Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Zynex submits FDA application for NiCO device

Zynex (NASDAQ:ZYXI) announced it has submitted a 510(k) application to the FDA for its NiCO Noninvasive CO-Oximeter device. The company stated that the submission marks a historic milestone in the evolution of pulse...

May 12, 2025

Developments

IPA reports new results validating in silico epitope mapping application

ImmunoPrecise Antibodies (IPA) (NASDAQ:IPA) announced new benchmarking results validating the accuracy and utility of its in silico epitope mapping application—part of the LENSai platform, which delivers x-ray-level...

May 12, 2025

Developments

FDA accepts Omeros’ BLA resubmission for narsoplimab in TA-TMA

Omeros Corporation (NASDAQ:OMER) announced that the FDA will review its resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated...

May 6, 2025

Developments

WHO approves Moleculin’s name for next-gen anthracycline

Moleculin Biotech (NASDAQ:MBRX) announced that the International Nonproprietary Names (INN) expert committee of the World Health Organization (WHO) has approved “naxtarubicin” as the non-proprietary name of its next...

May 6, 2025

Developments

Firefly acquires Evoke Neuroscience—resulting in multi-fold database, IP portfolio, and commercial footprint expansion

Firefly Neuroscience (NASDAQ:AIFF) has announced its acquisition of closely held Evoke Neuroscience, a medical device company developing and commercializing technologies to aid in the comprehensive assessment of brain...

May 5, 2025

Developments

Positive results from Perimeter’s B-Series OCT with ImgAssist AI 2.0 pivotal trial presented at ASBrS 2025

Perimeter Medical Imaging AI (TSXV:PINK; OTCQX:PYNKF) announced that detailed, positive results from the pivotal trial evaluating the use of its next-generation B-Series OCT with ImgAssist AI 2.0 for intraoperative...

May 5, 2025

Developments

electroCore acquires NeuroMetrix gaining access to Quell platform

electroCore (NASDAQ:ECOR) announced it has completed the merger with NeuroMetrix (NASDAQ:NURO), expanding its portfolio to include Quell Fibromyalgia Solution, strengthening its commercial reach, and positioning the...

May 2, 2025

Developments

Vaccine publishes study demonstrating benefits of PharmaJet’s Tropis needle-free system

Closely held PharmaJet announced the publication of a study in the top-tier journal Vaccine, which demonstrates the benefits of the company’s Tropis needle-free system compared to needle and syringe (N/S) for...

May 1, 2025

Developments

Profound reports positive perioperative data from randomized CAPTAIN trial comparing TULSA with Robotic Prostatectomy; Lake Street analyst suggests trial data will be well received by payors

Profound Medical (NASDAQ:PROF; TSX:PRN) announced initial perioperative data from its Level 1 post-market CAPTAIN trial comparing the safety and efficacy of the TULSA procedure with radical prostatectomy (RP) in men...

April 30, 2025

Developments

Immunic unveils positive data from Phase 2 trial of IMU-838 in progressive MS

Immunic (NASDAQ:IMUX) announced positive Phase 2 CALLIPER data demonstrating its nuclear receptor related 1 (Nurr1) activator—vidofludimus calcium (IMU-838)—reduced the risk of progressive multiple sclerosis (PMS)...

April 30, 2025

Developments

Polyrizon reports positive safety study of allergy blocker

Polyrizon (NASDAQ:PLRZ) announced the successful preliminary safety study of a formulation of its PL-14 Allergy Blocker, advancing the product’s development path. According to Polyrizon, the study, designed to assess...

April 25, 2025

Developments

Ekso names Bionic P&O as first Ekso Indego Personal distributor within the orthotics and prosthetics industry

Ekso Bionics Holdings (NASDAQ:EKSO) announced it has selected Bionic Prosthetics & Orthotics Group (Bionic P&O) as a non-exclusive distributor of its Ekso Indego Personal device—the alliance marking Ekso’s first...

April 23, 2025

Developments

FDA clears Aclaris’ IND application for ATI-052 trial

Aclaris Therapeutics (NASDAQ:ACRS) announced that the FDA has cleared its Investigational New Drug (IND) application for a Phase 1a/1b trial of ATI-052—expected to launch in Q2 of this year. According to Aclaris, the...

April 22, 2025

Developments

USPTO grants Atossa patents strengthening breast cancer treatment portfolio

Atossa Therapeutics (NASDAQ:ATOS) announced that the USPTO has granted a new patent for enteric oral formulations comprising (Z)-endoxifen, including methods of treating patients. According to Atossa, the patent...

April 22, 2025

Developments

PharmaJet to present insights from DNA cancer vaccine partner trials at WVC 2025

Closely held PharmaJet announced it will present insights from several DNA cancer vaccine partner trials using PharmaJet’s Precision Delivery Systems at the World Vaccine Congress (WVC) on April 23, 2025 at 12:25 pm ET...

April 17, 2025

Developments

eGenesis and OrganOx report FDA clearance of IND application for ACLF treatment

Closely held eGenesis and OrganOx announced that the FDA has cleared the IND application for EGEN-5784—a human-compatible, genetically engineered porcine liver—designed for use in combination with the OrganOx...

April 15, 2025

Developments

Ironwood reports updates on apraglutide following FDA interaction

Ironwood Pharmaceuticals (NASDAQ:IRWD) announced that a confirmatory Phase 3 trial evaluating apraglutide in short bowel syndrome with intestinal failure (SBS-IF) and dependence on parenteral support, is a requirement...

April 14, 2025

Developments

Mayo study validates Aditxt’s ADI-100 induces immune tolerance to GAD

Aditxt (NASDAQ:ADTX) announced that a Mayo Clinic study has confirmed ADI-100 induces immune tolerance to glutamic acid decarboxylase (GAD)—a key autoantigen connected to multiple autoimmune conditions including Type 1...

April 14, 2025

Developments

Clearmind initiates first U.S. trial of CMND-100 in AUD at Johns Hopkins

Clearmind Medicine (NASDAQ:CMND; FSE:CWYO) announced the initiation of its first U.S.-based Phase 1/2a trial of CMND-100 in alcohol use disorder (AUD) at the Johns Hopkins University School of Medicine. According to...

April 11, 2025

Developments

Chamath Palihapitiya Discusses Perimeter Medical’s AI-Driven Cancer Margin Imaging on Flagrant Podcast

During a recent episode of the Flagrant podcast hosted by Andrew Schulz and Akash Singh, investor and entrepreneur Chamath Palihapitiya offered a compelling example of how medical innovation can drive meaningful...

April 10, 2025

Developments

ARPA-H grants Ginkgo and partners $29M to advance distributed manufacturing of medicines using grain

Ginkgo Bioworks (NYSE:DNA) announced a new contract with the Advanced Research Projects Agency for Health (ARPA-H) and partners—Tritica Biosciences, US Pharmacopeia, On Demand Pharmaceuticals, and Isolere Bio by...

April 10, 2025

Developments

FDA grants three FTDs for Allogene’s ALLO-329

Allogene Therapeutics (NASDAQ:ALLO) announced that the FDA has granted three fast track designations (FTDs) for its ALLO-329, a next-generation dual-target CD19/CD70 allogeneic CAR T for the treatment of lupus...

April 8, 2025

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