Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

FDA grants Fast Track Designation to Cumberland’s ifetroban DMD program

Cumberland Pharmaceuticals (NASDAQ: CPIX) has received Fast Track Designation from the FDA for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients. The FDA has...

February 4, 2026

Developments

FDA clears Nanox’s TAP2D image enhancement technology

Nanox (NASDAQ: NNOX) has announced receiving FDA 510(k) clearance for TAP2D, a new cloud-enabled image enhancement capability for the Nanox.ARC and Nanox.ARC X digital tomosynthesis systems. According to Nanox, the FDA...

February 3, 2026

Developments

USPTO grants Acurx Pharmaceuticals patent for DNA Polymerase IIIC inhibitors

Acurx Pharmaceuticals (NASDAQ: ACXP) has been granted a new patent by the U.S. Patent and Trademark Office (USPTO) covering DNA Polymerase IIIC inhibitors including compositions of matter, methods of use, and...

February 2, 2026

Developments

Publication supports scientific rationale for Palvella’s QTORIN in DSAP

Palvella Therapeutics (NASDAQ: PVLA) announced that Clinical and Experimental Dermatology has published a peer-reviewed systematic review synthesizing clinical evidence on off-label topical statin use in porokeratosis...

February 2, 2026

Developments

Kazia reveals compelling data on nuclear PD-L1 degrader NDL2

Kazia Therapeutics (NASDAQ: KZIA) has announced compelling preclinical and translational data supporting the development of NDL2, a potentially first-in-class protein degrader designed to selectively eliminate nuclear...

January 30, 2026

Developments

Immunotherapy review highlights Faron’s bexmarilimab in immune-resistant cancer

Faron Pharmaceuticals (AIM: FARN; First North: FARON) has announced the publication of a comprehensive review article in the peer-reviewed journal Immunotherapy detailing the potential of the company’s lead candidate...

January 29, 2026

Developments

OSE expands lusvertikimab into new immune-mediated indications

OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) has announced that it has selected chronic pouchitis and hidradenitis suppurativa (HS) as new key indications for lusvertikimab, a potential first-in-class IL-7R...

January 29, 2026

Developments

FDA certifies LSL’s ophthalmic ointment manufacturing for U.S. market

LSL Pharma (TSXV: LSL) has announced that the FDA has certified the ophthalmic ointment manufacturing operations of its subsidiary, Steri-Med Pharma, clearing the company to commercialize ophthalmic ointment products in...

January 28, 2026

Developments

FDA grants En Carta BDD for EC Pocket Lyme test

Closely held En Carta Diagnostics has announced that its EC Pocket Lyme test for the early detection of Borrelia bacteria—the cause of Lyme disease—has received Breakthrough Design Designation (BDD) from the FDA. EC...

January 28, 2026

Developments

Omeros launches first commercial sales of YARTEMLEA for TA-TMA

Omeros (NASDAQ: OMER) has announced that it has completed its first commercial shipments of YARTEMLEA to distributors for the treatment of adult and pediatric patients with stem cell transplant-associated thrombotic...

January 27, 2026

Developments

Ernexa chosen as one of ten for JETRO acceleration program

Ernexa Therapeutics (NASDAQ: ERNA) has announced it was selected as one of only ten global companies to participate in the prestigious Japan Entry Acceleration Program (JEAP) by the Japan External Trade Organization...

January 27, 2026

Developments

Pluri completes first phase of placenta-derived biomaterials program

Pluri (NASDAQ, TASE: PLUR) has announced the completion of the first phase of its program with closely held Resbiomed Technologies OOD, a European biotechnology company developing extracellular-matrix- based...

January 22, 2026

Developments

Hoth reports positive interim results from trial of HT-001 in cancer patients

Hoth Therapeutics (NASDAQ: HOTH) has announced 100% clinical response and approximately 50% reduction in disease severity in the open-label pharmacokinetic (PK) cohort of its ongoing CLEER-001 clinical trial evaluating...

January 22, 2026

Developments

Actuate to advance Elraglusib tablet to Phase 1/2 program in refractory cancers

Actuate Therapeutics (NASDAQ: ACTU) has announced plans to initiate a Phase 1/2 clinical program evaluating the oral tablet dosage form of elraglusib in patients with advanced cancer. According to Actuate, the goal of...

January 21, 2026

Developments

BioNxt reports superior bioavailability of cladribine sublingual ODF

BioNxt Solutions (CSE: BNXT; OTCQB: BNXTF; FSE: BXT) has announced that it has completed a large-mass porcine comparative pharmacokinetic study and received preliminary results evaluating the absorption of cladribine...

January 19, 2026

Developments

Profusa initiates first commercial revenue with healthcare research offerings launch

Profusa (NASDAQ: PFSA) has announced the launch of its healthcare research version of its Lumee tissue oxygen monitoring into the contract research organizations (CRO) market, which is expected to generate immediate...

January 16, 2026

Developments

GT submits IND for GTB-5550 TriKE in solid tumors

GT Biopharma (NASDAQ: GTBP) has announced that it submitted an investigational new drug (IND) application to the FDA in December 2025 for GTB-5550 TriKE, a B7-H3-targeted natural killer (NK) cell engager for the...

January 15, 2026

Developments

Frontiers in Oncology to publish BioMark’s research on ML model for lung cancer detection

BioMark Diagnostics (CSE: BUX; FSE: 20B; OTCQB: BMKDF) has announced that the peer-reviewed journal Frontiers in Oncology has accepted for publication the company’s research on a machine learning (ML) predictive model...

January 15, 2026

Developments

Mount Sinai becomes first in NYC to deliver incision-free, MRI-guided prostate treatment with Profound’s TULSA-PRO

Profound Medical (NASDAQ: PROF; TSX: PRN) has announced that the world-renowned Mount Sinai Hospital, Metro New York (NYC), has successfully treated its first prostate cancer patient with the TULSA-PRO system. The TULSA...

January 15, 2026

Developments

cbdMD acquires Bluebird Botanicals

cbdMD (NYSE American: YCBD) has announced the strategic acquisition of closely held Bluebird Botanicals through an asset purchase comprised of an initial share issuance and earnout shares. According to cbdMD, the...

January 14, 2026

Developments

Clearmind achieves 100% treatment success in second cohort of CMND-100 trial in AUD

Clearmind Medicine (NASDAQ: CMND; FSE: CWY0) has announced the successful completion of treatment for all patients in the second cohort of its ongoing FDA-approved Phase I/IIa clinical trial evaluating CMND-100—the...

January 14, 2026

Developments

Cardiol achieves 50% enrollment milestone in Phase 3 MAVERIC recurrent pericarditis trial

Cardiol Therapeutics (NASDAQ: CRDL; TSX: CRDL) announced that it has surpassed 50% patient enrollment in MAVERIC, its Phase 3 randomized, double-blind, placebo-controlled, multi-center international trial evaluating...

January 13, 2026

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