FDA grants Fast Track designation to Coya Therapeutics' COYA 302 for ALS
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
Nurix reported new oncology preclinical data at AACR 2026 and outlined progress in its immunology degrader pipeline. The company said NX-3911 could enter an IND this year and Phase 1 data for bexobrutideg are planned this year.
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
Diakonos Oncology's Phase 2 glioblastoma trial of DOC1021 continues after independent safety review found no concerns. The company will present clinical data on the dendritic cell therapy at AACR and AAN conferences in April 2026.
C4 Therapeutics has initiated its Phase 2 MOMENTUM trial of cemsidomide in relapsed/refractory multiple myeloma, targeting enrollment completion in Q1 2027 and a registrational dataset by 2028. The company plans a combination study with elranatamab in Q2 2026.
The alopecia areata treatment market is projected to grow significantly through 2036, driven by rising prevalence and the anticipated launch of emerging therapies including JAK inhibitors and novel drug classes targeting immune pathways.
Coya Therapeutics detailed plans for a Phase 2 trial of combination immunotherapy targeting neuroinflammation in ALS, following a four-patient study showing biomarker improvements and reported slowing of disease progression.
Engineered regulatory T cell therapies are progressing through clinical trials for autoimmune diseases and organ transplant rejection, with CAR-Treg candidates showing promising early results in rheumatoid arthritis and other conditions.