Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Pentixapharm submits IND for hypertension diagnostic program

Pentixapharm Holding (Frankfurt Prime Standard: PTP) announced the submission of an Investigational New Drug (IND) application to the FDA for its lead CXCR4-targeted diagnostic program in treatment resistant...

May 11, 2026

Developments

JAMA Network Open publishes Red Light’s trial of psilocybin in cocaine use disorder

Red Light Holland (CSE: TRIP; FSE: 4YX; OTCQB: TRUFF) has highlighted the publication of a peer-reviewed randomized clinical trial in the Journal of American Medical Association (JAMA) Network Open evaluating a single...

May 8, 2026

Developments

Vistagen reports last patient visit in trial of fasedienol nasal spray in SAD

Vistagen (NASDAQ: VTGN) has announced that the last patient has completed the last visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4, the Phase 3 clinical trial evaluating fasedienol nasal...

May 8, 2026

Developments

PharmaJet Tropis Needle-free Injection System selected to deliver 1.4 million polio vaccine doses in Nigeria

Closely held PharmaJet announced that its WHO-prequalified Tropis ID Needle-free Injection System will be used to deliver approximately 1.4 million doses of fractional inactivated polio vaccine (fIPV), in partnership...

May 7, 2026

Developments

Entrada reveals positive topline results from study of ENTR-601-44 in DMD

Entrada Therapeutics (NASDAQ: TRDA) has announced positive topline data from Cohort 1 of the double-blind, placebo-controlled, multiple ascending dose portion of the Phase 1/2 ELEVATE-44-201 clinical study of ENTR-601...

May 7, 2026

Developments

Perimeter’s FDA PMA approved Claire OCT+AI highlighted on the Joe Rogan Experience podcast

Renowned Silicon Valley venture capitalist, entrepreneur, and former Facebook executive, Chamath Palihapitiya, sat down with popular national podcaster, Joe Rogan, yesterday afternoon to talk about various topics...

May 6, 2026

Developments

Aclarion expands use of Nociscan with Weill Cornell Medicine commercial agreement

Aclarion (NASDAQ: ACON, ACONW) has announced the establishment of a second agreement with Weill Cornell Medicine to expand the use of Nociscan in a study titled “Bone Marrow Aspirate Concentrate Injection with...

May 5, 2026

Developments

TriSalus launches trial evaluating pressure-enabled drug delivery in liver tumors

TriSalus Life Sciences (NASDAQ: TLSI) has initiated patient enrollment for its PREDICTT clinical trial designed to evaluate its novel Pressure-Enabled Drug Delivery (PEDD) approach in patients with primary or metastatic...

May 5, 2026

Developments

JASN publishes analysis highlighting favorable outcomes from Akebia’s Phase 3 study

Akebia Therapeutics (NASDAQ: AKBA) has announced the publication of a post-hoc win statistics analysis of all-cause mortality and hospitalization from its global Phase 3 INNO2VATE program in the peer-reviewed Journal of...

May 4, 2026

Developments

InflaRx reports new data for izicopan in liver microsomes

InflaRx (NASDAQ: IFRX) has announced new preclinical data demonstrating low reactive metabolite formation of izicopan in human liver microsomes. Izicopan is an investigational, orally administered, small molecule...

May 4, 2026

Developments

Can-Fite reports positive data from study of namodenoson in pancreatic cancer

Can-Fite Biopharma (NYSE American: CANF; TASE: CANF) has announced positive clinical data from its Phase 2a study of namodenoson in patients with advanced pancreatic cancer. According to Can-Fite, the data from the...

April 30, 2026

Developments

Oncotelic moving closer to commercial launch of AI-enabled robotics

Oncotelic Therapeutics (OTCQB: OTLC) has announced an update on the advancement of its proprietary AI platform and robotic integration toward commercialization, following the integration of approximately 28 million...

April 30, 2026

Developments

USPTO issues NoA to Nuwellis for catheter technology

Nuwellis (NASDAQ: NUWE) has announced that the U.S. Patent and Trademark Office (USPTO) has issued a notice of allowance (NoA) for a new patent covering its novel dual-lumen midline catheter technology designed for use...

April 28, 2026

Developments

VivoSim intestinal model combined with AI predicts drug-induced diarrhea without animal testing

VivoSim Labs (NASDAQ: VIVS) has announced the availability of an AI prediction tool leveraging its NAMkind intestinal models to accurately predict the potential of a drug to cause diarrhea in patients, eliminating...

April 28, 2026

Developments

Alto launches Phase 2b trial of ALTO-207 in TRD

Alto Neuroscience (NYSE: ANRO) has initiated its Phase 2b randomized, placebo-controlled trial of ALTO-207 in treatment-resistant depression (TRD), a program designed to replicate the strongly positive PAX-D study...

April 27, 2026

Developments

FDA grants Immutep ODD for efti in STS

Immutep (NASDAQ: IMMP) has announced that the FDA has granted orphan drug designation (ODD) for eftilagimod alfa (efti) for the treatment of soft tissue sarcoma (STS), a rare cancer with significant unmet medical need...

April 27, 2026

Developments

Clearmind reports positive topline results from CMND-100 trial in AUD

Clearmind Medicine (NASDAQ: CMND) has announced that CMND-100, the company’s proprietary non-hallucinogenic MEAI-based oral drug candidate for the treatment of alcohol use disorder (AUD), has met the primary endpoint in...

April 27, 2026

Developments

Senseonics launches 365-day implantable CGM for T1/T2 diabetes in Europe

Senseonics Holdings (NASDAQ: SENS) has announced the European launch of the world’s first and only one-year implantable continuous glucose monitoring (CGM) system—Eversense 365—now available to patients with Type 1 and...

April 27, 2026

Developments

Meta-analysis of 17 studies shows no clinically meaningful benefit from anti-amyloid Alzheimer’s drugs

According to the authors of a new Cochrane systemic review which examined data from 17 clinical trials with a total of 20,342 participants, the effect of amyloid‐beta‐targeting monoclonal antibodies on cognitive...

April 16, 2026

Developments

FDA grants Arbutus fast track designation for imdusiran in cHBV

Arbutus Biopharma (NASDAQ: ABUS) has announced that the FDA has granted fast track designation for imdusiran for the treatment of chronic hepatitis B (cHBV). Imdusiran is an RNAi therapeutic specifically designed to...

April 15, 2026

Developments

Stereotaxis to acquire Robocath

Stereotaxis (NYSE: STXS) has announced that it has entered into a definitive agreement to acquire closely held Robocath, a venture-backed innovator of robotic techniques for interventional cardiology and...

April 15, 2026

Developments

MHRA clears Poolbeg for cancer immunotherapy trial

Poolbeg Pharma (AIM: POLB; OTC: POLBF; FRA: POLBF) has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted the company clinical trial authorization for its TOPICAL trial with...

April 15, 2026

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