F4

Advancements Series to Educate About the Latest Developments in Hydrocarbon Remediation

Retrieved on: 
Wednesday, February 1, 2023
Porosity, Hydrocarbon, Insurance, Health, Bacteria, Air pollution, Safety, Environment, Advanced manufacturing, CO2, Water, Soil, F4, Environmental remediation

JUPITER, Fla., Feb. 1, 2023 /PRNewswire-PRWeb/ -- An upcoming segment of Advancements with Ted Danson will focus on recent improvements in sustainable remediation technology.

Key Points: 
  • JUPITER, Fla., Feb. 1, 2023 /PRNewswire-PRWeb/ -- An upcoming segment of Advancements with Ted Danson will focus on recent improvements in sustainable remediation technology.
  • In this segment, viewers will learn about an innovative process that allows natural occurring microbes to degrade hydrocarbons without posing any health or safety risks.
  • "The ecologically safe and natural process is considered 'nature's way' of solving contamination problems," said Kristy Sakell, producer for the Advancements series.
  • "We look forward to sharing this information on the series."

Akero Therapeutics Completes Enrollment of Phase 2b SYMMETRY Study and Announces Expected 2023 Milestones

Retrieved on: 
Wednesday, December 21, 2022
Clinical trial, Fibrosis, Lipoprotein, EFX, Fatty liver disease, Cirrhosis, T2D, Therapy, Human, Histology, NASH, Patient, Safety, FDA, F4, Diabetes, Roy Taylor (scientist), Pharmaceutical industry, Medical imaging, Åkerö

SOUTH SAN FRANCISCO, Calif., Dec. 21, 2022 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced that it has completed enrollment of the Phase 2b SYMMETRY main study evaluating efruxifermin (EFX) for the treatment of non-alcoholic steatohepatitis (NASH), in patients with compensated cirrhosis fibrosis stage 4 (F4). Enrollment is also complete for the expansion cohort, known as Cohort D, evaluating EFX in combination with GLP-1 therapy in patients with fibrosis stage 1-3 (F1-F3) and Type 2 Diabetes Mellitus (T2D).

Key Points: 
  • “We look forward to reporting SYMMETRY data later next year as we evaluate EFX’s potential to slow or reverse progression of cirrhosis.”
    The Phase 2b SYMMETRY main study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with compensated cirrhosis (F4, Child-Pugh class A).
  • One hundred eighty-two patients have been randomized to receive once-weekly subcutaneous dosing of 28mg EFX, 50mg EFX, or placebo.
  • To provide additional safety data from long-term follow up, patients will continue to receive EFX or placebo from 36 to 96 weeks.
  • Consistent with prior guidance, results from the Cohort D expansion cohort are expected in the second quarter of 2023, while results from the main study remain on track to be reported in the fourth quarter of 2023.

Efruxifermin Granted FDA Breakthrough Therapy Designation for NASH

Retrieved on: 
Thursday, December 8, 2022
Liver, Liver disease, Annual report, SAN, Inflammation, Cirrhosis, Prevalence, Cardiovascular disease, Security (finance), FDA, Food, US Foods, Breakthrough, Safety, EFX, Histology, Cancer, FGF21, NASH, Death, Trial of the century, Liver cancer, Non-alcoholic fatty liver disease, Liver failure, Risk, Fibrosis, Fatty liver disease, Disease, Type 2 diabetes, F4, Therapy, Lipoprotein, COVID-19, Metabolism, Patient, Compte rendu, Pharmaceutical industry, Åkerö, NAFLD

“We are proud to have the FDA recognize the potential therapeutic benefit of EFX through this Breakthrough Therapy Designation,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero.

Key Points: 
  • “We are proud to have the FDA recognize the potential therapeutic benefit of EFX through this Breakthrough Therapy Designation,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero.
  • “With the global prevalence of NASH continuing to rise, we are committed more than ever to developing therapeutics that can treat NASH holistically and reverse fibrosis rapidly.
  • The designation is based on topline data released in September from HARMONY, a Phase 2b study of EFX in patients with biopsy-confirmed pre-cirrhotic NASH, fibrosis stage 2 or 3 (F2-F3).
  • The study met its primary and secondary histology endpoints, which were selected to match endpoints accepted by the FDA for registrational trials.

