Actinogen Medical Ltd (ASX: ACW) shares are rocketing higher today and have now gained 165% since the start of 2021.
At the time of writing, the Actinogen share price is trading 23.26% higher for the day so far at 5.3 cents, up from just 2 cents at the start of March.
The company’s focus is the development of Xanamem, a novel treatment for Alzheimer’s disease and the cognitive deficiency associated with other neurological and metabolic diseases.
What’s been driving the Actinogen share price?
Whilst there is no news out of the company today, it’s possible the Actinogen share price is still riding the wave of several announcements released by the company over the last couple of months. At the end of March, Actinogen director George Morstyn acquired 2,550,000 shares in the company at a value of $71,782.73.
Actinogen shares have also been responding positively since the appointment of the company’s new CEO, Dr Steven Gourlay, on 15 March. Gourlay has more than 30 years’ experience in the development of novel therapeutics.
Investors are clearly confident that Gourlay brings considerable skills and experience to Actinogen, as the company moves into further clinical development of its lead compound, Xanamem.
But perhaps most pertinent to the company’s recent surge in value is the growing recognition of Xanamem on the international stage.
On 5 February, the United States Food and Drug Administration granted Actinogen’s drug Xanamem a Rare Paediatric Disease Designation for the treatment of Fragile X syndrome (FXS).
Fragile X syndrome is a rare and serious genetic disorder, typically diagnosed in children but with life-long symptoms. It is characterised by a range of developmental problems including behavioural problems, autism features, severe anxiety, cognitive impairment and disordered sleep.
Dr Bill Ketelbey, former CEO and MD of Actinogen Medical, said at the time that the FDA designation was extremely important for the company:
We are delighted to receive the Rare Paediatric Disease Designation from the FDA. The significant strategic advantages from this approval include commercial, development and regulatory benefits for the development of Xanamem in FXS, with priority review designed to increase overall speed to market.
Additionally, [this] designation includes the potential for the Company to receive a second, transferable priority review voucher that holds substantial additional value in it’s own right Actinogen has devoted increased resources to broadening Xanamem’s clinical development pipeline, with Fragile X syndrome selected as the second indication to pursue alongside Alzheimer’s disease.
The Actinogen share price is having a stellar start to 2021, thanks to a series of announcements since the beginning of the year. Reaching a new 52-week high of 5.6 cents in intraday trading today, Actinogen shares are now up by around 30% in a week. Over the past year, the company’s shares have outperformed the healthcare sector by around 170%.
Actinogen has a current market capitalisation of around $71 million.