The Rhythm Biosciences Ltd (ASX: RHY) share price had a day to forget on Monday.

The medical diagnostics technology's shares returned from a trading halt and crashed as much as 52% to 46 cents.

The ASX All Ords share ultimately recovered a touch and ended the day with a 38% decline to 59.5 cents.

Why did this ASX All Ords share get hammered?

Investors were hitting the sell button in a panic on Monday after the company was dealt a blow by the Australian Therapeutic Goods Administration (TGA).

According to an announcement, after the receipt and analysis of a thorough application review and its most recent engagement with the TGA, the company has decided to withdraw its current ColoSTAT application for an Australian Register of Therapeutic Goods (ARTG) listing.

Rhythm Biosciences' ColoSTAT product is a simple, low-cost, blood test for global mass market detection of colorectal cancer. It notes that worldwide, colorectal cancer is the third most common cancer in men and the second most common in women, accounting for an estimated 1.9 million new cases and 935,000 deaths annually.

Management advised that it is withdrawing its application because it simply does not have enough time to answer the regulator's questions within the necessary timeframe. This is because some questions will require new internal analytical testing and the TGA is reluctant to provide an extension beyond its 20 business days timeframe.

The good news is that this isn't the end of the road for ColoSTAT in Australia. Management intends to submit a new application with the TGA, in line to better meet their feedback and questions posed.  And while the company doesn't know when the new application will be submitted, it does expect it to be in the current calendar year.

Furthermore, this withdrawal does not impede the ASX All Ords share's proposed market entry activities into other CE Mark conforming territories and additional international markets, including the United States.

Management commentary

Rhythm Biosciences' Executive Chairman, Otto Buttula, was disappointed but remains positive on the future. Buttula said:

Having decided to withdraw RHY's current TGA submission for ColoSTAT is clearly disappointing for all stakeholders. Nonetheless, we appreciate the thorough review undertaken and meaningful dialogue with the TGA. Following the TGA's most recent feedback, both written and verbal and management / Board review, we believe that time constraints imposed result in a better opportunity for the Company to submit a new and strengthened application, in line with the questions raised in the TGA application review. Hence, with a new submission to be completed in line with the questions raised by the TGA, we believe we have a better blueprint to follow in framing our new application.

Therefore, I remain confident of a TGA registration for ColoSTAT in the future. Whilst Australia, as our home, remains important, it represents one of the smaller markets in our global aspirations and the Company has always intended to build the majority of its revenues in overseas territories. We look forward to keeping the market abreast of other positive developments in the near term.

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The All Ordinaries Index (ASX: XAO) is 1.85% in the red today, but these four All Ords shares are soaring higher.

The A2 Milk Company Ltd (ASX: A2M), Perpetual Ltd (ASX: PPT), Rhythm Biosciences Ltd (ASX: RHY) and Weebit Nano Ltd (ASX: WBT) share prices are all charging ahead.

The market overall is struggling today amid the US Federal Reserve raising interest rates by 0.75%. So why are these companies surging ahead of the ASX All Ords Index?

A2 Milk

A2 Milk shares are surging nearly 6% today. The company will be selling its infant formula to the United States. A2 Milk has received US Food and Drug Administration (FDA) approval to supply the product to the USA. A2 Milk sees this as a "significant opportunity" to develop its infant milk formula brand in the long term. However, A2 Milk added:

However, at this early stage, it is difficult to predict the IMF sales potential in the US which is a highly competitive market to enter.

Perpetual

Perpetual shares are rising 8% today. The company has rejected an offer from Regal Partners Limited and BPEA Private Equity Fund VIII to acquire 100% of Perpetual's shares. Perpetual said the $30 cash per share offer "materially undervalues Perpetual". Perpetual said:

This offer is uncertain and conditional and the Perpetual Board believes that it is not in the best interests of its shareholders to engage on this offer and has therefore rejected the offer.

Rhythm Biosciences

The Rhythm Biosciences share price is soaring nearly 10% today. Rhythm has expanded its international regulatory footprint. This includes registering cancer detection technology ColoSTAT product with the New Zealand national database of medical devices. This will mean the technology can now be marketed and sold in New Zealand.

Commenting on the news, CEO and managing director Glenn Gilbert said:

Rhythm is pleased to expand its international regulatory approval footprint into New Zealand which enables the Company to commence marketing and sales activities for ColoSTAT.

Weebit Nano

This ASX All Ords share is jumping nearly 6% today despite no news from the company. Weebit is a memory and semiconductor technology company. In a presentation this week, the company advised it has made significant technical and commercial progress in the last 12 months. The company is developing ReRam NVM memory technology. The NVM market is forecast to be worth $2.9 billion by 2027, Weebit Nano highlighted.

The post It's not all bad news for ASX All Ords shares today. Here are some big winners appeared first on The Motley Fool Australia.

