THERF - Trogarzo (ibalizumab) approved by FDA

https://theratechnologies.s3.amazonaws.com/prod/media/Press-…

Conference call later today. Great news that ibalizumab has been approved (TM name Trogarzo). We’ll be looking forward to learning the price of the drug. Longer term the rollout in the U.S. (the sales force expansion last year will come into play as they can quickly bring it to market. Then looking out a bit further their Europen application for approval.

“Today’s approval of TrogarzoTM by the FDA is great news for people infected with difficult- to-treat multidrug resistant HIV. We look forward to bringing this much-needed therapy to patients in the U.S within six weeks,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc. “We are grateful to the patients, investigators, as well as the FDA who supported the clinical development of TrogarzoTM, and are helping address this critical unmet medical need.”

John

TaiMed Biologics

Looks like it is on the Taipei Exchange, which I am not familiar with.

Whoops, I should have looked at the link before searching for the drug name, I guess.

Thera Technologies is the relevant company here, listed as TH on the TSE…and as THERF over the counter…which is in the subject line of the OP here.

https://finance.google.com/finance?q=TH&ei=sPeeWrDVCMKAm…

https://finance.google.com/finance?q=OTCMKTS%3ATHERF&ei=…

Now I feel silly a little…but a 5-letter ticker is not something I see too often. Now to actually read some of the press release after first immediately looking to see if the market has already reacted.

First HIV treatment approved with a new mechanism of action in more than 10 years

Infused every two weeks, only antiretroviral treatment (ART) that does not require
daily dosing

Trogarzo™ has no drug-drug interactions and no cross-resistance with other ARTs

From the FDA:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u…

1 Like

TaiMed Biologics

Looks like it is on the Taipei Exchange, which I am not familiar with.

Yes, volfan84, the developer of the drug is TaiMed Biologics. Theratechnologies (THERF on the pink sheets, TH on the Toronto stock exchange) is their partner marketing the drug. A good article explaining the long history of the drug, the production in China, etc. is here:

https://www.healthonym.com/ibalizumab-trogarzo-therf-taimed-…

In one form or another, Trogarzo’s history of preclinical development goes back to 1993. In the early 2000s a phase I clinical trial for the drug was run by Tanox Inc., a U.S. biopharmaceutical company.

Tanox was acquired by Genentech, Inc. in 2006. By 2007, TaiMed Biologics Inc. (a Taiwanese firm) licensed the medication from Genentech.