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64
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- New preclinical data presented at the 2026 AACR Annual Meeting demonstrates that opaganib enhances the efficacy of oxaliplatin plus doxorubicin chemotherapy in high-risk neuroblastoma by destabilizing n-Myc oncogene. - A separate study shows opaganib pre-treatment followed by low-dose diABZI potentiates STING-mediated effects and may augment anti-tumor immunity in triple-negative breast cancer models. - Opaganib, a first-in-class oral sphingosine kinase-2 inhibitor, has received FDA Orphan Drug and Rare Pediatric Disease designations for neuroblastoma treatment. - The drug has demonstrated safety and tolerability in over 470 people across multiple clinical studies and is currently being evaluated in a Phase 2 prostate cancer trial.
- The FDA has approved Micro Interventional Devices' MIA-T system for pivotal clinical trial use, marking a significant milestone for percutaneous tricuspid valve repair technology. - The STTAR-US trial will evaluate MIA-T's proprietary PolyCor anchors that reduce annular area and minimize tricuspid regurgitation through 12F delivery catheters. - The device addresses a major unmet need, as 1.6 million Americans suffer from tricuspid regurgitation but only a small percentage are eligible for surgical treatment. - MIA-T is positioned to capture part of the rapidly growing transcatheter tricuspid valve repair market, projected to exceed $3 billion annually by 2027.
- PhotoPharmics has assembled a Commercial Advisory Board of leading neurology and movement disorder experts to guide the market launch of Celeste, its FDA Breakthrough-designated phototherapy device for Parkinson's disease. - The board is chaired by Jordan Dubow, a movement disorders neurologist with over 20 years of experience who has contributed to more than 20 FDA drug applications and helped raise over $1 billion in biotech funding. - The company recently completed a $6 million Series B extension and has enrolled more than 200 patients in its Phase 3 "Light for PD" trial as it prepares for regulatory submission. - Celeste represents a non-invasive phototherapy approach designed to fill a critical gap in Parkinson's care by working alongside existing drug and surgical treatment options.
- UC Berkeley researchers have developed a revolutionary brain-computer interface that translates neural signals into spoken words with minimal delay, allowing a paralyzed woman to communicate in near real-time after 18 years of silence. - The AI-powered system maps brain activity to speech patterns, achieving voice output within one second of thought formation—a significant improvement over previous technologies that had delays of up to eight seconds. - Scientists incorporated the patient's pre-injury voice characteristics into the system and demonstrated the technology's ability to synthesize words outside its training vocabulary, suggesting broader applications for people with speech disabilities.