Here's why these two All Ords shares are smashing the index on Thursday:

Immutep Ltd (ASX: IMM)

The Immutep share price is up 5% to 31 cents. This morning the biotechnology company announced that a late-breaking abstract relating to its phase II TACTI-002 trial has been accepted for an oral presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022 this month.

The release notes that the presentation will include new clinical data for eftilagimod alpha (efti), its first-in-class soluble LAG-3 protein, in combination with pembrolizumab in 1st line non-small cell lung cancer (NSCLC) patients.

Last month, fast track designation was granted by the US FDA for efti in combination with pembrolizumab in 1st line NSCLC. This offers the potential for expedited development and review.

Rhythm Biosciences Ltd (ASX: RHY)

The Rhythm Biosciences share price is up almost 9% to $1.24. Investors have been buying this cancer diagnostics technology company following the release of an announcement relating to its ColoSTAT product.

According to the release, the company has continued the expansion of its international regulatory footprint after successfully registering ColoSTAT with the New Zealand national database of Medical Devices. This allows the lifesaving colorectal cancer detection technology to be marketed and sold in the country.

Rhythm's CEO and managing director, Glenn Gilbert, commented:

Bowel cancer is the second highest cause of cancer death in New Zealand and a growing issue with 1 in 10 now diagnosed under the age of 50. ColoSTAT is a simple blood test which has the potential to make a material impact on health outcomes through mass screening for higher participation to achieve early diagnosis. We look forward to working with the Ministry of Health's National Screening Unit to enhance New Zealand's National Bowel Screening Programme.

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The Rhythm Biosciences Ltd (ASX: RHY) share price is in the green during morning trade on Friday. This comes after the ASX All Ords company announced that its executive chair has just offloaded $6.5 million worth of his shares.

At the time of writing, the medical device company's shares are trading at $1.375, up 1.85%.

Rhythm chair sells down his stake

Investors are shrugging off the company's latest news, sending the Rhythm share price higher today.

According to Rhythm's release, its executive chair Otto Buttula offloaded $6.5 million worth of shares to a domestic institutional fund manager.

While the buyer's name wasn't disclosed, the on-market transaction involved 5,000 Rhythm shares sold at $1.30 apiece.

The exclusive share sale came from the Newfound superannuation fund in which Buttula is one of three members.

Rhythm stated that the primary purpose of the sale is to enhance portfolio diversification and better meet trustee, accounting, and auditor advice.

Prior to the sale, the superannuation fund's holding in Rhythm represented 95.9% of the total assets of the fund and 98.6% of its ASX listed company exposures.

However, now with the sale completed, the superannuation fund holds roughly 6.1 million Rhythm shares and about 2.1 million options at $1.80 each, expiring July 2024.

This is the first time Buttula has reduced his holdings in the ASX All Ords company since his appointment as chair in October 2019.

He also confirmed there is no intention to sell any further shares for the foreseeable future.

What did the chair of this ASX All Ords company say?

Commenting on the sale, Buttula said:

Whilst there is never a perfect time to reduce exposure to a company that you are immensely proud of being a part of, in this case, the numbers speak for themselves and a holding above 95% in one company exposure, particularly in a retirement fund, with two other members, was problematic and not prudent.

Despite the sale, my associated interests continue to maintain the largest shareholding in the company, maintaining a holding of 10.8% (ex-options). Importantly, I am also delighted to welcome another leading fund manager to the RHY register. The institutional fund manager is one of Australia's most successful and has conducted a period of due diligence on the prospects of the company.

Rhythm share price snapshot

Over the past 12 months, the Rhythm share price has gained 37% but fallen 11% year-to-date.

The company's shares reached a 2022 low of $1.01 in June before climbing in the weeks thereafter.

At today's prices, this ASX All Ords share has a market capitalisation of approximately $292.24 million with around 215.67 million shares on issue.

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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.

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Key points

• The Rhythm Biosciences share price finished the day up by more than 8% after earlier jumping by 19%
• The diagnostics company released its latest quarterly results today
• Its colorectal cancer detection product, ColoSTAT, is set to gain EU and UK commercial exposure

The Rhythm Biosciences Ltd (ASX: RHY) share price surged today following the company's latest quarterly activity update.

Among the business results, the diagnostic technology company released an update on its core product, ColoSTAT — a low-cost blood test used for the detection of colorectal cancer.

At the close of trading, the Rhythm Biosciences share price was up 8.43% at $1.35. During intra-day trade, it hit a high of $1.49, a gain of 19.2% on its previous closing price.

Let's dive in and dissect this update…

What did Rhythm Biosciences report?

The Rhythm Biosciences share price jumped into the green after the company reported a total of $5.5 million cash in the bank for the period ending 31 December 2021. (This excluded a placement of $6.5 million before costs which was completed this month).

Secondly, it received a rebate of $2.4 million from its R&D Tax Incentive claim, in which the Australian government "encourages companies to engage in R&D programs by providing a refundable tax offset of up to 43.5% on eligible activities".

