TG Therapeutics (NASDAQ: TGTX) shares were on fire, and the stock returned 90.65% on March 6, 2017. After Monday, TGTX was up 119.35% YTD and 82.14% over the past three months. Additionally, the stock was up 108.16% over the past month. Traders exchanged over 33M TGTX shares today, while the 30-day average daily volume was just over 400K shares.
Here’s a look at TGTX’s performance since late-December 2016:
Now, here’s the reason why TGTX caught on fire on March 6, 2017.
TG Therapeutics Announced Positive Phase 3 Data
TG Therapeutics announced positive topline results from its Phase III GENUINE clinical trial of TG-1101, or ublituximab, and ibrutinib in patients with previously treated high risk Chronic Lymphocytic Leukemia. The multi-centered clinical trial aimed to evaluate the safety and effectiveness of TG-1101.
In the Phase III clinical trial, the overall response rate was 80% for TG-1101 plus ibrutinib. However, ibrutinib, alone, had an overall response rate of just 47%.
TGTX CEO Michael S. Weiss stated, “TG-1101 is a highly potent next generation glycoengineered anti-CD20 monoclonal antibody. We believe the data today demonstrate that the addition of TG-1101 to ibrutinib enhances the therapeutic benefit of ibrutinib in patients with previously treated high risk CLL, the patient population with the poorest outcome on ibrutinib. We believe the results observed in the combination arm are extremely compelling and the regimen has the potential to become the standard of care for treating patients with high risk CLL that have progressed from other therapies…”
Weiss went on to say, “We believe that using combination therapy to accelerate and deepen response in poor prognosis high risk CLL is critically important for patient outcomes and we look forward to sharing these data with the FDA in the coming months to discuss filing for accelerated approval. Most importantly, we would like to thank the investigators and their patients for participating in this significant research.”
GENUINE Phase III Study Chair Weighs In
GENUINE Phase III Study Chair, Dr. Jeffrey Sharman, said, “Ibrutinib has been a great addition to our CLL armamentarium, however we have long believed that ibrutinib alone may not be enough, particularly for patients with high-risk disease. This study demonstrates that the addition of ublituximab, can significantly enhance the response rates without compromising safety. We believe that the rapid responses seen in our Phase 2 study with ublituximab plus ibrutinib are validated here in our Phase 3 GENUINE study and are important markers of improved overall efficacy and patient outcomes. I look forward to the presentation of the results at an upcoming medical meeting.”
TG Therapeutics could continue its rise after this data. TGTX just reached over $500M valuation due to the positive data. If the FDA approves TG-1101, it could push the company’s earnings and revenues higher. Moreover, this news could spur some M&A activity in TGTX.
TGTX Received Orphan Drug Status Previously
Prior to this, the FDA viewed TG-1101 as a potentially safe and effective treatment for a rare disease or disorder.
Now, TG Therapeutics received some good news prior to its Phase III trial, and TG-1101 could be a cash cow for the company. In January 2017, TGTX announced the U.S. FDA granted the company orphan drug designation combining TG-1101 and TGR-1202.
Weiss stated, “Receiving orphan drug designation for our proprietary combination of TG-1101 and TGR-1202 provides another layer of exclusivity protection on top of the composition of matter patents which were issued for TG-1101 and TGR-1202 last year and patents on the combination that have been filed and are pending approval…Additionally, with enrollment into our UNITY-CLL Phase 3 trial currently exceeding our expectations, we expect to be able to commence a regulatory filing for the combination in 2018 and having orphan drug designation will provide certain cost saving advantages for us during the regulatory approval process.”
The Bottom Line
TG Therapeutics was up over 90% today, and it could continue to rise off of the bullish news. TGTX reported its third quarter 2016 financial results on November 7, 2016, and the results were unsatisfactory. However, if TG-1101 gains FDA approval, that all could change. TGTX reported an EPS loss of 50 cents. Consequently, it missed analysts’ estimates by 19 cents, a negative surprise of over 60%. With the need for Chronic Lymphocytic Leukemia, the demand for TG-1101 could be high. If the FDA approves TG-1101, the company’s drug could generate earnings.