Month: May 2026

Autobahn Therapeutics Presents New Preclinical Data at ASCP Annual Meeting Demonstrating Elunetirom Drives Robust Bioenergetic and Neuroplastic Improvements in Neuronal Cultures

05/29/2026

New preclinical findings demonstrate elunetirom’s direct effects on key gene programs that drive mitochondrial biogenesis, ATP production, and neuroplasticity in neuronal cultures Topline data anticipated from Phase 2 AMPLIFY-BD study in adjunctive bipolar depression in 2Q26 and Phase 2 AMPLIFY study in adjunctive major depressive disorder in 3Q26 Excerpt from the Press Release: SAN DIEGO–(BUSINESS…

Arsenal Medical Receives FDA IDE Approval for the RADIANT Pivotal Trial of NeoCast™ in Chronic Subdural Hematoma

05/28/2026

A randomized, controlled study of a novel liquid embolic, NeoCast, adjunctive to surgery Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–Arsenal Medical, a clinical-stage company developing innovative biomaterial-based devices, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for RADIANT, a pivotal trial evaluating NeoCast™. NeoCast is a…

Prolocor Announces Results of NIH-funded Study Demonstrating That Platelet FcγRIIa Identifies Cancer Patients at Increased Risk of Death and Thrombotic Events

05/27/2026

Excerpt from the Press Release: PHILADELPHIA, PA / ACCESS Newswire / May 20, 2026 / Prolocor, Inc., a healthcare company developing the innovative diagnostic Prolocor pFCG™ test to identify patients at risk of thrombotic events, announced the publication of a recently completed study entitled Platelet FcγRIIa: A Novel Biomarker of Risk for Thromboembolism and Death…

Scribe Therapeutics Achieves Regulatory Clearance to Initiate First-in-Human Clinical Study of STX-1150 for LDL-C Reduction

05/26/2026

Excerpt from the Press Release: ALAMEDA, Calif.–(BUSINESS WIRE)–Scribe Therapeutics, Inc. (Scribe), a clinical-stage biotechnology company engineering purpose-built in vivo CRISPR technologies designed to extend healthy lifespan through disease prevention and durable therapeutic intervention, today announced that it has secured clearance from the Australian Therapeutic Goods Administration (TGA) to initiate a first-in-human clinical study of STX-1150…

Jupiter Endovascular Announces Positive Results From SPIRARE II Pivotal Trial at EuroPCR 2026

05/25/2026

Vertex Pulmonary Embolectomy System demonstrated significant right heart recovery, low adverse event rates, and reproducible performance across high-severity PE patients Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Jupiter Endovascular, Inc. today announced that the SPIRARE II pivotal trial evaluating the use of the company’s Vertex™ Pulmonary Embolectomy System in patients with acute, intermediate-risk pulmonary…

Sapu Nano Announces First Patient Dosed in Phase 1b Trial of Sapu003, an Intravenous Deciparticle™ Formulation of Everolimus

05/22/2026

First-in-human study evaluates weekly IV Sapu003 in advanced mTOR-sensitive solid tumors, including HR+/HER2- breast cancer, RCC, NETs, TSC-associated tumors, and HCC Excerpt from the Press Release: SAN DIEGO, Calif., May 13, 2026 (GLOBE NEWSWIRE) — Sapu Nano today announced that the first patient has been dosed in the Phase 1b clinical trial of Sapu003, the…

EyePoint Announces Third Consecutive Positive DSMC Recommendation for Phase 3 Wet AMD Trials for DURAVYU™, Building Confidence Ahead of Mid-2026 Topline Data

05/21/2026

– LUGANO topline data on track for mid-2026, with LUCIA readout to follow shortly after –  – Continued favorable safety profile observed in masked Phase 3 DURAVYU data, consistent with four previously completed clinical trials –  – All active patients in the treatment arm have reached their second DURAVYU dosing visit, with over 35% receiving…

Affinia Therapeutics Presents AFTX-201 Data and UPBEAT© Clinical Trial Design for BAG3-Associated Dilated Cardiomyopathy, Alongside Advances in BBB-Penetrant AAV Capsids and Proprietary Manufacturing, at the 29th ASGCT 2026 Annual Meeting

05/20/2026

Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–Affinia Therapeutics (“Affinia”), an innovative clinical-stage gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced the presentation of new preclinical and translational data on the company’s lead program AFTX-201, the design of the Phase 1/2…

Corvus Pharmaceuticals Presents Soquelitinib Phase 1 Atopic Dermatitis Data at the Society for Investigative Dermatology (SID) Annual Meeting

05/19/2026

New immunologic and biomarker data supports the potential of ITK inhibition with soquelitinib to increase persistent Treg cells and influence multiple inflammatory pathways. Data supports potential for soquelitinib to rebalance the immune system and produce drug-free remissions following discontinuation of therapy Immunologic markers consistent with soquelitinib’s novel mechanism of action and clinical results SID data…

GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors

05/18/2026

GTB-5550 is now the 3rd TriKE® to enter the clinic and an expansion into a broader solid tumor opportunity, with the Phase 1 trial likely to focus on prostate cancer patients during the dose escalation phase Company anticipates providing updates in 2H 2026 as enrollment progresses through dose escalation cohorts Excerpt from the Press Release:…