Pharmaceutical

Neuvivo’s NP001 for Treatment of ALS Slows Disease Progression Through Regulation of Microbial Translocation

12/07/2022

Paper Published in ‘Biomedicines’ Highlights MOA, Links Biomarker Changes to Positive Clinical Outcomes Excerpt from the Press Release: PALO ALTO Calif., Dec. 1, 2022 /PRNewswire/ — Neuvivo today announced the publication of a peer-reviewed paper titled: “Macrophage Targeted Sodium Chlorite (NP001) Slows Progression of ALS through Regulation of Microbial Translocation”. The goal of the biomarker-focused…

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Otsuka and Sunovion Initiate Clinical Development of Ulotaront for the Adjunctive Treatment of Major Depressive Disorder

12/06/2022

First Trial to Study a Trace Amine-Associated Receptor 1 (TAAR1) Agonist in Major Depressive Disorder (MDD) Excerpt from the Press Release: PRINCETON, N.J. & MARLBOROUGH, Mass.–(BUSINESS WIRE)–Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the first patient has been enrolled in a Phase 2/3 clinical study to evaluate…

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Praxis Precision Medicines to Advance PRAX-562 Phase 2 Study in Pediatric Patients with Developmental and Epileptic Encephalopathies

11/30/2022

Excerpt from the Press Release: BOSTON, Nov. 28, 2022 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced plans to initiate the PRAX-562 Phase 2 EMBOLD study for the treatment of…

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Aerovate Therapeutics Publishes Results of Phase 1 Study Evaluating AV-101 for the Treatment of Pulmonary Arterial Hypertension in ERJ Open Research

11/24/2022

Phase 1 results showed that AV-101 was generally well tolerated with significantly reduced systemic exposure compared to oral imatinib in healthy adult participants Excerpt from the Press Release: WALTHAM, Mass., Nov. 17, 2022 (GLOBE NEWSWIRE) — Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical-stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of…

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Kyowa Kirin and MEI Pharma Announce Topline Data from the Phase 2 MIRAGE Study Evaluating Zandelisib in Patients with Indolent B-cell non-Hodgkin’s Lymphoma in Japan

11/22/2022

Interim data from Phase II Study of Zandelisib shows 75.4% ORR in Japanese patients with Indolent B-cell NHL – – Publication of results from additional Phase 1 study now available in International Journal of Hematology– Excerpt from the Press Release: TOKYO & SAN DIEGO–(BUSINESS WIRE)–Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty…

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LianBio Doses First Patient in Phase 1 Trial of BBP-398 in Chinese Patients with Advanced Solid Tumors

11/21/2022

Excerpt from the Press Release: SHANGHAI, China and PRINCETON, N.J., Nov. 09, 2022 (GLOBE NEWSWIRE) — LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced the first patient has been dosed in its Phase 1 clinical trial of BBP-398, a SHP2 inhibitor,…

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ROME Therapeutics Demonstrates Efficacy of its Novel LINE-1 Reverse Transcriptase Inhibitor in Translational Models of Autoimmune Disease

11/18/2022

Company to share preclinical data from lead program in autoimmune disease at American College of Rheumatology (ACR) Convergence 2022 Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–ROME Therapeutics, a biotechnology company harnessing the power of the dark genome to develop breakthrough medicines for cancer and autoimmune diseases, today announced it will share preclinical data from its…

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Merrimack Provides Ipsen Report That Onivyde® Regimen Demonstrated Statistically Significant Improvement in Overall Survival in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

11/17/2022

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] announced that Ipsen, SA (“Ipsen”) issued a press release today reporting its primary analysis of the results of its Phase III NAPOLI 3 trial of Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a treatment…

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Kira Pharmaceuticals Presents Complete Data from Phase 1 SYNERGY-1 Trial of KP104 at American Society for Nephrology Kidney Week 2022

11/09/2022

Biomarker data demonstrates proof-of-concept for KP104’s dual-targeting mechanism via dose-dependent inhibition of alternative and terminal pathways and supports intravenous and subcutaneous administration of KP104 in phase 2 studies Excerpt from the Press Release: CAMBRIDGE, Mass., Nov. 3, 2022 /PRNewswire/ — Kira Pharmaceuticals, a global biotechnology company pioneering transformational complement therapies to treat immune-mediated diseases, today presented…

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Enrollment Completed in Phase 3 PATHFNDR-1 Study Evaluating Oral Paltusotine for the Treatment of Acromegaly

10/24/2022

Topline results for PATHFNDR-1 study expected in Q3 2023 Excerpt from the Press Release: SAN DIEGO, Oct. 13, 2022 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the completion of enrollment in the Phase 3 PATHFNDR-1 study. PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 studies evaluating the safety and efficacy of…

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