The Neuren Pharmaceuticals Ltd (ASX: NEU) share price is soaring to yearly highs on the back of positive phase three clinical trial results.
Shares are currently swapping hands at $3.40 apiece, up exactly 100% from yesterday's close.
Let's investigate what triggered the major boost for the drug therapy company today.
Why did Neuren announce?
Neuren reported positive results from phase three trials into the use of trofinetide to treat young women with Rett syndrome. Trofinetide has been granted fast-track status and orphan drug designation for Rett syndrome.
Acadia Pharmaceuticals (NASDAQ: ACAD) is conducting and funding the trials, but Neuren is eligible to receive milestone payments of up to US$455 million (AU$645 million). Neuren is also eligible for royalties on trofinetide sales if the drug is approved by the FDA.
Acadia is planning to meet with the FDA for a new drug application in the middle of 2022.
Neuren predicts it would earn AU$111 million in revenue over 2022 and 2023 for Rett syndrome, plus double-digit percentage royalties on net sales if trofinetide is approved and launched in the US.
Rett syndrome is a rare genetic mutation affecting brain development, primarily in girls.
What did management say?
Commenting on the news driving the Neuren Pharmaceuticals share price today, CEO Jon Pilcher said:
We are delighted with these robustly positive results and are now eager to see trofinetide progress through the regulatory approval process.
We are very grateful to the Rett syndrome community — the patients, their caregivers, study site personnel, physicians and everyone who participated in the Lavender study, as well as in Neuren's two Phase 2 studies that paved the way.
Neuren Pharmaceuticals share price snapshot
The Neuren Pharmaceuticals share price has skyrocketed 164% this year to date. It has also gained 170% over the past 12 months.
Earlier today, the share price reached $3.56, a yearly high. The yearly low is $1.18.
