ASX Health Stocks: FDA to expedite submission for Botanix's sweaty armpits gel

Botanix’s FDA submission gets accelerated
Release extends contract with Medgate to use the ResAppDx platform
Cyclopharm’s Technegas is used ahead of competitor products in Covid-19 diagnosis

Clinical dermatology company, Botanix Pharma (ASX:BOT), was up 13% this morning after revealing that the timing of its FDA submission has has been accelerated to Q3 2022.

Botanix is currently in the process of submitting a New Drug Approval (NDA) for its Sofpironium Bromide gel, 15%.

Sofpironium Bromide is a new chemical entity developed to be a once daily, topically administered therapy for the treatment of primary axillary hyperhidrosis (excessive underarm sweating, a medical condition).

It blocks sweating by binding to the receptor and thereby blocking the sweat signal.

A recent Phase 3 study demonstrated that approximately 85% of patients using Sofpironium Bromide experienced a clinically meaningful improvement in their condition over the course of the studies.

With the acceleration of the FDA approval timetable, Botanix has now ramped up its commercial launch preparation activities, which it says will need to be completed in anticipation of the product launch post FDA approval.

Meanwhile, ResApp (ASX:RAP) has agreed to a 12-month extension to its commercial licence agreement with Medgate, operator of the largest telemedical centre run by doctors in Europe.

The contract will allow the use of ResApp’s smartphone-based acute respiratory diagnostic test, ResAppDx, on Medgate’s telehealth platform.

ResAppDx uses machine-learning technology to analyse signatures in cough sounds to diagnose respiratory disease using a smartphone’s inbuilt microphone.

“It’s pleasing to see that Medgate extending the use of ResAppDx to additional patient journeys for the benefit of more patients and clinicians,” said ResApp CEO, Tony Keating.

“We believe this is further strong endorsement of the value of ResAppDx to patients, clinicians and telehealth providers.”

Botanix and Resapp share prices today:

Other notable ASX healthcare announcements today

Cyclopharm (ASX:CYC)

Cyclopharm says that an independent French multicentre study has reaffirmed that the company’s proprietary technology, Technegas, plays a key role in diagnosing pulmonary embolism in COVID-19 patients.

Technegas was used ahead of competitor products in 92% of cases evaluated.

The company says this reinforces the importance of nuclear medicine ventilation imaging using Technegas in ruling out Pulmonary Embolism (PE) in patients with Covid-19.

Over 530 million people worldwide are estimated to have had Covid-19 by June 2022, resulting in more than 6.3 million deaths.

Argenica Therapeutics (ASX:AGN)

The brain-focused biotech announced a number of encouraging findings from a peer-reviewed published study assessing the safety of its lead drug, ARG-007.

The study indicates that ARG-007, over a wide range of concentrations, is unlikely to induce a mast cell anaphylactoid-mediated reaction (allergic reactions) if administered to patients.

Chief Executive Officer Dr Liz Dallimore said: “We are delighted that this preclinical research into important safety aspects of ARG-007 has been recognised by the Journal of Biochemistry and Biophysics Reports.”