Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Actuate announces positive Phase 1 elraglusib results in pediatric cancer

Actuate Therapeutics (NASDAQ: ACTU) has announced results from the phase 1 portion of its Actuate-1902 Phase 1/2 clinical study evaluating elraglusib as a monotherapy or in combination with irinotecan, irinotecan plus...

January 7, 2026

Developments

YD Bio enters MOU to merge with EG BioMed

YD Bio (NASDAQ: YDES) has announced that it has entered into a Memorandum of Understanding (MOU) to merge with closely held EG BioMed—a biotechnology company specializing in DNA methylation–based cancer diagnostics and...

January 7, 2026

Developments

First patient dosed in Akebia’s Phase 2 trial of praliciguat in FSGS

Akebia Therapeutics (NASDAQ: AKBA) has announced that the first patient has been dosed in its Phase 2 clinical trial of praliciguat, an oral once-daily soluble guanylate cyclase stimulator being evaluated for the...

January 7, 2026

Developments

Johns Hopkins Medicine treats first commercial TULSA-PRO case; Profound marks major milestone as hospital launches iMRI suite to expand access to advanced prostate care

Profound Medical (NASDAQ: PROF; TSX: PRN) has announced that The Johns Hopkins Hospital has treated its first non-clinical-trial prostate cancer patient using the company’s TULSA-PRO system. The milestone marks the...

January 6, 2026

Developments

Polyrizon reports positive preclinical results of PL-14 vs HPMC

Polyrizon (NASDAQ: PLRZ) has announced new results from a preclinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation compared to hydroxypropyl methylcellulose (HPMC), an...

January 5, 2026

Developments

MetaVia reports positive results from Phase 1b trial of DA-1726 in metabolic disease

MetaVia (NASDAQ: MTVA) has announced positive, statistically significant results from the eight-week, non-titrated, 48 mg, multiple ascending dose (MAD) cohort of its Phase 1 clinical trial of DA-1726, a novel dual...

January 5, 2026

Developments

Hoth expands IP portfolio with filing of two patent applications

Hoth Therapeutics (NASDAQ: HOTH) has announced the filing of two U.S. provisional patent applications to expand its IP portfolio and establish a new oncology-focused dermatology platform targeting treatment-induced skin...

January 5, 2026

Developments

Annovis launches OLE study in Parkinson’s disease

Annovis Bio (NYSE: ANVS) has announced it will begin an open-label extension (OLE) study in January 2026 to evaluate the long-term safety and efficacy of buntanetap in Parkinson’s disease (PD) patients. The study aims...

December 19, 2025

Developments

Altimmune’s pemvidutide achieves key measures of success at 48 weeks in MASH trial

Altimmune (NASDAQ: ALT) has announced positive topline results from the IMPACT Phase 2b trial of pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, in patients with metabolic dysfunction-associated...

December 19, 2025

Developments

Ovid reports results of OV350 IV study

Ovid Therapeutics (NASDAQ: OVID) has announced that its Phase 1 study of OV350—the first direct activator of potassium chloride cotransporter 2 (KCC2) to be dosed in humans—administered intravenously (IV), has met its...

December 18, 2025

Developments

Tiziana doses first patient in Phase 2 trial of intranasal foralumab in AD

Tiziana Life Sciences (NASDAQ: TLSA) has announced that the first patient has been dosed with intranasal foralumab in its Phase 2 randomized, placebo-controlled clinical trial in patients with early Alzheimer’s disease...

December 17, 2025

Developments

VYNE and Yarrow announce merger agreement

VYNE Therapeutics (NASDAQ: VYNE) has announced that it has entered into a merger agreement with closely held Yarrow Bioscience, with the combined companies expected to operate as Yarrow Bioscience under the ticker...

December 17, 2025

Developments

FDA grants fast track designation for Adagene’s muzastotug

Adagene (NASDAQ: ADAG) has announced that the FDA has designated muzastotug, in combination with Merck’s (NYSE: MRK) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as a fast track product for adult patients with...

December 16, 2025

Developments

RedHill’s positive opaganib results indicate reduction in venetoclax resistant cells

RedHill Biopharma (NASDAQ: RDHL) has announced positive in vivo results that indicate opaganib combined with venetoclax reduces chronic lymphocytic leukemia (CLL) cells by half compared to controls—demonstrating...

December 15, 2025

Developments

Kyverna announces positive data from trial of miv-cel in SPS

Kyverna Therapeutics (NASDAQ: KYTX) has announced positive topline data from KYSA-8, its registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel)—a fully human, autologous CD19-targeting CAR T-cell therapy...

December 15, 2025

Developments

Cadrenal acquires VLX-1005 for patients with HIT

Cadrenal Therapeutics (NASDAQ: CVKD) has announced the acquisition of VLX-1005—a first-in-class, Phase 2 12-LOX inhibitor—along with additional 12-lipoxygenase (12-LOX) assets from closely held Veralox Therapeutics, for...

December 11, 2025

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

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