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Landos Biopharma, Inc. (LABP)

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Previous Close10.85
Open10.87
Bid9.56 x 800
Ask11.36 x 800
Day's Range10.05 - 10.87
52 Week Range8.82 - 16.99
Volume20,731
Avg. Volume322,976
Market Cap403.583M
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  • Landos Biopharma Announces the Appointment of Tiago Girão to its Board of Directors
    GlobeNewswire

    Landos Biopharma Announces the Appointment of Tiago Girão to its Board of Directors

    BLACKSBURG, Va., April 13, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma (NASDAQ: LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, today announced the appointment of Tiago Girão to its Board of Directors. Mr. Girão holds over 20 years of experience as a cross-functional leader who has held various positions in finance and operations for U.S. and global private and public life sciences companies. “We are pleased to welcome Tiago to Landos’ Board as the Chair of the Audit Committee, as his wealth of expertise managing strategic planning in finance and operations will provide an invaluable perspective to our growing clinical-stage company,” commented Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. “Tiago’s experience, which includes successful capital raising strategies and executing productive business development initiatives, will be important as we advance additional novel product candidates into clinical investigation.” Mr. Girão is currently the Chief Financial Officer of ProteoVant Therapeutics, a newly launched development-stage biotech company created by Roivant Sciences that focuses on the discovery and development of disease-modifying therapies by harnessing natural protein homeostasis processes. Formerly, Mr. Girão was the CFO and SVP of Operations at Cytori Therapeutics, a public biotechnology company where he notably helped raise over $120 million dollars through a combination of financings. Prior to this role, Mr. Girão held finance positions of increasingly responsibility at NuVasive Inc., a public medical device company. During his tenure, he was the lead corporate financial and accounting executive for NuVasive’s foreign units, including Japan, Latin America, Europe and Australia and was also heavily involved in major business and asset acquisitions. Earlier in his career, Mr. Girão held advancing roles and responsibilities with KPMG LLP and Ernst & Young LLP. “I am honored to join Landos’ Board and have the opportunity to collaborate alongside Landos’ knowledgeable and committed team as they strive to bring first-in-class oral therapeutics to patients with autoimmune diseases,” said Mr. Girão. “I look forward to leveraging my two-decades of financial leadership within the biotech space to support the Board and the management team in planning and implementing the Company’s future clinical strategy.” About Landos Biopharma Landos Biopharma is a clinical-stage biopharmaceutical company focused on the discovery and development of oral therapeutics for patients with autoimmune diseases that are the first to target new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma’s core expertise is in the development of therapeutic candidates targeting novel pathways at the interface of immunity and metabolism. Lead asset omilancor is a novel, oral, gut-restricted small molecule therapeutic candidate for the treatment of ulcerative colitis, Crohn’s disease and Eosinophilic Esophagitis that targets the LANCL2 pathway. NX-13 is a novel, oral, gut-restricted compound for the treatment of inflammatory bowel disease, which targets the NLRX1 pathway. Additional candidates are in development for the treatment of lupus nephritis, rheumatoid arthritis, multiple sclerosis, and diabetes. For more information, please visit www.landosbiopharma.com. Contacts: Thomas Hoffmann (investors)Solebury Trout646-378-2931thoffmann@soleburytrout.com Hannah Gendel (media)Solebury Trout646-378-2943hgendel@soleburytrout.com

  • Landos Biopharma Announces FDA Clearance of IND Application for Omilancor for the Treatment of Eosinophilic Esophagitis
    GlobeNewswire

    Landos Biopharma Announces FDA Clearance of IND Application for Omilancor for the Treatment of Eosinophilic Esophagitis

