Industry News

Aligos Therapeutics on Track to Complete Phase 2-Enabling Activities in 2023 for its Clinically Validated THR-ß Drug Candidate for NASH, ALG-055009

01/16/2023

– Final cohort of Phase 1 study projected to be complete in H1 2023 – – Phase 2-enabling GLP toxicology studies projected to be complete in H2 2023 – – Clinical update on all pipeline programs to be presented at the 2023 J.P. Morgan Healthcare Conference on January 12 at 10:30 a.m. PT – Excerpt…

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FDA Approves IND Submission Allowing ABVC BioPharma to Proceed With Clinical Study of ABV-1519 for Treatment of Non-Small Cell Lung Cancer

01/13/2023

Excerpt from the Press Release: FREMONT, CA, Jan. 05, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology today announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation…

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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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Helius Extends its Patient Therapy Access Program (PTAP), Bringing the Benefits of its PoNS® Device to More People with Multiple Sclerosis

01/12/2023

Excerpt from the Press Release: PTAP Lowers the Cost of PoNS Therapy™ for Qualified Americans NEWTOWN, Pa., Jan. 05, 2023 (GLOBE NEWSWIRE) — Helius Medical Technologies (NASDAQ: HSDT) today announced the extension of a program that puts the company’s Portable Neuromodulation Stimulator (PoNS®) into the hands of qualified Americans with multiple sclerosis (MS) at a…

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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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QurAlis Announces First-in-Human Dose in Phase 1 Clinical Trial of QRL-101, a First-in-Class Kv7 Precision Therapy for ALS

01/11/2023

QRL-101 aims to reduce hyperexcitability-induced motor neuron degeneration Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 5, 2023 /PRNewswire/ — QurAlis Corporation, a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets, today announced that the company recently initiated dosing in a Phase 1…

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Surface Oncology Announces First Patient Dosed in a Phase 1/2 Study Evaluating SRF114, a Potential Best-In-Class Anti-CCR8 Antibody, in Patients with Advanced Solid Tumors

01/11/2023

SRF114 is designed to preferentially deplete CCR8+ Treg cells within the tumor microenvironment and has demonstrated highly specific CCR8-exclusive binding and reduced tumor growth in pre-clinical studies Initial clinical data anticipated in 2024 Excerpt from the Press Release: CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) — Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing…

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TransCode Therapeutics Announces FDA Authorization to Proceed with First-In-Human Clinical Trial

01/10/2023

Excerpt from the Press Release: BOSTON, Dec. 29, 2022 (GLOBE NEWSWIRE) — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA Oncology Company™ committed to more effectively treating cancer using RNA therapeutics, announced today that it has received written authorization from the U.S. Food and Drug Administration (FDA) that it may proceed with its First-in-Human (FIH) Phase…

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Phio Pharmaceuticals Announces New Clinical Program to Study PH-762 for the Treatment of Cutaneous Squamous Cell Carcinoma

01/10/2023

Excerpt from the Press Release: MARLBOROUGH, Mass., Dec. 21, 2022 /PRNewswire/ — Phio Pharmaceuticals Corp., today announced it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL™ compound, PH-762. Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi…

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Minovia Therapeutics Reports First Clinical Data Demonstrating Disease-Modifying Efficacy and Safety of Mitochondrial Augmentation Therapy in Pediatric Patients with Primary Mitochondrial Diseases

01/10/2023

First in human clinical study provides proof-of-concept for mitochondrial augmentation therapy platform, which enables use of healthy mitochondria to improve mitochondrial function and mitigate effects of large-scale mitochondrial DNA (mtDNA) deletion syndromes Study showed improved quality of life measures in children with Pearson Syndrome and Kearns-Sayre Syndrome spectrum No treatment-related adverse effects reported in study…

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