FGF19

NGM Bio Provides Recent Business Highlights and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 11, 2024
Research, GDF15, PSC, Part, Vomiting, Pregnancy, MSS, Liver, Atlas, Preterm birth, NGM, LAIR1, Nausea, Hospital, ILT3, GFRAL, Food and Drug Administration, NASH, Therapy, Woman, Toxicology, Liver disease, CRC, Cirrhosis, Biomarker, Place of birth, Colorectal cancer, Agreement, Acquisition, Plan, FGF19, AASLD, FDA, Food, Weight loss, Primary sclerosing cholangitis, Pembrolizumab, Dehydration, Bile, Hyperemesis gravidarum, HG, Patient, Pre-eclampsia, Malnutrition, Pharmaceutical industry

--On February 26, 2024, announced that it had entered into the Agreement and Plan of Merger with Atlas Neon Parent, Inc., and Atlas Neon Merger Sub, Inc.--

Key Points: 
  • The combination of NGM707 and pembrolizumab was generally well-tolerated at all four doses (200, 600, 1200, 1800 mg) of NGM707.
  • Additional details can be found in NGM Bio’s recent filings with the United States Securities and Exchange Commission (SEC).
  • NGM Bio anticipates that the Offer and the Merger contemplated under the Merger Agreement will be consummated in the second quarter of 2024.
  • If the Merger is effected, NGM Bio’s common stock will be delisted from The Nasdaq Stock Market LLC and NGM Bio will be privately held.

NGM Bio Announces New Clinical Data from Ongoing Trial of NGM707 in Advanced Solid Tumors and Outlines Evolved Strategy for Aldafermin and NGM120 to Focus on Rare Conditions with Significant Unmet Need

Retrieved on: 
Tuesday, January 9, 2024
Bile, Woman, Hyperemesis gravidarum, Research, Biology, Hospital, Weight loss, MSS, FRS, Hepatology, University, ILT3, Liver disease, FGF19, GFRAL, LAIR1, Liver, Doctor of Philosophy, NASH, CRC, Pembrolizumab, Trial of the century, Neoplasm, NGM, SAN, PRS, Public health, Genetic epidemiology, Preterm birth, Vomiting, Cirrhosis, DCR, Dehydration, AASLD, Immunotherapy, Place of birth, Medicine, Pregnancy, Pre-eclampsia, Therapy, ELF, Patient, Bile acid malabsorption, Fibrosis, Nausea, Alkaline phosphatase, PSC, Gastrointestinal disease, CRN, IBS-D, Malnutrition, FDA, Biomarker, Pharmaceutical industry

NGM Bio also outlined its strategy to evolve clinical development of its product candidates aldafermin and NGM120 to focus on rare conditions characterized by significant unmet need.

Key Points: 
  • NGM Bio also outlined its strategy to evolve clinical development of its product candidates aldafermin and NGM120 to focus on rare conditions characterized by significant unmet need.
  • Recent landmark genetic research confirmed the link between this rare, devastating condition experienced during pregnancy to higher levels of GDF15.
  • Given our deep expertise in GDF15 biology, we believe we are well positioned to potentially pursue this indication for NGM120.
  • NGM Bio previously reported data from a randomized, double-blind, placebo-controlled Phase 2 study of aldafermin for the treatment of PSC.

NGM Bio Presents Positive Phase 2b Results from the ALPINE 4 Trial of Aldafermin in Patients with Compensated Cirrhosis (F4) Due to NASH at AASLD The Liver Meeting®

Retrieved on: 
Monday, November 13, 2023
Hepatitis, Arm, Safety, Randomness, SAN, ALT, FGF19, AASLD, Cirrhosis, Rosuvastatin, CRN, FDA, Non-alcoholic fatty liver disease, Metabolism, Liver, Therapy, Fatty liver disease, Prognosis, University, LSM, Manuscript, NGM, ELF, NASH, Fibrosis, Pharmaceutical industry, Medical imaging, Hepatology, Medicine, Patient

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today shared positive, comprehensive results from its Phase 2b ALPINE 4 trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated cirrhosis (liver fibrosis stage 4 or F4) due to NASH in an oral plenary presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®.

Key Points: 
  • The ALPINE 4 data shared at AASLD The Liver Meeting follow positive topline results on the primary endpoint reported by NGM Bio in May 2023.
  • It’s gratifying to see the potential impact aldafermin is having on NASH progression and liver health in patients with F4 NASH.
  • This Phase 2b data set furthers our belief in aldafermin’s therapeutic potential,” said Hsiao D. Lieu, M.D., Chief Medical Officer at NGM Bio.
  • ELF measures direct markers of liver fibrosis and can be used to predict liver-related events in patients with NASH and compensated cirrhosis.

