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TG Therapeutics, Inc. (TGTX)

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  • B
    Biotech
    More coverage. OncLive article:
    FDA Grants Ublituximab/Umbralisib Combo Fast Track Status in CLL
    October 21, 2020
    Gina Mauro

    The FDA has granted a fast track designation to the investigational CD20-directed monoclonal antibody ublituximab in combination with the PI3K-delta inhibitor umbralisib for the treatment of adult patients with chronic lymphocytic leukemia.

    The FDA has granted a fast track designation to the investigational CD20-directed monoclonal antibody ublituximab in combination with the PI3K-delta inhibitor umbralisib (U2 regimen) for the treatment of adult patients with chronic lymphocytic leukemia (CLL).1

    Positive topline results of the combination were unveiled in May 2020 from the phase 3 UNITY-CLL trial, in which the doublet improved progression-free survival (PFS) compared with obinutuzumab (Gazyva) plus chlorambucil in patients with previously untreated and relapsed/refractory disease.2 The study is being conducted under a Special Protocol Assessment agreement with the FDA.

    An independent review panel determined that the chemotherapy-free U2 combination induced a statistically significant improvement in PFS (P < .0001), and the panel recommended that the trial be stopped early.

    "We are extremely pleased to have received fast track designation for the ublituximab plus umbralisib regimen, or the U2 combination, to treat adult patients with CLL. The application for Fast Track was based on data from the UNITY-CLL phase 3 study that we announced earlier this year had met its primary endpoint of progression free survival,” said Michael S. Weiss, executive chairman and chief executive officer of TG Therapeutics, the developer of both agents.

    In the phase 3 UNITY-CLL trial, patients with both treatment-naïve and relapsed/refractory CLL were initially randomized into 1 of 4 treatment arms: single-agent ublituximab; single-agent umbralisib; U2; or obinutuzumab plus chlorambucil. The trial design did allow for discontinuation of the 2 monotherapy arms following a positive assessment of the U2 combination. Randomization, at that point, continued with the U2 and obinutuzumab/chlorambucil arms only.

    Overall, the trial enrolled 420 patients across these 2 arms, which comprised approximately 60% treatment-naïve patients and 40% of relapsed/refractory patients. The primary endpoint is PFS and, if positive, will be used to support the submission for full approval of the U2 combination in this patient population.

    Previously, a number of doublet and triplet combinations including umbralisib and/or ublituximab have shown intriguing results in CLL. For example, the triplet regimen of pembrolizumab (Keytruda) plus umbralisib/ublituximab induced a 90% objective response rate (ORR) in patients with relapsed/refractory disease.3 Nine of 10 patients with CLL receiving the triplet achieved a response, including 1 complete response (CR) and 8 partial responses (PRs), according to data from a phase 1/2 study presented at the 2018 ASH Annual Meeting.

    Furthermore, the triplet of umbralisib, ublituximab, and venetoclax (Venclexta) induced a CR rate of 44% as a treatment for patients with relapsed/refractory chronic CLL in a phase 1/2 dose-escalation study.4 At the end of 12 cycles of treatment with the regimen, the ORR was 100%, which included the CR rate of 44%. In an assessment of peripheral blood, all patients were negative for minimal residual disease (MRD). In the bone marrow, 78% were MRD-negative (< .01%) and 22% were MRD intermediate (.01% to 1.0%). At a median follow-up of 6.4 months (range, 0.7 to 19.0+), no patients had progressed.

    In long-term data from the phase 3 GENUINE study, the combination of ublituximab and ibrutinib (Imbruvica) improved PFS, as determined by an independent review committee, versus single-agent ibrutinib in patients with relapsed/refractory high-risk CLL.5 Results showed that the ORR was 78%, which included a CR rate of 7%, compared with a 45% ORR in the single-agent ibrutinib arm where there were no CRs. Additionally, 19% of patients in the ublituximab arm were MRD negative versus 2% of patients on ibrutinib alone. Overall, 66% of patients had a >75% decrease in lymph node size with ublituximab plus ibrutinib compared with 52% for ibrutinib alone.

    “This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL,” Weiss concluded. “We look forward to presenting data from the UNITY-CLL phase 3 trial later this year, which we plan to use as the basis of a U2 regulatory submission for CLL.”

    References

    TG Therapeutics announces fast track designation granted by the FDA to ublituximab in combination with umbralisib for the treatment of adult patients with chronic lymphocytic leukemia. News release. TG Therapeutics. October 21, 2020.
    Bullish
  • B
    Biotech
    B. Riley Securities
    $TGTX Ublituximab the Ultimate Fast-Follower in the Fastest Growing Drug Class in Multiple Sclerosis; Reiterate Buy,
    PT from $37 to $52
    Bullish
  • B
    Biotech
    TG Therapeutics Announces Fast Track Designation Granted by the FDA to Ublituximab in Combination with Umbralisib for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia
    Oct 21, 2020

    PDF Version
    NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the combination of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of adult patients with chronic lymphocytic leukemia (CLL).

    Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased to have received Fast Track designation for the ublituximab plus umbralisib regimen, or the U2 combination, to treat adult patients with CLL. The application for Fast Track was based on data from the UNITY-CLL Phase 3 study that we announced earlier this year had met its primary endpoint of progression free survival. This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL.” Mr. Weiss continued, “We look forward to presenting data from the UNITY-CLL Phase 3 trial later this year, which we plan to use as the basis of a U2 regulatory submission for CLL.”

    ABOUT FAST TRACK
    Fast Track is a program designed to expedite the development and review of drugs that treat serious conditions and that demonstrate the potential to address an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy.

