Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

GeoVax expands with additional solid tumor targets for Gedeptin

GeoVax Labs (NASDAQ: GOVX) has announced the expansion of its oncology development strategy to evaluate additional solid tumor targets for Gedeptin—its gene-directed enzyme prodrug therapy. According to GeoVax, the...

September 24, 2025

Developments

IGC announces pre-clinical data for TGR-63 in AD

IGC Pharma (NYSE: IGC) has announced preclinical findings on its investigational small molecule candidate for Alzheimer’s disease (AD) demonstrating that TGR-63 extends its therapeutic potential beyond previously...

September 24, 2025

Developments

Hemogenyx, Cellin sign LOI to commercialize cell therapy for R/R AML in Estonia

Hemogenyx Pharmaceuticals (LSE: HEMO) has announced the signing of a letter of intent (LOI) with closely held Cellin Technologies to explore the commercialization of its HG-CT-1 CAR-T cell therapy for the treatment of...

September 23, 2025

Developments

EC and Swissmedic approve KalVista’s oral treatment for HAE

KalVista Pharmaceuticals (NASDAQ: KALV) announced that the European Commission (EC) and Swiss Agency for Therapeutic Products (Swissmedic) have approved EKTERLY (sebetralstat), a novel, oral plasma kallikrein inhibitor...

September 19, 2025

Developments

Palisade announces positive PALI-2108 data

Palisade Bio (NASDAQ: PALI) has announced new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor. The company plans to present the results in an oral...

September 17, 2025

Developments

Vivos unveils landmark trial results in pediatric OSA treatment

Vivos Therapeutics (NASDAQ: VVOS) has announced first time, peer-reviewed published data confirming that the Vivos Daytime-Nighttime Appliance (DNA) is both safe and efficacious in treating children suffering from...

September 17, 2025

Developments

FDA grants Corbus fast track designation for CRB-701 in HNSCC

Corbus Pharmaceuticals (NASDAQ: CRBP) has announced that the FDA has granted fast track designation to its next-generation Nectin-4 antibody drug conjugate CRB-701 for the treatment of recurrent or metastatic head and...

September 16, 2025

Developments

Adagene, Exelixis amend license agreement to develop third masked mAb

Adagene (NASDAQ: ADAG) has announced an amendment to the 2021 collaboration and license agreement with Exelixis (Nasdaq: EXEL) to enable the development of a third novel masked monoclonal antibody (mAb) drug conjugate...

September 16, 2025

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

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