Rhythm Biosciences share price lifts 5% on TGA news

The company is hoping to market and sell its cancer test kit in Australia this year.

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Key points

  • Rhythm Biosciences shares are rising again after a rollercoaster morning
  • The company has filed for Australian Register of Therapeutic Goods (ARTG) listing for its cancer test kit, ColoSTAT
  • Management is expecting a decision from the TGA within the next three to six months

The Rhythm Biosciences Ltd (ASX: RHY) share price is on a rollercoaster ride today following the company’s latest release.

It surged 11.57% at market open today before falling to $1.18 — 2.5% lower than its previous close. However, the medical device company’s shares have since bounced back and are now swapping hands for $1.27 — a 4.96% gain on the day.

For context, the All Ordinaries Index (ASX: XAO) is currently down 0.84%.

What did Rhythm announce?

The Rhythm Biosciences share price is bouncing around today after the company advised it has filed with the Australian Therapeutic Goods Administration (TGA) for the listing of ColoSTAT on the Australian Register of Therapeutic Goods (ARTG).

An experimental test kit, ColoSTAT is being developed as a low-cost, easy-to-use blood test to detect colorectal cancer.

The regulatory milestone would pave the way for the company to market and sell ColoSTAT within Australia.

Rhythm noted that the lifesaving cancer detection technology can potentially make a meaningful difference to millions of people around the world. 

With filing now completed, the TGA will assess Rhythm’s ARTG listing submission and hopefully provide final approval to begin commercial activities.

The company anticipates the review process will be finalised within the next three to six months.

In the interim, Rhythm is focusing on executing across a number of key technical, administrative, and logistical activities for ColoSTAT. This includes supporting the pathway to market entry, both domestically and internationally, later this year.

Commenting on the news that appears to be driving the Rhythm Biosciences share price today, CEO and managing director Glenn Gilbert said:

This is an exciting time for all Rhythm stakeholders and indeed global cancer diagnostics markets. The team continues to diligently execute on our plans as we target ColoSTAT revenues in late CY22.

We are very close to being in a unique position to transform and revolutionise the colorectal diagnostics market with our lifesaving cancer detection technology.

Rhythm Biosciences share price snapshot

The Rhythm Biosciences share price has accelerated by 46% in the past 12 months, reflecting positive investor sentiment. The company’s shares reached an all-time high of $2.08 in November, before treading lower.

At today’s prices, Rhythm presides a market capitalisation of roughly $256.89 million, with approximately 214.08 million shares on issue.

Motley Fool contributor Aaron Teboneras 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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