SignalFDA/Bio
Eloxx Pharmaceuticals Finalizes 52-Week Phase 2 EXPRESS Study Design in Nonsense-Mutation ADPKD and Appoints T.R. Srinivas, M.D., Chief Medical Officer
Eloxx finalizes 52-week Phase 2 EXPRESS study design in ADPKD and appoints new CMO.
Context
What happened: Eloxx Pharmaceuticals (Nasdaq: ELOX) finalized the design of its 52-week Phase 2 EXPRESS study of exaluren in nonsense-mutation ADPKD and appointed T.R.
Why it matters: FDA feedback noted a substantial, durable htTKV treatment effect with supporting eGFR and safety data could serve as a potential basis for Breakthrough Therapy Designation, and FDA identifies htTKV change as a potential surrogate endpoint for accelerated approval. Orphan drug designation was granted for ADPKD in the US in addition to Europe.
Market: -0.1% today ($43.16), -17.3% YTD — as of 07:45 UTC
What changed
Eloxx Pharmaceuticals (Nasdaq: ELOX) finalized the design of its 52-week Phase 2 EXPRESS study of exaluren in nonsense-mutation ADPKD and appointed T.R.
Why it matters
FDA feedback noted a substantial, durable htTKV treatment effect with supporting eGFR and safety data could serve as a potential basis for Breakthrough Therapy Designation, and FDA identifies htTKV change as a potential surrogate endpoint for accelerated approval. Orphan drug designation was granted for ADPKD in the US in addition to Europe.
Market: -0.1% today ($43.16), -17.3% YTD — as of 07:45 UTC