Gannex Published Phase I Data of ASC42, a Novel Farnesoid X Receptor Agonist on the Journal Drugs in R&D

Retrieved on: 
Monday, November 6, 2023
TC, PD, UDCA, Hepatology, Ursodeoxycholic acid, AST, Primary biliary cholangitis, PBC, Pharmacokinetics, Phase, American Association for Geriatric Psychiatry, NASH, GGT, Medicine, Non-alcoholic fatty liver disease, FXR, NAFLD, Obeticholic acid, Safety, ALT, Patient, OCA, Diagnosis, FGF19, New England, Pharmaceutical industry, Gannex

In-house developed by Gannex, ASC42 is a novel non-steroidal, selective, potent FXR agonist with best-in-class potential and global intellectual property.

Key Points: 
  • In-house developed by Gannex, ASC42 is a novel non-steroidal, selective, potent FXR agonist with best-in-class potential and global intellectual property.
  • On July 20, 2023, Gannex announced the completion of patient enrollment for Phase II clinical trial of ASC42 for PBC.
  • The Phase II clinical trial of Gannex's in-house developed farnesoid X receptor agonist ASC42 will be completed soon.
  • The topline data of the Phase II clinical trial are expected to be released by the end of 2023.

NGM Bio Announces Oral Plenary Presentation of Data from Phase 2b ALPINE 4 Trial of Aldafermin in Compensated Cirrhosis (F4) Due to NASH at Upcoming AASLD The Liver Meeting®

Retrieved on: 
Wednesday, October 11, 2023
Hepatology, Therapy, AASLD, NASH, American Association for the Study of Liver Diseases, Cirrhosis, Liver, Fatty liver disease, SAN, FGF19, NGM, Patient, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that an abstract related to comprehensive results from the company’s Phase 2b ALPINE4 trial of aldafermin in patients with compensated cirrhosis (liver fibrosis stage 4, or, F4) due to nonalcoholic steatohepatitis (NASH) has been selected for an oral plenary presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, which will take place November 10-14, 2023, in Boston, MA.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that an abstract related to comprehensive results from the company’s Phase 2b ALPINE4 trial of aldafermin in patients with compensated cirrhosis (liver fibrosis stage 4, or, F4) due to nonalcoholic steatohepatitis (NASH) has been selected for an oral plenary presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, which will take place November 10-14, 2023, in Boston, MA.
  • Positive results from the ALPINE 4 study: a randomized, double-blind, placebo-controlled, multicenter, Phase 2b trial evaluating multiple doses of the FGF19 analogue aldafermin in patients with compensated cirrhosis due to nonalcoholic steatohepatitis

NGM Bio Announces Presentation of Data from Phase 2 Investigator-Sponsored Trial of Aldafermin for the Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) and Bile Acid Malabsorption (BAM) at Digestive Disease Week 2023

Retrieved on: 
Monday, May 8, 2023
BAM, Gastrointestinal disease, IBS-D, Bile, Mayo Clinic, Therapy, BSFS, FGF19, Abdominal pain, BAD, Bristol stool scale, Data analysis, Patient, IBS, NGM, Clinical professor, Fasting, Medical imaging, Pharmaceutical industry

An estimated 25 – 50% of patients with diarrhea-predominant IBS, or IBS-D, have evidence of BAM, also known as bile acid diarrhea (BAD).

Key Points: 
  • An estimated 25 – 50% of patients with diarrhea-predominant IBS, or IBS-D, have evidence of BAM, also known as bile acid diarrhea (BAD).
  • Patients with idiopathic BAM with IBS-D have decreased production of the hormone FGF19.
  • Patients treated with aldafermin also had significantly decreased fecal total bile acids at days 14 and 28 compared to placebo (p=0.002 and p
  • There was numerically improved stool consistency in patients on aldafermin over time, particularly in week 4 of treatment, compared to placebo (p=0.047).

NGM Bio Reports First Quarter 2023 Financial Results and Provides Business Highlights, Including Topline ALPINE 4 Data

Retrieved on: 
Thursday, May 4, 2023
Therapy, NASH, ILT3, FGF19, LAIR1, ELF, Fibrosis, Development, Patient, NGM, Health, Research, Pembrolizumab, Cirrhosis, Safety, Medical imaging, Management, Pharmaceutical industry, Cryptocurrency, Merck

“We are pleased with the results of the ALPINE 4 trial supporting the therapeutic potential of aldafermin in patients with advanced NASH.

