Pharmaceutical

Vial Announces Enrollment of First Patient in Phase II Clinical Trial TLL018-205 for the Treatment of Plaque Psoriasis Sponsored by Highlightll Pharmaceutical

01/23/2023

Excerpt from the Press Release: SAN FRANCISCO, Jan. 19, 2023 /PRNewswire/ — Vial, a global tech-enabled CRO providing next-generation clinical trial management services, announced that the first patient has been enrolled in the clinical trial TLL018-205, a Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of TLL-018 in human subjects with moderate…

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Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis

01/13/2023

As previously reported, resmetirom demonstrated improvements in NASH and liver fibrosis on liver biopsies, the primary endpoints of the MAESTRO-NASH trialA supportive analysis using consensus reads of digitized biopsy images by the central pathologists replicated the positive primary endpoint resultsThese data will be presented at the NASH-TAG Conference on Friday January 6th, 2023 Excerpt from…

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Sionna Therapeutics Announces Advancement of Cystic Fibrosis Pipeline Programs and Presentation at J.P. Morgan 41st Annual Healthcare Conference

01/12/2023

– Enrolling Phase 1 study of lead NBD1 modulator, SION-638, following IND clearance from the FDA; data expected in the second half of 2023 – – SION-109, targeting complementary mechanism ICL4, on-track for IND submission in the first half of 2023 – – Three additional development candidates nominated for progression including two Series 2 NBD1…

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Alnylam Submits CTA Application for ALN-KHK, an Investigational RNAi Therapeutic for the Treatment of Type 2 Diabetes

01/09/2023

–Company Expects to Initiate a Phase 1/2 Study for ALN-KHK in Early 2023, with Initial Results Expected in Late 2023 – Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi (RNA interference) therapeutics company, announced today that the Company has submitted a Clinical Trial Authorization (CTA) application to Health…

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Maze Therapeutics Announces Completion of Phase 1 First-in-Human Trial Evaluating MZE001 as a Potential Oral Treatment for Pompe Disease

12/20/2022

MZE001 was Well-Tolerated and Reduced Glycogen Accumulation in Blood Cells in Healthy Volunteers, Supporting Advancement into Phase 2 Clinical Trial Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Maze Therapeutics, a company translating genetic insights into new precision medicines, today announced the completion of its first-in-human clinical trial designed to evaluate the safety, tolerability,…

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Rezolute Announces Initiation of a Phase 2 Study of RZ402 in Patients with Diabetic Macular Edema

12/19/2022

RZ402 is an oral therapy being developed as a potential alternative to invasive and suboptimal injections into the eye Excerpt from the Press Release: REDWOOD CITY, Calif., Dec. 15, 2022 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of…

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Moderna and Merck Announce mRNA-4157/V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination with KEYTRUDA(R) (pembrolizumab), Met Primary Efficacy Endpoint in Phase 2b KEYNOTE-942 Trial

12/16/2022

mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with high risk of recurrence following complete resection Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical…

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Corvus Pharmaceuticals Presents Updated Data from CPI-818 (ITK Inhibitor) Phase 1/1b Clinical Trial at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition

12/14/2022

Results in patients with refractory T cell lymphoma demonstrated CPI-818’s anti-tumor activity and effects on T cell differentiation which indicate therapeutic potential in Th2 and Th17-mediated autoimmune and allergic diseases Corvus confirms plans to initiate a Phase 2 clinical trial of CPI-818 in T cell lymphoma and a Phase 1 clinical trial in atopic dermatitis,…

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Biomea Fusion Presents at the 2022 ASH Annual Meeting Preclinical Data on BMF-500 Supporting its Potential as the Most Potent and Selective FLT3 Inhibitor to Date

12/13/2022

BMF-500, an investigational third generation covalent FLT3 inhibitor, demonstrated preclinically: Biomea Fusion remains on track to file an IND for BMF-500 in the first half of 2023 Excerpt from the Press Release: REDWOOD CITY, Calif., Dec. 12, 2022 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing…

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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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