In early morning trade, the biopharma company’s shares were up 2.7% to $1.50. But the Neuren share price has since sunk 3.75% to $1.41 at the time of writing. The All Ordinaries Index (ASX: XAO) is also down today, currently 0.45% lower at 6992 points.
A quick take on Neuren
Based in Victoria, Australia, Neuren develops therapies for an array of neurodevelopmental and neurodegenerative disorders. The company currently has 2 key drug products in the pipeline, NNZ-2566 and NNZ-2591. The first of which is aimed at treating Rett syndrome and Fragile X syndrome. Both are currently in phase 3 and phase 2 trials, respectively.
The second drug in development, NNZ-2591, is advancing to provide remedy for Phelan-McDermid, Angelman and Pitt Hopkins syndromes. Neuren is conducting phase 1 trials with plans to commence phase 2 sometime this year.
What did Neuren announce?
Neuren has been granted received three Orphan designations for its second lead drug candidate, NNZ-2591. This treats Phelan-McDermid, Angelman and Pitt Hopkins syndromes.
The favourable decision from the European Commission was based on the recommendations of the European Medicines Agency (EMA).
Orphan designation relates to a company receiving bonus benefits from achieving incentivised targets. This includes free protocol assistance, fee reductions, and 10 years of market exclusivity within the European Union. The period can be extended with a further 2 years if the company is approved for paediatric use.
That means that no other similar product can be granted a marketing authorisation approval from the EMA or EU countries.
About the Neuren share price
The Neuren share price has fallen more than 45% in the past 12 months.
The company’s shares hit a multi-year high of $3.04 in February before COVID-19 sent shockwaves throughout the world. The result left the Neuren share price plummeting to a 52-week low of 96.5 cents.