F2

Madrigal Pharmaceuticals to Present Multiple Rezdiffra™ (resmetirom) and Health Economics Outcomes Research Abstracts in NASH/MASH at the EASL Congress

Retrieved on: 
onsdag, maj 29, 2024
Patient, F2, Liver disease, EASL, Exercise, Disease, Cirrhosis, Fatty liver disease, Congress, NASH, Biomarker, THR, ELF, Fibrosis, Diet, Therapy, Quality of life

“The data we will be presenting at EASL further support Rezdiffra as the foundational therapy in NASH and Madrigal as the leading company in the field," said Bill Sibold, Chief Executive Officer of Madrigal.

Key Points: 
  • “The data we will be presenting at EASL further support Rezdiffra as the foundational therapy in NASH and Madrigal as the leading company in the field," said Bill Sibold, Chief Executive Officer of Madrigal.
  • Mr. Sibold continued, “Additionally, we will be presenting important new real-world data examining the burden of uncontrolled NASH on patients and the health system.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
  • Late-breaking oral presentation: “Identification and validation of pre-identified morphological baseline features for prediction of fibrosis progression in MAESTRO-NASH” [Friday, June 7 at 17:45 CEST.

Inventiva announces the positive recommendation of the fourth DMC of the NATiV3 Phase III clinical trial with lanifibranor in patients with MASH/NASH

Retrieved on: 
torsdag, maj 16, 2024
Patient, F2, Clinical trial, Safety, F4, Fatty liver disease, F1, Observation, SUSAR, Data monitoring committee, Euronext Paris, DMC, Pharmaceutical industry

The Data Monitoring Committee recommended to continue the clinical trial without modification of the current protocol, based on the pre-planned review of safety data.

Key Points: 
  • The Data Monitoring Committee recommended to continue the clinical trial without modification of the current protocol, based on the pre-planned review of safety data.
  • The DMC review confirms the good safety profile of lanifibranor.
  • The safety data was unblinded to the DMC but remains blinded with respect to the Company.
  • The DMC review supports the continuation of the NATiV3 clinical trial without modification to the current trial protocol.

Zealand Pharma Announces Financial Results for the First Quarter of 2024

Retrieved on: 
torsdag, maj 16, 2024
DREAM, Partnership, Credit, Patient, European Investment Bank, F2, CGM, Short bowel syndrome, Complement component 3, NDA, US FDA, Obesity, EASL, Clinical trial, Congress, Overweight, FDA, S&M, DKK, Boehringer Ingelheim, Danske Bank, PDUFA, Cirrhosis, EUR, SBS, F1, Weight loss, Part, G&A, EIB, BofA Securities, Pharmaceutical industry

Cash position includes cash, cash equivalents and marketable securities, as well as Tranche A of EIB loan disbursed in Q1 2024.

Key Points: 
  • Cash position includes cash, cash equivalents and marketable securities, as well as Tranche A of EIB loan disbursed in Q1 2024.
  • Survodutide, a glucagon/GLP-1 receptor dual agonist: Boehringer Ingelheim announced positive results from Phase 2 trial in MASH.
  • These results will be presented at the European Association for the Study of the Liver (EASL) congress in Milan, Italy on June 7, 2024.
  • Zealand expects to initiate the first-in-human clinical trial of ZP9830 in the second half of 2024.

Sagimet Biosciences Reports First Quarter 2024 Financial Results and Provides Corporate Updates

Retrieved on: 
onsdag, maj 15, 2024
Patient, Pharmacokinetics, F2, EASL, FDA, Safety, SAN, F3, Biopsy, FASN, Liver, Fibrosis, Research, Food and Drug Administration, Three Months, Pharmaceutical industry

SAN MATEO, Calif., May 15, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today reported financial results for the quarter ended March 31, 2024, and provided recent corporate updates.

Key Points: 
  • “Sagimet continues to focus on advancing the clinical development of denifanstat in MASH,” said David Happel, Chief Executive Officer of Sagimet.
  • We look forward to presenting the full FASCINATE-2 Phase 2b 52-week biopsy results at EASL in June 2024.
  • Research and development expense for the quarter ended March 31, 2024 was $5.3 million compared to $4.5 million for the first quarter of 2023.
  • Net loss for the first quarter ended March 31, 2024 was $6.6 million compared to a net loss of $6.6 million for the first quarter of 2023.

Sagimet Announces Oral Presentation of Data from the Phase 2b FASCINATE-2 Study of Denifanstat in MASH at EASL International Liver Congress 2024

Retrieved on: 
tisdag, maj 7, 2024
University, FASN, EASL, Hepatology, F2, Patient, Fibrosis, SAN, Division, MASH

SAN MATEO, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced a General Session oral presentation of denifanstat Phase 2b FASCINATE-2 study data in metabolic dysfunction-associated steatohepatitis (MASH) will be given at the European Association for the Study of the Liver (EASL) International Liver Congress 2024 held in Milan, Italy from June 5-8, 2024.

