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Fulcrum Therapeutics initiates multi-center Phase 3 trial with losmapimod » 07:0806/2406/24/20
Fulcrum Therapeutics announced that it received early notification from the U.S. Food and Drug Administration that the company may proceed with initiating a Phase 3, randomized, double-blind, placebo-controlled trial of losmapimod in higher risk hospitalized adults with COVID-19. Losmapimod is an orally available selective p38alpha/beta mitogen activated protein kinase inhibitor. The LOSVID trial is a Phase 3, international, multicenter trial designed to assess the safety and efficacy of a 15 mg twice per day oral dose of losmapimod compared to placebo for 14 days on top of standard of care in approximately 400 patients hospitalized with COVID-19 and at risk of progression to critical illness based on older age and elevated systemic inflammation. The primary endpoint is the proportion of patients who progress to death or respiratory failure by day 28. Additional secondary endpoints include clinical status on days seven and 14 as measured on the nine point WHO ordinal scale of COVID-19 severity, total number of study days free of oxygen supplementation, all-cause mortality, length of hospitalization and ICU stay, adverse events and viral clearance. An interim analysis will be conducted in the fourth quarter of 2020 for futility and sample size re-estimation by an independent data monitoring committee when approximately 50 percent of subjects complete the 28-day visit. Topline data is expected to be reported in the first quarter of 2021. Based on its mechanism of action and preclinical and clinical studies, Fulcrum believes that inhibiting the p38 MAPK pathway with losmapimod has the potential to treat COVID-19 by reducing the acute exaggerated pro-inflammatory responses to SARS-CoV-2 infection and restoring the antigen-specific immune responses needed for viral clearance potentially leading to improved clinical outcomes.
Fulcrum Therapeutics files to sell 4.03M shares of common stock for holders 16:1806/2206/22/20
Fulcrum Therapeutics downgraded to Neutral from Buy at BofA » 06:2006/1906/19/20
BofA analyst Tazeen Ahmad…
BofA analyst Tazeen Ahmad downgraded Fulcrum Therapeutics to Neutral from Buy with a higher price target of $23, up from $19. The stock price has appreciated to a level that is near full valuation relative to the stage of development of the company's "diverse" pipeline, the analyst tells investors in a research note. With a 35% probability of success for Losmapimod - up from 25% prior view - Ahmad models peak sales of $1.4B in 2030.
Fulcrum Therapeutics downgraded to Neutral from Buy at BofA » 06:0406/1906/19/20
BofA downgraded Fulcrum…
BofA downgraded Fulcrum Therapeutics to Neutral from Buy.
Fulcrum Therapeutics upgraded to Outperform from Market Perform at Raymond James » 07:5006/1706/17/20
Raymond James analyst…
Raymond James analyst David Long upgraded Fulcrum Therapeutics to Outperform from Market Perform with a $12 price target.
Fulcrum Therapeutics initiated with a Buy at BTIG » 19:3906/1606/16/20
BTIG analyst Dae Gon Ha…
BTIG analyst Dae Gon Ha initiated coverage of Fulcrum Therapeutics with a Buy rating and $27 price target. The company's lead asset - losmapimod - has the potential to become the first approved treatment for facioscapulohumeral muscular dystrophy, the analyst tells investors in a research note, adding that given the estimated prevalence of 16K-38K U.S. cases, he sees an attractive market opportunity with significant upside potential.
Fly Intel: Pre-market Movers » 09:0306/1006/10/20
GMAB, FULC, TRUE, DUO, LAKE, UNFI, RRGB, CMCM, GME, SBUX, SALT, CSII
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Fulcrum Therapeutics holds a conference call » 07:5506/1006/10/20
Management discusses evaluating Losmapimod as a potential treatment for COVID-19 on a conference call to be held on June 10 at 8:30 am. Webcast Link
Fulcrum Therapeutics expects cash to fund requirements into 1Q22 » 07:0606/1006/10/20
The Company expects that…
The Company expects that its cash, cash equivalents, and marketable securities of $81.2M as of March 31, 2020, together with the $68.5M in gross proceeds from its private placement, will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2022.
Fulcrum Therapeutics to evaluate losmapimod as COVID-19 treatment » 07:0506/1006/10/20
Fulcrum Therapeutics announced plans to evaluate losmapimod as a potential treatment for patients with COVID-19. Fulcrum has submitted an investigational new drug application to support initiation of a randomized, placebo-controlled, Phase 3 clinical trial in hospitalized patients in the United States following Pre-IND consultation via the Coronavirus Treatment Acceleration Program. Several lines of preclinical and clinical evidence indicate that activation of the p38 mitogen-activated protein kinase significantly contributes to the pathogenesis of coronavirus infections including COVID-19. p38 MAPK is well known as an important mediator of acute response to stress, including acute inflammation. In two clinical studies reported in the literature, an oral dose of 15 mg twice per day of losmapimod in older individuals restored the normal immune response to a viral antigen challenge and demonstrated resolution of acute inflammation, a relevant observation because the majority of severe and fatal cases of COVID-19 occur in older individuals. Additionally, in prior human clinical trials predominantly in chronic inflammatory conditions, losmapimod had an immediate effect on a number of inflammatory biomarkers that have been associated with poor prognosis in COVID-19, including C-reactive protein and interleukin-6. In previous trials in more than 3,600 subjects, losmapimod exhibited favorable safety and tolerability not significantly different from placebo. These trials have also indicated that losmapimod had good exposure after oral dosing and robust target engagement. The Company believes that losmapimod has the potential to treat COVID-19 by reducing the acute exaggerated pro-inflammatory responses to SARS-CoV-1 infection and restoring the antigen-specific immune responses needed for clearance of SARS-CoV-2, potentially leading to improved clinical outcomes. Additionally, p38 inhibition has been demonstrated to reduce angiotensin II-induced endothelial and organ damage in several experimental models and may address the renin-angiotensin system imbalance that is believed to contribute to key morbidities in COVID-19 patients.