Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Firefly nears launch of NVIDIA-powered human brain model

Firefly Neuroscience (NASDAQ: AIFF) has announced a greater than 20-fold expansion of its commercial footprint, and a 33-fold Increase in its EEG/ERP scan volumes. Through its acquisition of closely held Evoke...

March 4, 2026

Developments

FDA approves Perimeter’s Claire, first AI imaging device for breast cancer surgery

Perimeter Medical Imaging AI (TSXV: PINK; OTCQX: PYNKF) has announced that it has received FDA premarket approval (PMA) for Claire—formerly the Perimeter OCT B-Series with ImgAssist AI 2.0—the first AI-enabled imaging...

March 3, 2026

Developments

Psyence ships GMP-compliant psilocybin to Australia for Phase 2b trial

Psyence BioMed (NASDAQ: PBM) has announced the export of fully GMP-compliant manufactured psilocybin product NPX-5 to Australia for the ongoing Phase 2b clinical trial evaluating natural psilocybin for the treatment of...

March 3, 2026

Developments

Rein doses first patient in Phase 2 trial of LTI-03 in IPF

Rein Therapeutics (NASDAQ: RNTX) has announced that the first patient has been dosed in its Phase 2 clinical trial evaluating LTI-03 for idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease with...

March 3, 2026

Developments

AIM signs Phase 3 design deal for Ampligen in pancreatic cancer

AIM ImmunoTech (NYSE American: AIM) has announced the signing of an agreement with Thermo Fisher Scientific’s (NYSE: TMO) PPD clinical research business to design its Phase 3 clinical trial for Ampligen in the treatment...

March 2, 2026

Developments

Zomedica expands distribution with Moichor partnership

Zomedica (OTCQB: ZOMDF) has entered into a commercial distribution agreement with closely held Moichor, a veterinary reference and point-of-care laboratory service, to expand its distribution of TRUVIEW(R) digital...

February 25, 2026

Developments

Tiziana announces positive new biomarkers for nasal foralumab

Tiziana Life Sciences (NASDAQ: TLSA) has announced new biomarker data from a late-breaking poster presented by investigators from Brigham and Women’s Hospital, Boston, showing nasal foralumab downregulates cerebrospinal...

February 25, 2026

Developments

FDA grants QIDP for Armata’s AP-SA02

Armata Pharmaceuticals (NYSE American: ARMP) has announced that the FDA has granted AP-SA02 Qualified Infectious Disease Product (QIDP) designation for intravenous use in the adjunct treatment of complicated bacteremia...

February 23, 2026

Developments

C4 doses first patient in Phase 2 trial of cemsidomide in RRMM

C4 Therapeutics (NASDAQ: CCCC) has announced that the first patient has been dosed in the Phase 2 MOMENTUM trial evaluating cemsidomide in combination with dexamethasone for the treatment of relapsed/refractory multiple...

February 23, 2026

Developments

Acrivon launches internal CLIA-certified lab

Acrivon Therapeutics (NASDAQ: ACRV) has announced the completion and certification of its internal, wholly-owned and operated Clinical Laboratory Improvement Amendment (CLIA)-certified laboratory, located on premises in...

February 18, 2026

Developments

Lipocine Completes Last Patient Last Visit in Pivotal Phase 3 Trial of LPCN 1154 for Postpartum Depression

Lipocine (NASDAQ: LPCN) has announced that the last patient has completed the final study visit in the Phase 3 trial of its oral brexanolon, LPCN 1154, for the treatment of postpartum depression (PPD). According to...

February 18, 2026

Developments

IP Australia grants Klotho 18 claims for s-KL

Klotho Neurosciences (NASDAQ: KLTO) has announced that IP Australia has accepted 18 claims within its patent application covering the composition and use of its human secreted Klotho protein, s-KL isoform. The patent...

February 18, 2026

Developments

Bioxytran reports positive Phase 2 data for ProLectin-M

Bioxytran (OTCQB: BIXT) has announced positive clinical results from its recently completed Phase 2 randomized, double-blind, placebo-controlled, dose-optimization trial evaluating ProLectin-M in subjects with...

February 13, 2026

Developments

FDA clears Precision’s IND for PBGENE-DMD

Precision BioSciences (NASDAQ: DTIL) has announced that the FDA has granted a Study May Proceed notification, allowing initiation of clinical trial site activation for the Phase 1/2 FUNCTION-DMD trial of PBGENE-DMD in...

February 13, 2026

Developments

INOVAIT honors Profound with 2025/26 Mount Logan Award recognizing Tulsa Procedure for prostate disease

Profound Medical (NASDAQ: PROF; TSX: PRN) has announced that it has received the 2025/2026 Mount Logan Award from INOVAIT, the Canadian national network for commercializing breakthroughs in image-guided therapy and AI...

February 12, 2026

Developments

The Journal, Heart Failure, publishes results from Cardiol’s Phase 2 ARCHER study

Cardiol Therapeutics (NASDAQ: CRDL; TSX: CRDL) has announced that results from its Phase 2 ARCHER study evaluating CardiolRx in 109 patients with acute myocarditis using advanced magnetic resonance imaging measures of...

February 10, 2026

Developments

BioSyent to acquire Oral Science

BioSyent (TSXV: RX) has entered into a Share Purchase Agreement to acquire closely held Oral Science, a Canadian distributor of specialized healthcare products for dental hygiene and oral health based in Brossard...

February 10, 2026

Developments

PreveCeutical files patent for delivery of CNS-active agents

PreveCeutical Medical (CSE: PREV; OTCQB: PRVCF) has filed an international patent application for the delivery of CNS-active therapeutic agents covering methods and formulations aimed at addressing treatment challenges...

February 9, 2026

Developments

Exicure reports publication highlighting Phase 2 burixafor data showing rapid stem cell mobilization

Exicure (NASDAQ: XCUR) announced that Annals of Hematology has published results from a Phase 2 clinical study demonstrating rapid stem cell mobilization with burixafor (GPC-100/TG-0054)—a highly selective CXCR4...

February 6, 2026

Developments

Cognition lengthens Zervimesine program in DLB

Cognition Therapeutics (NASDAQ: CGTX) has extended the duration of the expanded access program (EAP) for dementia with Lewy bodies (DLB) from the original 12 months to include several more months of treatment. According...

February 6, 2026

Developments

PRO FAMILIA and Profound mark 500 Sonalleve Procedures; expand access to incision-free women’s healthcare

Profound Medical (NASDAQ:PROF; TSX:PRN) announced today that PRO FAMILIA Specialist Hospital in Rzeszów, Poland has completed its 500th Sonalleve Procedure. The MRI-guided therapy provides women with a non-surgical...

February 5, 2026

Developments

JPO grants patent to Marvel for MB-204

Marvel Biosciences (TSXV: MRVL; OTCQB: MBCOF) has been granted a patent for its lead therapeutic candidate MB-204 by the Japanese Patent Office (JPO) covering composition of matter and methods of use claims. MB-204 is a...

February 4, 2026

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