Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Fractyl increases focus on key gene therapy programs

Fractyl Health (NASDAQ:GUTS) has announced plans to prioritize its REMAIN-1 pivotal study, advance its novel Rejuva gene therapy platform into first-in-human studies, and pause investment in its Revita programs for Type...

January 31, 2025

Developments

INBS upgrades portable drug screening reader with multilingual capabilities

Intelligent Bio Solutions (INBS) (NASDAQ:INBS) has announced plans to upgrade its drug screening reader, the Intelligent Fingerprinting Drug Screening System, to support multiple languages across North and South...

January 31, 2025

Developments

HeartBeam files 510(k) application with FDA for ECG software

HeartBeam (NASDAQ:BEAT) has announced the submission of a 510(K) application to the FDA for its 12-lead electrocardiogram (ECG) synthesis software, designed to analyze diverse cardiac rhythms and arrhythmias, leveraging...

January 30, 2025

Developments

HOOKIPA completes enrollment in Phase 1b study of HB-500 in HIV

HOOKIPA Pharma (NASDAQ:HOOK) has announced the completion of enrollment for its Phase 1b trial evaluating HB-500 in patients with HIV. The company stated that the study is comprised of two dose-escalation cohorts, with...

January 30, 2025

Developments

Tectonic announces positive Phase 1b results for TX45 in HFpEF

Tectonic Therapeutic (NASDAQ:TECX) has announced positive interim data from its Phase 1b acute hemodynamic clinical trial of TX45 in Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (“PH...

January 30, 2025

Developments

Polyrizon files patent application with ILPO for T&T technology

Polyrizon (NASDAQ:PLRZ) has announced the filing of a patent application for its advanced intranasal drug delivery system Trap & Target (T&T) technology, with the Israel Patent Office (ILPO). The company stated...

January 30, 2025

Developments

Model Medicines unveils AI-driven pipeline breakthrough; demonstrates end-to-end drug discovery capabilities

Closely held Model Medicines has announced the unveiling of a generative AI-driven, multi-modal therapeutic pipeline breakthrough, showcasing its end-to-end drug discovery capabilities for novel target discovery...

January 28, 2025

Developments

NLS launches preclinical program for Mazindol ER in fentanyl addiction

NLS Pharmaceutics (NASDAQ:NLSP; NASDAQ:NLSPW) has announced the launch of a preclinical program to evaluate Mazindol ER as a novel treatment for fentanyl dependence. According to the Centers for Disease Control and...

January 28, 2025

Developments

Conduit partners with Sarborg to advance drug development with AI

Conduit Pharmaceuticals (NASDAQ:CDT) has announced that the first phase in its collaboration with Sarborg, aimed at integrating advanced AI and cybernetics technology into its operations has been completed. The company...

January 28, 2025

Developments

Stereotaxis receives CE Mark for cardiac ablation catheter

Stereotaxis (NYSE:STXS) has announced that it has received European CE Mark approval for its MAGIC ablation catheter, designed to perform cardiac ablation procedures aimed at treating heart arrhythmia. According to...

January 27, 2025

Developments

RenovoRX highlights abstract showcasing promising PK data for TAMP in LAPC

RenovoRX (NASDAQ:RNXT) has announced that an abstract presented at the ASCO Gastrointestinal Cancers Symposium 2025 highlights promising pharmacokinetic (PK) data from its patented Trans-Arterial Micro-Perfusion (TAMP)...

January 27, 2025

Developments

Veru reports positive topline results of Phase 2b study of enobosarm for weight loss

Veru (NASDAQ:VERU) has announced positive topline results from its Phase 2b QUALITY clinical study evaluating the safety and efficacy of enobosarm in patients receiving WEGOVY (semaglutide) for weight reduction...

January 27, 2025

Developments

Social Capital’s Chamath Palihapitiya calls out Perimeter’s AI-driven cancer margin visualization technology on X show

Chamath Palihapitiya Renowned Silicon Valley venture capitalist, entrepreneur, and former Facebook executive, Chamath Palihapitiya, sat down with Tucker Carlson today to talk about several topics, including AI’s...

January 24, 2025

Developments

Greenwich adds Harvard and Johns Hopkins sites to Phase 3 trial

Greenwich LifeSciences (NASDAQ:GLSI) has announced the launch of two new clinical sites for its FLAMINGO-01 Phase 3 trial of GLSI-100 in HER2 breast cancer, including Harvard and Johns Hopkins Universities...

