General Forum, page-1019

G'day everyone!!

Small mention of CDX in an article today that I just spotted - see below. Hope it formats OK


After Neuren’s success, which other ASX health stocks are knocking on the US FDA door?
As Neuren Pharmaceuticals (ASX:NEU) continues to savour the sweet taste of US Food and Drug Administration approval, which other ASX health stocks are hoping to follow in its footsteps?
NEU’s large pharmac partner Acadia (Nasdaq:ACAD) announced on March 10 that the FDA had approved trofinetide, now dubbed Daybue, for the treatment of Rett syndrome in adult and pediatric patients two years of age and older.
As *’s very own small-cap share analyst Tim Boreham told readers after the announcement Trofinetide is one of only a handful of drugs developed from scratch in Australia (with help from the Kiwis in Neuren’s case) and approved by the FDA.
It’s the first since the FDA granted approval to Telix Pharmaceuticals (ASX:TLX) for its Illucix prostate cancer diagnostic in December 2021.
Petra Capital healthcare analyst Tanushree Jain said FDA approval is a watershed event for a company and can transform them from a risk perspective and financially.
News of the FDA approval saw the NEU share price soar 60% in the five days following announcement of the FDA approval.
CardieX (ASX:CDX)
CDX is waiting on a 510k clearance for its PULSE device for central blood pressure and associated cardiovascular health monitoring.
While it has been in process since June 2022, CDX has completed the additional information request process from FDA with a response expected in coming months.
Pulse will be the first cloud-connected, customisable, multi-use arterial biometric monitor to include CardieX subsidiary ATCOR’s SphygmoCor central aortic blood pressure technology.