Thirdly, it made three executive and non-executive enrolments to its board, including CEO Glenn Gilbert additionally taking on the role of managing director.

But probably most notable for the healthcare company was the progressing commercialisation of its product — the ColoSTAT.

ColoSTAT EU exposure

Rhythm Biosciences' ColoSTAT product was recently granted a "CE Mark". This means it has met all provisions of EU legislation required to be sold within the European Economic Area (EEA).

According to Listcorp, colorectal cancer — which the ColoSTAT aims to detect — is the third most common form of cancer for men, and second for women.

This certification exposes the company to 231 million people and a market valued at US$12 billion.

And since the quarter, its CE Mark certification now encapsulates England, Wales, Scotland, and Northern Ireland.

While the company is continuing to test its product to ensure "highly accurate, consistent and reproducible results" — at 84% sensitivity and 95% specificity — it has confirmed the product "significantly outperforms the current market testing regime, by as much as 33%".

The company is therefore confident it will perform well in the market.

Looking forward, Rhythm Biosciences has employed a "platform expansion program", using similar technology of ColoSTAT to diagnose other types of cancers.

Breast, cervical, lung, gastric, and pancreatic cancers are to be targeted for similar commercial pathways.

Rhythm Biosciences share price snapshot

The Rhythm Biosciences share price has jumped by 48% in the last six months. However, it is down around 12% this year to date.

The company has a market capitalisation of $265.99 million and over 213 million shares outstanding.

The post Here's why the Rhythm Biosciences (ASX:RHY) share price soared 8% today appeared first on The Motley Fool Australia.

The Rhythm Biosciences Ltd (ASX: RHY) share price is surging on Thursday afternoon trade. This comes after the company announced two positive updates regarding its ColoSTAT product and a share placement.

At the time of writing, the medical device company's shares are trading for $1.65, up 10.74%.

What's driving the Rhythm share price higher?

Investors are fighting to get a hold of Rhythm shares after digesting the company's latest releases.

In its first statement, Rhythm advised that it has expanded the CE Mark registration to the United Kingdom for ColoSTAT.

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

The regulatory milestone allows the company to market and sell ColoSTAT within England, Wales, Scotland and Northern Ireland.

Rhythm noted that Europe and the United Kingdom represent a significant addressable screening population for ColoSTAT of over 231 million people. This has a potential combined value of around US$12 billion.

In addition to the announcement, the company revealed it undertook a private share placement to a global institutional funds manager.

Approximately $6.53 million was raised through the issuance of 4.67 million Rhythm shares at a price of $1.40 apiece.

The proceeds of the placement are expected to be allocated towards progressing Rhythm's global commercial market entry activities for ColoSTAT.

Furthermore, the company will seek to develop additional cancer diagnostic targets.

Management highlighted that the funds will provide enough cash runway until late 2023, not including any commercial revenues achieved.

Rhythm share price snapshot

The Rhythm share price has accelerated by 29% 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 $344.76 million, with approximately 208.95 million shares on issue.

The post Here's why the Rhythm (ASX:RHY) share price is up 11% today appeared first on The Motley Fool Australia.

The Rhythm Biosciences Ltd (ASX: RHY) share price is on the move today. This comes after the company revealed its intentions to expand ColoSTAT into new cancer markets.

At the time of writing, the medical device company's shares are trading for $1.75 cents, up 4.79%.

What's driving the Rhythm share price higher?

Investors are fighting to get a hold of Rhythm shares after digesting the company's encouraging announcement.

According to the release, Rhythm advised that it has identified five new cancer detection markets to expand its platform technology.

As such, ColoSTAT is believed to hold multi-cancer detection properties, which could provide a foundation to expand the platform. Cancer markets include breast, cervical, lung, gastric, and pancreatic.

Rhythm's ColoSTAT is an experimental test kit that is being trialled as a low-cost, easy-to-use blood test to detect colorectal cancer.

It is estimated that around 850,000 people lose their life from colorectal cancer each year. In the United States, Europe, and Australia, over 130 million people aged between 50-74 years are unscreened for colorectal cancer. This represents an addressable market opportunity of more than $6.5 billion.

The strategic plan to expand the technological platform will form part of a research and development program. This is expected to follow a similar commercial pathway as to ColoSTAT.

The program will have access to $0.75 million worth of funds sourced from the company's last capital raising. In addition, the program could be eligible for the government R&D tax incentive rebate as well as other grants.

Rhythm CEO and managing director, Glenn Gilbert commented:

As we move closer to the launch of our initial cancer detection product ColoSTAT in 2022, the Company is making positive progress with respect to its broader strategy to leverage our cancer detection technology into other global cancer markets. Ultimately, Rhythm believes it can make a meaningful impact for improved health outcomes across millions of people around the world.

More on the Rhythm share price

The Rhythm share price has accelerated by 110% in the past 12 months, reflecting positive investor sentiment. Additionally, the company's shares reached an all-time high of $2.08 last month, before treading slightly lower.

