Neurizon Therapeutics' (ASX:NUZ) lead amyotrophic lateral sclerosis (ALS) drug candidate, NUZ-001, received orphan medicinal product designation from the European Medicines Agency, according to a Tuesday filing with the Australian bourse.
The designation offers benefits like reduced regulatory fees, free protocol assistance, and 10 years of market exclusivity in the European Union upon product approval, the filing said.
The company plans to expedite preparations for the phase 2/3 Healey ALS platform trial to facilitate the clinical validation of NUZ-001, according to the filing.
Neurizon Therapeutics' shares fell nearly 3% in afternoon trade Wednesday.
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