Neuren Pharmaceuticals Ltd (ASX: NEU) shares are trending higher in early afternoon trade. This comes after the biotech company announced it has successfully completed manufacturing a drug substance for its Phase 2 trials.
At the time of writing, the Neuren share price has jumped to an intraday high of $1.28, up 1.99% for the day so far.
What did Neuren announce?
The Neuren share price is edging higher as investors appear pleased with the company's progress.
According to its release, Neuren's second drug candidate, NNZ-2591, has been manufactured ahead of Phase 2 trials. The company is currently preparing to submit Investigational New Drug (IND) applications to the United States Food and Drug Administration (FDA). If approved, this will enable Neuren to run clinical trials in children who suffer from Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome.
Neuren's latest announcement ticks off four of the milestones the company set out for 2021 in a recent corporate presentation. At current, five remaining checkpoints are still to be completed. These include:
- Submission of the NNZ-2591 IND to the FDA.
- Completing patient enrolment in the trofinetide Rett syndrome Phase 3 study.
- Commencing NNZ-2591 Phase 2 trials.
- Achieving orphan designation status in the United States and Europe for Prader-Willi syndrome.
- Compiling results from the Trofinetide Rett syndrome Phase 3 trial (result highlights to be released in Q4 2021).
Commentary from the CEO
Neuren CEO Jon Pilcher hailed the company's developments, saying:
We have successfully developed a proprietary process for large scale manufacturing with exceptional purity and high yield. This is a key part of the strong foundations we have built for NNZ-2591, which can now be leveraged across multiple valuable indications.
As well as supplying the upcoming trials in Phelan-McDermid, Angelman and Pitt Hopkins, the campaign has produced enough drug substance at no extra cost to supply a Phase 2 trial in Prader-Willi syndrome.
Neuren share price performance overview
The Neuren share price has been a weak performer over the past 12 months, falling by nearly 28%. Neuren shares took a wild ride last year, hitting a low of 96.5 cents in March before accelerating to $1.845 in June.
Based on the current share price, Neuren has a market capitalisation of around $144 million.
