Case Study Archive

RiverVest News and Views

Lumena Pharmaceuticals: Treating life-threatening pediatric liver diseases

Mirum Pharmaceuticals: Getting patients with rare liver disease the relief they need

Reneo Pharmaceuticals Receives Fast Track Designation from the FDA for Mavodelpar (REN001) in a Genotype of Long-Chain Fatty Acid Oxidation Disorder (LC-FAOD) – 1/31/2023
Alleviant Medical Closes $75M in Financing; Receives FDA IDE Approval for Pivotal Clinical Trial – 1/26/2023
Glycomine Announces First Patient Dosed in Phase 2 Clinical Study of GLM101, a Potential Treatment for PMM2-CDG – 1/9/2023
Spruce Biosciences and Kaken Pharmaceutical Announce Strategic Partnership and Exclusive Licensing Agreement to Develop and Commercialize Tildacerfont For CAH in Japan – 1/5/2023
Mirum Pharmaceuticals‘ LIV MARLI (maralixibat) Approved by the European Commission for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome Two Months and Older – 12/13/2022
Bluejay Therapeutics Received Regulatory Clearance to Initiate Clinical Studies of BJT-778 for Treatment of Chronic Hepatitis B and Chronic Hepatitis D – 12/1/2022
SeQure Dx emerges from stealth mode to fulfill the promise of on-target gene editing therapies for biopharma partners, physicians, and patients – 11/16/2022
Bonum Therapeutics Announces a $93M Series A Financing to Advance a Novel and Validated Class of Conditionally Active Therapies – 11/15/2022
Positive Topline Data Announced from Mirum’s LIVMARLI Phase 3 MARCH Study in Progressive Familial Intrahepatic Cholestasis (PFIC) – 10/24/2022
Avalyn Pharma Appoints Lyn Baranowski Chief Executive Officer – 10/17/2022
Mirum Pharmaceuticals Announces Positive CHMP Opinion for LIVMARLI (maralixibat) Oral Solution for Cholestatic Pruritus in Patients with Alagille Syndrome Two Months of Age and Older – 10/14/2022
Teleflex Completes Acquisition of Standard Bariatrics – 9/28/2022
Good Therapeutics Announces Acquisition of Conditionally Active PD-1-regulated IL-2 Program by Roche – 9/7/2022
Teleflex to Expand It’s Surgical Portfolio with Differentiated Stapling Technology for Bariatric Surgery – Signs Definitive Agreement to Acquire Standard Bariatrics – 8/22/2022
Bluejay Therapeutics raises $41 million in Series B round to drive clinical trials in chronic hepatitis. – 8/16/2022
Mirum Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Update – 8/4/2022
Allakos Provides Business Update and Reports Second Quarter 2022 Financial Results – 8/4/2022
Reneo Pharmaceuticals Reports Positive Results from REN001 Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) Study and Provides Additional Development Updates – 7/27/2022
Wugen Receives U.S. FDA Fast Track and Rare Pediatric Disease Designations for WU-CART-007 for the Treatment of R/RT-ALL/LBL 7/19/2022
Allakos, Inc. Provides Business Update and Reports First Quarter 2022 Financial Results – 5/6/2022
Reneo Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update – 3/23/2022
Wugen Announces First Patient Dosed in Phase 1/2 Trial of WU-CART-007 for the Treatment of Patients with R/RT-ALL/LBL, 3/15/2022
Spruce Biosciences Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Updates – 3/14/2022
Mirum Pharmaceuticals Reports Fourth Quarter and Year-End 2021 Financial Results and Provides Business Update – 3/9/2022
Xilio Therapeutics Reports Pipeline and Business Progress and Fourth Quarter and Full Year 2021 Financial Results – 3/1/2022
Standard Bariatrics Achieves Final Series B Funding Early, 2/28/2022
Oxford Finance Announces the Closing of a $50 Million Credit Facility With OncoResponse – 2/15/2022
Arch Oncology Receives U.S. FDA Orphan Drug Designation for AO-176, a Next-Generation Anti-CD47 IgG2 Antibody, for the Treatment of Multiple Myeloma – 1/21/2022
Xilio Therapeutics Announces Initiation of Patient Dosing in Phase 1/2 Clinical Trial of XTX202 for the Treatment of Patients with Solid Tumors – 1/20/2021
Titan SGS from Standard Bariatrics, Inc. Passes 1,000 Clinical Case Uses – 1/19/2022
Glycomine Announces First Dosing in Phase 1 Clinical Study of GLM101 – 12/17/2021
InterVene’s BlueLeaf Endovenous Valve Formation (EVF) System Granted Breakthrough Device Designation by the FDA – 12/13/2021