At today's prices, Rhythm presides a market capitalisation of roughly $365.54 million, with approximately 208.88 million shares on issue.

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The Rhythm Biosciences Ltd (ASX: RHY) share price is in the red today after the company announced a board and management restructure.

At the time of writing, the cancer diagnostics company is trading down 4.26% at $1.76. This follows a stellar day in the market on Tuesday which saw the Rhythm Biosciences share price surge 11.21% to an intraday high of $2 before closing at $1.83.

What did Rhythm Biosciences announce today?  

In today's release, the company announced significant changes to the board and management structure, effective immediately.

Non-executive chair Otto Buttula moves to executive chair, while CEO Glenn Gilbert joins the board as a managing director.

The promotion for Buttula will see his pay increase from $84,000 to $150,000, while Gilbert's take-home salary will stay the same.    

Commenting on the changes, Buttula said:

The board has decided to make these changes at a pivotal time to leverage Glenn and my joint experience driving corporate and commercial scale-up activities. Glenn has already established a robust platform that has positioned Rhythm to continue maximising value for all stakeholders.

I view this executive function for the chair to be a short-term, but important role to provide further executive corporate support to the company as it enters several critical commercialization agreements across the globe.

What else is news at Rhythm Biosciences?

Investors appeared to welcome an announcement from the company yesterday which included an update on its ColoStat blood test for detecting colorectal cancer.  

The company said it had achieved a major regulatory milestone for the commercialisation of ColoStat, paving the way for commersialisation in global markets including Europe.

According to Rhythm Biosciences, Colostat will reduce health costs, sickness and deaths associated with colorectal cancer by increasing current screening rates.

Rhythm Biosciences share price snapshot

The Rhythm Biosciences share price has skyrocketed this year, up 187.7% in the past 12 months.

On Tuesday, the share price was in the green 7.4% at the close after the ColoStat regulatory milestone.

The post Rhythm Biosciences (ASX: RHY) share price slumps amid 'pivotal' board changes appeared first on The Motley Fool Australia.

At the time of writing, the cancer diagnostics technology company's shares are up 15% to $1.90.

This means the Rhythm Biosciences share price is now up an impressive 68% in 2021.

Why is the Rhythm Biosciences share price rocketing higher today?

Investors have been bidding the Rhythm Biosciences share price higher today following the release of an update relating to its ColoSTAT product.

ColoSTAT is a simple, low-cost, blood test for global mass market detection of colorectal cancer. The company notes that colorectal cancer is the third most common cancer in men and the second most common in women globally, accounting for an estimated 1.9 million new cases and 935,000 deaths annually.

According to today's release, the company has achieved a major regulatory milestone for the commercialisation of ColoSTAT. The product has been granted CE Mark and fully conforms with the European Directives for IVD Medical Devices.

Management highlights that this critical regulatory achievement is a result of robust and stringent analytical testing and adherence to design and development procedures.

Rhythm Biosciences' CEO, Glenn Gilbert, said: "The achievement of this regulatory milestone continues to validate our commercial pathway into significant global markets, with Europe alone representing a massive addressable population of over 231 million people. This significant achievement represents an initial step change in the Company and is a testament to the dedication and commitment of the entire Rhythm team. Rhythm is currently assessing its commercialisation options to market ColoSTAT into Europe."

What's next?

The company notes that being granted CE Mark was a critical component in its commercial plan and priority market entry strategy. It allows Rhythm to commercialise, market and sell ColoSTAT in a significant global market across Europe and other countries which recognise CE.

Management estimates that this customer market currently represents an addressable screening population of over 231 million people, with a combined value of US$12 billion.

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It was a mixed bag of results for ASX healthcare shares as we walked through October, as some names came in red hot, whilst others missed the mark completely.

After a sharp downturn in late September, where it lost around 7% in just one week, the S&P/ASX 200 Health Care Index (XHJ) rebounded 4% and began climbing northwards once more.

Within this group lies a subset of individual companies that gave back handsomely to shareholders last month.

Here are four of the standouts from the ASX healthcare basket for the month of October.

Healthia Ltd (ASX: HLA)

Shares in healthcare group Healthia soared 13% in October towards their 52-week high, closing the month at $2.05 per share.

Driving this upside was positive catalysts from the company's acquisition of the Back in Motion physiotherapy franchise, which settled during the month.

This strategic acquisition gives Healthia exposure to a suite of physiotherapy clinics across Australia and New Zealand, thereby strengthening its Allied Health portfolio.

Healthia provided another update at month's end confirming it had acquired a further 18 Back in Motion clinics, thereby bringing the total number of clinics acquired to 32 – half of the company's 64 physio clinics in total.

Investors sent Healthia shares flying on the news, bidding prices higher after coming off a low of $1.78 mid-month.

From this point, Healthia shares jumped over 15%, to finish October, and finished yesterday's session in the green at $2.02.

Ramsay Health Care Limited (ASX: RHC)

Global hospital giant Ramsay Healthcare had a turbulent month, however, came out on top as we rolled over into November.

