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Farmas USA

135K respuestas
Farmas USA
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Farmas USA
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#99945

Re: Farmas USA

TGTX (en realidad ha sido +90%)

TGTX Up 75% Today - GENUINEly Surprised by the Timing, not the Positive Results

GENUINEly Surprised by the Timing, not the Positive Results 
Raymond James - March 6, 2017 

Reni Benjamin, Ph.D., (212) 883-4615,  [email protected] 
Bin Lu, Ph.D., Res. Assoc., (212) 883-6548,  [email protected] 

Recommendation: We are reiterating our Strong Buy rating for TG Therapeutics given that the 
Phase III GENUINE Study met its primary endpoint in both the intent-to-treat population and 
the treated population. While we had been expecting a positive readout in May/June, our 
belief in TG-1101’s additive therapeutic activity has been confirmed given that the absolute 
ORR improvement of 33% achieved by TG-1101 plus ibrutinib over ibrutinib alone (80% vs 
47%, P < 0.001) was significantly greater than the pre-specified threshold of 20%. Given the 
positive GENUINE data, the potential for an accelerated approval in high-risk CLL, the potential 
to initiate a Phase III MS program, the continued advancement of the UNITY-CLL Phase III 
study, and a cash position of $44 million (pro forma), we continue to recommend shares to 
risk-tolerant investors. 

• Like bacon, everything is better with an anti-CD20. As a reminder, the pivotal Phase III 
GENUINE Study (126 randomized patients) was designed to evaluate TG-1101 (an antiCD20 
monoclonal antibody) plus ibrutinib vs ibrutinib alone in patients with previously 
treated high risk chronic lymphocytic leukemia (CLL). The study met its primary endpoint 
with TG-1101 plus ibrutinib achieving a statistically significant improvement in overall 
response rate (ORR) compared to ibrutinib alone in the intent to treat (ITT) population 
(p=0.001) as well as the treated population (80% vs 47%, P < 0.001). While nine and five 
responders from both arms included in the primary analysis are awaiting additional 
confirmation visits, in our opinion, these patients treated by the TG-1101 combo are likely 
to maintain the responses given that it was infrequent (< 3% in the combination arm) for 
initial responses to fail to be confirmed. In terms of safety, the combination was well 
tolerated with a safety profile consistent with that established in the previous Phase II 
study. The company plans to present the full data at a medical meeting (likely ASCO) in 
1H17 and meet with FDA in 2H17 to discuss a potential BLA filling (1H18) for an 
accelerated approval. 

• FDA likes randomized trial results. While there is no doubt that the GENUINE study has 
produced positive results, investors are likely to question whether the ORR data is robust 
enough to support a potential accelerated approval. In our opinion, given that ibrutinib, 
idelalisib, and venetoclax all gained one or more accelerated approvals based on ORR 
results from single-arm studies (see Exhibit 1 for more detail), we believe there is high 
likelihood for approval based on the randomized design and comparison with the 
standard of care. 

• Clinical investigator highlights unmet need and enthusiasm over results. During the call, 
Dr. Anthony Mato from the University of Pennsylvania, a lead investigator of the 
GENUINE trial, shared his perspectives, including: 1) The results are overwhelmingly 
positive given that the high-risk population are the most difficult-to-treat CLL patients; 2) 
The delta in the response rate shows the synergistic effect between TG-1101 and 
ibrutinib, and it is not likely to decrease even if the response rate of ibrutinib as a single 
agent may improve a little bit over time based on his experience of treating patients with 
ibrutinib alone; 3) TG-1101 did not add much toxicity to ibrutinib aside from infusionrelated 
reactions, which were infrequent and mild and have not caused a single 
discontinuation among the patients he treated; 4) It is important to have another CD20 
antibody which can add treatment benefits on top of ibrutinib given that the majority of 
CLL patients would likely have failed on rituximab; and 5) Neither ibrutinib or venetoclax 
represents a cure in the high-risk setting and both have poor responses as monotherapy 
with venetoclax only reaching 3% MRD negativity in patients.  

Company Description ____________________ 

TG Therapeutics, Inc., based in New York, New York, is a biotechnology company focused on commercializing 
innovative therapies for the treatment of cancer and other large areas of unmet need. Currently, the 
company is developing two advanced stage therapeutics: 1) TG-1101 (ublituximab) – a novel 
glycoengineered monoclonal antibody targeting the CD20, an established target of monoclonal antibodies 
including rituximab, obinutuzumab, and ofatumumab, all of which are currently approved for the treatment 
of B-cell lymphomas and leukemias; and 2) TGR-1202 – an orally available PI3K delta inhibitor, another 
validated target linked to the proliferation and survival of B-lymphocytes, and which culminated with the 
approval of Gilead’s Zydelig. In addition, the company's pipeline also includes a PD-L1 inhibitor, a 
GITR agonist, and an IRAK4 inhibitor

#99947

Re: Farmas USA

Suntrust ha subido el PT de TGTX a $26 (de $19) y Landenburg a $30

#99949

Re: Farmas USA

Eso es mantequilla

#99951

Re: Farmas USA

En serio no pasó hambre, pero lo que sí extraño es lo dulce, aunque un chocolatito negro al 81% nunca falla después d comer y cenar para la ansiedad del tabaco.

#99952

Re: Farmas USA

yo soy de los que se meten una tarta en solitario y aun esta con ganas de otra.

Pero hace tiempo que descubri dos truquillos que minimizan esa sensacion de necesidad de dulce. Uno es tomarme de vez en cuando un batido de proteinas sabor chocolate, con poca agua, bien denso. Y otro son unas pastillitas de "picolinato de cromo" para ayudar a regular la insulina. Efecto placebo o no .. el vicio de lo dulce lo lleva uno mejor.

De todos modos, operacion bikini + dejar de fumar ... telita marinera con el reto. Ánimo.

Y dicho esto, perdonad por el offtopic.

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