Standard Bariatrics, Inc. Reaches Sales Milestone With Titan SGS™ – 12/13/2021
Allakos Announces Expansion of Lirentelimab Development into Atopic Dermatitis, Chronic Spontaneous Urticaria and Asthma – 11/30/2021
Lonza and BlueJay Therapeutics Announce Manufacturing Agreement for its Antibody BJT-778 Targeting Chronic HBV Infection – 11/17/2021
Cardialen Receives FDA Approval to Conduct Clinical Trial of Low-Energy Atrial Fibrillation Treatment – 11/17/2021
Six-Year Natural History Comparison with Mirum’s LIVMARLI (maralixibat) Demonstrates Event-Free Survival and Transplant-Free Survival in Patients with Alagille Syndrome – 11/15/2021
Wugen Presents New Preclinical Data from Novel Memory Natural Killer (NK) Platform at The Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting – 11/12/2021
Scout Bio Named Best New Start-Up for 2021 – 11/08/2021
Biolinq raises $100 million for needle-free biosensors for diabetes monitoring – 11/2/2021
Xilio Therapeutics Announces Closing of Initial Public Offering – 10/26/2021
U.S. FDA Approves LIVMARLI (Maralixibat) as the First and Only Approved Medication for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome One Year of Age and Older – 9/29/2021
Xilio Therapeutics Announces Initiation of Patient Dosing in Phase 1/2 Clinical Trial of XTX101 for the Treatment of Patients with Solid Tumors – 9/16/2021
Scout Bio Successfully Completes Pilot Clinical Study of SB-001, A Single-Injection AAV Gene Therapy for the Treatment of Feline CKD-Associated Anemia – 9/9/2021
Sparrow Pharmaceuticals Expands Executive Leadership With Appointment of Frank Czerwiec, MD as Chief Medical Officer and Jamie MacPherson, PharmD as Vice President of Regulatory Affairs and Quality – 8/17/2021
Spruce Biosciences Reports Second Quarter 2021 Financial Results and Provides Corporate Updates – 8/10/2021
Allakos Provides Business Update and Reports Second Quarter 2021 Financial Results – 8/9/2021
Mirum Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Update – 8/5/2021
SeQure Dx Announces $17.5M Series A Funding – 8/3/2021
Mirum Pharmaceuticals And GC Pharma Enter Into Exclusive Licensing Agreement To Develop And Commercialize Maralixibat For Rare Liver Diseases In South Korea – 7/26/2021
Wugen Raises $172 Million to Advance Clinical State Memory NK Cell Platform, Progress Best-In-Class AML Program, and Initiate Multiple Solid Tumor Trials – 7/15/2021
Neuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius® High Frequency Nerve Block System – 06/29/2021
Glycomine’s Natural History Study Informs Potentially Lifesaving Update to Standard of Care for PMM2-CDG Patients – 6/29/2021
Mirum Pharmaceuticals Presents Analyses From Its Rare Disease Programs at the EASL International Liver Congress 2021 – 6/23/2021
Spruce Biosciences Announces Publication Of Phase 2 Results For Tildacerfont In Journal Of Clinical Endocrinology And Metabolism – 6/21/2021
Xilio Therapeutics Announces FDA Acceptance of IND Application for XTX101 for the Treatment of Solid Tumors – 6/17/2021
Standard Bariatrics Secures $35M in Series B Funding to Accelerate Development and Commercialization of Their First Bariatric Surgical Platform for Sleeve Gastrectomy – 6/1/2021
Spruce Biosciences Presents Phase 2 Data for Tildacerfont in Adults with Congenital Adrenal Hyperplasia at 23rd European Congress of Endocrinology – 5/24/2021
New Allakos Data Presented at DDW 2021 Suggest that Eosinophilic Gastritis and/or Eosinophilic Duodenitis (EG/EoD) is Highly Underdiagnosed and may be a Common Cause of Moderate-to-Severe Gastrointestinal Symptoms – 5/24/2021
Sparrow Pharmaceuticals Presents Data on SPI-62 at the European Congress of Endocrinology – 5/22/2021
Reneo Pharmaceuticals Reports First Quarter 2021 Financial Results – 5/20/2021
Sparrow Pharmaceuticals Secures $50 Million Series A Financing – 5/18/2021
Spruce Biosciences Reports First Quarter 2021 Financial Results and Provides Corporate Updates – 5/12/2021

RiverVest News and Views

Lumena Pharmaceuticals: Treating life-threatening pediatric liver diseases

Mirum Pharmaceuticals: Getting patients with rare liver disease the relief they need

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