The Suda Pharmaceuticals Ltd (ASX: SUD) share price has soared 207.4% today, at the time of writing. The surge came following the company's announcement that its Zolpimist product has been approved by the TGA (Therapeutic Goods Administration). ZolpiMist is an oral spray for the treatment of insomnia.
In an investor presentation released by Suda Pharmaceuticals earlier this month, the company estimated the market for insomnia treatments will be approximately US$4 billion by 2026. Furthermore, according to the National Institutes of Health, as reported by Sleep Foundation, an estimated 30% of the general population complains of sleep disruption and 10% have associated symptoms during the day.
TGA approval
The approval follows an announcement from Suda Pharmaceuticals on 12 May 2020 outlining its decision to register a supplemental active pharmaceutical ingredient (API) supplier and manufacturer which required an amendment to an existing TGA submission. Therefore, today's decision will benefit the company by reducing the costs of raw material and its finished product to create increased value.
According to the market release today, the TGA approval was achieved ahead of a projected Q4 2020 deadline. The decision enables Suda's Zolpimist product to be sold in Australia, allows more competitive pricing and supports further submissions across more locations.
Suda Pharmaceuticals CEO and Managing Director, Dr Michael Baker, commented:
"The TGA submission was a combined effort by Suda's technical team as well as our regulatory consultant, Pharma to Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future".
Other recent announcements
Earlier this month, Suda Pharmaceuticals raised $3.56 million in an entitlement offer. The purpose of the funds was to assist with the development of the company's anagrelide technology, which is used in the treatment of cancer, and its OroMist platform. The funds are also earmarked to be used for potential acquisition of new assets and general working capital.
About the Suda Pharmaceuticals share price
According to its website, Suda Pharmaceuticals is a leader in reformulating and delivering medications through the use of oral sprays. It argues patients typically take medication as pills, tablets or capsules yet less than 25% of the medication is absorbed into the bloodstream. This compares to up to 95% absorption through a simple spray into the mouth.
The company's product, ZolpiMist, is also FDA (Food and Drug Administration) approved in the United States.
At time of writing the Suda Pharmaceuticals share price is trading at 8.3 cents.
