GPR119

NeuroBo to Present Latest Pre-Clinical Data on Cardiometabolic Assets, DA-1241 and DA-1726, Targeting MASH and Obesity, at Scientific Conferences in June

Retrieved on: 
tisdag, april 30, 2024
Contract research organization, American Diabetes Association, GAN, Part, Congress, EASL, Gubra, OXM, Weight loss, GCGR, GLP1R, GPR119, Obesity, SAD, Glucagon-like peptide-1 receptor, MASH, Pharmaceutical industry

"We have completed enrollment for Part 1 of our Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

Key Points: 
  • "We have completed enrollment for Part 1 of our Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
  • DA-1726 has consistently shown, in our preclinical data, to sustain weight loss in diet-induced obese models by decreasing food consumption and boosting energy expenditure.
  • Both programs are progressing well, and we have been able to significantly accelerate the clinical timelines for DA-1726.
  • A member of the Dong-A ST Research Center will present pre-clinical data on DA-1726 in a poster presentation at this scientific session in Orlando, FL.

NeuroBo Pharmaceuticals Receives Safety Review Committee Approval to Continue With Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH

Retrieved on: 
onsdag, mars 13, 2024
SRC, Week, Cirrhosis, ALT, Disease, Safety, Part, Patient, GPR119, Aes, Șaeș, Alanine transaminase, MASH, Clinical trial, Type, Liver disease, T2DM, Triglyceride, Pharmaceutical industry

CAMBRIDGE, Mass., March 13, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced receipt of Safety Review Committee (SRC) approval, recommending that the two-part Phase 2a trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), continue without modification following a blinded safety review of the first six months of study conduct. The Phase 2a clinical trial is designed to evaluate the efficacy and safety of DA-1241, for the treatment of MASH. The company anticipates a full data readout from the trial in the second half of 2024.

Key Points: 
  • The Phase 2a clinical trial is designed to evaluate the efficacy and safety of DA-1241, for the treatment of MASH.
  • The company anticipates a full data readout from the trial in the second half of 2024.
  • Each of the two-parts of the Phase 2a trial of DA-1241 are designed to be 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel clinical studies to evaluate the efficacy and safety of DA-1241 in subjects with presumed MASH.
  • Subjects will be randomized in a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo.

NeuroBo Pharmaceuticals Strengthens Board of Directors with the Appointment of James P. Tursi, M.D.

Retrieved on: 
måndag, november 6, 2023
Auxilium, GCGR, Research and Development Council of New Jersey, Research, Medical college, IND, Glucagon-like peptide-1 receptor, Physician, GPR119, GSK plc, Development, Oxyntomodulin, Endo International, Ferring Pharmaceuticals, Johns Hopkins, NASH, Medicine, Biology, Ursinus College, OXM, Obstetrics, Tursi, Drexel University College of Medicine, GLP1R, Chemistry, Fatty liver disease, Bachelor of Science in Human Biology, Johns Hopkins Hospital, Investigational New Drug, Pharmaceutical industry, Gynaecology

Dr. Tursi will also serve as a member of the Board's Nominating and Corporate Governance Committee.

Key Points: 
  • Dr. Tursi will also serve as a member of the Board's Nominating and Corporate Governance Committee.
  • "James is a proven leader, with nearly 20 years in the pharmaceutical industry and over 30 total years of medical experience," stated Andrew I. Koven, Chairman of NeuroBo's Board of Directors.
  • As such, I look forward to working closely with the NeuroBo leadership team and my fellow Directors to maximize the potential for the Company's next generation pharmaceuticals to treat cardiometabolic diseases."
  • Previously, from April 2020 until January 2022, Dr. Tursi was Chief Scientific Officer U.S. for Ferring Pharmaceuticals.

CymaBay Reports Second Quarter and Six Months Ended June 30, 2023 Financial Results and Provides Corporate Update

Retrieved on: 
torsdag, augusti 10, 2023
Leona, EASL, Conference call, PBC, CMC, ULN, ALP, Research, Alkaline phosphatase, European Association for the Study of the Liver, Fibrosis, Primary biliary cholangitis, Hypoglycemia, HIV disease progression rates, Patient, Investment, Risk, Itch, GPR119, UDCA, Therapy, Hand, Technology transfer, Disease, Pharmaceutical industry, Cryptocurrency, Liver, Conference

NEWARK, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, announced today corporate updates and financial results for the second quarter ended June 30, 2023.

Key Points: 
  • ET
    NEWARK, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, announced today corporate updates and financial results for the second quarter ended June 30, 2023.
  • Research and development expenses for the three months ended June 30, 2023, and 2022 were $19.5 million and $17.9 million, respectively.
  • Research and development expenses for the six months ended June 30, 2023 were $38.1 million and $36.3 million, respectively.
  • Net loss for the six months ended June 30, 2023 was $29.6 million and $54.9 million, or ($0.30) and ($0.62), respectively.