    Third potential indication for omilancor (BT-11), a first-in-class candidate for the treatment of autoimmune diseasesBLACKSBURG, Va., April 06, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma (NASDAQ: LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for omilancor (BT-11), a novel, orally administered, gut-restricted LANCL2 agonist, in development for the treatment of Eosinophilic Esophagitis (EoE). With up to 160,000 patients in the United States, EoE is an orphan disease without a current FDA-approved therapeutic. Landos expects to initiate patient dosing in the first half of 2022. “The clearance of this IND for our lead asset omilancor for a third indication, Eosinophilic Esophagitis, exemplifies the candidate’s versatility to potentially target and treat multiple autoimmune diseases that face significant treatment challenges,” commented Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. “EoE results from a dysregulation of Th2-mediatied immunity that can cause inflammation, chronic pain and frequent hospitalizations, of which approximately one third of patients do not respond to the current standard of care. Based on the trials we have conducted to date, we believe omilancor’s established safety and tolerability profile and efficacy in reducing inflammation through the activation of LANCL2 supports the promise of omilancor to treat this underserved patient population.” This trial is a randomized, double-blind, placebo-controlled Phase 1b study designed to evaluate the safety and pharmacokinetics of omilancor in patients with active Eosinophilic Esophagitis (EoE). A total of 36 patients will be randomized in a 1:1:1 ratio to receive either omilancor 500 mg twice daily, omilancor 1000 mg once daily, or placebo for 12 weeks. Each of the treatment arms will include 12 subjects. The safety primary endpoint will measure the frequency and severity of adverse events as well as changes in clinical chemistry and hematology from baseline. The secondary endpoint is pharmacokinetic analysis of omilancor plasma levels at various time intervals post-dosing in addition to evaluating the mean concentration of omilancor in esophageal biopsy tissue after 12 weeks of dosing. About Eosinophilic Esophagitis Eosinophilic Esophagitis is a chronic disease of the esophagus that stems from an excessive Th2 response in the esophagus that is thought to result from increased stimulation by epithelial cells and dendritic cells. The inflamed esophagus can cause chronic pain, frequent hospitalizations and emergency room visits, difficulty eating or swallowing and formation of fibrotic structures. With no FDA-approved treatments for this disease, current management of EoE often consists of proton pump inhibitors, corticosteroids or inhaled medications typically used for asthma. Therapeutic candidates in development are primarily corticosteroids and biologics; however, these are likely to have similar limitations to those observed in IBD, including a presence of side effects and loss of response over time. Given the prevalence of EoE within both pediatric and adult populations, there is an unmet need for therapeutics with limited risk for side effects. About Omilancor (BT-11) Omilancor is a novel, orally-active, gut-restricted small molecule investigational drug that targets the Lanthionine Synthetase C-Like 2 (LANCL2) pathway impacting the gastrointestinal tract. LANCL2 plays an important role in the immunoregulatory process. By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune cells, omilancor is designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory markers in regulatory T cells (Treg) within the site of inflammation. The Company reported initial Phase 2 results of omilancor evaluating patients with ulcerative colitis in 2021 and expects to initiate a Phase 3 trial in the second half of 2021. Additionally, Landos plans to initiate a Phase 2 trial of omilancor in patients with Crohn’s disease in the first half of 2021. About Landos Biopharma Landos Biopharma is a clinical-stage biopharmaceutical company focused on the discovery and development of oral therapeutics for patients with autoimmune diseases that are the first to target new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma’s core expertise is in the development of therapeutic candidates targeting novel pathways at the interface of immunity and metabolism. Lead asset omilancor is a novel, oral, gut-restricted small molecule therapeutic candidate for the treatment of ulcerative colitis, Crohn’s disease and Eosinophilic Esophagitis that targets the LANCL2 pathway. NX-13 is a novel, oral, gut-restricted compound for the treatment of inflammatory bowel disease, which targets the NLRX1 pathway. Additional candidates are in development for the treatment of lupus nephritis, rheumatoid arthritis, multiple sclerosis, and diabetes. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for Landos Biopharma, Inc. (the “Company”), including statements about the Company’s strategy, clinical development of the company’s therapeutic candidates, the Company’s anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates and other similar risks. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. Contacts:Thomas Hoffmann (investors)Solebury Trout646-378-2931thoffmann@soleburytrout.com Hannah Gendel (media)Solebury Trout646-378-2943hgendel@soleburytrout.com

  • Landos Biopharma Announces Positive Results from a Phase 1 Study of NX-13 in Healthy Volunteers
    GlobeNewswire

