Cholestasis

Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, February 11, 2022
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Primary sclerosing cholangitis, Patient, Cholestatic pruritus, Marketing, Degenerative disease, European Medicines Agency, Pregnancy, Medication, Primary biliary cholangitis, Spiroplasma mirum, Nasdaq, Professional Football Compensation Committee, PFIC, Institute of Liver and Biliary Sciences, Biliary atresia, IBAT, Financial compensation, VISTAS, Cholestasis, Employment, Alagille syndrome, RSU, Pharmaceutical industry

The Compensation Committee of Mirums Board of Directors approved the awards as an inducement material to the new employees employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The Compensation Committee of Mirums Board of Directors approved the awards as an inducement material to the new employees employment in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The awards are subject to the terms and conditions of Mirums 2020 Inducement Plan and the terms and conditions of an applicable award agreement covering the grant.
  • Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases.
  • In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome.

Mirum Pharmaceuticals to Present at SVB Leerink 11th Annual Global Healthcare Conference

Retrieved on: 
Wednesday, February 9, 2022
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, European Medicines Agency, Degenerative disease, Investor, Primary biliary cholangitis, PFIC, IBAT, Cholestasis, Pregnancy, Patient, Alagille syndrome, Cholestatic pruritus, Biliary atresia, Spiroplasma mirum, VISTAS, Primary sclerosing cholangitis, Institute of Liver and Biliary Sciences, Marketing, Pharmaceutical industry

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases.

Key Points: 
  • Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases.
  • Mirums late-stage pipeline includes two investigational treatments for debilitating liver diseases affecting children and adults.
  • In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome.
  • Mirum has submitted a Marketing Authorization Application to the European Medicines Agency for maralixibat for the treatment of cholestatic liver disease in patients with Alagille syndrome.

Bon Secours Liver Institute of Richmond Participating in RESPONSE, a Global Phase 3 Clinical Research Study Evaluating an Investigational Therapy for the Treatment of Primary Biliary Cholangitis (PBC)

Retrieved on: 
Thursday, February 3, 2022
Urine, Swelling, Bilirubin, Safety, Risk, Patient, Digestive, Fatty liver disease, UDCA, Liver disease, ULN, National Institute of Diabetes and Digestive and Kidney Diseases, Liver cancer, Food, ALP, Liver, Bile, Hepatocellular carcinoma, Liver transplantation, EMA, Cirrhosis, Bon, Primary biliary cholangitis, Itch, Pakistan Kidney and Liver Institute, Cholestasis, Inflammation, Abdominal pain, Breakthrough therapy, Alkaline phosphatase, Kidney, Weakness, Jaundice, Bon Secours Health System, Diarrhea, Health, European Medicines Agency, PBC, Travel, GLOBE, National Institute, Institute of Liver and Biliary Sciences, Nausea, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Hepatitis, Weight loss, Pharmaceutical industry, Medical imaging, Diabetes

RICHMOND, Va., Feb. 03, 2022 (GLOBE NEWSWIRE) -- Bon Secours Liver Institute of Richmond is enrolling participants into RESPONSE, a global phase 3 clinical research study evaluating the safety and efficacy of seladelpar, an investigational drug for people already diagnosed with PBC who have been using ursodeoxycholic acid (also known as UDCA or ursodiol) but have not achieved the recommended treatment goal or cannot tolerate UDCA. PBC is a chronic, serious and potentially life-threatening liver disease.

Key Points: 
  • The most common early symptoms of PBC are itching (pruritus) and fatigue,1 which can be very debilitating for some people.
  • Bon Secours Liver Institute of Richmond, a part of the Bon Secours Health System of Virginia, provides medical care for patients with all forms of acute and chronic liver disease.
  • This includes treatment for all forms of chronic viral hepatitis, fatty liver disease, liver cirrhosis and its complications, and hepatocellular carcinoma.
  • The mission of the Liver Institute ofRichmond is to offer the best and most comprehensive care for patients with liver disease.