NeuroBo Pharmaceuticals, Inc. Appoints Pharmaceutical Industry Executive, Mark A. Glickman, to its Board of Directors

Retrieved on: 
fredag, maj 12, 2023
Auxilium, Glucagon-like peptide-1 receptor, OXM, Union of Sales and Marketing Professionals, Medical device, Senior, International Management Institute, Bhubaneswar, NASH, Esperion Therapeutics, Marketing, Abbott Laboratories, State university system, Business, Head, Sale, Political science, Esperies, Business administration, Investigational New Drug, GCGR, New York University Stern School of Business, GPR119, GLP1R, Sales and operations planning, Fatty liver disease, Growth, Commercial, Therapy, IND, Oxyntomodulin, Student Senators Council of New York University, Endo International, Pharmaceutical industry, Management

"Mark is a highly accomplished pharmaceutical industry executive with more than 30 years of industry experience, including many senior leadership positions," said Andrew I. Koven, Chairman of NeuroBo's Board of Directors.

Key Points: 
  • "Mark is a highly accomplished pharmaceutical industry executive with more than 30 years of industry experience, including many senior leadership positions," said Andrew I. Koven, Chairman of NeuroBo's Board of Directors.
  • "I am excited to join the NeuroBo Board of Directors at such an important stage for the Company, especially during the advancement of the Company's two promising cardiometabolic assets," said Mr. Glickman.
  • "I look forward to working with my fellow Directors and the NeuroBo leadership team as we position the Company for long-term growth and value creation."
  • Prior to this role, he served as Chief Business Officer, Commercial of TherapeuticsMD, Inc. since June 2021.

NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 2a Clinical Trial of DA-1241 for the Treatment of NASH

Retrieved on: 
tisdag, maj 2, 2023
Glucagon-like peptide-1 receptor, Interim, OXM, Obesity, NASH, Week, Alanine transaminase, Sitagliptin, Safety, Aes, Liver disease, T2DM, Inflammation, Part, Trial of the century, Șaeș, Fibrosis, Prediabetes, Patient, GCGR, Lipid metabolism, GPR119, Type, Liver, GLP1R, Chemokine, ALT, Cytokine, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Oxyntomodulin, Food, Pharmaceutical industry

BOSTON, May 2, 2023 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist. The company plans to initiate a two-part, Phase 2a clinical trial of DA-1241, for the treatment of nonalcoholic steatohepatitis (NASH), in the third quarter of 2023.

Key Points: 
  • The company plans to initiate a two-part, Phase 2a clinical trial of DA-1241, for the treatment of nonalcoholic steatohepatitis (NASH), in the third quarter of 2023.
  • "In Phase 1a/1b clinical studies, DA-1241 was well tolerated in both healthy volunteers and in patients with type 2 diabetes mellitus (T2DM).
  • For these reasons, we believe that the mechanism of action of DA-1241 will translate into a safe and effective treatment for NASH.
  • We are eager to initiate the two-part, Phase 2a clinical trial of DA-1241, which we expect will occur in the third quarter of this year.

NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co. Ltd. Announce Strategic Collaboration to License and Develop Portfolio of Dong-A's Cardio-Metabolic Therapies

Retrieved on: 
torsdag, september 15, 2022
Securities Exchange Act of 1934, Inflammation, Jeong-Dong Lee, Trial of the century, COVID-19, Fibrosis, Weight loss, Oxyntomodulin, Sale, Honigman LLP, Diabetic neuropathy, NASH, Neurodegeneration, Nasdaq, Company, Acquisition, Obesity, Form 10-K, Partnership, Achievement, U.S. Securities and Exchange Commission, Forward-looking statement, Patient, GIP, KOSE, Liver disease, OXM, Lipid metabolism, Glucagon-like peptide-1 receptor, PYY, Moelis & Company, Fatty liver disease, Private Securities Litigation Reform Act, GCGR, Security (finance), Prospectus, GLP1R, SEC, Government budget balance, Annual report, GPR119, Pharmaceutical industry

"The acquisition of these two cardiometabolic assets marks a seismic shift for NeuroBo, providing us with a highly promising, diversified pipeline with several upcoming value inflection points in the NASH and obesity space -- areas with enormous market opportunity," stated Gil Price, M.D., President and Chief Executive Officer of NeuroBo. "Through this agreement, Dong-A, one of our largest shareholders, has reaffirmed its commitment to remain a long-term strategic partner of NeuroBo. Dong-A is dedicated to our success and we are grateful it has also committed to provide continued support to facilitate the clinical development of the licensed assets. Once the transaction has closed, which is contingent upon certain closing conditions, we will be uniquely positioned to initiate a phase 2a study of DA-1241 in NASH in the first half of 2023, with data expected in the second half of 2024. We also intend to initiate a phase 1a safety study of DA-1726 in the first half of 2023, for which data is expected in the second half of 2023. We are truly excited about the prospects of NeuroBo as we transition to a cardiometabolic company across the large and growing markets of obesity and NASH."

Key Points: 
  • Under the license agreement, NeuroBo will be responsible for global development, regulatory and commercial activities other than for certain Asian-Pacific geographies.
  • Dong-A will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Korea.
  • "Through this agreement, Dong-A, one of our largest shareholders, has reaffirmed its commitment to remain a long-term strategic partner of NeuroBo.
  • However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so.

CymaBay Reports Second Quarter and Six Months Ended June 30, 2022 Financial Results and Provides Corporate Update

Retrieved on: 
torsdag, augusti 11, 2022
U.S. Securities and Exchange Commission, Leona, Association, Hand, Survival, Primary biliary cholangitis, NDA, CEO, EASL, PBC, Investment, Alkaline phosphatase, Clinical trial, Conference call, Disease, European Medicines Agency, Annual report, Thakeham, Security (finance), Priority, Fibrosis, Patient, Liver disease, Therapy, American Association for the Study of Liver Diseases, Twitter, Hypoglycemia, Itch, Associate, Safety, Doctor of Philosophy, NASDAQ, GPR119, Research, Hepatitis, Food and Drug Administration, University, Investor, Ursodeoxycholic acid, European Association for the Study of the Liver, University of Toronto, LinkedIn, Pharmaceutical industry, Dentistry, GLOBE, Liver, Conference

NEWARK, Calif., Aug. 11, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the second quarter ended June 30, 2022.

Key Points: 
  • ET
    NEWARK, Calif., Aug. 11, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the second quarter ended June 30, 2022.
  • Second Quarter and Six Months Ended June 30, 2022, Financial Results
    Research and development expenses for the three months ended June 30, 2022, and 2021 were $17.9 million and $16.7 million, respectively.
  • Research and development expenses for the six months ended June 30, 2022, and 2021 were $36.3 million and $29.1 million, respectively.
  • General and administrative expenses for the six months ended June 30, 2022, and 2021 were $12.0 million and $11.8 million, respectively.

CymaBay Reports First Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
torsdag, maj 12, 2022
Leona, GPR119, Journal, Patient, Hypoglycemia, Itch, PBC, NASDAQ, Therapy, Liver, Thakeham, Ursodeoxycholic acid, Week, Conference call, Safety, Primary biliary cholangitis, Alkaline phosphatase, ALP, CEO, Institute of Liver and Biliary Sciences, GLOBE, Pharmaceutical industry, Hepatology, Conference

NEWARK, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the first quarter ended March 31, 2022.

Key Points: 
  • ET
    NEWARK, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the first quarter ended March 31, 2022.
  • Published results from Phase 2, 52-week study of seladelpar in patients with primary biliary cholangitis (PBC) in the Journal of Hepatology.
  • First Quarter Ended March 31, 2022 Financial Results
    Research and development expenses for the three months ended March 31, 2022 and 2021 were $18.4 million and $12.4 million, respectively.
  • CymaBay disclaims any obligation to update these forward-looking statements except as required by law.

CymaBay Reports Fourth Quarter and Year Ended December 31, 2021 Financial Results and Provides Corporate Update

Retrieved on: 
torsdag, mars 17, 2022
Therapy, Liver support system, Conditional sentence, Liver, CEO, Cirrhosis, MD, Association, Food and Drug Administration, Twitter, Goal, GLOBE, Fibrosis, Annual report, Quarter, Disease, Security (finance), Population, Ursodeoxycholic acid, Institute of Liver and Biliary Sciences, American Association, Efficacy, Conference, LinkedIn, Leona, PBC, Industry, Hepatitis, Director, U.S. Securities and Exchange Commission, GPR119, Hypoglycemia, Safety, Primary biliary cholangitis, NASDAQ, Investor, Investment, Growth, Clinical trial, Board, European Medicines Agency, Endocrinology, Hand, ALP, Gilead, AASLD, COVID, American Association of Clinical Endocrinologists, Alkaline phosphatase, Research, Portal, Priority, Digital, Itch, Evidence, Pharmaceutical industry, Medicine, Management, Animal, Thakeham, Patient

Sujal Shah, President and CEO of CymaBay, stated, 2021 was a year of growth for CymaBay and included accomplishments that position CymaBay for long-term success.

Key Points: 
  • Sujal Shah, President and CEO of CymaBay, stated, 2021 was a year of growth for CymaBay and included accomplishments that position CymaBay for long-term success.
  • Despite these challenges, we have seen steady progress since re-initiating our development program in PBC in 2021.
  • Fourth Quarter and Year Ended December 31, 2021 Financial Results
    Research and development expenses for the three months ended December 31, 2021 and 2020 were $18.4 million and $10.7 million, respectively.
  • General and administrative expenses for the three months ended December 31, 2021 and 2020 were $6.1 million and $5.2 million, respectively.