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Keep up with the regulator's latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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Aligos Therapeutics Announces IND Clearance for NASH lead, ALG-055009- Phase 2a NASH protocol on track to be submitted to the IND in Q4 2023, enrollment expected to begin in Q1 2024
9/21/2023
Aligos Therapeutics, Inc. announced it has received clearance of its Investigational New Drug application from the US Food and Drug Administration for ALG-055009, it’s thyroid hormone receptor beta agonist, intended for the treatment of nonalcoholic steatohepatitis.
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89bio Announces U.S. FDA has Granted Breakthrough Therapy Designation for Pegozafermin in Nonalcoholic Steatohepatitis (NASH)
9/21/2023
89bio, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pegozafermin in patients with nonalcoholic steatohepatitis (NASH).
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New Anti-Cancer Opportunities Revealed for Hepion Pharmaceuticals’ Rencofilstat in Cancer Screening Program
9/21/2023
Hepion Pharmaceuticals, Inc. announced results from a study with in which the anti-cancer activity of Hepion’s lead drug candidate, rencofilstat, was tested in a high through-put screen on 850 cancer cell lines spanning 28 types of cancer at the PRISM lab at the Broad Institute of MIT and Harvard.
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Hepion Pharmaceuticals to Participate in 2023 Cantor Global Healthcare Conference
9/21/2023
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) today announced that its Chief Executive Officer, Robert Foster, PharmD, PhD, will participate in a panel discussion during the 2023 Cantor Global Healthcare Conference on Wednesday, September 27, 2023 at 9:45 a.m. ET in NYC.
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After a sluggish start to the year, experts expect an uptick in IPO offerings moving into fall, although it’s unlikely 2023 will fully shrug off its slump.
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Hepagene Therapeutics Announces FDA Clearance of Investigational New Drug Application (IND) for HPG7233 THR Beta Agonist
9/20/2023
Hepagene Therapeutics, Inc. a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its HPG7233.
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Inventiva and Hepalys Pharma, Inc. announce exclusive licensing agreement to develop and commercialize lanifibranor in Japan and South Korea
9/20/2023
Inventiva (Euronext Paris and Nasdaq: IVA), and Hepalys Pharma, Inc. have entered into an exclusive licensing agreement (the “Agreement”) to develop and commercialize Inventiva’s proprietary drug candidate lanifibranor for the treatment of non-alcoholic steatohepatitis (NASH) in Japan and South Korea.
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Metadeq Diagnostics Announces Three HeparDx™ Posters will be Presented at EASL SLD Summit 2023
9/20/2023
Metadeq Diagnostics, Inc. announced the presentation of three posters at the EASL SLD Summit 2023 in Prague, Czech Republic.
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Genflow Biosciences PLC Announces Company Update - September 20, 2023
9/20/2023
Genflow Biosciences Plc (“Genflow” or “the Company”) (LSE:GENF) (OTCQB:GENFF), today announced the receipt of written comments from the Federal Agency for Medicines and Health Products,
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89bio to Participate in the 2023 Cantor Global Healthcare Conference
9/20/2023
89bio, Inc. today announced that the Company’s Management will participate in a fireside chat and one-on-one investor meetings at the 2023 Cantor Global Healthcare Conference, being held in New York, NY on Tuesday, September 26, 2023 at 11:40 AM ET.
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GENFIT Reports First Half-Year 2023 Financial Results and Provides Corporate Update
9/20/2023
GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced its first half-year 2023 financial results and provided a corporate update.
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Hepion Pharmaceuticals Discovers Novel Rencofilstat Action in Liver Cancer
9/19/2023
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) today announced new research findings uncovering a previously unknown mechanism by which Hepion’s lead drug candidate, rencofilstat, may exert anti-cancer activity.
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Elevar Therapeutics Joins Benefactors Council of Blue Faery, Leading Hepatocellular Carcinoma Advocacy Group
9/19/2023
Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, announced a new partnership with the Benefactors Council of Blue Faery: The Adrienne Wilson Liver Cancer Association, a leading hepatocellular cancer advocacy group.
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Poolbeg Pharma PLC Announces Immunomodulator I Patent Opposition Withdrawal
9/19/2023
Poolbeg Pharma announces that the opposition to one of its European patents that was previously filed by a third party is to be withdrawn.
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Lipocine to Present at the Cantor Fitzgerald Global Healthcare Conference
9/19/2023
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that Dr. Mahesh Patel, President and Chief Executive Officer, will present and meet with investors at the 2023 Cantor Fitzgerald Global Healthcare Conference to take place September 26th to September 28th in New York City.
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NeuroBo Pharmaceuticals Doses First Patient in Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of NASH
9/15/2023
NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO) today announced dosing of the first patient in its two-part, Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, for the treatment of nonalcoholic steatohepatitis (NASH), at The Pinnacle Edinberg/South Texas Research Institute in Edinburg, Texas, under the supervision of Principal Investigator, Dr. David Ramirez.
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Pliant Therapeutics Appoints Minnie Kuo as Chief Development Officer
9/15/2023
Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced the appointment of Ms. Minnie Kuo as Chief Development Officer.
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Bristol Myers Squibb’s pipeline cuts, announced Thursday during its R&D Day, include a mid-stage drug candidate for nonalcoholic steatohepatitis and an anti-TIGIT solid tumor program.