Tag: TGTX

  • TG Therapeutics Inc (TGTX) stock soared in the current market trading session; find out why

    TG Therapeutics Inc (TGTX) stock soared in the current market trading session; find out why

    TG Therapeutics Inc. (TGTX) stock soared by 1.71% to the price of $45.04 in the current market at the time of writing. TGTX stock previously closed at $45.83. TGTX stock traded today at a volume of 1.74 million shares. This volume was 0.28 million higher than the average daily volume of 1.42 million shares for the past 3 months. In the last 12 months, TGTX stock soared by 344.09%, however, in the past week the stock moved down by -1.86%. The stock has lost -13.67% in the three previous months, and over the previous six months, an additional 47.36%. Furthermore, TG Therapeutics Inc. is currently valued at $6.72 billion with 124.19 million outstanding shares.

    Operational background of TG Therapeutics Inc.

    TG Therapeutics is a commercial-stage biopharmaceutical company that is focused on designing, acquiring, and commercializing novel and unique treatments to meet the unmet needs of patients. These treatments are specifically for diseases related to autoimmunity as well as B-cell malignancies.  The leading treatments and therapeutics of TGTX include Ublituximab (for treating B-cell non-hodgkin lymphoma, CLL, multiple sclerosis relapsing form), Umbralisib (for treating CLL, marginal zone, and follicular lymphoma), and Cosibelimab (blocker of death-ligand), in addition to having these and many more medicines commercialized, the TGTX stock has an active research pipeline.

    Latest approvals and investigative studies performed at TGTX

    The latest approval received by the company from the FDA is for UKONIQTM which is in medical terms, an oral inhibitor containing P13K delta and CK1-epilson. The company is working on two programs that are currently in phase 3 developments which are meant for the treatment of RMS and CLL along with several phase 1 medicines in the investigational phase.

    TGTX stock announced that it has achieved positive results from Ultimate I & II which were phase 3 studies that were actively controlled and were purposed for the evaluation of ublituximab.  The study ended up with results that concluded that both tests had met their primary endpoint for ublituximab; statistically reduced ARR in 96 week period.

    At the American Academy of Neurology’s 73rd Annual meeting, TXTG will be presenting the results of this study on 17th April 2021. According to Lawrence Steinman, MD, Zimmermann who was the global chair for Ultimate I and II stated that the results of the studies reduced the relapses in the patients as well as reduced the inflammatory activity. The studies also reduced lesions in the brain and chances of disability progressions had a low rate in RMS patients when treated with ublituximab.

    Future prospects of Ublituximab

    The studies tested the efficacy of infusion activity of 450 mg Ublituximab one hour every six months. The results were conducted under special protocol assessment that was made with the FDA. The next aim is to use the results of this study and its efficacy to push for a Biological License submission for ublituximab. This will be targeted for 2021’s third quarter.

  • Don’t Miss these 15 Biotechnology Value Stocks

    Biotech and Major Pharmaceuticals are back in the news with the Covid-19 Pandemic. Life science investors basically endorse developments that might decide the human race’s future, but what would invest in ‘cures’ mean from a cash flow point of view?
    On Thursday, a panel of independent health professionals voted 17-4 in support of the Food and Drug Administration(FDA), providing emergency permission to the applicant for the COVID-19 vaccine from BioNTech and Pfizer Inc.
    In other news Gilead Sciences Inc (GILD) revealed that it would buy MYR GmbH in cash for roughly EUR 1.15 billion ($1.39 billion), granting it access to the German biotech company’s therapy for extreme viral hepatitis.
    In yesterday’s trading session, the following stocks were the major key players.

    Immutep Limited (NASDAQ:IMMP) shares were trading up 163.43% at $5.69 at the time of writing on Thursday after declaring that its Chinese partner, EOC Pharma will commence a new Phase II clinical trial in up to 152 metastatic breast cancer patients in China.

    Immutep Limited (NASDAQ:IMMP) share price went from a low point around $0.53 to briefly over $3.10 in past 52 weeks, though shares have since pulled back to $5.69. IMMP market cap has remained high, hitting $280.46M at the time of writing.

    If we look at the recent analyst rating IMMP, B. Riley FBR initiated coverage on IMMP shares with a Buy rating.

    TG Therapeutics Inc. (TGTX) stock soar by 40.85% to $41.72 after reportingpositive topline results from the ULTIMATE I & II Phase 3 studies evaluating Ublituximab Monotherapy for the treatment of patients with multiple sclerosis. The most recent rating by JP Morgan, on September 01, 2020, is at an Overweight.

    Heat Biologics Inc. (HTBX) last closed at $0.93, in a 52-week range of $0.19 to $4.30.

