Biopharmaceutical

Tranquis Therapeutics Announces Successful Completion of Phase 1 Clinical Trial of TQS-168

06/13/2022

-TQS-168 was well tolerated and demonstrated excellent pharmacokinetic properties- -Tranquis plans to start a Phase 2 trial in ALS by the end of 2022- Excerpt from the Press Release: REDWOOD CITY, Calif.–(BUSINESS WIRE)–Tranquis Therapeutics, Inc., a clinical stage immuno-neurology company developing innovative medicines with the potential to revolutionize the management of neurodegenerative and aging-related diseases,…

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Nexus Medical Labs Receives FDA Emergency Use Authorization for SARS-CoV-2 Test Using the RHINOstic™ Automated Nasal Swab from Rhinostics

06/03/2022

Automated and Easily Scalable Swab-Based Workflow Supports Increased Sample Throughput and Processing Consistency Excerpt from the Press Release: WALTHAM, Mass. & WATERTOWN, Mass.–(BUSINESS WIRE)–Rhinostics Inc. and Nexus Medical Labs recently received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a molecular SARS-CoV-2 test enabling unsupervised self-collection. The test, based on…

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Scilex, a Sorrento Company, Announces Initiation of a Phase 2 Study to Evaluate the Safety and Efficacy of SP-103 in Subjects with Acute Low Back Pain

05/31/2022

Dosing of the first subject in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 (lidocaine topical system) 5.4% in subjects with moderate to severe acute lower back pain (LBP). The trial will enroll 80 patients with acute lower back pain. SP-103 is a pharmacologically validated…

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Vaxart Announces the Publication of Studies in the Peer-Reviewed Journal Science Translational Medicine That Suggest Mucosal Immunization Could Decrease SARS-CoV-2 Transmission

05/30/2022

A preclinical study in hamsters showed both a decrease in infectious virus and in transmission Phase 1 data measuring cross-reactivity also included in the publication Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., May 19, 2022 (GLOBE NEWSWIRE) — Science Translational Medicine has published the results of a Duke University-led preclinical hamster transmission study that found that…

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RenovoRx to Present Preclinical Research Data Demonstrating its Innovative Therapy Platform’s Potential Utility for the Treatment of Bile Duct Cancer

05/30/2022

Study to be Presented at the Global Embolization Oncology Symposium Technologies (GEST) 2022 Excerpt from the Press Release: LOS ALTOS, Calif.–(BUSINESS WIRE)–RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announces that it will present preclinical research supporting its planned second clinical indication, bile duct cancer,…

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Mustang Bio Announces Updated Interim Data on X-Linked Severe Combined Immunodeficiency Treatment with Lentiviral Vector Gene Therapy Support Upcoming Multicenter Pivotal Phase 2 Trial for MB-107

05/26/2022

All 23 treated patients are alive at 2.6-year median follow-up without evidence of malignant transformation Data representing largest cohort of infants with XSCID treated with gene therapy presented at the 25th Annual Meeting of the American Society of Gene & Cell Therapy Excerpt from the Press Release: WORCESTER, Mass., May 19, 2022 (GLOBE NEWSWIRE) — Mustang…

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ASLAN Pharmaceuticals Presents Late-Breaking Poster on Eblasakimab and Neuronal Itch Mechanisms at the 2022 Society for Investigative Dermatology Annual Meeting

05/26/2022

Excerpt from the Press Release: MENLO PARK, Calif. and SINGAPORE, May 20, 2022 (GLOBE NEWSWIRE) — ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced the presentation of a poster highlighting new data and insights related to neuronal itch mechanisms through eblasakimab’s targeting of IL-13Rα1 at…

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Amylyx Pharmaceuticals Announces Publication of Data Showing Randomization to AMX0035 Prolonged Tracheostomy/Ventilation-free Survival and Reduced Occurrence of First Hospitalization

05/25/2022

Adding to previously reported overall functional and survival benefit data for AMX0035, these findings support effect of AMX0035 on disease progression in ALS Randomization to AMX0035 resulted in a lower occurrence of death or tracheostomy/permanent assisted ventilation by 49% and first hospitalization by 44% over the Phase 2 trial and duration of follow-up Excerpt from the Press…

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PureTech Presents Additional Phase 1 Data for LYT-100 at American Thoracic Society 2022

05/25/2022

Further data from Phase 1 study in healthy older adults demonstrate improved tolerability profile of LYT-100 compared to pirfenidone Data support the planned LYT-100 dose-ranging registration-enabling studies in idiopathic pulmonary fibrosis, with topline results expected in 2023 Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage…

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Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular Dystrophy

05/23/2022

Pre-IND meeting request granted by FDA’s Division of Neurology I Excerpt from the Press Release: BOSTON, May 12, 2022 /PRNewswire/ — Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that the US Food and Drug Administration (FDA) Office of Orphan…

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