Galectin Therapeutics, Inc. (GALT) - NASDAQ
  • Wed, May 11, 8:31 AM
    • Galectin Therapeutics (NASDAQ:GALT) completes enrollment in its Phase 2 clinical trial, NASH-FX, assessing lead product candidate GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with advanced (stage 3) fibrosis. The single-site study is being conducted at the San Antonio Military Medical Center in Texas. Top-line results should be available by late September, as previously planned.
    • The 30 subjects in NASH-FX were split into two equal arms to receive either 8 mg/kg of GR-MD-02 or placebo every other week for 16 weeks (nine total doses). The primary endpoint is the mean change in liver fibrosis as measured by multi-parametric magnetic resonance imaging (LiverMultiScan) developed by UK-based Perspectum Diagnostics.
    • GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis. Another mid-stage NASH study, NASH-CX, started in July 2015 with top-line data expected in Q4 2017. It is also being evaluated for the treatment of psoriasis.
    • Shares are up 16% premarket on light volume.
    • Previously: Galectin's mid-stage study of GR-MD-02 in NASH with advanced fibrosis underway (Sept. 16, 2015)
    • Previously: Galectin initiates enrollment in mid-stage trial of GR-MD-02 in NASH (July 1, 2015)
    | Wed, May 11, 8:31 AM | 1 Comment
  • Tue, May 10, 8:09 AM
    | Tue, May 10, 8:09 AM
  • Wed, Apr. 6, 1:45 PM
    | Wed, Apr. 6, 1:45 PM | 19 Comments
  • Fri, Mar. 18, 11:52 AM
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    • Depomed (DEPO -0.5%) initiated with Outperform rating and $21 (62% upside) price target by Leerink Swann.
    • Galectin Therapeutics (GALT +1.6%) initiated with Buy and $6 (380% upside) price target by Roth Capital.
    | Fri, Mar. 18, 11:52 AM
  • Tue, Mar. 15, 8:49 AM
    • Galectin Therapeutics (GALT) FY15 results: Revenues: $0; R&D Expense: $13.1M (+56.0%); SG&A: $6.97M (-0.6%); Operating Loss: ($20.1M) (-30.5%); Net Loss: ($21.1M) (-24.1%); Loss Per Share: ($0.88) (-12.8%); Quick Assets: $25.8M (-11.3%).
    • No guidance given.
    | Tue, Mar. 15, 8:49 AM
  • Tue, Mar. 15, 8:06 AM
    | Tue, Mar. 15, 8:06 AM
  • Tue, Feb. 2, 8:02 AM
    | Tue, Feb. 2, 8:02 AM | 17 Comments
  • Nov. 20, 2015, 12:47 PM
    | Nov. 20, 2015, 12:47 PM
  • Nov. 20, 2015, 10:28 AM
    • Galectin Therapeutics (GALT -11.3%) inks a securities purchase agreement with institutional investors for the sale of 4,761,900 shares of common stock at $2.06 plus five-year warrants to purchase up to 3,571,425 shares of common at $2.50.
    • Net proceeds will fund clinical trial expenses, R&D and general corporate purposes. Closing date is November 25.
    | Nov. 20, 2015, 10:28 AM
  • Nov. 16, 2015, 8:21 AM
    • The design of a pivotal Phase 3 clinical trial assessing GENFIT's (OTCPK:GNFTF) lead product candidate, Fast Track-tagged Elafibranor (GFT505), for the treatment of non-alcoholic steatohepatitis (NASH) has been finalized. The study is set to commence this quarter.
    • The 1,800-subject, randomized, double-blind, placebo-controlled trial will be conducted across 200 centers worldwide. The study population will include NASH patients who have a NAFLD Activity Score (NAS) of at least 4, with F2 (light) or F3 (severe) fibrosis. Participants will receive 120 mg of Elafibranor or placebo once daily. An interim analysis will be performed on the first 900 patients after 72 weeks that will support initial regulatory approval. To support full approval, the trial will continue to conclusion to show the impact of Elafibranor on the prevention of cirrhosis and other liver-related outcomes on the full study population. A group of F1 fibrotic patients who have cardiometabolic co-morbidities will be enrolled as well. The study will continue post-marketing and will remain blinded after the interim analysis. All patients will be followed until the occurrence of a pre-defined number of progressions to cirrhosis or other liver-related events.
