] - The study has received approval from multiple Ethics Committees and adheres to ISO 14155:2020 for Good Clinical Practice [2] Market Potential - FemBloc addresses a significant unmet need in women's reproductive health, with no comparable alternatives currently available, indicating a broad global market potential [3][5] - The company aims to build a foundation for broader physician adoption and reimbursement through the generation of real-world data from the clinical study [3]

Core Insights - Femasys Inc. has received MHRA approval for its FemBloc Permanent Birth Control, marking a significant step in its European commercialization strategy [1][2] - The approval follows the CE mark received earlier and positions Femasys to secure strategic partnerships for commercialization in the UK [2] - FemBloc is a non-surgical solution for permanent birth control, utilizing a patented delivery system to create natural scar tissue for occlusion, thus avoiding the risks associated with surgical sterilization [3][5] Company Overview - Femasys is focused on making fertility and non-surgical permanent birth control more accessible and cost-effective through a patent-protected portfolio of products [4] - The company is actively commercializing its innovations in the U.S. and key international markets, with a fertility portfolio that includes FemaSeed and FemVue [4] - FemBloc is the first non-surgical, in-office alternative to surgical sterilization, with plans for commercialization through strategic partnerships in select European countries [5] Market Context - The UK is one of the largest healthcare markets in Europe, emphasizing women's health solutions, which provides a favorable environment for innovative technologies like FemBloc [2] - The single-payer NHS system in the UK facilitates the adoption of technologies that improve access and reduce costs [2] - FemBloc's approval validates its safety and effectiveness, allowing Femasys to cater to a diverse patient population in this critical market [2]