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Highlights:
- Rhythm Biosciences Limited (ASX:RHY) shares came under selling pressure and lost over half their market value on Monday.
- The cancer biotech company is withdrawing its present ColoSTAT® application for ARTG listing.
- RHY will submit a fresh ColoSTAT® application to the ARTG later this year.
Shares of cancer biotech company Rhythm Biosciences Limited (ASX:RHY) came under sharp selling pressure on Monday and lost more than half of their market value at their lowest intraday level. At around 2:25 pm AEDT on Monday, 6 March 2023, the RHY shares traded 41.15% lower at AU$0.565 after making an intraday low of AU$0.460.
Worth mentioning here is RHY shares resumed trading today after they were put on a trading halt on 1 March 2023, pending an announcement. The previous closing price of the stock on ASX was AU$0.96.
Through an ASX announcement, the company today informed that it has decided to withdraw its present ColoSTAT® application for an Australian Register of Therapeutic Goods (ARTG) listing.
On 12 May 2022, the company informed that it had filed with TGA for ColoSTAT® listing on the ARTG. It was a substantial regulatory landmark for the company as its approval would have carved the path for the ColoSTAT® sale for clinical usage in Australia.
ColoSTAT® is a blood test created by Rhythm Biosciences for detecting colorectal cancer. It is targeted towards international mass market screening.
However, today’s announcement states that the latest decision to withdraw the ColoSTAT® listing application was taken after engagement with TGA as it intends to submit a new application that can better answer the queries posed by TGA. The new application will be submitted later this year, the company said.
The company also said the application withdrawal does not impede its proposed market entry activities into other CE Mark conforming territories and additional international markets, including the US.
About Rhythm Biosciences ColoSTAT® application submission
The submission made by Rhythm Biosciences was thorough, technical, and more than thirteen hundred pages. RHY thinks it can answer most of the queries within the essential timespan pursued by the TGA, which is twenty business days.
A minority of queries need fresh internal analytical testing by the company. It needs three unique production batches of commercially manufactured ColoSTAT® test kits from its foreign-located manufacturer known as Biotem.
The logistical and supply chain timing would stop the company from being able to obtain commercially manufactured test kits along with responding to the minority queries posed by the TGA.
As per the latest engagement with the Australian Therapeutic Goods Administration, in accordance with their normal policies, they have informed that they would be hesitant to offer more than twenty business days needed by the company to adequately respond to all the queries.
