Why the Actinogen (ASX:ACW) share price is rocketing 17% higher

This biotech has been given some good news…

| More on:
Vanadium Resources share price person riding rocket indicating share price increase

Image source: Getty Images

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The Actinogen Medical Ltd (ASX: ACW) share price has been a strong performer on Wednesday morning.

At the time of writing, the shares of the biotechnology company developing an innovative treatment for cognitive impairment are up 17% to 17 cents.

This means the Actinogen share price is now up an incredible 750% since the start of the year.

Why is the Actinogen share price charging higher?

Investors have been bidding the Actinogen share price higher today after it provided an update on its dealings with the US Food and Drug Administration (FDA).

According to the release, the company has received written supportive US FDA advice in response to its Pre-Investigational New Drug Application (Pre-IND) submission for its fragile X syndrome (FXS) program. FXS is an inherited genetic disease passed down from parents to children that causes intellectual and developmental disabilities.

Actinogen sought a Pre-IND meeting with the FDA to discuss its lead molecule, Xanamem, and the FXS clinical program. Today's release reveals that the advice received indicates that the data package and trial design proposed for the IND submission would be sufficient, subject to final review of all supportive documentation submitted. As a result, the company plans to file the full IND submission during the third quarter of 2021.

In addition, Actinogen advised that the two parties are also in agreement on the proposed Phase II adolescent patient population to be studied. The Phase II XanaFX study will be a randomised, placebo-controlled, double-blind, 12-week trial investigating the safety and efficacy of Xanamem in male adolescents who suffer from FXS.

The study will be conducted in Australia and is expected to commence in the fourth quarter of this year.

Actinogen's CEO and MD, Dr Steven Gourlay, commented: "The FDA's positive Pre-IND advice for FXS marks a significant milestone in the clinical development of our second disease program. It provides greater confidence that we will obtain support from the FDA for the investigation of Xanamem in this disease that has a high unmet medical need for effective therapies."

"There are no currently approved therapies for FXS. The Company is advancing the planning for its Phase II XanaFX trial which is expected to commence by the end of the year. Actinogen is now positioned to progress its clinical programs with multiple Phase II trials and is well funded to advance the development pipeline," he concluded.

Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.

More on Share Gainers

Man with rocket wings which have flames coming out of them.
Share Gainers

Guess which ASX All Ords stock just rocketed 34% on strong earnings growth

Investors just sent this ASX All Ords stock surging 34%. Here’s what’s happening.

Read more »

A businessman looking at his digital tablet or strategy planning in hotel conference lobby. He is happy at achieving financial goals.
Share Gainers

Why Dimerix, Newmont, Regal Partners, and Titomic shares are storming higher

These shares are having a good finish to the week. Let's see why.

Read more »

Two happy excited friends in euphoria mood after winning in a bet with a smartphone in hand.
Share Gainers

Why Fortescue, Lynas, PEXA, and Regis Healthcare shares are charging higher

These shares are having a strong session on Thursday. But why?

Read more »

A young man talks tech on his phone while looking at a laptop. A financial graph is superimposed across the image.
Share Gainers

Why Capricorn Metals, Insignia, Perseus Mining, and Qoria shares are storming higher

These shares are having a strong session on Tuesday. But why?

Read more »

A man clenches his fists in excitement as gold coins fall from the sky.
Share Gainers

Why Amaero, AMP, Block, and South32 shares are racing higher today

These shares are starting the week on a positive note. But why?

Read more »

Ten happy friends leaping in the air outdoors.
Share Gainers

Here are the top 10 ASX 200 shares today

It was another momentous session for ASX shares this Friday.

Read more »

Overjoyed man celebrating success with yes gesture after getting some good news on mobile.
Share Gainers

Why BHP, Catalyst Metals, Mesoblast, and Pilbara Minerals shares are shooting higher

These shares are ending the week with a bang. But why?

Read more »

Doctor doing a telemedicine using laptop at a medical clinic
Healthcare Shares

The Mesoblast share price just rocketed 38%! Here's why

ASX investors just sent the Mesoblast share price up 38%. But why?

Read more »