Imugene share price jumps 32% on FDA news

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

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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.

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