ASX Health Stocks: Rhythm crashes 45pc after withdrawing TGA application for ColoSTAT
Health & Biotech
Health & Biotech
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Rhythm Biosciences (ASX: RHY) crashed 47% this morning after withdrawing its ColoSTAT application for an Australian Register of Therapeutic Goods (ARTG) listing announced last year.
The decision came after Rhythm received an application review from the TGA, which required the company to respond within 20 business days.
While the company believes it’s in a position to answer most of the questions, its says a small number of questions require new internal analytical testing, which in turn requires three different production batches of commercially made ColoSTAT test-kits from its overseas-based manufacturer, Biotem.
In recent discussions, the TGA has clearly advised that it would be reluctant to provide an extension beyond the 20 business days required by RHY.
Coupled with the logistical and supply chain timing, this would prevent RHY being able to receive these commercially made test-kits and answer the minority of questions raised by the TGA.
On a positive note, Rhythym also announced that it intends to submit a new ColoSTAT application with the TGA, in line to better meet the regulator’s feedback and questions,
The new application will be submitted at a date to be determined, however is expected to be in the current calendar year.
“Having decided to withdraw RHY’s current TGA submission for ColoSTAT is clearly disappointing for all stakeholders,” said Rhythm’s executive chairman, Otto Buttula.
“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,” Buttula added.
The US FDA has cleared PYC Therapeutics (ASX:PYC) to commence the first ever human trial in Retinitis Pigmentosa Type 11 (RP11).
This comes as PYC’s Investigational New Drug (IND) application for its investigational drug candidate (known as VP-0013) was approved by the FDA.
The PYC share price rose as high as 12% on the news.
The clinical trial represents the first potential treatment option to enter human studies for RP11, a blinding eye disease that begins in childhood and ultimately leads to legal blindness in middle age.
The disease affects around 1 in every 100,000 people and is caused by insufficient expression of the PRPF31 gene in the retina.
PYC’s VP-001 is a precision therapy that aims to restore the expression of the PRPF31 gene back to levels required for the normal function of the retina.
VP-001 utilises PYC’s proprietary drug delivery technology to overcome the major challenge for RNA drugs by ensuring that sufficient drug reaches its target inside the cells affected by RP11.
Following this development, PYC has now applied for human ethics approval before commencing to enrol patients in the clinical trial, and anticipates dosing the first RP11 patient with VP-001 in the second quarter of this year.
“The validation of PYC’s platform technology as we move ahead into human trials has implications for our entire pipeline of first-in-class and potentially disease-modifying drugs,” said PYC CEO, Dr Rohan Hockings.
“The potential for patient-impact now extends well beyond RP11.”