This ASX healthcare share just crashed 49%, here's why

Kazia's GBM Agile pivotal study has encountered a roadblock.

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Key points

  • Kazia shares tumble to a multi-year low of 26 cents during mid-morning trade
  • The company received word from the sponsor of the GBM Agile study that the second stage will not go ahead
  • Kazia noted that the first stage of recruitment will continue as planned, with results expected in the second half of 2023

In case you were wondering, it is the Kazia Therapeutics Ltd (ASX: KZA) share price that's crashing heavily today.

After opening at 35 cents for the day, shares in the oncology-focused drug development company are continuing to freefall.

At the time of writing, Kazia shares are fetching a multi-year low of 26 cents, down 49.02%.

Let's take a look at what could be causing this downfall.

What did Kazia update the ASX with?

Investors are heading for the exits following the company's latest progress update on its GBM Agile pivotal study.

A brain-penetrant inhibitor, paxalisib is under development to treat glioblastoma which is a common and very aggressive brain cancer.

According to the release the Global Coalition for Adaptive Research (GCAR), the sponsor of the study, advised Kazia that the treatment arm did not meet pre-defined criteria for continuing to a second stage.

This comes despite the first stage of the paxalisib arm completing recruitment.

While no reason was given, the patients enrolled in the first stage will continue with their treatment as per protocol.

Kazia anticipates it will receive the final analysis of study results in the second half of the next calendar year.

Following the outcome, the study will not open to the paxalisib arm in Germany or China.

Although, Kazia stated it will work with its licensing partner to determine the way forward in China.

Management commentary

Kazia CEO Dr James Garner said:

GBM AGILE was designed as an adaptive study, with the potential to follow a range of different paths to completion.

Today's news defines the remaining trajectory of the study, with modestly positive implications for both costs and timelines, and with some specific consequences for regulatory strategy in China. It does not allow us to draw any meaningful inferences about the outcomes of the study, and indeed it is critical for regulatory purposes that we remain blinded to the evolving data.

We look forward to reporting final results in 2H CY2023, as currently planned.

Garner went on to add:

In the meantime, we are excited by some of the emerging data in diffuse intrinsic pontine glioma (DIPG) and brain metastases, which have become increasingly important areas of focus for the company and look forward to sharing more detail on those activities in due course.

Kazia share price snapshot

While nobody likes their stock falling, it's been a difficult 12 months for Kazia shareholders.

After reaching a 52-week high of $1.65 towards the back end of last year, it has been all downhill ever since.

Kazia shares have lost more than 75% of their value in 2022.

Motley Fool contributor Aaron Teboneras 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.

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