Shares in the ASX healthcare behemoth jumped 4% from month start to end, however, came off a low of $65.94 at the midpoint to accelerate northwards at a rapid pace.

Investors piled in and added another $5.28 per share in a number of days for Ramsay, as state governments in NSW and Victoria began to roll back COVID-19 restrictions that were limiting hospital patient turnover.

News of the restrictions easing sent Ramsay shares soaring in the days afterwards, as investors appeared to regain confidence in the hospital specialist once again.

This came off a solid first quarter performance on the chart for Ramsay, where it also gained another $6.80 or 11% per share in the three months ending 30 September 2021.

Ramsay shares are set to open the session at $71.85 after inching a further 1% higher in yesterday's trade.

Aroa Biosurgery Ltd (ASX: ARX)

Shares in soft tissue regeneration company Aroa Biosurgery were another takeout from the ASX healthcare basket last month.

After a wild ride, the wound care and tissue reconstruction specialist finished the month in the green, posting a solid 6.25% gain to close out October.

However, at one point, Aroa shares were trading around 15% higher at $1.22, after the company released its preliminary half year results.

It was a robust half for the Aroa, hallmarked by a contract extension for its Myriad products. This decision enables around 1,500 hospitals and healthcare systems access to its Myriad segment.

Aroa shares jumped on news of the company's performance and contract extension, with investors securing their position in the company's growth engine in numbers.

After another day in the green, Aroa shares finished the session 1.8% higher at $1.125 yesterday.

Rhythm Biosciences Ltd (ASX: RHY)

Shares in medical diagnostics company Rhythm Biosciences were star performers last month, claiming a 33.5% gain for its shareholders to bite into.

It was all systems go for Rhythm in October, as investors bid up its share price in rapid succession towards the back end of the month.

Perhaps they were seeking to own a piece of a company making significant advancements in the field of medical diagnostics – like with its ColoSTAT testing technology.

ColoSTAT is the company's low-cost blood test for the early detection of colorectal cancer.

Rhythm claims this disruptive technology is significantly cheaper and easier to administer than the current standard of care.

And oh my, is Rhythm projecting some serious numbers for its growth outlook in this segment.

The company forecasts a total addressable 'screening value' of US$38 billion and a total addressable market of over 770 million people in its market projections for ColoSTAT.

In fact, Rhythm reckons that it can even reach up to a billion people if the standard screening age is lowered to 45 years old.

Rhythm expects it will derive first revenues from the product in late 2022 and is currently working on building out its pipeline of other cancer diagnostics.

For now, it is set to open the session at $1.70 after climbing a further 1.5% into the green yesterday.

Honourable mentions include Volpara Health Technologies Ltd (ASX: VHT) who was up around 10% but fell sharply in the last week of October; and Impedimed Limited (ASX: IPD), which climbed 7 cents per share to post a new 52-week high of 19 cents.

The post These were the best performing ASX healthcare shares in October appeared first on The Motley Fool Australia.

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 post Here's why the Rhythm Biosciences share price (ASX:RHY) is jumping higher today appeared first on The Motley Fool Australia.

The Rhythm Biosciences Ltd (ASX: RHY) share price is lifting in early trade today as the medical technology company released an investor presentation.

At the time of writing, Rhythm Biosciences shares are changing hands at $1.50 each, signifying an 11% gain on the day.

Here are the details out of Rhythm's camp today.

What was announced?

Rhythm gave a presentation regarding its "simple, low-cost blood test for the early detection of colorectal cancer", known as ColoSTAT.

The company explains that ColoSTAT is a disruptive and transformative technology that is significantly cheaper and easier to administer than competing tests.

In fact, the assay format of ColoSTAT is designed to "integrate with existing pathology lab infrastructure" using a combination of a test kit and an algorithm to analyse the results.

It appears the company expects tremendous growth for the industry, forecasting a US$38 billion total addressable "screening value" and a total addressable market of 771 million people.

It forecasts it has the potential to reach 1 billion people if the screening age is lowered to 45 years old. This is based on what the US Preventative Services Task Force is currently advocating.

If Rhythm wants to successfully commercialise the product, its tests "must demonstrate both sensitivity greater than or equal to 74% and specificity greater than or equal to 90%".

According to the company, it would meet these requirements in the US now "based on the study 6 performance of 84% sensitivity and 95% specificity".

Aside from this, the company has also filed intellectual property (IP) patents in all its major target markets.

The patent, which expires in 2031, has been granted in a number of jurisdictions with just India pending.

Rhythm is targeting initial revenues for the product in late 2022 and it has already commenced its "platform technology pipeline for additional cancer detection tests".

What's next for Rhythm Biosciences?

The presentation also contained several "future value inflection points" that may weigh in on the Rhythm Biosciences share price.

It stated that it expects CE Mark submission and approval in Europe to be completed in late 2021. At the same time, it has progressed regulatory post-clinical trial recruitment in Australia for its "Study 7".

