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.
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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.
