Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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

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

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