The European Medicines Agency (EMA) has granted Molefy Pharma the Orphan Drug Designation (ODD) for its candidate AP-2, an innovative therapy developed for the treatment of amyotrophic lateral sclerosis (ALS).
This designation is awarded to medicines with the potential to treat rare and severe diseases in the European Union, when they offer a significant benefit over limited or non-existent treatment options.
The EMA’s recognition marks a key milestone for Molefy Pharma, a company driven by the Spanish technology group ARQUIMEA, with the scientific support of researchers from the CSIC. This achievement reinforces their shared commitment to develop innovative therapies from Spain that address major global challenges in rare diseases, such as ALS — one of the most devastating neurodegenerative disorders.
“The EMA’s recognition of a Spanish company highlights the country’s scientific talent and its ability to deliver competitive clinical development at a European level. At ARQUIMEA, we will continue supporting Molefy Pharma to turn this designation into real outcomes for patients,” said Diego Fernández, President of ARQUIMEA.
