Australian and Taiwan approval for TLC19 comes after the acceptance of TLC’s investigational new drug application.
Shares of Taiwan Liposome Company Ltd. (TLC) escalates over 31% in today’s trading session. The stock price jumped soon after the company reported that it has obtained the approval in Australia and Taiwan to initiate phase 1 trials of TLC19 for the treatment of COVID-19 disease.
TLC traded above the $6 price mark in the premarket on Wednesday before it opened the market at $6.48. TLC shares have traded with a consistent trend over the past couple of months until today’s rise above $6.
Currently, at 3:26 P.M. EDT, TLC was trading at $5.98 up by 37.47%. The stock touched the day’s high of $6.81, which was its highest trading price since mid-August. The market capitalization was around $238.56 million.
The clinical-stage pharmaceutical firm’s potential treatment for COVID-19 obtained the acceptance of its investigational new drug (IND) application from the Taiwan Food and Drug Administration (TFDA) yesterday while in Australia the Bellberry Human Research Ethics Committee approved TLC’s phase 1 clinical trials of TLC19.
TLC19 is a Hydroxychloroquine Liposome Inhalation Suspension that will be used as a cure against the novel COVID-19 virus. The Phase 1 trials will evaluate the tolerance and safety of TLC19, and also observe the primary endpoints through single dose testing of inhaled TLC19 among 30 healthy volunteers.
The President of TLC, George Yeh mentioned that they are waiting to launch the Phase 1 trials of TLC19 in collaboration with its experienced and globally recognized partners in both Taiwan and Australia. Those partners will help TLC gain government incentives and benefits and support their testing period with fast paced development.
The receipt of this ethics approval is a major advantage for TLC in enhancing its clinical trial notification (CTN) application process. Taiwan is one of those few countries that have resisted against the COVID-19 virus as compared to other developed nations. For this achievement, Taiwan is widely known among the international community for taking successful measures against the global virus.
As a part of the government’s ‘Taiwan Can Help’ initiative, TLC is committed to bringing a practical bridge that will slow down the spread of the virus until an effective vaccine becomes available globally.
On the other side, Australia’s approach towards COVID-19 fight varies based on its recruitment pool. The Australian government offers a 40% financial rebate for clinical trial spending under the R&D tax incentive program.
Taiwan Liposome Company, Ltd. (TLC) is fully focused to make phase 1 trials a success and obtain the primary endpoint of the testing. The data from the initial trial will serve as a basis for subsequent clinical trials in patients with COVID-19.