January 23, 2025

Developments

EMA grants IRLAB waiver from pediatric studies of mesdopetam in PD

IRLAB Therapeutics (STO:IRLAB-A; FRA:6IRA) has announced that the European Medicines Agency (EMA) has granted a waiver allowing the company to bypass pediatric studies of mesdopetam, enabling a focus on patient groups...

January 23, 2025

Developments

IPA’s AI-designed GLP-1 therapies aim to improve treatment for T2D

IPA (ImmunoPrecise Antibodies) (NASDAQ:IPA) has announced the development of a new class of GLP-1 therapies—leveraging AI—to enhance the efficacy, safety, and longevity of treatments for Type 2 diabetes (T2D) and...

January 22, 2025

Developments

FDA grants RPDD to MeiraGTx’s treatment for LCA1

MeiraGTx (NASDAQ:MGTX) has announced that its AAV8-RK-RetGC program for the treatment of patients with Leber congenital amaurosis due to GUCY2D mutations (LCA1) has been granted Rare Pediatric Disease Designation (RPDD)...

January 22, 2025

Developments

Revelation launches Phase 1b study of Gemini in CKD

Revelation Biosciences (NASDAQ:REVB) has announced the commencement of its PRIME Phase 1b clinical study evaluating escalating doses of Gemini, its intravenously administrated proprietary formulation of phosphorylated...

January 21, 2025

Developments

Nanobiotix doses first patient in Phase 2 study of radioenhancer in NSCLC

Nanobiotix (NASDAQ:NBTX; Euronext:NANO) has announced the dosing of the first patient in its CONVERGE Phase 2 study, evaluating its potential first-in-class radioenhancer, JNJ-1900 (NBTXR3), in patients with stage 3 non...

January 21, 2025

Developments

BioNxt moves R&D to Gen-Plus in Munich

BioNxt Solutions (CSE:BNXT; OTC:BNXTF; FSE:BXT) has announced that it will transition its research and development activities to Gen-Plus, a contract research and development organization in Munich, Germany, effective...

January 21, 2025

Developments

R&M features Izotropic in US breast cancer analysis and forecast

Izotropic (CSE:IZO; OTCQB:IZOZF; FSE:1R3) announced its inclusion in a Research and Markets (R&M) report analyzing the US breast cancer screening and diagnostic market. According to Izotropic, the R&M analysis...

January 17, 2025

Developments

Evaxion completes dosing of personalized vaccine for advanced melanoma

Evaxion Biotech (NSADAQ:EVAX) has announced the completion of dosing for 16 patients in a Phase 2 trial of its lead asset, EVX-01, a personalized cancer vaccine under development for advanced melanoma. According to...

January 16, 2025

Fractyl increases focus on key gene therapy programs

INBS upgrades portable drug screening reader with multilingual capabilities

HeartBeam files 510(k) application with FDA for ECG software

HOOKIPA completes enrollment in Phase 1b study of HB-500 in HIV

Tectonic announces positive Phase 1b results for TX45 in HFpEF

Polyrizon files patent application with ILPO for T&T technology

Model Medicines unveils AI-driven pipeline breakthrough; demonstrates end-to-end drug discovery capabilities

NLS launches preclinical program for Mazindol ER in fentanyl addiction

Conduit partners with Sarborg to advance drug development with AI

Stereotaxis receives CE Mark for cardiac ablation catheter

RenovoRX highlights abstract showcasing promising PK data for TAMP in LAPC

Veru reports positive topline results of Phase 2b study of enobosarm for weight loss

Social Capital’s Chamath Palihapitiya calls out Perimeter’s AI-driven cancer margin visualization technology on X show

Greenwich adds Harvard and Johns Hopkins sites to Phase 3 trial

EMA grants IRLAB waiver from pediatric studies of mesdopetam in PD

IPA’s AI-designed GLP-1 therapies aim to improve treatment for T2D

FDA grants RPDD to MeiraGTx’s treatment for LCA1

Revelation launches Phase 1b study of Gemini in CKD

Nanobiotix doses first patient in Phase 2 study of radioenhancer in NSCLC

BioNxt moves R&D to Gen-Plus in Munich

R&M features Izotropic in US breast cancer analysis and forecast

Evaxion completes dosing of personalized vaccine for advanced melanoma

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