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Tag: Galapagos

  • Galapagos (NASD:GLPG) Stock Gains Pre-Market Momentum

    Galapagos (NASD:GLPG) Stock Gains Pre-Market Momentum

    The US stock market is witnessing a notable surge in the value of Galapagos NV (NASDAQ: GLPG) shares. The stock increased by 6.55% as of the most recent pre-market check, trading at $30.25. This was on top of a previous session advance of 9.66%, which ended at $28.39. This encouraging pattern comes after the firm gained a significant regulatory approval last week, which gave its stock performance even more traction.

    Galapagos Won FDA Approval for ATALANTA-1 Study

    The FDA in the United States has accepted Galapagos NV’s application for an Investigational New Drug (IND) for ATALANTA-1, the company said recently. With this permission, the business may move forward with a Phase 1/2 multicenter research assessing GLPG5101, a product that uses autologous CD19 CAR-T cells for cell therapy. The goal of the trial is to evaluate GLPG5101’s viability, safety, and effectiveness in treating patients with relapsed or resistant non-Hodgkin lymphoma (R/R NHL).

    Innovative CAR-T Therapy Manufacturing

    Utilizing Galapagos’ decentralized cell therapy manufacturing infrastructure, GLPG5101 is a breakthrough in CAR-T cell therapy. This technology can generate and deliver new, healthy cells in as little as seven days from vein to vein in the median vein.

    The primary objective of the ATALANTA-1 study’s Phase 1 phase is to assess GLPG5011’s safety and preliminary effectiveness in order to establish the appropriate dosage for Phase 2 of the trial. Assessing the decentralized manufacturing approach’s viability and effectiveness are secondary goals.

    Positive Outlook of GLPG for Phase 2 and Upward

    Evaluation of GLPG5101’s objective response rate, full response rate, response duration, progression-free survival, overall survival, and safety will be the main goals of the Phase 2 trial. Additionally, the possibility of decentralized production will be further investigated in this study.

    Every patient who signs up for the research will be followed up with for a full year. Promising early findings from the current Phase 1/2 ATALANTA-1 research in Europe support GLPG5101’s potential to be a successful therapy for R/R NHL.

    With the latest FDA clearance, Galapagos NV has achieved a major step in commercializing its ground-breaking CD19 CAR-T cell treatment in the United States. With its sophisticated workflow management software, automated production, and unique quality control techniques, the Galapagos platform has the potential to revolutionize the cell therapy industry.

  • Galapagos NV (GLPG) Stock Trending Lower Despite Successful Topline Results from GLPG3667 and GLPG 3970 Studies

    Galapagos NV (GLPG) stock prices were down a marginal 1.79% as of the market closing on July 14th, 2021, bringing the price per share down to USD$65.80. Subsequent premarket fluctuations have seen the stock fall by 11.14%, bringing it down to USD$58.47.

    GLPG3667

    July 14th, 2021 saw the company announce positive topline results from the evaluation of GLPG3667, a proprietary TYK2 compound. The randomized, placebo-controlled, double-blind Phase 1b study had a total of 31 patients enrolled, each with a diagnosis ranging from moderate to severe plaque psoriasis. Patients were randomized in a 1:1:1 ratio and were administered a daily oral dose of GLPG3667 or a placebo over the course of four weeks. The main objectives of the study were to evaluate the safety and tolerability of the treatment, as well as signs indicating clinical activity.

    Success of the Study

    The treatment was found to be well tolerated during the course of the trial, barring one patient in the low dose group having interrupted the study for one day on account of the exacerbation of psoriasis. Any treatment related adverse events were mild in nature and transient, with no deaths or serious adverse events being reported. By Week 4, 40% of patients in the high dose group had a PASI 50 response, which is indicative of a minimum 50% improvement in PASI from baseline.

    GLPG3970

    Concurrently, the company announced the success of topline results from three patient studies for GLPG3970. The study evaluated the proprietary salt inducible kinase 2/3 inhibitor. The studies were randomized, placebo-controlled, double blind, with a Phase 1b study in patients with moderate to severe psoriasis. Two Phase 2a studies were also conducted in patients with moderate to severely active UC and RA.

    Continued Success

    With the treatment being administered orally once-daily for a period of 6 weeks, the main objectives were to evaluate the safety and tolerability of GLPG3970, as well as early signs of biologic and clinical effect. The treatment was generally safe and well tolerated across all three studies. No deaths or serious adverse events were reported, while the majority of treatment emergent adverse events were mild to moderate in nature.

    Future Outlook for GLPG

    Armed with the success of its various studies, GLPG is poised to capitalize on the opportunities presented to it as it further develops its flagship treatments. The company is keen to push for the accelerated development and eventual commercialization of its pipeline of products. Investors are hopeful that the proliferation of the treatment will result in sustained and significant increases in shareholder value.