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Highlights:
- Neuren Pharmaceuticals Limited (ASX:NEU) has gained 231.79% in the last one year.
- In its FY22 results, NEU’s profit after tax stood at AU$0.2 million versus loss after tax of AU$7.8 million in pcp.
- In September last year, the massive rise in the company’s market cap led to NEU being promoted into the S&P/ASX 300 index.
The S&P/ASX 200 is a benchmark index for the Australian stock market. It has declined 3.01% in the last one year period, as of Tuesday, 11 April 2023. Compared to it, in the same period, Neuren Pharmaceuticals Limited (ASX:NEU) has gained 231.79% outperforming the benchmark index.
Let’s look into the details behind NEU’s gain in the last one year.
Neuren Pharmaceuticals Limited (ASX: NEU)
The biopharma company focused on neurological conditions closed Tuesday, 0.538% down at AU$12.940. In the last one year, the stock has gained 231.79% and 62.76% on a YTD basis.
In February, the company released its FY22 results ended 31 December last year. During the reported period, revenue was noted at AU$14.6 million obtained under a licence deal with Acadia (2021: nil), and foreign exchange gains were AU$1.2 million compared to AU$0.4 million in pcp. The profit after tax stood at AU$0.2 million versus loss after tax of AU$7.8 million in pcp.
The net cash obtained (from operating activities) during the reported period was AU$3.6 million versus AU$10 million in pcp. As of 31 December, last year, the company had cash reserves of AU$40.2 million, increasing from AU$36.8 million in pcp.
In September last year, the massive rise in the company’s market cap led NEU being promoted into the S&P/ASX 300 index.
On the operations front, in September last year, FDA accepted for review the NDA for trofinetide drug for the treatment of Rett syndrome in both adults and pediatric patients (two years or older), which was submitted in July by Acadia. Further, FDA permitted a priority review along with the allotment of PDUFA action date of 12 March this year.
In October last year, NEU obtained from Acadia a payment of US$10 million after the acceptance of the NDA review by the FDA. Conditional on NDA’s consent, NEU anticipates securing revenue this year, (for Rett syndrome) in the US region of AU$104 million with double-digit percentage royalties on net sales.
Further, four IND applications were approved by FDA for NNZ-2591 in Angelman, Pitt Hopkins, Prader-Willi and Phelan-McDermid syndrome. While phase 2 clinical trials have started for Phelan-McDermid syndrome trials, along with good safety and tolerability profile. Start-up activities are continuing for the Phase 2 clinical trial in Prader-Willi syndrome. CMC and non-clinical studies are moving ahead as planned in Phase 3 preparation across multiple indications.
