- Despite the healthcare sector index ending in the red, two healthcare companies witnessed a significant rise in their respective stock prices.
- Alterity and Telix saw an increase of ~871% and ~17%, respectively.
- Alterity Therapeutics received guidance from the US FDA for development pathway of its lead candidate ATH434, and now its securities are placed in a trading halt pending an announcement.
- Telix Pharmaceutical received Breakthrough Therapy grant designation for renal cancer imaging product TLX250-CDx from the FDA.
The Australian healthcare system is robust and has many investment opportunities in biotech, pharma companies, medical device players, hospitals and among others. Healthcare system in Australia is considered as one of the best across the world. Amid the COVID-19 turmoil, there are some ASX-listed healthcare companies which are focused towards growth and development.
On 1 July 2020, S&P/ASX 200 Health Care Sector settled at 41,870.9, indicating a fall of 0.76% as compared to the last close, while the benchmark index S&P/ASX 200 closed at 5,934.4, up by 0.62%.
Despite S&P/ASX 200 Health Care sector index ending in red, there were two healthcare companies witnessed a significant rise in their share price. In this article, we will cover these two ASX-listed healthcare shares that have seen their respective share price skyrocket today – ATH and TLX.
Alterity Therapeutics Received Guidance for ATH434 from FDA
Stock Information: ATH stock ended the trading session at A$0.165, an astronomical rise of 870.588% over its last close. The market cap of the stock stood at A$17.64 million, with 1.04 billion outstanding shares trading on the ASX.
About Alterity Therapeutics: ASX-listed healthcare company Alterity Therapeutics Limited (ASX:ATH) is engaged in developing therapies for individuals having neurodegenerative disorders. ATH434, the lead candidate of Alterity, is the first new generation of small molecules that are designed for inhibiting aggregation of pathological proteins involved in neurodegeneration.
The first disease target selected by ATH is multiple system atrophy, which is a highly debilitating disorder without any approved treatments.
Pause in Trading
Earlier in the day, Alterity Therapeutics had informed the market that its securities are placed in a trading halt pending it releasing an announcement.
Alterity signed an agreement with the US FDA on the non-clinical examinations required to assist the Phase 2 clinical trial.
On 30 June 2020, Alterity Therapeutics revealed that the Company received guidance from the US FDA concerning the development pathway for its lead candidate, ATH434 for the treatment of multiple system atrophy (MSA), which is a Parkinsonian disorder.
Currently, there are no approved treatments for multiple system atrophy, and thus, no regulatory standard for accepted efficacy endpoints is available. For this, the FDA and Alterity will collaborate to develop an endpoint that is best suitable for treating multiple system atrophy patients to be analysed.
The FDA has also urged Alterity to use information from a natural history study that the Company has planned with clinical and neuroimaging specialists at the US-based Vanderbilt University Medical Center.
Moreover, the FDA agreed to critical aspects of Phase 2 clinical trial design that includes the proposed patient population, safety monitoring strategy, as well as strategy for assessing drug exposure for the duration of the study.
After successfully completing Phase 1 clinical trial last year, Alterity recently met with the FDA for a pre-investigational new drug (IND) meeting to obtain input on the clinical development plan for ATH434, as well as feedback on Phase 2 clinical trial design.
Dr David Stamler, Chief Medical Officer, Alterity Therapeutics, commented:
Telix Received Breakthrough Designation for TLX250-CDx from FDA
Stock Information: TLX stock ended the day’s trading session at A$1.495 soaring by 16.797% from its previous close. The market cap of the stock stood at A$324.79 million, with nearly 253.74 million shares trading on ASX.
About Telix Pharmaceuticals: Melbourne-headquartered, clinical-stage healthcare player Telix Pharmaceuticals Limited (ASX:TLX) is engaged in developing diagnostic and therapeutic products by using MTR (Molecularly Targeted Radiation). The Company has its operations across the United States, Belgium, and Japan. TLX is into the development of clinical-stage oncology medicine portfolio to address unmet medical requirements in kidney, prostate, and brain tumour.
On 1 July 2020, Telix Pharma revealed that the US FDA granted Breakthrough Therapy designation for renal cancer imaging product TLX250-CDx (89Zrgirentuximab) of Telix.
Under this Breakthrough Therapy status, the FDA and Telix Pharma will work closely, and FDA will provide guidance to the Company on the development of TLX250-CDx for indeterminate renal masses diagnosis.
Breakthrough Therapy designation provides several considerable advantages to Telix, including Fast Track designation eligibility, more frequent and intensive interactions with the FDA, and the opportunity to submit a rolling BLA (Biological Licence Application) for TLX250-CDx
Moreover, the criteria for Breakthrough Therapy designation need initial clinical proof indicating that the product may have a significant improvement on a minimum one clinically substantial endpoint over available care.
Dr Christian Behrenbruch, CEO Telix stated: