EDAP Overview

Genenta Science S.p.A. Update: After a significant drop in regular trading due to a $15 million capital raise announcement, Genenta's shares saw a modest recovery in after-hours trading, indicating potential stabilization as investors assess the long-term impact of the company's strategic collaborations.

EDAP TMS S.A. Recovery: Despite a sharp decline during the day, EDAP's stock rebounded in after-hours trading, reflecting renewed speculative interest, particularly ahead of upcoming investor meetings at the UBS Global Healthcare Conference.

BridgeBio Pharma Inc. Anticipation: BridgeBio's shares rose significantly after hours, driven by investor optimism regarding the upcoming Phase 3 trial results for ADH1, with topline data expected to be released soon.

OrthoPediatrics Corp. Financial Performance: Following the release of its Q3 financial results, OrthoPediatrics experienced a surge in after-hours trading, buoyed by revenue growth and FDA approvals, leading to an optimistic revision of its full-year revenue guidance.

Advancements in Cancer Immunotherapy: MIT and Harvard scientists have engineered CAR-NK cells that evade the immune system, enhancing cancer destruction and enabling immediate off-the-shelf treatments. The global cancer immunotherapy market is projected to grow significantly, driven by innovations in cellular therapies and biomarker-driven drug development.

GT Biopharma's Clinical Progress: GT Biopharma is advancing its Phase 1 trial of GTB-3650 for treating relapsed or refractory blood cancers, showing promising early results in immune activation without significant side effects. The company plans to file for human trials of its solid tumor-targeting therapy, GTB-5550, by late 2025.

Evaxion's Personalized Cancer Vaccine: Evaxion A/S is set to present two-year data from its Phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine, demonstrating a 69% overall response rate in advanced melanoma patients. The company emphasizes the importance of personalized therapies in oncology.

RenovoRx and EDAP TMS Innovations: RenovoRx has initiated a registry study to evaluate its drug-delivery device, RenovoCath, for solid tumors, while EDAP TMS gained national attention for its non-invasive Focal One Robotic HIFU treatment for prostate cancer, highlighting advancements in minimally invasive cancer therapies.

Reimbursement Announcement: The French Ministry of Health has approved reimbursement for the Focal One Robotic HIFU procedure, allowing eligible patients to access this non-invasive treatment for localized prostate cancer as of September 1, 2025.

Impact on Patient Access: This reimbursement milestone is expected to significantly increase patient access to effective prostate cancer treatments and may accelerate similar reimbursements in other European countries, driven by positive clinical evidence from studies like HIFI and FARP.