As well, it will continue progressing its IP approvals in different markets while building out its sales and distribution channels for ColoSTAT.

Rhythm Biosciences share price snapshot

The Rhythm Biosciences share price has been an outsized winner this year to date posting a return of 72% since January 1. Indeed, it's up almost 14% over the last month alone.

On a 12 month basis, the company's shares have rallied an incredible 618%.

These results have far outpaced the S&P/ASX 200 Index (ASX: XJO)'s climb of around 21% over the same time.

The post Why is the Rhythm Biosciences (ASX:RHY) share price up 11% on Monday? appeared first on The Motley Fool Australia.

The Rhythm Biosciences Ltd (ASX: RHY) share price is on the move during late morning trade on Thursday.

This comes after the medical device company provided an update in regards to its colorectal cancer test kit product, ColoSTAT.

At the time of writing, the Rhythm share price is up 10% to $1.32 apiece.

Rhythm progresses towards commercialisation of test kit

In today's release, Rhythm advised it has continued to conduct confirmatory testing on its ColoSTAT proprietary medical device.

Previously, Rhythm achieved positive results from its Study 6 findings in mid-March. It stated that the ColoSTAT prototype test kit demonstrates an accuracy of 84% sensitivity at 95% specificity.

This means the ColoSTAT blood test is 33% more accurate than the current market standard faecal tests.

Rhythm stated that it is advancing its approval process with the Therapeutic Goods Administration (TGA) for ColoSTAT. Achieving regulatory approval is the final hurdle for entering the Australian market.

In Europe, Rhythm has submitted its CE Mark application and is anticipating approval by end of the year. The company notes that the recent confirmatory testing is designed to support the criteria required to obtain a CE Mark.

A final study is underway following the completion of the patient recruitment phase last month. Rhythm expects to deliver the report in the first half of 2022.

Rhythm CEO, Glenn Gilbert, said:

Our visible path to market is emerging as our ongoing testing program continues to provide the company with confidence moving through the regulatory phase. The high accuracy of our cancer diagnostics technology has the potential to deliver positive outcomes for millions of people around the world. This is an exciting time for all stakeholders as we focus on the massive global market opportunity ahead of us.

More on ColoSTAT and colorectal cancer

ColoSTAT is an experimental test kit being trialled as a low-cost and easy-to-use blood test that detects colorectal cancer.

An estimated 850,000 people lose their lives from colorectal cancer each year.

In the United States, Europe, and Australia, more than 130 million people aged 50-74 years have not been tested for colorectal cancer. This represents an addressable market opportunity worth more than $6.5 billion.

Rhythm share price snapshot

The Rhythm share price has accelerated by 500% in the past 12 months, reflecting positive investor sentiment.

The shares reached an all-time high of $1.675 in March before some profit-taking investors swooped in.

At today's price, Rhythm presides a market capitalisation of roughly $281.9 million with 208.8 million shares on issue.

The post Why is the Rhythm (ASX:RHY) share price climbing 10% today? appeared first on The Motley Fool Australia.

The predictive diagnostics company's shares ended the day 12% higher at $1.32.

This means the Rhythm Biosciences share price is now up 550% over the last 12 months.

Why did the Rhythm Biosciences share price surge higher today?

Investors were bidding the Rhythm Biosciences share price higher today following the release of a milestone announcement.

According to the release, the company has completed recruitment for its clinical trial (Study 7) for ColoSTAT.

ColoSTAT is a globally marketed, low-cost, simple blood test for the early detection of colorectal cancer aimed at mass-market screening.

The release explains that Rhythm Biosciences has now successfully recruited 815 patients across 11 Australian clinical trial sites. This was deemed to be an adequate number of patients following a detailed consultation with leading industry professionals and the company's biostatisticians and Clinical Research Organisation (CRO).

Management notes that the recruitment phase is a highly involved and resource intensive component of the clinical trial. Therefore, it feels the completion of this phase represents a significant milestone towards the final completion of the clinical trial study.

What's next?

The good news for the Rhythm Biosciences share price is that ColoSTAT could be generating revenue in the not so distant future.

The company will now commence testing the collected blood samples, finalise and lock the patient database, and other routine associated works. It will also progress the next stages in finalising the trial, before completing the final clinical study report.

If all goes to plan, the clinical trial is targeted for completion in the first half of calendar year 2022. After which, it is hoping for approval to market ColoSTAT within Australia later that year.

European trials are ongoing as well, with a filing expected to be made before the end of the year.

Management commentary

Rhythm's CEO, Glenn Gilbert, said: "With the recruitment target now met for the ColoSTAT clinical trial, the Company remains fully focused on working with our partners to progress through the remaining phases for trial completion."

"In the context of market conditions made extremely difficult by COVID-19, I am proud of the achievement by the entire Rhythm team, our trial sites, CRO, operations and laboratory partners. This milestone should not be understated, considering the recruitment phase is typically the most resource, logistically challenging and cost intensive component of completing a clinical trial," he added.

