IMPACT DUCHENNE and the ongoing Phase 1/2 INSPIRE DUCHENNE clinical trials are components of an integrated, multi-trial clinical development program designed to evaluate the safety and efficacy of a single intravenous dose of SGT-003 in individuals living with Duchenne.

Read more about Solid Biosciences Doses First Participant in Phase 3 IMPACT DUCHENNE Clinical Trial Evaluating SGT-003 in Duchenne Muscular Dystrophy.

“Part B of our LIGHTHOUSE study is delivering exactly as we expected — a favorable safety profile, schisis resolution, and functional improvements at six months that closely replicate what we observed at the same time point in Part A of the study. Foveal schisis closure was observed in four of six treated adults, and there was no structural change observed in untreated control subjects or untreated contralateral eyes. The kinetics of microperimetry response across Cohort 4 mirror what we saw in Part A of the study. No serious adverse events were observed in any Part B cohort, including in our pediatric patients,” said Shannon Boye, PhD, Co-Founder and Chief Scientific Officer of Atsena.

Read more about Atsena Presents Positive Interim Six-Month Results From Part B of Phase 1/2/3 LIGHTHOUSE Trial Evaluating ATSN-201 in Patients With X-Linked Retinoschisis.

“Kriya is committed to overcoming key barriers to making gene therapies broadly accessible globally. We built our company from the beginning to ensure our therapies not only have transformative therapeutic potential but also serve the real world needs of patients affected by chronic diseases,” said Shankar Ramaswamy, M.D., Co-Founder and CEO of Kriya.

Read more about Kriya Announces Presentations at ASGCT 2026 Highlighting Advances Across Gene Therapy Platform.

The US Food and Drug Administration approved the first gene therapy for inherited hearing loss, a one-time treatment that proved to be life-changing for a small number of children in a clinical trial who were born without hearing.

The condition it treats is rare, affecting up to about 50 babies born each year in the US with mutations in a gene known as OTOF. But the therapy’s effect can be profound: In a trial of 20 kids, 16 had improvements in hearing about five months after treatment. Five of 12 who were followed for at least 11 months had their hearing essentially restored to normal.

Read more about FDA Approves First Gene Therapy for Inherited Deafness, Shown To Restore Hearing for Children With Rare Condition.

“This Orphan designation recognizes SGT-003’s potential to address the significant unmet need in Duchenne muscular dystrophy and supports our firm commitment to advancing SGT-003 for patients globally,” said Jessie Hanrahan, Ph.D., Chief Regulatory & Preclinical Operations Officer at Solid Biosciences.

Read more about Solid Biosciences Announces Receipt of European Commission Orphan Drug Designation for SGT-003 for the Treatment of Duchenne Muscular Dystrophy.

“We are excited that the DMC has recommended that we proceed with the pivotal Part C cohort,” said Kenji Fujita, MD, Chief Medical Officer of Atsena Therapeutics. “This recommendation reflects the strength of the safety and efficacy data we have accumulated to date and brings us one step closer to delivering what we believe will be the first approved therapy for patients with XLRS.”

Read more about Atsena Therapeutics Receives Data Monitoring Committee Recommendation To Proceed With Pivotal Part C Cohort of Phase 1/2/3 LIGHTHOUSE Trial Evaluating ATSN-201 in Patients With X-Linked Retinoschisis.

The SMBE Award program, now in its 34th year, is designed to identify and celebrate high-performing manufacturers, strengthen organizational learning and capability, and elevate a company’s visibility and manufacturing excellence throughout the region.

Read more about LightPath Technologies Receives Highly Innovative Design Award From the Sterling Council.

neuropacs is the first medical device classified by the FDA under the new category of “Parkinsonian syndrome diagnostic aid.” The software analyzes diffusion MRI data to generate a classification report based on degenerative brain patterns of multiple system atrophy Parkinsonian variant (MSAp) and progressive supranuclear palsy (PSP), providing supplemental information to neuroradiologists and neurologists as part of a comprehensive clinical assessment to help in differentiating these diseases from Parkinson’s disease (PD).

Read more about FDA Grants De Novo Classification to Neuropacs, a First-in-Class AI-Based MRI Diagnostic Aid for Parkinsonian Syndromes.

FCIF is a statewide initiative designed to accelerate the development of innovative cancer therapies and strengthen Florida’s life sciences ecosystem by supporting promising research programs and emerging biotechnology companies. Myosin Therapeutics was selected for funding based on the scientific innovation and clinical potential of MT-125, the company’s lead oncology therapeutic candidate. The award will specifically support clinical trial activities being conducted at the Mayo Clinic campus in Jacksonville, FL.

Read more about Myosin Therapeutics Awarded Florida Cancer Innovation Fund Grant to Support STAR-GBM Clinical Trial.

Within these parameters, INZECTO uses insect biology to control pests, replacing broad spraying with long-lasting, professional-grade solutions that are easy to deploy and cost-effective. The startup’s solutions began in Dr. Philip Koehler’s Entomology and Nematology Lab at the University of Florida.

Read more about Safe, Biology-Driven Pest Control for People and Planet.