Day: March 1, 2021
— Received FDA approval of IMCIVREE™ (setmelanotide), the first-ever therapy for chronic weight management in patients with obesity due to POMC, PCSK1 or LEPR deficiency —— Announced positive topline data from Phase 3 pivotal trial evaluating setmelanotide in Bardet-Biedl and Alström syndromes; on-track to complete regulatory submissions to FDA and EMA for BBS in 2H 2021 —— Announced data from five cohorts in Phase 2 Basket Study demonstrating proof-of-concept in HET POMC, PCSK1 or LEPR deficiencies, and obesity due to SRC1 and SH2B1 deficiencies —— Advancing broad development program for setmelanotide, with five Phase 2 and 3 clinical studies expected to initiate in 2021 in MC4R pathway-related rare genetic diseases of obesity —— Strengthened financial position with net proceeds of...
Allakos Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
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REDWOOD CITY, Calif., March 01, 2021 (GLOBE NEWSWIRE) — Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a business update.2020 AccomplishmentsAnnounced positive results from our prospective prevalence study showing that 45% (181/405) of symptomatic patients biopsied with chronic unexplained gastrointestinal (GI) symptoms or functional gastrointestinal disorders (FGIDs) such as irritable bowel syndrome (IBS) and functional dyspepsia (FD) met the histologic criteria for eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD). The results suggest that EG and/or EoD are significantly underdiagnosed among...
Applied Molecular Transport Expands Clinical Pipeline and Announces First Subject Dosed in Phase 1a Trial of Oral AMT-126
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Company expands pipeline with second clinical program, AMT-126, an oral IL-22 fusion biologic therapy for diseases associated with intestinal epithelial barrier defectsIL-22 deficiency implicated in broad range of gastrointestinal-focused and peripheral diseases ranging from ulcerative colitis to multiple rheumatologic disordersComplete oral AMT-126 Phase 1a/b data in healthy volunteers and patients anticipated in 2022Company on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials from its comprehensive clinical program beginning in the second half of 2021SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) — Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced the first in human dosing in its Phase 1a clinical trial of oral AMT-126....
Brunswick Exploration Options Nickel Property in Quebec
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MONTREAL, March 01, 2021 (GLOBE NEWSWIRE) — Brunswick Exploration Inc. (“BRW” or the “Company”) is pleased to announce that is has signed option and purchase agreements from a private company and prospectors to acquire a 100% interest in the Lac Édouard Nickel Project (“Lac Édouard” or the “Property”), located 40 km northeast of the town of La Tuque, Quebec, and 125 km northwest of Quebec City. Access to the site is by paved road and includes a significant nickel-copper mineralized mafic-ultramafic body that was last drilled in 1971 and which offers excellent exploration potential.Mr. Killian Charles, President of BRW, commented: “We are very excited to announce this new greenfield nickel-copper project for the Company, especially in light of rising nickel and copper prices and projected high demand for nickel in a decarbonizing...
Exploration Brunswick optionne une propriété de nickel au Québec
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MONTRÉAL, 01 mars 2021 (GLOBE NEWSWIRE) — Exploration Brunswick inc. (« BRW » ou la « Société ») a le plaisir d’annoncer la signature d’ententes d’option et d’acquisition avec une société privée et des prospecteurs, visant l’acquisition d’une participation de 100 % dans le projet nickélifère du Lac Édouard (« Lac Édouard » ou la « propriété »), situé à 40 km au nord-est de la ville de La Tuque au Québec, et à 125 km au nord-ouest de la ville de Québec. Le site est accessible par une route pavée et englobe un important corps mafique-ultramafique minéralisé en nickel-cuivre, où les derniers travaux de forage remontent à 1971 et qui présente un excellent potentiel d’exploration.M. Killian Charles, président de BRW, a déclaré : « Nous sommes très heureux d’annoncer ce nouveau projet de nickel-cuivre de la Société, en terrain peu exploré,...
Cue Biopharma to Present at the Cowen 41st Annual Health Care Conference
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CAMBRIDGE, Mass., March 01, 2021 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, announced today that it will present at the Cowen 41st Annual Health Care Conference being held virtually from March 1-4, 2021.At the conference, Cue Biopharma will provide an overview highlighting recent developments of the Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform, its expanding pipeline and anticipated milestones. The presentation will also include an update on the Company’s ongoing Phase 1 monotherapy dose escalation trial of CUE-101 as well as its combination trial of CUE-101 with KEYTRUDA® (pembrolizumab) as first-line treatment for...
Selecta Biosciences to Participate in the H.C. Wainwright Global Life Sciences Conference
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WATERTOWN, Mass., March 01, 2021 (GLOBE NEWSWIRE) — Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, today announced that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., and Chief Financial Officer, Brad Dahms, will participate in the virtual H.C. Wainwright Global Life Sciences Conference to be held March 9-10, 2021.The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7 a.m. EST on Tuesday, March 9, 2021.A webcast will also be available in the Investors & Media section of the company’s website at www.selectabio.com.About Selecta Biosciences, Inc.Selecta Biosciences Inc. (NASDAQ: SELB) is leveraging its clinically...
Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy
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DUBLIN, Ireland, March 01, 2021 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021.“The FDA’s acceptance of our NDA for once-nightly FT218 and assignment of a PDUFA target action date of October 15th represents another important milestone on the path towards receiving approval. We are confident in our regulatory filing strategy and we look forward to working with the Agency in our pursuit of bringing this important treatment to...
Ceridian Completes Acquisition of Ascender
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SYDNEY, Australia, March 01, 2021 (GLOBE NEWSWIRE) — Ceridian (NYSE: CDAY; TSX: CDAY), a global leader in human capital management (HCM) technology, today announced it has completed the acquisition of Ascender HCM Pty Limited, a leading HR and payroll solutions provider in the Asia Pacific Japan (APJ) region. The acquisition was previously announced on February 1, 2021 and closed effective today.“Ceridian provides the most comprehensive human capital management and payroll solution in the APJ region, and this is an exciting milestone as we continue to scale and accelerate our global growth strategy,” said David Ossip, Chairman and CEO, Ceridian. “Together with Ascender, we’ll provide unmatched value to customers through our product innovation and local expertise, coupled with the continued expansion of the Dayforce platform.”A leading...
ADM Endeavors, Inc. (OTCQB: ADMQ) Announces Important New Texas Contracts; “Positive Significant Impact on Future Sales”
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Dallas, TX, March 01, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — ADM Endeavors, Inc. (OTCQB: ADMQ) announced today that the city of Arlington (home of the Dallas Cowboys and the Texas Rangers) has chosen to piggyback onto an original Tarrant County, Texas, bid award, which gave the Company the opportunity to be on the bid list for 525 government entities throughout Texas. “We are also pleased to announce that the school districts of Wylie, Mesquite and Round Rock have chosen to work with our subsidiary, Just Right Products,” said ADM Endeavors CEO Marc Johnson. He added that these new contracts “should have a positive significant impact on future sales for Just Right Products.”https://admendeavors.com/https://www.facebook.com/admqendeavors/https://www.fwpromo.com/https://www.justrightproducts.com/ADM Endeavors, Inc. sells...