    Sangamo Therapeutics Inc. (NASDAQ:SGMO) Shares headed rising, higher as much as 52.98%. Pfizer Inc. (PFE) and Sangamo Therapeutics, Inc. (SGMO), on December 7, 2020 declared updated follow-up data from the Phase 1/2 Alta study of giroctocogene fitelparvovec (SB-525 or PF-07055480), an investigational gene therapy for patients with severe hemophilia A. The most recent rating by BofA Securities, on September 08, 2020, is at a Buy.

    Entera Bio Ltd. (NASDAQ:ENTX) rose 8.18% after gaining more than $0.09 on Thursday following the firm revealed FDA approval of IND application for EB613 – an Oral Human Parathyroid Hormone (1-34) for the treatment of Osteoporosis.

    Aytu BioScience Inc. (AYTU) last closed at $8.13, in a 52-week range of $3.35 to $29.90 after announcing definitive merger agreement with Neos Therapeutics, creating a combined $100M revenuespecialty pharmaceutical company.

    Amarin Corporation plc (AMRN) stock soar by 8.04% to $4.97. The most recent rating by JP Morgan, on September 29, 2020, is at a Neutral.

    Editas Medicine Inc. (NASDAQ:EDIT) Shares headed rising, higher as much as 32.15% following an announcement from the company that it submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical trial of EDIT-301. The most recent rating by Wells Fargo, on December 10, 2020, is at an Overweight.

    Hepion Pharmaceuticals Inc. (NASDAQ:HEPA) rose 9.04% after gaining more than $0.15 on Thursday.

    Akebia Therapeutics Inc. (AKBA) last closed at $2.95, in a 52-week range of $2.09 to $13.71. The firm recently revealed the latest scheduled program of AkebiaShares, a peer-to-peer educational series for the kidney community.

    BioCryst Pharmaceuticals Inc. (BCRX) stock soar by 5.37% to $7.65. The company recently announced transactions with Royalty Pharma (RPRX) and Athyrium Capital Management, LP, totaling $325 million in funding for BioCryst, with $250 million available at closing, to support the launch of ORLADEYO™ (berotralstat) in hereditary angioedema (HAE) and the development of its oral Factor D inhibitor, BCX9930. The most recent rating by JP Morgan, on September 29, 2020, is at an Overweight.

    Acasti Pharma Inc. (NASDAQ:ACST) Shares headed rising, higher as much as 1.70%. The company on November 16, 2020 released its operating and financial results for the second quarter of fiscal 2021 ended September 30, 2020. The most recent rating by Oppenheimer, on September 01, 2020, is at a Perform.

    Ocugen Inc. (NASDAQ:OCGN) fall -1.79% after losing more than -$0.01 on Thursday after reporting that it will postpone its 2020 Annual Meeting of Stockholders to December 23, 2020.

    Inovio Pharmaceuticals Inc. (INO) last closed at $11.36, in a 52-week range of $2.42 to $33.79. The firm recently revealedthe successful dosing of its first subject in its Phase 2 clinical trial for COVID-19 DNA vaccine candidate, INO-4800, in China. Analysts have a consensus price target of $13.71.

    Cellectar Biosciences Inc. (CLRB) stock soar by 3.47% to $2.09. The most recent rating by Oppenheimer, on July 01, 2020, is at an Outperform.

  • TG Therapeutics (NASDAQ: TGTX) Ublituximab Receives Fast Track Designation In US

    TG Therapeutics (NASDAQ: TGTX) Ublituximab Receives Fast Track Designation In US

    TG Therapeutics, Inc. (NASDAQ: TGTX) has announced Wednesday that it has received the Fast Track Designation for its ublituximab/umbralisib combo for the treatment of adult patients with chronic lymphocytic leukemia (CLL) from the FDA.

    Fast Track is basically the program developed to speed up the review of drugs that treat serious diseases and address unmet medical needs. Filling an unmet medical need is to provide the treatment for those diseases for which no medical treatment is available earlier or offering a medical treatment that may be better than available therapy.

    TG Therapeutics, Inc. (NASDAQ: TGTX) shares were trading up 0.31% at $28.75 at the time of writing on Wednesday. TG Therapeutics, Inc. share price went from a low point around $5.38 to briefly over $31.97 in the past 52 weeks, though shares have since pulled back to $28.75. TGTX market cap has remained high, hitting $334.37M at the time of writing.

    The application of Fast Track designation is based on the data from UNITY-CLL Phase 3 study. The company has announced earlier in UNITY-CLL Phase 3 data that the treatment has shown a positive result. This Fast Track Designation is very important for the company. UNITY-CLL Phase 3 is the study to analyze the combination of ublituximab and umbralisib. Ublituximab is a glycoengineered anti-CD20 monoclonal antibody, and umbralisib is a dual inhibitor of PI3K-delta and CK1-epsilon.

    Chronic lymphocytic leukemia (CLL) is a serious issue in the current period as more than 20,000 new cases have been reported alone in the US. After initial treatment, its symptoms disappear for a period of time but the disease is considered incurable. People need additional treatment after the return of the malignant cells.