Management estimates that ColoSTAT has a $6.5 billion market opportunity across the US, European, and Australian markets.

The post Rhythm Biosciences (ASX:RHY) share price jumps 12% on key milestone appeared first on The Motley Fool Australia.

In afternoon trade, the predictive diagnostics company's shares are up 8.5% to $1.14.

Why is the Rhythm Biosciences share price racing higher?

Investors have been bidding the Rhythm Biosciences share price higher today after the release of a positive update.

According to the release, the Therapeutic Goods Administration (TGA) has formally accepted Rhythm's manufacturers evidence documentation. This documentation is required for the approval of its ColoSTAT product in Australia and completes the first step for regulatory approval in the country.

ColoSTAT is aimed to be a globally marketed, low-cost, simple blood test for the early detection of colorectal cancer for mass-market screening.

What now?

With step one of the TGA submission process complete, the company will now push ahead with the filing of an Australian Register of Therapeutic Goods (ARTG) listing.

The ARTG listing will contain further comprehensive documentation. This includes the product technical files, clinical evaluation reports, and similar documentation.

Rhythm's CEO, Glenn Gilbert, commented: "Progress for regulatory approval in Australia has commenced and it is pleasing to have received the TGA's acceptance of our Manufacturers Evidence."

"Our expectation remains that patient recruitment for the clinical trial (Study 7) is to be completed in the near term. Again, the application for a CE Mark for European approval is independent of both the clinical trial being completed and TGA application. CE Mark filing remains on track for late this calendar year," he added.

Investors appear excited that this product could soon be generating revenue and saving lives. The company estimates that over 850,000 people die from colorectal cancer each year. It also notes that there is a market opportunity of more than $6.5 billion per year in the US, EU, and Australian markets.

The Rhythm Biosciences share price is up 24% over the last 30 days.

The post Why the Rhythm Biosciences (ASX:RHY) share price is jumping 8% today appeared first on The Motley Fool Australia.

The Rhythm Biosciences Ltd (ASX: RHY) share price is charging higher in afternoon trade, up 7% to $1.21 per share.

Below we take a look at what's driving investor interest in the ASX medical diagnostics technology company.

What did Rhythm announce?

The Rhythm Biosciences share price is gaining after the company reported it had successfully completed its non-renounceable pro-rata rights issue to raise $4.3 million, before costs.

While Rhythm set out to raise $4.3 million, it said actual subscriptions – including "entitlements, additional shares applied for, and letter of commitments" – totalled $12.05 million.

With actual subscriptions some 280% more than Rhythm was seeking, it said its share registry will return funds to unsuccessful applicants "as soon as practicable".

As interest ran stronger than anticipated, the company said it will now offer a small "heavily scaled back placement". This will select sophisticated and other exempt investors who had provided commitment letters for the previous offer.

Up to 1.5 million shares will be issued at a price of 85 cents per share to raise $1.28 million before costs. Rhythm said participants will also be offered 2 varieties of attaching, unlisted options.

John Hancock, who cornerstoned the placement, said: "The innovative ColoSTAT product, developed from research by the CSIRO and Rhythm, has the potential to be a global game-changer in the early mass-market screening for colorectal cancer."

Commenting on the offer, Rhythm's CEO, Glenn Gilbert said:

I'm pleased that the offer was strongly supported by existing shareholders, alongside the board and myself, further demonstrating our alignment. Coupled with an R&D tax incentive refund, expected shortly, the company is well funded to execute on our development and commercialisation plans outlined in our FY22 strategic plan.

Rhythm Biosciences share price snapshot

The Rhythm Biosciences share price has gained an eye-popping 991% over the past 12 months. Over that same time, the All Ordinaries Index (ASX: XAO) is up 27%.

Over the past month, Rhythm's shares are up 24%.

The post Why the Rhythm Biosciences (ASX:RHY) share price is flying higher today appeared first on The Motley Fool Australia.

Four ASX shares that are not letting that hold them back are listed below. Here's why they are storming higher:

ARB Corporation Limited (ASX: ARB)

The ARB share price is up 8% to $44.68. Investors have been buying the 4×4 parts manufacturer's shares following the release of a market update. According to the release, ARB achieved a 33.9% increase in unaudited sales revenue to $623 million in FY 2021. Things were even better on the bottom line thanks to margin expansion. The company expects its profit before tax to be within the range of $145 million to $150 million. This will be an increase of 85.5% to 92% on FY 2020's profit before tax of $78.1 million.

Rhythm Biosciences Ltd (ASX: RHY)

The Rhythm Biosciences share price is up 4% to 88.5 cents. This morning the diagnostics company announced the creation of a wholly owned US domiciled entity, IchorDX. This will enable Rhythm to pursue its international expansion activities for ColoSTAT in one of its largest priority markets. ColoSTAT is intended to be a simple, affordable, minimally invasive and effective blood test for the early detection of bowel cancer. Management notes that the US market represents one of the largest diagnostic markets in the world, with a current addressable market of over 94 million people.

