Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

Should You Worry About What TG Therapeutics Inc (NASDAQ:TGTX) Has Just Done?

TG Therapeutics Inc (NASDAQ:TGTX) has unexpectedly altered the protocol for the GENUINE Phase 3 clinical trial of its lead drug candidate TG-1101. The compound is being developed as a potential treatment for relapsed high-risk chronic lymphocytic leukemia (CLL).

The original study plan

As per the original plan, there were two parts to the Phase 3 study of TG-1101. Part 1 of the study was to test TG-1101 in combination of AbbVie Inc (NYSE:ABBV)’s approved CLL drug known Imbruvica. TG Therapeutics intended to enroll 200 patients in Part 1 study whose primary endpoint was to be the change in overall response rate (ORR).

On the other hand, Part 2 was to still test TG-1101 as a combination treatment with Imbruvica with the endpoint being progression-free survival (PFS).



The amended study plan

TG Therapeutics’ amendment of the study protocol for GENUINE Phase 3 trial of TG-1101 has affected Part 1 but completely eliminated Part 2. The effect on Part 1 is that instead of enrolling 200 patients, the study will now enroll 120 patients. Part 2 has been done away with and that could be the reason investors abandoned the stock immediately the news of the study protocol amendment entered the market.

FDA approval of the study amendment

TG Therapeutics said that the FDA has blessed its changes in GENUINE study plan, adding that the changes will enable it to seek accelerated approval of TG-1101 if the remaining Part 1 study is successful. Furthermore, TG Therapeutics said the amendment of the Phase 3 study plan would save it at least $10 million in costs related to the development of TG-1101 over the coming two years.

Patient enrollment

TG Therapeutics plans to complete enrollment for the GENUINE study by the end of 2016. Topline data from the study are expected in 1H2017, with application for approval targeted for early 2018.

Heightened approval risk

Despite TG Therapeutics’ soothing explanation of the change in GENUINE study protocol, investors seemed to worry that skirting progression-free survival test reduces the approval chances of TG-1101. The reasoning is that if Part 1 study that measures ORR didn’t pan out, maybe the Part 2 study, which was set to measure PFS, would save the day. Now it seems as TG Therapeutics has put all its eggs in one basket.

Follow Tg Therapeutics Inc. (NASDAQ:TGTX)
Trade (NASDAQ:TGTX) Now!

TG Therapeutics stock gained 3.66% to close the last session at $6.23.

Note: This article is written by Andy Parker and was originally published at Market Exclusive.

Biotech Stock Alert - 20% Guaranteed Return in One Year

Hedge Funds and Insiders Are Piling Into

One of 2015's best hedge funds and two insiders snapped up shares of this medical device stock recently. We believe its transformative and disruptive device will storm the $3+ billion market and help it achieve 500%-1000% gains in 3 years.

Get your FREE REPORT and the details of our 20% return guarantee today.

Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.
Loading Comments...

Thanks! An email with instructions is sent to !

Your email already exists in our database. Click here to go to your subscriptions

Insider Monkey returned 102% in 3 years!! Wondering How?

Download a complete edition of our newsletter for free!