Institute of Liver and Biliary Sciences

Obstetric and Neonatal Professionals Must Work More Closely with Pregnant People to Identify Liver Diseases Early

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수요일, 2월 1, 2023

“Most pregnant women and families of young children were never informed that liver health is an essential aspect of a healthy pregnancy and birth.

Key Points: 
  • “Most pregnant women and families of young children were never informed that liver health is an essential aspect of a healthy pregnancy and birth.
  • Existing nonalcoholic fatty liver disease (NAFLD) has been tied to intrahepatic cholestasis of pregnancy (ICP) , an issue with the flow of bile in the liver, which affects 1 in 300 pregnancies.
  • For any liver disease during pregnancy or early in life, early diagnosis is critical to access the complex, robust care required to mitigate issues.
  • If liver diseases are ignored during pregnancy, it can lead to serious health complications for both the mother and the baby.

GENFIT Announces 2023 Financial Calendar

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화요일, 1월 24, 2023

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland) January 24, 2023 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs, today announced its provisional financial calendar for 2023.

Key Points: 
  • Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland) January 24, 2023 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs, today announced its provisional financial calendar for 2023.
  • Publication of revenue and cash position at December 31, 2022
    The 2022 Universal Registration Document and Annual Financial Report (included in the Universal Registration Document), as well as the Annual Report on Form 20-F will be made public by the end of April 2023.
  • Publication of revenue and cash position at March 31, 2023

Can-Fite Announces $7.5 Million Concurrent Registered Direct Offering and Private Placement

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수요일, 1월 11, 2023

In a concurrent private placement, Can-Fite has also agreed to issue and sell 363,637 of its ADS (or ADS equivalents in lieu thereof), at the same purchase price as in the registered direct offering.

Key Points: 
  • In a concurrent private placement, Can-Fite has also agreed to issue and sell 363,637 of its ADS (or ADS equivalents in lieu thereof), at the same purchase price as in the registered direct offering.
  • Each ADS represents three hundred (300) ordinary shares, par value NIS 0.25 per share, of Can-Fite.
  • The offering of the ADSs (or ADS equivalents) to be issued in the registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
  • A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC.

Can-Fite Submits Market Registration Plan to European Medicines Agency for Piclidenoson in the Treatment of Psoriasis; FDA Submission to Follow

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화요일, 1월 10, 2023

A submission to the U.S. Food and Drug Administration (FDA) will follow.

Key Points: 
  • A submission to the U.S. Food and Drug Administration (FDA) will follow.
  • Registration plans for both the EMA and FDA include final efficacy and safety results from Can-Fite’s successful COMFORT™ Phase III study and the protocol for the Company’s upcoming Phase III pivotal trial together with a request for registration advice from the regulators.
  • Current chemistry, manufacturing, and controls (CMC), nonclinical data, and human pharmacokinetic data are also included.
  • “This submission represents an important step toward the pivotal Phase III study and subsequent marketing approval of Piclidenoson,” said Dr. Pnina Fishman, CEO & CSO of Can-Fite BioPharma.

Genethon Launches Pivotal Clinical Trial of Gene Therapy for Crigler-Najjar Syndrome, a Rare Liver Disease

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화요일, 1월 10, 2023

Genethon , a unique non-profit gene therapy R&D organization founded by the French Muscular Dystrophy Association (AFM-Telethon), has launched a pivotal clinical trial in Europe for treatment of Crigler-Najjar syndrome, a life threatening liver disease.

Key Points: 
  • Genethon , a unique non-profit gene therapy R&D organization founded by the French Muscular Dystrophy Association (AFM-Telethon), has launched a pivotal clinical trial in Europe for treatment of Crigler-Najjar syndrome, a life threatening liver disease.
  • “This new step demonstrates once again the excellence of the research conducted at Genethon, which is today one of the major players in gene therapy at the international level."
  • Crigler-Najjar syndrome is a rare genetic liver disease characterized by abnormally high levels of bilirubin in the blood (hyperbilirubinemia).
  • The gene therapy, administered intravenously, was designed by Genethon's Immunology and Gene Therapy of Liver Diseases team, led by Dr. Giuseppe Ronzitti.

Ipsen to Acquire Albireo Accelerating Growth in Rare Disease With Treatments for Several Pediatric Liver Diseases

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월요일, 1월 9, 2023

Ipsen (Euronext: IPN: ADR: IPSEY) and Albireo (Nasdaq: ALBO) today announced that they have entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases.

