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Minoryx gains FDA approval to initiate a Phase 3 clinical trial in patients with cerebral Adrenoleukodystrophy

2023-05-31 US trial with leriglitazone to commence in mid-2023 providing an FDA-approved route to US market whilst EMA evaluates European Marketing Authorization Application (MAA) Mataró, Barcelona, Spain, May 31, 2023 – Minoryx Therapeutics, a registration stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders, today announces the US Food and Drug Administration (FDA) approval…

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Aura Biosciences to Participate in the JMP Securities Life Sciences Conference

May 12, 2023 PDF Version BOSTON–(BUSINESS WIRE)–May 12, 2023– Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced that Elisabet de los Pinos, PhD, Chief Executive Officer, will participate in a fireside chat at the JMP Securities Life Sciences Conference on Tuesday, May 16, 2023, at 2:00…

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Aura Biosciences Reports First Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights

May 11, 2023 PDF Version U.S. Food and Drug Administration (FDA) Guidance in Type C Meeting Supports Global Phase 3 Trial in Early-stage Choroidal Melanoma Enrollment Complete in Phase 2 Trial in Choroidal Melanoma Using Suprachoroidal Route of Administration BOSTON–(BUSINESS WIRE)–May 11, 2023– Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like…

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Data from Mirum’s LIVMARLI Studies Presented at ESPGHAN Annual Meeting

May 19, 2023 FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced data presented during the 55th European Society for Pediatric, Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Annual Meeting. Among the data presented were four oral and three poster presentations featuring analyses from LIVMARLI® (maralixibat) oral solution clinical studies. “We are thrilled to present data further…

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Hepatology Communications Publishes Data from Mirum’s LIVMARLI in Primary Sclerosing Cholangitis

May 18, 2023 FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that Hepatology Communications published data from the CAMEO study evaluating the safety, tolerability, and efficacy of LIVMARLI® (maralixibat) oral solution in patients with primary sclerosing cholangitis (PSC). The CAMEO study was the first proof-of-concept study evaluating an ileal bile acid transporter (IBAT) inhibitor in…

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Mirum Pharmaceuticals to Showcase LIVMARLI Data at ESPGHAN Annual Meeting

May 17, 2023 FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that it will present data at the upcoming 55th Annual European Society for Pediatric, Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Annual Meeting, taking place May 17-20, 2023, in Vienna, Austria. The company will present data from its LIVMARLI® (maralixibat) oral solution clinical studies in Alagille…

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Mirum Pharmaceuticals Announces Enrollment Completion in Phase 2b EMBARK Biliary Atresia Study

May 11, 2023 FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced it has completed enrollment of its Phase 2b EMBARK study for pediatric patients with biliary atresia, the most common indication for pediatric liver transplant. The EMBARK study is a global, double-blind, randomized, placebo-controlled, 26-week trial evaluating the efficacy and safety of LIVMARLI®…

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

FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that on May 10, 2023, the Compensation Committee of Mirum’s Board of Directors granted inducement awards consisting of non-qualified stock options to purchase 20,850 shares of common stock and 10,430 restricted stock units (“RSUs”) to five new employees under Mirum’s 2020 Inducement Plan. The Compensation…

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Mirum Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Business Update

May 04, 2023 – $31.6 million total revenue, including net product sales for LIVMARLI® (maralixibat) oral solution of $29.1 million, for first quarter 2023– Conference call to provide business updates today, May 4 at 1:30 p.m. PT/4:30 p.m. ET FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today reported financial results for first quarter 2023 and…

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Minoryx presents positive interim results from NEXUS registration study for leriglitazone targeting pediatric ALD patients with cerebral adrenoleukodystrophy (cALD)

2023-04-25 Initial evidence of disease stabilization was demonstrated for all patients using radiological, clinical and plasma biomarker assessments at 6 months (24 weeks) of treatment Mataró, Barcelona, Spain, April 25, 2023 – Minoryx Therapeutics, a registration stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders, today announces 24-week interim results…

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