Key Points: 
  • “We are pleased with the results of the ALPINE 4 trial supporting the therapeutic potential of aldafermin in patients with advanced NASH.
  • Jin-Long Chen, Ph.D., who founded NGM Bio and served as Chief Scientific Officer and as a member of NGM Bio’s Board of Directors, resigned from NGM Bio effective April 4, 2023.
  • NGM Bio expects to incur approximately $5.0 million in charges in connection with the restructuring, the majority to be incurred in the second quarter.
  • NGM Bio expects its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the second quarter of 2025.

NGM Bio Provides Business Highlights and Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Tuesday, February 28, 2023
Congress, Safety, ESMO, FGF19, C3, Week, European Society for Medical Oncology, LAIR1, ILT3, Research, Multiple myeloma, NGM, Merck & Co., Drug discovery, Patient, R, ASH, Geographic atrophy, Therapy, SAN, NASH, GA, AML, CD3, Society, Macular degeneration, Pharmaceutical industry, Cryptocurrency, Merck

SOUTH SAN FRANCISCO, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today provided business highlights and reported financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today provided business highlights and reported financial results for the fourth quarter and full year ended December 31, 2022.
  • Preliminary findings indicated that NGM707 was generally well tolerated across all dose levels and demonstrated early signals of anti-tumor activity across multiple tumor types.
  • NGM Bio reported a net loss of $36.4 million and $162.7 million for the quarter and year ended December 31, 2022, respectively, compared to a net loss of $27.2 million and $120.3 million for the same periods in 2021.
  • Cash, cash equivalents and short-term marketable securities were $271.5 million as of December 31, 2022, compared to $366.3 million as of December 31, 2021.

NGM Bio Outlines Corporate Strategy and Provides Guidance on Key Priorities

Retrieved on: 
Monday, January 9, 2023
Congress, Merck, Retina, AML, GFRAL, Multiple myeloma, NGM, Geographic atrophy, Safety, ILT3, C3, FGF19, ASH, LAIR1, Conference, GDF15, Week, ESMO, AACR, Therapy, Patient, Drug discovery, Macular degeneration, European Society for Medical Oncology, Cancer, SAN, Society, Pancreatic cancer, NASH, Pembrolizumab, Medical imaging, Fine chemical, Pharmaceutical industry, Vaccine

“In 2022, NGM Bio sharpened its focus on oncology solid-tumor clinical development.

Key Points: 
  • “In 2022, NGM Bio sharpened its focus on oncology solid-tumor clinical development.
  • Dr. Woodhouse continued, “Our strategy in 2023 is to focus our clinical development efforts on our portfolio of four clinical-stage oncology programs while operating our prolific drug discovery engine to generate next-generation biologic therapeutics.
  • For our programs outside this area of focus, in retinal disease and NASH, we will seek development partners with relevant domain expertise.
  • Presented additional findings from post-hoc analyses from the CATALINA trial at The Retina Society Annual Scientific Meeting in Q4 2022.

NGM Bio Provides Business Highlights and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 3, 2022
MSD, Private Securities Litigation Reform Act, GDF15, Biology, FGF19, Bias, GFRAL, Failure, U.S. Securities and Exchange Commission, Disease, SEC, SAN, Congress, GLOBE, Fatty liver disease, Retina, NGM, Health, Geographic atrophy, Prostate cancer, Patient, Cancer, Protein engineering, Research, ILT3, Merck & Co., COVID-19, Pancreatic cancer, Cirrhosis, Therapy, LAIR1, NASH, Conference, Nasdaq, Risk, Merck Sharp & Dohme Federal Credit Union, Pembrolizumab, AACR, Liver, Pharmaceutical industry, Medical imaging, Merck

SOUTH SAN FRANCISCO, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a clinical-stage biotechnology company focused on discovering and developing transformative therapeutics for patients, today provided business highlights and reported financial results for the quarterly period ended September 30, 2022. 

Key Points: 
  • MK-3655 is an agonistic antibody product candidate binding to fibroblast growth factor receptor 1c-beta-klotho that Merck licensed from NGM Bio.
  • NGM Bio reported a net loss of $47.3million for the quarter ended September30, 2022, compared to a net loss of $28.9 million for the same period in 2021.
  • R&D expenses were $46.1million for the quarter ended September30, 2022, compared to $38.7million for the same period in 2021.
  • NGM Bio expects its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the fourth quarter of 2024.