    A drug that receives Fast Track designation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the Biologic License Application or New Drug Application.

    ABOUT UNITY-CLL PHASE 3 TRIAL
    UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the combination of ublituximab plus umbralisib, or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, umbralisib single agent, ublituximab plus umbralisib and an active control arm of obinutuzumab plus chlorambucil. A prespecified analysis was conducted to assess the contribution of ublituximab and umbralisib in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Full enrollment into the UNITY-CLL Phase 3 trial completed in October of 2017 with approximately 420 subjects enrolled to the two combinations arms. This trial enrolled approximately 60% treatment-naïve CLL patients and 40% relapsed or refractory CLL patients. The primary endpoint for this study was superior Progression Free Survival (PFS) for the U2 combination compared to the control arm to support the submission for full approval of the U2 combination in CLL. Positive topline results from this trial were announced in May 2020. The UNITY-CLL Phase 3 trial is being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

    ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
    Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia, and in 2020 it is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States1. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.
    Bullish
  • B
    Biotech
    The path to $100+ is not linear.

    Stamina
    Persistence
    Knowledge
    No margin
    No stop gaps
    Continuous due diligence will help you with the above.
    Bullish
  • T
    Terry
    Following shows what the FDA is looking for before "Fast Tracking" a Drug:

    If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

    Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
    Avoiding serious side effects of an available therapy

    Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome

    Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment

    Ability to address emerging or anticipated public health need
  • D
    Daniel
    Tax Ramifications on a Biden Presidency. I can't help but think that if MW gets a good enough offer from a major biopharma company by end of year, that he might take the buyout. Hear me out. If someone offers him $60 pps, I think that he takes it. On a Bident presidency, his capital gain would go back to 39.6% and I believe that he lives in State of New Jersey and they moved their tax rate to 10.75% on their highest earners. Under Trump for this last year, he would be looking at 23.8% for a long term capital gain. That is a huge difference.
  • B
    Biotech
    Each day which passes is a day closer to the day:
    - ublituximab data for multiple Sclerosis is released
    - ASH 20 Abstracts are released and the actual Dec ASH presentations
    - TGTX holds the investor day
    - margin call ins for the 14 million shares short (some losing all their belongings)

    Today we have a dip of $1. So what in the greater scheme of events. As Jefferies said we could have a 50%+ spike on data read out ($15+).
  • S
    Steve
    Rituximab was the leading therapy in CLL, generating about $4.5B in 2018. Roche developed Gazyva to replace Ritux once it went off-label. Gazyva is expected to do around $5B in annual sales by 2022.

    Just to give you an idea of the market size potential here.
  • O
    Ouch
    Its very simple...IF you believe TGTX can do say ~$4B annually from their drug therapies revenues contribution mix, the rewards from this current stock price level should be enormous....Just look at AMGN's revenues to market cap(5.5{X})....Equated would = TGTX at $173
  • B
    Biotech
    $10B+ annual revenues is TGTX potential
    $3.6B is TGTX market cap

    At x6 peak revenues the market cap shoots from $3.6B to > $60B

    Holding on no matter what. Be strong. Know what you own.
    Bullish
  • B
    Biotech
    The 14M shares short desperately need to cover their positions. Rest assured they did more due diligence then you. Their only way out is to make weak holders scream and trigger their stop gaps.

    Holding on tight baby.

    11/05 ASH abstracts.
    Any day MS data. E
    Early December TGTX investor day during ASH20
    2021 approvals begin
  • B
    Biotech
    Laden TGTX: Fast Track Designation Granted for U2 in CLL; Reiterate Buy Rating and $44 PT
    Bullish
  • F
    FMK
    Same pattern with Unity...investors get nervous about data and timeline ..SP goes down...TG delivers..SP goes up ...rinse and repeat...
    Bullish
  • J
    JL
    Cramer just gave TGTX and MW a shoutout, likes the stock, wants MW to come back on the show.
    Where you at Mike?
  • F
    Fred
    Well even though I don't like garp....he may be right about the ms results. They should have been released by now. mw may be holding back on releasing the results because they are not what the company expected . In other words, the results may be positive but not better than the current therapy available. This selloff is starting to concern me and I'm sure there are other longs concerned as well. Not selling but concerned.
  • Y
    Yum Yum
    Folks don’t worry about the daily gyrations in the stock price. Shorts are trying to shake some weak hands of their shares while they still can. The drop in price is just that, it has no relevance to the underlying fundamentals, clinical trial(s)/pending results, etc...I’m staying in this long.
    Bullish
  • O
    Ouch
    Some upcoming catalysts for TGTX:
    1) Of course, the long awaited ULTIMATE MS PHASE III, which is super duper close in revelation.
    2) Numerous data revelations at ASH(December, 2020) including the full CLL(U2) data. Including also, U2 in combination trial data, which could potentially mean U2 in combo becoming the next new standard of care(this could be bigger than the MS data reveal, IMO)....
    3) CLL NDA filing(Q4, 2020)
    4) MZL FDA decision(Feb 15, 2021) breakthrough, priority review designated
    5) FL FDA decision(July, 2021)
  • F
    Felix
    Target price 200% higher than today’s unrealistic value. Lots of good news on the horizon, besides Cramer’s off hand blessing.
  • B
    Biotech
    These price gyrations make me confident we got a winner.

    Cheers to all soon to be millionaires
    Bullish
  • H
    Hohum
    This is well within the higher highs and higher lows pattern. We should see us going back to new highs, hopefully much higher highs on the back of great MS data reveal! GL