NorthSea Therapeutics Initiates Phase 1 Trial of SEFA-6179, Targeting the Orphan Indication Intestinal Failure-Associated Liver Disease

Retrieved on: 
Wednesday, February 2, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, NSV, Safety, Short bowel syndrome, Patient, Therapy, Cirrhosis, Liver disease, Cell, Lists of diseases, Dyslipidemia, ICONA, PN, Liver, NASH, Steatosis, MCFA, Seed, Liver failure, Hypertriglyceridemia, Cholestasis, Pharmacotherapy, Population, Death, Pharmacokinetics, Rigshospitalet, Adult, Live at Montreux and Northsea, Parenteral nutrition, Fibrosis, Biomarker, Myofibroblast, BASF, Institute of Liver and Biliary Sciences, Department, SEFA, NST, Collagen, BGV, Mouse, Fatty liver disease, Liver injury, United Kingdom, Metabolism, Pharmaceutical industry, Medical imaging, Dietary supplement, Intestinal failure-associated liver disease (IFALD), SEFA-6179, NorthSea Therapeutics, INTESTINAL FAILURE-ASSOCIATED LIVER DISEASE (IFALD), SEFA-6179, NORTHSEA THERAPEUTICS

The Phase 1 SEFA-6179 clinical trial is being conducted in the United Kingdom and is expected to enroll approximately 90 healthy participants.

Key Points: 
  • The Phase 1 SEFA-6179 clinical trial is being conducted in the United Kingdom and is expected to enroll approximately 90 healthy participants.
  • The study is a randomized, placebo-controlled, single and multiple ascending dose trial, evaluating the safety, tolerability and pharmacokinetics of SEFA-6179.
  • The icosabutate Phase 2b ICONA trial in patients with biopsy-confirmed NASH is scheduled to readout in the first quarter of 2023.
  • Two additional SEFAs are in clinical development: SEFA-1024 is in Phase 1 to be developed for patients with severe hypertriglyceridemia, and SEFA-6179 is in Phase 1 development for the orphan indication IFALD (Intestinal Failure Associated Liver Disease).

Liver Institute Northwest Participating in RESPONSE, a Global Phase 3 Clinical Research Study Evaluating an Investigational Therapy for the Treatment of Primary Biliary Cholangitis (PBC)

Retrieved on: 
Tuesday, February 1, 2022
Urine, Swelling, Bilirubin, Safety, Risk, Patient, Digestive, Liver disease, UDCA, ULN, National Institute of Diabetes and Digestive and Kidney Diseases, Liver cancer, Food, ALP, Pacific Northwest, Liver, Bile, EMA, Primary biliary cholangitis, Itch, Cholestasis, Inflammation, Abdominal pain, Breakthrough therapy, Alkaline phosphatase, Kidney, Weakness, Jaundice, Diarrhea, European Medicines Agency, PBC, GLOBE, Institute of Liver and Biliary Sciences, Nausea, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, National Institute, Weight loss, Pharmaceutical industry, Medical imaging, Diabetes

Seladelpar (study drug) is a potent, selective, orally active peroxisome proliferator-activated receptor delta (PPAR) agonist in development for the treatment of people with PBC and other liver diseases.

Key Points: 
  • Seladelpar (study drug) is a potent, selective, orally active peroxisome proliferator-activated receptor delta (PPAR) agonist in development for the treatment of people with PBC and other liver diseases.
  • The most common early symptoms of PBC are itching (pruritus) and fatigue,1 which can be very debilitating for some people.
  • The mission of the Liver Institute Northwest is to improve the liver health of people in the Pacific Northwest.
  • We bring state-of-the-art treatment and cutting-edge clinical trials offering new therapies for patients with liver disease.

