Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Xtant launches next-gen nanOss Strata synthetic bone graft

Xtant Medical (NYSE American: XTNT) has announced the commercial launch of its next-generation innovative synthetic bone graft in the nanOss line, Strata. According to Xtant, the nanocrystalline structure of...

December 11, 2025

Developments

AC Immune reports positive interim data of a-syn active immunotherapy in early PD

AC Immune (NASDAQ: ACIU) has announced positive interim safety and efficacy results from the Phase 2 VacSYn trial of its wholly-owned anti-alpha-synuclein (a-syn) active immunotherapy, ACI-7104.056, in early Parkinson’s...

December 11, 2025

Developments

FDA clears HeartBeam’s cable-free, 12-lead ECG for at-home use

HeartBeam (NASDAQ: BEAT) has announced that the FDA has granted 510(k) clearance for its first-ever, cable-free, 12-lead electrocardiogram (ECG) synthesis software for the at-home assessment of arrhythmias. According to...

December 11, 2025

Developments

FDA grants Senti RMAT for SENTI-202 in R/R AML

Senti Bio (NASDAQ: SNTI) has announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202, the company’s potential first-in-class Logic Gated off-the-shelf chimeric antigen...

December 9, 2025

Developments

Formycon, MS partner to commercialize Keytruda biosimilar candidate in MENA region

Formycon AG (FSE: FYB, Prime Standard) and closely held MS Pharma have jointly announced that they have entered into an exclusive licensing and supply agreement for the commercialization of FYB206—Formycon’s biosimilar...

December 9, 2025

Developments

Greenwich completes enrollment of FLAMINGO-01 open label arm

Greenwich LifeSciences (NASDAQ: GLSI) has announced the completion of enrollment in the open label non-HLA-A*02 arm of FLAMINGO-01. FLAMINGO-01 is a Phase III clinical trial designed to evaluate the safety and efficacy...

December 8, 2025

Developments

Moleculin enters agreement with research group to evaluate Annamycin for GBM

Moleculin Biotech (NASDAQ: MBRX) has announced that it has entered into a research and material transfer agreement with non-profit CIC biomaGUNE for preclinical research evaluating Annamycin for the treatment of...

December 8, 2025

Developments

Immutep and Dr. Reddy’s Labs collaborate to commercialize oncology drug

Immutep (ASX: IMM; NASDAQ: IMMP) and Dr. Reddy’s Laboratories (BSE: 500124; NSE: DRREDDY; NYSE: RDY; NSEIFSC: DRREDDY) have announced that they have entered into a strategic collaboration and exclusive licensing...

December 8, 2025

Developments

Stanford’s Dr. Ghanouni receives Cum Laude award for RSNA presentation on CAPTAIN trial of TULSA v robotic radical prostatectomy

Profound Medical (NASDAQ:PROF; TSX:PRN) has announced that Pejman Ghanouni, MD, PhD, associate professor in the Department of Radiology, Division of Body MRI at Stanford University School of Medicine, has received the...

December 5, 2025

Developments

Ekso inks agreement to become exclusive U.S. distributor of MediTouch’s groundbreaking BalanceTutor rehab system

Ekso Bionics Holdings (NASDAQ: EKSO) has announced that it has entered into an agreement with Israel-based closely-held MediTouch (MediTouch) to become the exclusive authorized sales agent and distributor of MediTouch’s...

December 4, 2025

Developments

ADC announces updated data from trial of ZYNLONTA with glofitamab in r/r DLBCL

ADC Therapeutics (NYSE: ADCT) announced updated data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in...

December 3, 2025

Developments

Black Diamond announces Phase 2 data for silevertinib in 1L NSCLC

Black Diamond Therapeutics (NASDAQ: BDTX) has announced topline data from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with non-classical epidermal growth factor...

December 3, 2025

Developments

Capricor reports positive topline results from Phase 3 study of Deramiocel in DMD

Capricor Therapeutics (NASDAQ: CAPR) has announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel for the treatment of Duchenne muscular dystrophy (DMD). HOPE-3 is a randomized...

December 3, 2025

Developments

Actinium reports ATNM-400 data showing potent efficacy in TNBC

Actinium Pharmaceuticals (NYSE American: ATNM) has announced compelling preclinical data for ATNM-400, a first-in-class Actinium-225 (AC-225) antibody radioconjugate, in hormone receptor positive (HR+), HER2 positive...

December 1, 2025

Developments

BiomX reports update on trial of BX004 in CF

BiomX (NYSE American: PHGE) has announced that the FDA is continuing its evaluation of the nebulizer device used for drug administration in the company’s Phase 2b trial of BX004 in patients with cystic fibrosis (CF)...

November 26, 2025

Developments

Ripple enters into a collaboration with Bausch + Lomb

Closely held Ripple Therapeutics has announced that, earlier this year, it entered into an evaluation program and licensing option agreement with an affiliate of Bausch + Lomb (NYSE/TSX: BLCO). Under the terms of the...

November 25, 2025

Developments

Clearmind’s DSMB recommends continuation of trial for CMND-100 in AUD; patient enrollment at TASMC kicks off

Clearmind Medicine (NASDAQ: CMND; FSE: CWY0) has announced that its independent Data and Safety Monitoring Board (DSMB) has completed a scheduled interim review of its ongoing FDA-approved multinational Phase I/IIa...

November 25, 2025

Developments

PetVivo launches AI platform reducing vet client acquisition costs by 50-89%

PetVivo Holdings (OTCQX: PETV; OTCID: PETVW) has announced the launch of PetVivo.ai that delivers a veterinary client acquisition cost of $42.53—a 50% to 89% reduction compared to $80 to $400 typically spent by...

November 25, 2025

Developments

Psyence reports major breakthrough in establishing pharmaceutical-grade ibogaine supply

Psyence BioMedical (NASDAQ: BPM) has announced it has sourced a sustainable supply of high-potency iboga bark—through its strategic partner, closely held PsyLabs—a significant achievement as the company prepares for the...

November 20, 2025

Developments

OS to spin off OSAH into a standalone company

OS Therapies (NYSE American: OSTX) has announced its intent to spin off OS Animal Health (OSAH)—the company’s wholly owned subsidiary developing OST-HER2 for canine osteosarcoma—into a standalone public company...

November 20, 2025

Developments

Profound celebrates The Hong Center’s 200th independent TULSA procedure; Dr. Mark Hong sees TULSA ultimately replacing radical prostatectomy as a first-line option for prostate cancer

Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) has announced today that The Hong Center Scottsdale, led by Dr. Y. Mark Hong of Integrative Urology in Phoenix, Arizona, has achieved a world-first milestone: 200 TULSA...

November 18, 2025

Developments

Quanterix highlights landmark study published in Brain validating dual approach for personalized MS monitoring

Quanterix (NASDAQ: QTRX) has announced the publication of a landmark study in the peer-reviewed scientific journal Brain, validating that multiplexed Simoa assays for Glial Fibrillary Acidic Protein (GFAP) and...

November 18, 2025

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