- A panel of the European Medicines Agency (EMA) recommended granting orphan drug designation to Clene ( NASDAQ: CLNN ) CNM-Au8 to treat amyotrophic lateral sclerosis (ALS).
- The EMA's Committee for Orphan Medicinal Products (COMP) decision was was backed by data from a phase 2 trial called RESCUE-ALS and preclinical ALS models, the company said in a July 19 press release.
- ALS is a progressive nervous system disease affecting the nerve cells in the brain and spinal cord, causing loss of muscle control.
- In EU the orphan drug status is given to therapies aimed at treating a serious or life-threatening disease affecting not more than five in 10K people in the EU. The designation has benefits, including 10 years of market exclusivity, if approved.
- CLNN -4.97% to $4.59 premarket July 19
For further details see:
Clene ALS therapy gets EMA panel backing for orphan drug status