    • The primary endpoint is the resolution of NASH without worsening of fibrosis.
    • NASH-related tickers: (NASDAQ:TBRA)(NASDAQ:ICPT)(NASDAQ:DRRX)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:CNAT)(NASDAQ:VBLT)(NASDAQ:RPTP)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)
    | Nov. 16, 2015, 8:21 AM | 21 Comments
  • Nov. 9, 2015, 8:24 AM
    • Galectin Therapeutics (NASDAQ:GALT): Q3 EPS of -$0.26 misses by $0.06.
    | Nov. 9, 2015, 8:24 AM
  • Sep. 25, 2015, 2:01 PM
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    • Intrexon (XON -6.1%) initiated with Buy rating and $69 (66% upside) price target by Stifel.
    • Galectin Therapeutics (GALT -2.6%) initiated with Buy rating and $7 (210% upside) price target by H.C. Wainwright.
    • Infinity Pharmaceuticals (INFI -6.7%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target lowered to $13 (51% upside) from $15.
    • Immunogen (IMGN -5.3%) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $9 (15% downside risk) from $10.
    • Horizon Pharma (HZNP -3.3%) downgraded to Hold from Buy by Brean Capital. Price target removed.
    | Sep. 25, 2015, 2:01 PM | 4 Comments
  • Sep. 24, 2015, 11:52 AM
    • Galectin Therapeutics (GALT -0.9%) initiates a 10-subject Phase 2a pilot study of GR-MD-02 in moderate-to-severe plaque psoriasis. The open-label trial will enroll patients with PASI scores of ~12 with psoriasis affecting ~10% of their skin's surface area. Subjects will receive 8 mg/kg of GR-MD-02 every other week for a total of seven infusions. The primary endpoint is PASI-75 (75% reduction in severity 30 days following the last infusion). PASI (Psoriasis Area Severity Index) is a composite measure of the severity of psoriasis for an individual patient.
    • The company decided to explore the potential therapeutic benefit of GR-MD-02 in moderate-to-severe plaque psoriasis after a participant in the company's Phase 1 study in NASH reported the resolution of her psoriasis following treatment with GR-MD-02. Her condition remained in remission for 17 months following her fourth infusion.
    • According to the International Federation of Psoriasis Associations, ~3% of the global population is affected by some form of psoriasis. In the U.S., the proportion is ~2%.
    • GR-MD-02, the company's lead product candidate in its fibrosis program, is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis.
    | Sep. 24, 2015, 11:52 AM
  • Sep. 16, 2015, 11:58 AM
    • Galectin Therapeutics (GALT +3.4%) announces the start of its Phase 2 clinical trial, called NASH-FX, evaluating its investigational GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with advanced fibrosis.
    • The 30-subject study will be split into two arms: 15 patients will receive 8 mg/kg of GR-MD-02 and 15 will receive placebo every other week for 16 weeks. The primary efficacy endpoint is an assessment of fibrosis as measured by MRI imaging. Secondary endpoints will assess liver stiffness, which correlates to the degree of fibrosis. Top-line data are expected in Q3 2016.
    • GR-MD-02, the company's lead product candidate in its fibrosis program, is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis.
    • Another Phase 2 trial, called NASH-CX, commenced in early July.
    | Sep. 16, 2015, 11:58 AM
  • Aug. 13, 2015, 9:19 AM
    | Aug. 13, 2015, 9:19 AM | 5 Comments
  • Aug. 13, 2015, 8:40 AM
    • The USPTO issues a Notice of Allowance to Galectin Therapeutics (NASDAQ:GALT) for its patent application number 13/726,900 titled, "Galactose-pronged polysaccharides in a formulation for antifibrotic therapies." The patent, when issued, will extend the coverage of the company's pectin-derived compounds to include treatment of chronic kidney disease associated with the development of fibrosis, established kidney fibrosis, chronic lung disease associated with the development of fibrosis and established lung fibrosis.
    • Update: shares are up 22% premarket on higher-than-normal volume.
    | Aug. 13, 2015, 8:40 AM
Company Description
Galectin Therapeutics, Inc. operates as a biotechnology company, which engages in drug research and development to create new therapies for fibrotic disease and cancer. Its drug candidates are based on the method of targeting galectin proteins, which are key mediators of biologic and pathologic... More
Sector: Healthcare
Industry: Drugs - Generic
Country: United States