Cardiex jumps after sales update

Cardiex (ASX:CDX) jumped +15% this morning after reporting a sales update.

The company said its sales have been strong, pointing towards potential record revenues for FY24.

Significant contributions have come from its pharmaceutical sales division and markets serving research and clinicians.

Projected revenues for FY24 are now expected to exceed $12 million, a substantial increase from $6.01 million in FY23.

Sales to the research market in May marked a six-month high, and with June historically being its strongest month in this sector, the company anticipates achieving record research sales by the end of the financial year.

Additionally, under new leadership, CDX’s pharmaceutical team is actively exploring multiple new opportunities, aiming to sustain sales growth from FY24 into FY25.

Meanwhile, the company said the first batch of its Conneqt Pulse production units is set to arrive in early July.

These units will be distributed to CDX’s initial pilot partners, key opinion leaders (KOLs), and members of its clinician network.

A full production run of 3,000 units is scheduled for Q1 FY25, with deliveries to the US starting at that time.

Importantly, the company says it has over 30,000 units in chip inventory and a robust relationship with chip suppliers, ensuring readiness to fulfill future orders.

The Conneqt Pulse is a wearable health monitoring device designed to track various physiological parameters such as blood pressure and heart rate.

It’s intended to provide users with real-time health insights and facilitate proactive management of cardiovascular health.


Recce’s R327 included in WHO’s report

Recce Pharmaceuticals (ASX:RCE), a company pioneering synthetic anti-infectives, has achieved a significant milestone with its primary candidate, RECCE 327 (R327).

R327 has been included in the World Health Organization’s (WHO) latest report on Antibacterial Agents in Clinical Development and Preclinical Development.

The WHO report assesses both traditional and innovative antibacterial agents under development globally.

It specifically evaluates how well these compounds address infections caused by priority pathogens identified in the WHO’s updated 2024 list.

R327 stands out in the report as it is categorised by the WHO as an ATP (Adenosine Triphosphate) production disruptor, a unique classification within the report.

ATP serves as the primary energy source within cells for various functions. By disrupting ATP production directly, rather than through secondary mechanisms, R327 shows potential effectiveness against a broad spectrum of bacterial pathogens, including both Gram-positive and Gram-negative bacteria.

“There is a demand for new antibiotic therapies, and this report further showcases R327’s potential as a novel treatment for a broad range of life-threatening and resistant bacteria,” said CEO of Recce Pharma, James Graham.


Clinuvel starts new program on Parkinson’s

Clinuvel Pharmaceuticals (ASX:CUV) has announced a new clinical program to study afamelanotide as a potential treatment for early-stage Parkinson’s Disease (PD) in fair-skinned patients.

This drug activates a receptor called melanocortin-1 (MC1R), which is important in both skin and brain cells. Studies have shown that people with fair skin, often associated with MC1R malfunction, have a higher risk of developing Parkinson’s.

The aim of the program is to investigate whether afamelanotide can reduce levels of α-synuclein — a harmful substance found in PD patients’ brains — and potentially protect midbrain neurons.

This hypothesis is supported by previous research demonstrating afamelanotide’s ability to improve neurodegenerative conditions in animal models of Parkinson’s.

Afamelanotide is currently approved in Europe and the USA under the name SCENESSE for treating a condition called erythropoietic protoporphyria (EPP).

The upcoming CUV901 study, set to begin in 2024, will be the first human trial evaluating afamelanotide specifically as a therapy for Parkinson’s Disease.


Race’s drug granted US FDA designation

Meanwhile, Race Oncology (ASX:RAC) announced that the US FDA has extended Rare Paediatric Disease Designation (RPDD) to RC220 bisantrene for the treatment of childhood (paediatric) subtypes of AML.

This grant builds on the previous designation awarded to RC110 in 2018.

RPDD is reserved for treatments addressing serious or life-threatening diseases affecting fewer than 200,000 people in the US, predominantly children under 18 years old.

This designation not only underscores the urgency of finding therapies for rare paediatric diseases, but also positions Race to potentially receive a Priority Review Voucher (PRV) upon RC220’s approval.

PRVs can expedite the review process for future drug applications or be sold to other companies, often fetching substantial sums exceeding $100 million.