Mouth spray maker Suda Pharmaceuticals’ (ASX:SUD) has finally delivered a long awaited gift for shareholders: the Australian regulator has approved a product, and ahead of schedule too.

The stock jumped over 250 per cent in morning trading.

Suda (ASX:SUD) share price chart


The Therapeutic Goods Administration (TGA) approved ZolpiMist — Suda’s mouth spray reformulation of insomnia drug zolpidem — for sale in Australia.

It wasn’t expected to do so until the December quarter.

The approval means ZolpiMist will be included on the Australian Register of Therapeutic Goods and can therefore be sold in Australia.

Suda says it will also help partners TEVA, Mitsubishi Tanabe Pharma Singapore and MTP Korea with their regulatory submissions in their respective territories.

Suda has been working on ZolpiMist since January 2015 when it licensed zolpidem from Amherst Pharma. It has a platform dubbed OroMist which can deliver active ingredients through the oral-mucosa, or the lining of the mouth.


Bumpy road

Since listing in 2002, Suda’s track record hasn’t been without hiccups.

Past hurdles have included a German lawsuit, settled in 2018, the TGA knocking back its malaria mouth spray at the end of 2019, and the ASX rejecting a bid to buy a cancer technology last month.

But the TGA news appears to have been a winner with investors.

Suda has eight irons in the fire, from deals to reformulate products with Odessa and Sanofi to arrangements to look at marijuana mouth sprays.

The next drug in the pipeline is anagrelide, a cancer treatment reformulation but Suda is looking for acquisitions as well.

CEO Dr Michael Baker points to the board’s collective backgrounds in deal sourcing and making — it includes former Viralytics boss Paul Hopper as chair — as an indication of what the strategy is for the future.


In other ASX small cap health news:

Just over 48 per cent of Cann Global’s (ASX:CGB) $4.2m capital raising has gone begging, with the offer closing with just $2.2m raised.

Up-and-comers LBT Innovations (ASX:LBT) and ResApp (ASX:RAP) both issued quarterlies but neither received any cash payments from customers in the June quarter.