    Landos Biopharma Announces Positive Results from a Phase 1 Study of NX-13 in Healthy Volunteers

    NX-13 was well tolerated with no reported serious adverse events All primary and secondary endpoints in the Phase 1 study of NX-13 were met Landos expects to initiate a Phase 1b trial of NX-13 in patients with ulcerative colitis (UC) later this year BLACKSBURG, Va., March 04, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma (NASDAQ: LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, today announced NX-13, the Company’s first-in-class novel, orally administered therapeutic candidate for the treatment of inflammatory bowel disease (IBD), has successfully met all primary and secondary endpoints in a Phase 1 study. The data showed that NX-13 was well tolerated following evaluation of multiple doses over one and seven days compared with placebo. “The favorable results from this trial underscore the promise of NX-13’s novel multimodal mechanism of action, targeting the NLRX1 pathway locally in the GI tract, and its potential to bring a new approach to treating patients with IBD,” commented Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. “As a part of our growing franchise of gut-restricted, oral therapeutics for ulcerative colitis (UC) and Crohn’s disease (CD) with novel immunometabolic mechanisms, we are excited that NX-13 met all primary and secondary endpoints in this first-in-humans study.” “By using Landos’ powerful LANCE discovery and development platform, we have identified three novel mechanisms of therapeutic efficacy (LANCL2, NLRX1 and PLXDC2) and developed seven novel product candidates around those targets. Our lead product candidates (BT-11 and NX-13) are in clinical testing and our development pipeline currently targets up to 14 autoimmune disease indications. We are pleased that it took only 18 months for NX-13 to advance from discovery to Phase 1 clinical testing and we are looking forward to initiating a Phase 1b trial in patients with UC later this year,” commented Raquel Hontecillas, PhD, Chief Scientific Officer of Landos. The Phase 1 trial was a randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability and pharmacokinetics of NX-13, which was orally administered. The single ascending dose arm consisted of 35 healthy volunteers in a total of five cohorts (250 to 4,000 mg). The multiple ascending dose arm consisted of 21 healthy volunteers enrolled in a total of three cohorts (1,000 to 4,000 mg). Within each cohort in both dose arms, five participants received NX-13 and two participants received placebo. Across the eight cohorts, no SAEs were reported. The maximum tolerated dose was identified to be 10-fold greater than the anticipated therapeutic dose. Following the positive results from the Phase 1 study, Landos plans to initiate a Phase 1b trial of NX-13 in patients with ulcerative colitis in 2021. Additionally, building on the success of the LANCE computational platform in BT-11 and NX-13, Landos anticipates filing at least three new INDs in 2021. About NX-13 NX-13 is a first-in-class, orally active, gut-restricted, small molecule therapeutic candidate for the treatment of inflammatory bowel disease. NX-13 targets NLRX1, a mitochondria-associated receptor with the ability to modulate immune responses. By activating the NLRX1 pathway, NX-13 is designed to increase oxidative phosphorylation in immune cells, reduces differentiation of effector CD4-positive T cells, and decrease production of inflammatory cytokines. About Landos Biopharma Landos Biopharma is a clinical-stage biopharmaceutical company focused on the discovery and development of oral therapeutics for patients with autoimmune diseases that are the first to target new mechanisms of action, including the LANCL2, NLRX1 and PLXDC2 immunometabolic pathways. Landos Biopharma’s core expertise is in the development of therapeutic candidates targeting novel pathways at the interface of immunity and metabolism. Lead asset BT-11 is a novel, oral, gut-restricted small molecule therapeutic candidate for the treatment of ulcerative colitis and Crohn’s disease that targets the LANCL2 pathway. NX-13 is a novel, oral, gut-restricted compound for the treatment of inflammatory bowel disease, which targets the NLRX1 pathway. Additional candidates are in development for the treatment of lupus nephritis, rheumatoid arthritis, multiple sclerosis, and diabetes. Contacts: Thomas Hoffmann (investors) Solebury Trout646-378-2931thoffmann@soleburytrout.com Hannah Gendel (media)Solebury Trout646-378-2943hgendel@soleburytrout.com