Here’s why the Rhythm Biosciences share price (ASX:RHY) is jumping higher today

Regulatory momentum filled Rhythm’s quarter with positive inflection points.

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Shares in medical diagnostics company Rhythm Biosciences Ltd (ASX: RHY) are edging higher in afternoon trade today.

At the time of writing, Rhythm Biosciences shares are changing hands at $1.59 apiece, which is an almost 3% gain from yesterday’s close.

What’s up with Rhythm Biosciences share price today?

Rhythm Biosciences is on the move as the company released its quarterly activities and earnings report for the period ending 30 September 2021.

In its report, Rhythm outlined several investment highlights concerning ColoSTAT – the company’s “simple, low-cost blood test for the early detection of colorectal cancer, aimed at global mass market screening”.

For instance, it formed a ‘100% owned’ entity in the US, known as IchorDX, Inc., which “provides optionality and a visible pathway for ColoSTAT in one of the world’s largest diagnostic markets”.

It also remains on track for its CE Mark application and approval out of Europe to be completed by the end of this year, per the release.

Meanwhile, in Australia, the company also “successfully submitted the first two key steps for Therapeutic Goods Administration (TGA) approval”.

Already, the TGA has accepted Rhythm’s manufacturers evidence documentation, according to the release.

The next step for Rhythm in this process is to list on the Australian Register of Therapeutic Goods (ARTG), but not before compiling the necessary onboarding documentation and evidence. Rhythm expects this to be completed by 2H FY22, as per the announcement.

Aside from this, the company also successfully recruited the first 815 people into its upcoming ColoSTAT clinical trial – Study 7.

It also left the quarter with $5.28 million in cash on its balance sheet, with another $2.4 million coming from an R&D refund.

What’s next for Rhythm Biosciences?

Rhythm is adamant that it is “well funded to execute its development and commercial plans outlined in (its) FY22 strategic plan”.

It also expects a reduction in variable costs over the remainder of FY22, and as mentioned, expects to receive CE Mark submission later in CY21.

The company also is set to “progress and finalise regulatory requirements for TGA submission and confirm commercialisation pathways for ColoSTAT in various jurisdictions”.

Rhythm Biosciences share price has soared over 677% in the last 12 months, after gaining a further 82% since January 1.

The author Zach Bristow has no positions 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.

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