Key Points: 
  • SAN MATEO, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced a General Session oral presentation of denifanstat Phase 2b FASCINATE-2 study data in metabolic dysfunction-associated steatohepatitis (MASH) will be given at the European Association for the Study of the Liver (EASL) International Liver Congress 2024 held in Milan, Italy from June 5-8, 2024.
  • General Session Oral Presentation Title: Denifanstat, a fatty acid synthase (FASN) inhibitor, shows significant fibrosis improvement and MASH resolution in FASCINATE-2, a Ph2b 52 week international, randomized, double blind, placebo-controlled trial in patients with F2 or F3 fibrosis.
  • Presenter: Rohit Loomba M.D., MHSc, ASLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, United States

Madrigal Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates

Retrieved on: 
tisdag, maj 7, 2024
FDA, CFO, EDT, Liver disease, Portola Pharmaceuticals, Safety, Food, Security (finance), Abstract (summary), Marketing, MAA, CHMP, Fatty liver disease, Webcast, Prescription, NASH, Therapy, THR, F2, Oral medicine, Cirrhosis, Patient, EMA, Fibrosis, Committee, Diagnosis, Health, Standard of care, Marketing Authorisation Application, Biotechnology, Food and Drug Administration, Pharmaceutical industry

Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis.

Key Points: 
  • Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis.
  • Madrigal is focused on the approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of specialist physicians.
  • The accelerated approval of Rezdiffra was based on results from the Phase 3 MAESTRO-NASH trial, which was published in The New England Journal of Medicine in February 2024.
  • At 8 a.m. EDT today, May 7, 2024, the Company will host a webcast to review its financial and operating results and provide a general business update.

F2 Strategy Appoints Jay Halbert as Chief Financial Officer

Retrieved on: 
tisdag, april 16, 2024
Software, Technology, Professional Services, Finance, CFO, Marketing, Growth, Comcast Spectacor, F2, Medarex, Record, Connective tissue, Acquisition, Consultant, Management

F2 Strategy , a leading wealth management technology services company, today announces the hiring of Jay Halbert to the newly created chief financial officer (CFO) position.

Key Points: 
  • F2 Strategy , a leading wealth management technology services company, today announces the hiring of Jay Halbert to the newly created chief financial officer (CFO) position.
  • Halbert will assume a pivotal role in overseeing the entirety of the rapidly growing company’s financial operations, including accounting; financial reporting, planning and analysis; and budgeting and banking relationships.
  • His extensive and diverse background renders him a significant asset to F2 Strategy as it diversifies its services within the financial services industry, particularly with its latest foray into marketing consulting.
  • Jay's wealth of experience and demonstrated success make him an ideal fit for this crucial role as we continue to drive F2 Strategy forward."

Madrigal Pharmaceuticals Announces U.S. Availability of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic NASH with Moderate to Advanced Liver Fibrosis

Retrieved on: 
tisdag, april 9, 2024
Diagnosis, Biopsy, Fatty liver disease, Cirrhosis, Exercise, F2, Patient, Prescription, MD, Diet, Fibrosis, Pharmacy, NASH, Therapy, FDA, THR, JD

I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH.

Key Points: 
  • I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH.
  • Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.
  • This program is designed to help patients navigate insurance and affordability challenges and provide co-pay support for eligible patients.
  • Madrigal has also established a patient assistance program (PAP) to help patients with no insurance access Rezdiffra.

Sagimet Biosciences Reports Full Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
måndag, mars 25, 2024
Research, FASN, Fatty liver disease, Congress, Exercise, Progression-free survival, F2, Patient, SAN, Food and Drug Administration, F3, G&A, IPO, Obesity, IND, Acne, Bevacizumab, Glioblastoma, Fibrosis, Clinical trial, NASH, FDA, Drug development, Pharmaceutical industry

SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today reported financial results for the full year ended December 31, 2023, and provided corporate updates.

Key Points: 
  • In January 2024, Sagimet sold 9,000,000 shares of its Series A common stock in an underwritten public offering and received $104.7 million in net proceeds.
  • In November 2023, Sagimet presented preclinical data evaluating denifanstat alone or in combination with semaglutide in mouse models of MASH at the 7th Obesity and NASH Drug Development Summit.
  • In October 2023, Sagimet’s license partner for China, Ascletis Bioscience Co. Ltd. (Ascletis), presented Phase 2 topline results at the European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin, Germany.
  • In July 2023, Sagimet closed an upsized IPO of Series A common stock, at a public offering price of $16.00 per share.

FDA’s Approval of Breakthrough NASH Treatment Opens Door for a Long-Neglected Patient Population

Retrieved on: 
torsdag, mars 14, 2024
Organization, Obesity, Cirrhosis, Exercise, Cardiology, Partnership, F2, Risk, Patient, Fatty liver disease, Hope, Diet, NASH, Language, Liver disease, Liver cancer, Hypertension, FDA, Drug development, JD, Food, GLI

Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise.

Key Points: 
  • Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise.
  • This breakthrough follows years of NASH patient-led, multi-stakeholder advocacy and partnership with researchers in both drug and diagnostic development.
  • “Today’s announcement represents the culmination of the work of the united NASH community.
  • It is particularly satisfying that we can mark Women’s History Month with a breakthrough from a female-founded company.