Akamis Bio has completed enrollment of 33 patients in its Phase 1b FORTRESS study of NG-350A combined with chemoradiotherapy for mismatch repair-proficient rectal cancer. Earlier results showed a 50% composite response in ten patients, while the full dataset is expected in the first half of 2027.
Coya Therapeutics plans to extend treatment beyond 48 weeks for eligible ALSTARS participants receiving COYA 302 for amyotrophic lateral sclerosis. The decision follows completion of targeted enrollment, while randomized efficacy results remain expected in early 2027 and a separate frontotemporal dementia study has been delayed.
OKYO Pharma’s urcosimod moves toward Phase 3 as the biotech targets neuropathic corneal pain, a severe ocular condition without approved therapy.
D1 receptor targeting may change Tourette syndrome care. Ecopipam’s Phase 3 data now face the bigger test: regulation and adoption.
Roche and BMS present updated prasinezumab and BMS-986446 data at AD/PD 2026. What it means for Phase III plans and tau targeting. Read the analysis.
SCYNEXIS advances IV SCY-247 into Phase 1 for invasive candidiasis. Explore what this means for resistance and regulation.
The U.S. Food and Drug Administration (FDA) has granted INTENT Biologics a full pediatric study waiver for its lead candidate, PEP Biologic, under IND 019567. The waiver, part of an agreed Initial Pediatric Study Plan (iPSP), applies to the product’s adult-focused development for diabetic foot ulcers (DFUs), a serious chronic wound indication preparing for pivotal
Alessa's Enolen earns FDA fast track for localized prostate cancer. Find out how this implant could redefine early-stage treatment and challenge current norms.