Mirum Announces Label Expansion for LIVMARLI in the United States to Include Infants Three Months of Age and Older

Mirum Announces Label Expansion for LIVMARLI in the United States to Include Infants Three Months of Age and Older

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a reduction in age from one year to three months for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS). The label expansion was based on data from the RISE study which characterized the safety and tolerability of LIVMARLI in infants under one year of age with ALGS.

Us2.ai to Deliver AI-Enabled Echocardiography Decision Support to Brigham and Women’s Hospital’s Cardiac Imaging Core Laboratory

SINGAPORE--(BUSINESS WIRE)--Us2.ai, a Singapore-based medtech firm backed by IHH Healthcare, Heal Partners and Sequoia India will provide AI software that assists in analyzing research echocardiograms or heart ultrasounds to Brigham and Women’s Hospital’s Cardiac Imaging Core Laboratory. Us2.ai’s software platform aims to improve the speed and scalability of the Cardiovascular Imaging Core Laboratory (CICL), part of the Brigham and Women’s Hospital (BWH) Division of Cardiovascular Medicine.

SG energy storage firm VFlowTech raises $10m in Series A funding

SINGAPORE, 7 February 2023 – VFlowTech, the Singapore-based provider of vanadium-based redox flow batteries, has raised US$10 million in a Series A funding round. Led by Japan-based venture capital (VC) firm Real Tech Holdings, the oversubscribed round was participated in by returning investors ranging from corporate investors including SEEDS Capital, Wavemaker Partners and Sing Fuels to personal investors like Michael Gryseels (Chairman of VFlowTech), as well as new international VC and strategic investors including İnci Holding (Türkiye), Pappas Capital (US) and Carbon Zero Venture Capital (Singapore). VFlowTech will use the funds to set-up a 200MWh production line capacity and scale up the manufacturing of its 250 kWh modular vanadium-based long duration energy storage solutions. It will also use the funds to expand its market presence to Türkiye, the US, Japan, China and India with new partners. The company also plans to intensify research and development efforts to further improve its best-in-class technology, as well as increase system capacity and explore new markets with emerging demand for sustainable energy storage solutions.

Life Sciences Summit

Peter Young will be participating on a panel titled "Investor and Partner Insights" on November 2nd at the virtual Life Sciences Summit.

Positive Topline Data Announced from Mirum’s LIVMARLI Phase 3 MARCH Study in Progressive Familial Intrahepatic Cholestasis (PFIC)

FOSTER CITY, CA--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced positive topline results from its pivotal Phase 3 MARCH study evaluating LIVMARLI® (maralixibat) oral solution in 93 patients with progressive familial intrahepatic cholestasis (PFIC) in a broad range of subtypes, age one to 17 years. The primary endpoint of improvement in pruritus severity in PFIC2 was statistically significant (p=0.0098).

“The advancement of new medications, particularly for rare diseases like PFIC, is incredibly important and provides hope to families who are in need of a treatment option that can effectively address itch, the most burdensome aspect of the disease”

The primary analysis was conducted in PFIC2 patients (n=31). The secondary analyses were evaluated in the All-PFIC cohort, which included PFIC2 as well as additional PFIC subtypes (n=64). The Full-Study population included All-PFIC as well as supplemental patients who had previously undergone surgery, had truncating mutations and other patients (n=93).