Sezzle Inc (ASX: SZL)

The Sezzle share price has jumped 7% to $8.53. This morning the buy now pay later (BNPL) provider revealed that Discover Financial Services has agreed to invest US$30 million into Sezzle. Discover has 48 million merchant locations and generated US$417 billion in total network volume last year. In addition to the investment, the two parties plan to work on a buy now, pay later network solution on the Discover Global Network.

Spark Infrastructure Group (ASX: SKI)

The Spark share price has stormed 7.5% higher to $2.66 after receiving and then rejecting a takeover approach. This morning the energy network operator revealed that it received a conditional and non-binding indicative proposal from Ontario Teachers' Pension Plan Board (OTPP) and Kohlberg Kravis Roberts & Co (KKR) of $2.70 cash per share. The Spark Board believes it undervalues the company.

The post Why ARB, Rhythm Biosciences, Sezzle, & Spark shares are storming higher appeared first on The Motley Fool Australia.

In afternoon trade, the early cancer detection-focused predictive diagnostics company's shares are up 6% to 90 cents.

This latest gain means the Rhythm Biosciences share price is now up over 1,000% during the last 12 months.

Why is the Rhythm Biosciences share price charging higher today?

The catalyst for the rise in the Rhythm Biosciences share price on Thursday has been the release of an update on its US expansion strategy.

According to the release, the company has established a wholly owned US domiciled entity, IchorDX, as part of its US market entry plan. Management notes that this will enable Rhythm to pursue its international expansion activities for ColoSTAT in one of its largest priority markets.

ColoSTAT is the company's lead product and intended to be a simple, affordable, minimally invasive and effective blood test for the early detection of bowel cancer.

The release highlights that the US market represents one of the largest diagnostic markets in the world, with a current addressable market of over 94 million people. It also sees scope for this number to grow in the short term by a further 21%. This follows the US Preventative Services Task Force's recommendation that the colorectal cancer screening age be reduced from 50 to 45 years of age.

In light of this, it isn't hard to see why the Rhythm Biosciences share price is on the rise again today.

Rhythm's CEO, Glenn Gilbert, commented: "The establishment of IchorDX, Inc., in the US demonstrates our commitment to accelerate our international expansion plans, offer additional optionality to our corporate structure and aim to create a global footprint for Rhythm's transformative cancer detection technology."

"The reality is that the global need for a simple and accurate mass screening blood test for colorectal cancer is growing. This first step to enter the US market moves Rhythm closer to meeting this need," he added.

The post Why the Rhythm Biosciences (ASX:RHY) share price is racing 6% higher appeared first on The Motley Fool Australia.

The Rhythm Biosciences Ltd (ASX: RHY) share price is rising following the company's latest addition to its ColoSTAT clinical trial.

In early morning trade, the medical device company's shares were up 3.57% to $1.015 before retreating to $1.00 at the time of writing, up 2%.

What did Rhythm announce?

In its statement, Rhythm advised Sonic Healthcare Limited (ASX: SHL) business, Sonic Clinical Services, has joined its ColoSTAT clinical trial.

Rhythm's ColoSTAT is an experimental test kit that is being trialled as a low-cost, easy-to-use blood test to detect colorectal cancer.

Sonic Clinical Services' Independent Practitioner Network (IPN) Medical Centres will bring a network of independent clinicians across NSW and Victoria.

IPN is recognised as Australia's largest network of medical clinics. Currently, the business has more than 2,000 doctors across 160 medical centres nationally, providing 10 million consultations per year.

The first patients from Sonic Clinical Services' IPN medical centres have already been recruited.

Rhythm CEO Glenn Gilbert said:

We are already working with Sonic Healthcare under an existing partnership for the storage and testing of ColoSTAT blood samples as part of the Study 7 clinical trial.

Expanding this partnership with an additional division, in Sonic Clinical Services' IPN, is a natural progression that will ultimately contribute to the success of the ColoSTAT clinical trial.

More on ColoSTAT and the Rhythm share price

Rhythm develops and commercialises Australian medical diagnostics technology for sale in domestic and international markets. The company's ColoSTAT is the first proposed product-in-development intended to accurately test and detect the early stages of colorectal cancer.

It's estimated around 850,000 people lose their life from colorectal cancer each year.

In the United States, Europe, and Australia, more than 130 million people aged between 50-74 years are unscreened for colorectal cancer. This represents an addressable market opportunity of more than $6.5 billion.

The Rhythm share price has accelerated by 1,300% in the past 12 months, reflecting positive investor sentiment. Additionally, the company's shares reached an all-time high of $1.675 in March, before some profit-taking swooped.

At today's prices, Rhythm has a market capitalisation of roughly $205 million, with approximately 202 million shares on issue.

The post Why the Rhythm (ASX:RHY) share price is climbing today appeared first on The Motley Fool Australia.