89bio Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 10, 2022
SAN, GLOBE, Private Securities Litigation Reform Act, Fibrosis, Health, TG, Investment, Disclosure, Research and development, FGF21, FDA, Fatty liver disease, ESC, Sale, European Society of Cardiology, Safe harbor, COVID-19, Half-life, R, SEC, The O.C., Diabetes, Safety, Time, Hypertriglyceridemia, Research, Liver, Patient, NAS, Administration, Congress, Trial of the century, Pharmaceutical industry, G&A, F4

SAN FRANCISCO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today reported its financial results for the third quarter ended September 30, 2022.

Key Points: 
  • Successfully completed enrollment in the ENLIVEN Phase 2b trial; topline data expected in the first quarter of 2023.
  • FDA meeting planned in the fourth quarter of 2022 to gain alignment and feedback based on regulatory precedent for approval of drugs in SHTG.
  • Presented additional positive results from ENTRIGUE Phase 2 trial of pegozafermin at European Society of Cardiology (ESC) Congress 2022.
  • As of September 30, 2022, 89bio had cash, cash equivalents, and short-term investments of $193.3 million.

Akero Therapeutics to Present at Upcoming Healthcare Conferences in November

Retrieved on: 
Thursday, November 10, 2022
SAN, GLOBE, Fibrosis, FGF21, Fatty liver disease, NASH, EFX, Therapy, F4, Åkerö, Safety, Type 2 diabetes, Company, Disease, Conference, Patient, Metabolism, Pharmaceutical industry

ET

Key Points: 
  • ET
    Live webcasts of the Company presentations will be available through the investor relations section of the Company's website at www.akerotx.com .
  • Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including non-alcoholic steatohepatitis (NASH), a disease without any approved therapies.
  • The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH.
  • Visit us at akerotx.com and follow us on LinkedIn and Twitter for more information.

Akero Therapeutics to Present Late-Breaking Oral and Poster presentations on EFX Today at AASLD’s The Liver Meeting® 2022

Retrieved on: 
Monday, November 7, 2022
Patient, Private Securities Litigation Reform Act, Liver failure, F4, Risk, SAN, Cancer, GLOBE, Security (finance), Death, American Association for the Study of Liver Diseases, NASH, Liver cancer, Non-alcoholic fatty liver disease, Adult, Fibrosis, Safety, Fatty liver disease, Compte rendu, COVID-19, Therapy, Molecule, Trial of the century, AASLD, Type 2 diabetes, Pharmacology, Cirrhosis, Annual report, U.S. Securities and Exchange Commission, Cardiovascular disease, Metabolism, Human, Liver, Inflammation, Lipoprotein, Disease, EFX, Time, SEC, American Association, Association, Diabetes, FGF21, Pharmaceutical industry, Åkerö, NAFLD

There are no approved treatments for the condition and NASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe.

Key Points: 
  • There are no approved treatments for the condition and NASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe.
  • The study enrolled a total of 128 patients, randomized to receive once-weekly subcutaneous doses of 28mg or 50mg EFX, or placebo for 24-weeks.
  • EFX is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins.
  • The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH.

89bio Presents Additional Exploratory Analyses from the Phase 1b/2a NASH Study of Pegozafermin at AASLD The Liver Meeting® 2022

Retrieved on: 
Saturday, November 5, 2022
Disclosure, Private Securities Litigation Reform Act, SAN, Cohort, Histology, Liver, GLOBE, Triglyceride, Fibrosis, Fatty liver disease, American Association for the Study of Liver Diseases, Poster, COVID-19, Institute of Liver and Biliary Sciences, Half-life, Trial of the century, AASLD, Marie Cassidy, The O.C., Steatosis, Safe harbor, Health, Cirrhosis, Inflammation, Hypertriglyceridemia, Lipid metabolism, FGF21, SEC, Association, Diabetes, Patient, American Association, Medical imaging, Pharmaceutical industry, F4

SAN FRANCISCO, Nov. 05, 2022 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced the presentation of post-hoc exploratory analyses of additional data from the paired-biopsy, open-label expansion cohort (Cohort 7) in the Phase 1b/2a proof-of-concept study evaluating pegozafermin in patients with nonalcoholic steatohepatitis (NASH). These data were featured in a poster presentation (abstract #36901) at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2022, being held virtually and in Washington, D.C., from November 4 – 8, 2022. A copy of the poster presentation will be accessible under “Scientific Publications” in the pipeline section of 89bio’s website.