Mirum Pharmaceuticals Provides Business Update and Highlights Key 2022 Corporate Milestones

Retrieved on: 
Tuesday, January 11, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Abdomen, VISTAS, FSV, Stomach, Private Securities Litigation Reform Act, European Medicines Agency, Liver injury, Degenerative disease, Cholestasis, NASDAQ, Breakthrough therapy, Biliary atresia, Primary biliary cholangitis, U.S. Securities and Exchange Commission, Pregnancy, Pain scale, Marketing, Gastrointestinal bleeding, Vitamin, Conference, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Alagille syndrome, COVID-19, Primary sclerosing cholangitis, Diarrhea, Adoption, Institute of Liver and Biliary Sciences, IBAT, Food, Cholestatic pruritus, Interim, FDA, PFIC, Patient, Vitamin A, Skin, Pain, Hand, Symptoms of COVID-19, Investment, Webcast, Exercise, Spiroplasma mirum, Nausea, Bone, Liver, Medication, Investor, Sale, Security (finance), Vomiting, Pharmaceutical industry, LIVMARLI™ (maralixibat) oral solution, Mirum Pharmaceuticals, Inc., LIVMARLI™ (MARALIXIBAT) ORAL SOLUTION, MIRUM PHARMACEUTICALS, INC.

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today provided a corporate update and highlighted key 2022 milestones in conjunction with its presentation at the 40th Annual J.P. Morgan Virtual Healthcare Conference.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today provided a corporate update and highlighted key 2022 milestones in conjunction with its presentation at the 40th Annual J.P. Morgan Virtual Healthcare Conference.
  • As of December 31, 2021 Mirum had preliminary unaudited cash, cash equivalents, and short-term investments of approximately $261.5 million.
  • Recent achievements and corporate updates:
    Successful first quarter of LIVMARLI commercialization with approximately $3.0 million in net product revenue.
  • Anticipated milestones for Mirum include:
    Launch commercial early access programs in international markets for LIVMARLI in the first half of 2022.

Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, January 11, 2022
Biotechnology, General Health, Other Health, Health, Pharmaceutical, Patient, VISTAS, Spiroplasma mirum, European Medicines Agency, Alagille syndrome, Degenerative disease, Primary sclerosing cholangitis, Cholestasis, Financial compensation, Institute of Liver and Biliary Sciences, Biliary atresia, Primary biliary cholangitis, Medication, Professional Football Compensation Committee, Pregnancy, Nasdaq, IBAT, Employment, RSU, Marketing, Cholestatic pruritus, PFIC, Pharmaceutical industry

The Compensation Committee of Mirums Board of Directors approved the awards as an inducement material to the new employees employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The Compensation Committee of Mirums Board of Directors approved the awards as an inducement material to the new employees employment in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The awards are subject to the terms and conditions of Mirums 2020 Inducement Plan and the terms and conditions of an applicable award agreement covering the grant.
  • Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases.
  • In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome.

Mirum Pharmaceuticals to Present at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022

Retrieved on: 
Tuesday, January 4, 2022
Biotechnology, Pharmaceutical, Health, Pregnancy, PFIC, Cholestatic pruritus, Primary sclerosing cholangitis, European Medicines Agency, Investor, Patient, Primary biliary cholangitis, Cholestasis, Biliary atresia, IBAT, Conference, Medication, VISTAS, Spiroplasma mirum, Institute of Liver and Biliary Sciences, Marketing, Nasdaq, Alagille syndrome, Pharmaceutical industry

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that it will present at the annual J.P. Morgan Healthcare Conference taking place virtually January 10-13, 2022.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that it will present at the annual J.P. Morgan Healthcare Conference taking place virtually January 10-13, 2022.
  • Mr. Peetz and members of Mirums leadership team will be available for one-on-one meetings during the conference.
  • Additionally, the company will participate in a fireside chat at the upcoming H.C. Wainwright Virtual BIOCONNECT 2022 Conference.
  • A webcast of the presentation will be accessible from the Investors & Media section of Mirums website beginning January 10, 2022, at 7:00 a.m.

