Imugene share price jumps 32% on FDA news

Here's why this biotech is having a strong start to the session.

| More on:
Cropped shot of an attractive young female scientist working on her computer in the laboratory.

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 Imugene Limited (ASX: IMU) share price is charging higher on Tuesday morning.

At the time of writing, the immuno-oncology company's shares are up 32% to 12 cents.

Why is the Imugene share price charging higher?

Investors have been buying the company's shares following the release of a positive update on its MAST (Metastatic Advanced Solid Tumours) clinical program which is evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA).

According to the release, the MAST clinical program has been granted Fast Track designation from the US Food and Drug Administration (FDA).

This is good news as Fast Track designation comes with several benefits. This includes increased frequency of meetings with the FDA to discuss the drug's development plan, eligibility for Accelerated Approval and Priority Review, and a rolling review in support of a New Drug Application or Biologic License Application.

The release notes that FDA Fast Track was granted based on the promising data package from Imugene detailing phase 1 efficacy and tolerability data in patients suffering from bile duct cancer.

Bile duct cancer is a rare disease in which malignant cancer cells form in the bile ducts. They are difficult to treat and typically respond poorly to immunotherapy drugs.

Imugene's CEO and MD, Leslie Chong, was pleased with the news: Ms Chong said:

The Fast Track process of drug development is designed to facilitate the development, and the review of drugs to treat serious conditions and fill an unmet medical need, with Fast Track status often leading to earlier drug approval and access by patients.

Imugene's CMO, Dr Paul Woodard, added:

We are very encouraged to received Fast Track Designation by the FDA. We have received a high level of interest from clinicians in the emerging data from the difficult to treat bile duct cancer patient population.

The Imugene share price is still down 50% over the last 12 months despite today's gain.

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 Scott Phillips.

More on Healthcare Shares

Senior woman using cpap machine to stop choking and snoring from obstructive sleep apnoea with bokeh and morning light background.
Healthcare Shares

Up more than 75% since October 2023 — are ResMed shares a buy, hold or sell?

ResMed shares have surged more than 75% since October 2023, but is it too late to buy? We break down…

Read more »

Stethoscope with a piggy bank in the middle.
Broker Notes

Australian health insurance: Does Macquarie prefer Medibank or NIB shares?

Medibank and NIB shares have both surged in 2025. Here’s what Macquarie expects now.

Read more »

Two brokers analysing stocks.
Healthcare Shares

Why does Macquarie think Fisher & Paykel shares are a buy?

Fisher & Paykel Healthcare Corporation Ltd (ASX: FPH) shares have been on form over the past 12 months. During this…

Read more »

Overjoyed man celebrating success with yes gesture after getting some good news on mobile.
Healthcare Shares

Which small cap ASX share is jumping 10% on strong results

Investors have been bidding this stock higher today. But why?

Read more »

Cropped shot of an attractive young female scientist working on her computer in the laboratory.
Healthcare Shares

Why Macquarie forecasts 30-50% upside for these ASX All Ords healthcare stocks

Macquarie updated its target price on these three ASX All Ords healthcare stocks.

Read more »

A woman jumps for joy with a rocket drawn on the wall behind her.
Healthcare Shares

Guess which ASX 200 stock is jumping 10% on big news

This stock is catching the eye with a strong gain on Thursday. But why?

Read more »

a young woman holds her hand to her ear and leans sideways as if to listen to something that's surprising her as her eyes and her mouth are wide open.
Healthcare Shares

Down 15% since January, are Cochlear shares now a buy?

Let's see what analysts are saying about this blue chip.

Read more »

Green arrow with green stock prices symbolising a rising share price.
Healthcare Shares

Guess which popular ASX 200 stock is up nearly 60% in less than 2 months?

Investors who bought this ASX 200 stock in the recent dip have been strongly rewarded.

Read more »