Key Points: 
  • These data were featured in a poster presentation (abstract #36901) at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2022, being held virtually and in Washington, D.C., from November 4 8, 2022.
  • In this open-label cohort, NASH patients were treated once weekly for 20 weeks with 27 mg of pegozafermin.
  • For the primary analysis, biopsies were read centrally at baseline and at end of treatment by a single expert liver pathologist (central reader).
  • Pegozafermin is currently being evaluated in the Phase 2b ENLIVEN trial in NASH and is expected to move into Phase 3 program for SHTG in 2023.

Akero Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Friday, November 4, 2022
Patient, Private Securities Litigation Reform Act, Exercise, American Association for the Study of Liver Diseases, Adult, Liver cancer, AES, Appetite, Research, Nausea, Annual report, U.S. Securities and Exchange Commission, Human, Inflammation, Disease, Lipoprotein, SEC, Morgan Stanley, Liver failure, SAN, GLOBE, Non-alcoholic fatty liver disease, Fibrosis, Fatty liver disease, Type 2 diabetes, Diarrhea, Cirrhosis, Compte rendu, Security (finance), FGF21, Cancer, F4, Histology, COVID-19, Nature, Review, Cardiovascular disease, Defecation, Diabetes, American Association, Risk, Death, NASH, Safety, Therapy, Trial of the century, AASLD, Jefferies, Metabolism, Liver, EFX, Association, Pharmaceutical industry, Copper, Medical imaging, NAFLD, Åkerö

(Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported third quarter financial results for the period endingSeptember 30, 2022 and provided business updates.

Key Points: 
  • (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported third quarter financial results for the period endingSeptember 30, 2022 and provided business updates.
  • Akero reported positive Week 24 results from the Phase 2b HARMONY study evaluating EFX in the treatment of adult patients with pre-cirrhotic NASH (F2-F3).
  • Akero remains on track to report results of Cohort D in the first half of 2023.
  • Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Akero Therapeutics to Present at the H.C. Wainwright 6th Annual NASH Investor Conference

Retrieved on: 
Tuesday, October 11, 2022
SAN, Åkerö, Disease, Therapy, Webcast, Conference, EFX, Lists of diseases, Patient, NASH, FGF21, Company, Type 2 diabetes, Safety, GLOBE, F4, Fibrosis, Metabolism, Fatty liver disease, Pharmaceutical industry

(Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will present at the H.C. Wainwright 6th Annual NASH Virtual Investor Conference on Monday, October 17, 2022, at 12:00 p.m. E.T.

Key Points: 
  • (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will present at the H.C. Wainwright 6th Annual NASH Virtual Investor Conference on Monday, October 17, 2022, at 12:00 p.m. E.T.
  • A webcast of the Company presentation will be available through the investor relations section of the Company's website at www.akerotx.com .
  • Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including non-alcoholic steatohepatitis (NASH), a disease without any approved therapies.
  • The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH.

Akero Therapeutics Announces Closing of Upsized Public Offering of Common Stock and Full Exercise of Underwriters' Option to Purchase Additional Shares

Retrieved on: 
Monday, September 19, 2022
Lists of diseases, Fatty liver disease, Safety, F4, EFX, Fibrosis, Åkerö, Sale, FGF21, NASH, U.S. Securities and Exchange Commission, Madison Avenue, Jefferies Group, 2nd Floor (Nina song), Therapy, Jefferies, Metabolism, Patient, File, Exercise, Type 2 diabetes, Broadridge Financial Solutions, Nasdaq, Morgan Stanley, Varick Street, Telephone, SAN, Prospectus, Attention, GLOBE, SEC, Disease, Pharmaceutical industry

The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately$230.0 million.

Key Points: 
  • The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately$230.0 million.
  • J.P. Morgan, Morgan Stanley, and Jefferies acted as joint book-running managers for the offering.
  • Canaccord Genuity acted as lead manager and H.C. Wainwright & Co. acted as co-manager for the offering.
  • The shares of common stock were offered by Akero pursuant to a shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC) and automatically became effective upon filing.