Albireo Announces Positive Topline Data from Phase 1 Study of A3907

Retrieved on: 
Thursday, December 16, 2021
Institute of Liver and Biliary Sciences, OLE, Clinical trial, Liver failure, Cirrhosis, Population, Jaundice, Primary sclerosing cholangitis, Fatigue, Boston Business Journal, Primary biliary cholangitis, Liver, PBC, Inflammation, Disease, Neoplasm, Mouse, Adult, Biliary atresia, Forward-looking statement, Transaminase, FDA, Bile, Physician, IND, EMA, U.S. Securities and Exchange Commission, Plasma, Safety, Security (finance), PSC, Program, GLOBE, ECG, Cholestasis, Liver disease, Nasdaq, Hematology, Conditional sentence, Cell damage, Cholesterol, Disorder, Itch, Șaeș, Company, BOLD, Private Securities Litigation Reform Act, AstraZeneca, Kidney, Annual report, C4, Pharmacokinetics, Patient, Alagille syndrome, Infection, Fibrosis, Pharmaceutical industry, Medical imaging, PFIC

BOSTON, Dec. 16, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced positive topline results from its Phase 1 clinical trial of A3907, the first oral systemic apical sodium-dependent bile acid transporter (ASBT) inhibitor. The study achieved both primary and secondary objectives. Phase 1 study is a first-in-human, double-blind, single and multiple ascending dose study in healthy adult subjects to investigate the safety, tolerability, pharmacokinetics of orally administered A3907. A3907 was safe and well tolerated in this study at systemic exposures that demonstrated therapeutic benefits in preclinical models. With the potential to inhibit ileal, renal and hepatic ASBT, A3907 could provide the optimal balance of efficacy and tolerability in patients in multiple liver diseases.

Key Points: 
  • Phase 1 study is a first-in-human, double-blind, single and multiple ascending dose study in healthy adult subjects to investigate the safety, tolerability, pharmacokinetics of orally administered A3907.
  • A3907 was safe and well tolerated in this study at systemic exposures that demonstrated therapeutic benefits in preclinical models.
  • The results from our Phase 1 study of A3907 show that the drug candidate is safe and well tolerated with favorable pharmacokinetics and high systemic exposure, giving us the greenlight to advance to a Phase 2 study, said Jan Mattsson, Chief Scientific Officer of Albireo.
  • The completed Phase 1 study of A3907 is a first-in-human, double-blind, single and multiple ascending dose study in healthy adult subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an A3907 oral formulation.

Albireo Presenting New Bylvay™ (odevixibat) Data at NASPGHAN 2021

Retrieved on: 
Monday, December 13, 2021
UDCA, Sleep, Cholestasis, Liver disease, Nasdaq, Albireo, Ursodeoxycholic acid, Safety, Alagille syndrome, Disease, Quality of life, Data, Ageing, Progressive familial intrahepatic cholestasis, Natural history, GLOBE, Augmented fifth, Society, Pharmaceutical industry, Silviculture, PFIC, Patient, Itch

BOSTON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, will be presenting five posters on Bylvay (odevixibat) at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) meeting being held December 12–18. Data will be presented that show evidence of correlations in serum bile acid reductions and long-term improvements in pruritus and sleep in patients with progressive familial intrahepatic cholestasis (PFIC); reductions in serum bile acids and improvements in pruritus with and without concomitant ursodeoxycholic acid (UDCA) and/or rifampicin use; and the efficacy and safety of Bylvay in patients with PFIC and prior partial external biliary diversion (PEBD). Data on disease burden and natural history of PFIC will be presented to describe the clinical characteristics of the disease. There will also be a poster presentation on the Phase 3 double-blind, randomized, placebo-controlled ASSERT study of Bylvay in Alagille syndrome (ALGS). Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi) that is approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC and in Europe for the treatment of all types of PFIC in patients aged 6 months or older.

Key Points: 
  • Data on disease burden and natural history of PFIC will be presented to describe the clinical characteristics of the disease.
  • There will also be a poster presentation on the Phase 3 double-blind, randomized, placebo-controlled ASSERT study of Bylvay in Alagille syndrome (ALGS).
  • Safety and tolerability were comparable in patients using vs not using UDCA and/or rifampicin with Bylvay.
  • As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur.