Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Actinogen, FDA agree on activities toward marketing approval of Xanamem for AD

Actinogen Medical (ASX: ACW) has announced that an agreement with the FDA has been reached in a scheduled Type C meeting on the manufacturing, clinical, and nonclinical activities required for a future US marketing...

September 16, 2025

Developments

Entera reports positive data for oral GLP-2 tablet for SBS at 2025 ESPEN Congress

Entera Bio (NASDAQ: ENTX) has announced the presentation of a poster highlighting pharmacokinetic data relating to its first-in-class oral GLP-2 analog program for the treatment of short bowel syndrome (SBS), at the...

September 16, 2025

Developments

Cocrystal showcases potential first oral antiviral for norovirus

Cocrystal Pharma (NASDAQ: COCP) has announced that the scientific foundation and clinical progress of its lead pan-viral protease inhibitor, CDI-988, was discussed by President and CEO, Dr. Sam Lee, in a presentation at...

September 12, 2025

Developments

Karyopharm completes enrollment of Phase 3 SENTRY trial in MF

Karyopharm Therapeutics (NASDAQ: KPTI) has announced enrollment completion in its Phase 3 SENTRY trial, designed to evaluate selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis (MF) patients. According...

September 10, 2025

Developments

BioXcel announces positive topline data for BXCL501 in bipolar and schizophrenia

BioXcel Therapeutics (NASDAQ: BTAI) has announced positive topline exploratory efficacy data from its SERENITY At-Home pivotal Phase 3 safety trial of BXCL501 (IGALMI) for agitation associated with bipolar disorders or...

September 10, 2025

Developments

FDA grants Greenwich fast track designation for GLSI-100

Greenwich LifeSciences (NASDAQ: GLSI) announced that the FDA has granted GLSI-100 fast track designation for the treatment of patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment...

September 10, 2025

Developments

Perimeter Joins ASBrS Industry Relations Council

Perimeter Medical Imaging AI (TSX-V:PINK; OTCQX: PYNKF) announced that it has joined the American Society of Breast Surgeons (ASBrS) Industry Relations Council (IRC). The ASBrS is the primary leadership organization for...

September 8, 2025

Developments

iMDX launches novel registry database; reports positive strategic update

Insight Molecular Diagnostics (iMDX) (NASDAQ: IMDX) has announced a positive strategic update and novel registry to gather real-world data on patient experiences and outcomes concerning its flagship kidney transplant...

September 8, 2025

Developments

Pasithea enrolls Cohort 2 for trial of PAS-004 in NF1 after SRC review

Pasithea Therapeutics (NASDAQ: KTTA) announced that the Safety Review Committee (SRC) has recommended its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PAS-004...

September 8, 2025

Developments

Firefly partners with HealingMaps to offer cognitive electrophysiology analytics to 2500+ clinics across North America

Firefly Neuroscience (NASDAQ: AIFF) announced a new partnership with HealingMaps the leading directory for ketamine, psychedelic-assisted therapy, and transcranial magnetic stimulation (TMS) clinics, and Advanced...

September 5, 2025

Developments

Health Canada grants Palisade NOL for trial of PALI-2108 in FSCD

Palisade Bio (NASDAQ: PALI) has announced receiving a No Objection Letter (NOL) from Health Canada for its clinical trial application to evaluate PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor, in...

September 5, 2025

Developments

AIM highlights compelling data for Ampligen in PC at conference in Poland

AIM ImmunoTech (NYSE American: AIM) announced the latest in a growing body of positive data from its lead clinical program, Ampligen, for the treatment of pancreatic cancer (PC), in a presentation at the 5th Annual...

September 5, 2025

Developments

Vyome announces positive interim data on VT-1953 in MFW

Vyome Holdings (NASDAQ: HIND) has announced the interim results from its investigator –initiated Phase 2 Proof of Concept study of VT-1953 topical gel in patients with malignant fungating wounds (MFW). According to...

September 4, 2025

Developments

Lyell initiates Phase 3 CAR T-cell therapy trial in R/R LBCL; forms expert steering committee

Lyell Immunopharma (NASDAQ: LYEL) has announced the initiation of PiNNACLE—H2H, a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial evaluating rondecabtagene autoleucel (ronde-cel, also known as...

September 3, 2025

Developments

Oncolytics reveals updated safety data for pelareorep in GI tumors

Oncolytics Biotech (NASDAQ: ONCY) has announced that data continues to demonstrate a favorable safety profile for intravenously administered pelareorep across multiple gastrointestinal (GI) tumors, and in combination...

September 2, 2025

Developments

Providence Saint Joseph Medical Center acquires Perimeter’s OCT imaging technology

Providence Saint Joseph Medical Center—a nationally recognized, 383-bed, not-for-profit hospital in Burbank, California— has announced that it has adopted Perimeter Medical Imaging AI’s (TSXV: PINK; OTCQX: PYNKF)...

August 29, 2025

Developments

Firefly deploys NVIDIA L40S GPU acceleration to power next-gen CLEAR Platform

Firefly Neuroscience (NASDAQ: AIFF) has announced the unveiling of its new ‘CLEAR’ (CLeaning EEG ARtifacts) Platform, a proprietary next-generation preprocessing technology designed to deliver unrivalled...

August 26, 2025

Developments

WHO, UNICEF rollout Afghanistan polio vaccination campaign with PharmaJet Tropis ID delivery system

Closely held PharmaJet has announced that its WHO prequalified Tropis ID delivery system will be used to support a polio eradication campaign sponsored by the National Emergency Operation Center (NEOC) Afghanistan...

August 19, 2025

Developments

Soligenix receives orphan drug designation for treatment of Behçet’s disease

Soligenix (NASDAQ: SNGX) has announced that the FDA has granted orphan drug designation to dusquetide—the active ingredient in SGX945—for the treatment of Behçet’s disease, upon review of Phase 2 trial results...

August 18, 2025

Developments

USPTO grants Unicycive’s UNI-494 patent for CKD

Unicycive Therapeutics (NASDAQ: UNCY) has announced that the U.S. Patent and Trademark Office has issued a patent for UNI-494 to treat chronic kidney disease (CKD). According to Unicycive, the patent follows the...

August 18, 2025

Developments

Swissmedic grants Mainz approval to market ColoAlert

Mainz Biomed (NASDAQ: MYNZ) has announced that its non-invasive colorectal cancer (CRC) screening test—ColoAlert—has been registered and approved for distribution by the Swiss regulatory and supervisory authority...

August 13, 2025

Developments

Trinity achieves breakthrough trial results for next-gen CGM sensor

Trinity Biotech (NASDAQ: TRIB) has announced compelling clinical trial results demonstrating a major technical breakthrough and de-risking the commercial pathway for its next-generation continuous glucose monitoring...

August 12, 2025

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