Key Points: 
  • Ipsen (Euronext: IPN: ADR: IPSEY) and Albireo (Nasdaq: ALBO) today announced that they have entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases.
  • “Our Rare Disease franchise is strengthened with Bylvay, which, in addition to being the first-approved treatment in PFIC, has two further indications being investigated in rare liver conditions that are underserved.
  • “Our talented team at Albireo have advanced the first Phase III studies in three different pediatric liver diseases while discovering two promising new clinical stage bile acid modulators.
  • Goldman Sachs is acting as exclusive financial advisor to Ipsen and Orrick Herrington & Sutcliffe LLP as legal counsel to Ipsen.

Top Gastroenterology and Liver Disease Specialist, Dr. David P. Yamini, is Named a 2023 Top Doctor by Los Angeles Magazine

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수요일, 1월 11, 2023

SANTA MONICA, Calif., Jan. 11, 2023 /PRNewswire-PRWeb/ -- Dr. David Yamini has been placed on Los Angeles Magazine's "Top Doctor" list for 2023. His elite training, credentials and excellent bedside manner as a sought-after gastroenterologist and digestive disease specialist have once again earned him a spot on this coveted list. The magazine's decision for inclusion is made through an extensive nomination and review process conducted by PRS (Professional Research Services), which involves a peer-to-peer survey and voting from practicing physicians throughout Los Angeles County. The list of prominent physicians will appear in the upcoming issue of Los Angeles Magazine and is online at http://www.lamag.com/top-doctors.

Key Points: 
  • SANTA MONICA, Calif., Jan. 11, 2023 /PRNewswire-PRWeb/ -- Dr. David Yamini has been placed on Los Angeles Magazine's "Top Doctor" list for 2023.
  • His elite training, credentials and excellent bedside manner as a sought-after gastroenterologist and digestive disease specialist have once again earned him a spot on this coveted list.
  • The list of prominent physicians will appear in the upcoming issue of Los Angeles Magazine and is online at http://www.lamag.com/top-doctors .
  • At his practice, Dr. David Yamini offers advanced diagnostic and therapeutic procedures and has established a reputation as one of the foremost Los Angeles gastroenterologist and liver disease specialist .

Aligos Therapeutics on Track to Complete Phase 2-Enabling Activities in 2023 for its Clinically Validated THR-ß Drug Candidate for NASH, ALG-055009

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목요일, 1월 5, 2023

SOUTH SAN FRANCISCO, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company remains on track to complete all Phase 2-enabling activities in 2023 for ALG-055009, its thyroid hormone receptor beta (THR-ß) drug candidate for nonalcoholic steatohepatitis (NASH).

Key Points: 
  • “Initial Phase 1 clinical data demonstrate that ALG-055009 is favorably differentiated compared to frontrunner THR-ß drug candidates such as resmetirom,” said Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board at Aligos.
  • The planned upcoming Phase 2 study of ALG-055009 will be important in assessing the spectrum of activity of this molecule.
  • We anticipate completing the final cohort of the Phase 1 study (NCT05090111) in H1 2023 where the relative bioavailability of the Phase 2 drug formulation will be assessed.
  • Dr. Blatt’s presentation will also be posted on the Aligos website at the time of the conference.

HOOKIPA Pharma Achieves $5 Million Milestone Payment from Gilead Sciences for Progress in the Development of Hepatitis B Vaccine

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수요일, 1월 4, 2023

“We’re proud of our team for achieving this milestone in our collaboration with Gilead and excited that the hepatitis B candidate is progressing to the clinic,” said Joern Aldag, Chief Executive Officer.

Key Points: 
  • “We’re proud of our team for achieving this milestone in our collaboration with Gilead and excited that the hepatitis B candidate is progressing to the clinic,” said Joern Aldag, Chief Executive Officer.
  • Gilead is solely responsible for further development and commercialization of the hepatitis B product candidate.
  • HOOKIPA is eligible to receive milestone payments based on the achievement of specified development, regulatory, and commercial milestones up to a total of more than $190 million.
  • The hepatitis B program is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead.

Albireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

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화요일, 12월 20, 2022

The restricted stock units were granted as an inducement material to Dr. Streck’s acceptance of employment with Albireo in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The restricted stock units were granted as an inducement material to Dr. Streck’s acceptance of employment with Albireo in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The restricted stock units vest over a four-year period, subject to the employee’s continued service with Albireo through the applicable vesting dates.
  • The vesting schedule for each restricted stock unit is 25 percent on the one-year anniversary of the employee’s start date with Albireo and 75 percent in 12 equal quarterly installments thereafter.
  • The restricted stock units are subject to the terms and conditions of Albireo’s 2020 Inducement Equity Incentive Plan.