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Tag: cytokine

  • NRx Pharmaceuticals, Inc. (NRXP) Stock Surges ZYESAMI Role in Pandemic Response

    NRx Pharmaceuticals, Inc. (NRXP) Stock Surges ZYESAMI Role in Pandemic Response

    NRx Pharmaceuticals, Inc. (NRXP) stock prices skyrocketed by 42.84% shortly after market trading commenced on July 19th 2021, bringing the price per share up to USD$12.17 early on in the trading day.

    ZYESAMI’s Role in Covid-19

    July 21st, 2021 saw the company announce data about ZYESAMI (aviptadil) at the Disease Control and Prevention Summit., in regard to the role of the treatment in preventing Cytokine Storm in Covid-19 patients. The presentation will showcase the statistically significant effect of ZYESAMI in mitigating the sharp rise in cytokines, which are closely linked to mortality in Covid-19 patients. This was consolidated by the completion of a recent Phase 2b/3 trial of ZYESAMI, wherein the change in cytokine level was a prespecified endpoint.

    Details of the Study

    Patients treated in the study showed a minimal increase in IL-6, as compared to patients treated with a placebo reported a statistically significant elevation in interleukin 6 cytokine levels. The patient set was diverse, with varying levels of the severity of Covid-19 infection and distribution among both tertiary care and community hospitals.

    Accelerated Development

    The findings have been submitted to the U.S. Food and Drug Administration as supplements to the Emergency Use Authorization application that has been submitted as is currently pending. The company is also submitting a biomarker letter of intent to the FDA as a part of its biomarker program, as pre the authorization of the 21st Century Cures Act.

    Scope of ZYESAMI

    With Covid-19 hospitalizations continuing to rise around the world, the placebo-controlled biomarker data signals the critical role that ZYESAMI has the potential to play in the prevention of the sudden elevation of cytokines that is linked to mortality. A biomarker-based regulatory path seems cleared on the basis of the link established between the clinical effect of ZYESAMI on survival and recovery in conjunction with measurable biologic chance in cytokine levels. The effects of a cytokine storm are lethal and are associated with mortality resulting from a variety of fatal conditions, including, but not limited to, Acute Respiratory Distress Syndrome, a common cause of death in sepsis, and amniotic fluid embolus.

    Future Outlook for NRXP

    Armed with a highly promising advancement in the fight against the continuing global coronavirus pandemic, NRXP is poised to capitalize on the prospective market space that has become accessible to it. With such spearheaded market penetration, current and potential investors are hopeful that management will be able to leverage their resources to facilitate effective distribution of the offering in a timely manner to ensure maximum profitability.

  • Cytosorbents Corp. (CTSO) Stock Continues Climb Following FDA Approval to Conduct STAR-T Trial in U.S

    Cytosorbents Corp. (CTSO) stock prices surged by 17.41% as of the market closing on July 6th, 2021, bringing the price per share up to USD$8.63 at the end of the trading day. Subsequent pre-market fluctuations have seen the stock dip by 7.76%, bringing it down to USD$7.96.

    FDA Approval of IDE Application

    July 6th, 2021 saw the company announce the full approval of its Investigational Device Exemption application to support FDA regulatory clearance to conduct the STAR-T trial in the U.S. The Safe and Timely Antithrombotic Removal – Ticagrelor is a double blind, randomized, controlled trial that is being performed under the recent FDA Breakthrough Designation. The Designation was granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during critical cardiothoracic surgery using the company’s proprietary adsorption technology.

    STAR-T Trial

    STAR-T will enroll a maximum of 120 patients across 20 U.S clinical sites, with enrollment expected for the summer of 2021. The study’s primary endpoint will evaluate the reduction in risk of peri-operative bleeding complications arising from the use of DrugSorb-ATR in patients with ticagrelor who undergo cardiothoracic surgery, as compared to standard of care alone.

    Additional Details

    The trial will also facilitate the evaluation of the reduction in ticagrelor blood levels and various additional outcomes to encapsulate the comprehensive potential clinical and cost-economic benefits of the treatment. The company forecasts a completion in 2022 based on the promising activity exhibited by participating sites. CTSO plans to continue its collaboration with the FDA to leverage the priority review stemming from the granting of a Breakthrough Designation for its ticagrelor removal application.

    Scope of DrugSorb-ATR

    A very high risk of perioperative bleeding makes the conducting of cardiac surgery on patients that are on antithrombotic agents a major issue across all U.S cardiac surgery centers. This issue results in morbidity, mortality, as well as higher costs, thus proving a major problem for patient management by cardiac surgeons around the world. Currently, surgery needs to be delayed until the effects of antithrombotic agents wear off or, in cases of extreme urgency, surgery is conducted regardless of the elevated bleeding risk.

    Future Outlook for CTSO

    Armed with the approval and support of the FDA for its flagship treatment, CTSO is poised to push for the commercialization and proliferation of DrugSorb-ATR. Investors are hopeful that the company will be able to leverage its resources to accelerate the development of the treatment, resulting in substantial and sustained increases in shareholder value.