Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

First patient dosed in Delcath’s global trial of HEPZATO in mBC

Delcath Systems (NASDAQ: DCTH) has announced that the first patient has been dosed at the European Institute of Oncology (IEO) in Milan, Italy, in its global Phase 2 clinical trial evaluating HEPZATO in combination with...

July 9, 2026

Developments

MAIA reports strong data from trial of 3L therapy in NSCLC

MAIA Biotechnology (NYSE American: MAIA) has announced positive initial efficacy data from its Phase 2 THIO-101 clinical trial expansion, Part C, evaluating its lead candidate, ateganosine, a dual mechanism of action...

July 9, 2026

Developments

FDA grants RPDD to Vanda’s investigational CMT2S therapy

Vanda Pharmaceuticals (NASDAQ: VNDA) has announced that the FDA has granted Rare Pediatric Disease Designation (RPDD) to its investigational antisense oligonucleotide therapy—VCA-894A—for the treatment of Charcot-Marie...

July 8, 2026

Developments

FDA accepts Organogenesis’ ReNu BLA for knee OA

Organogenesis Holdings (NASDAQ: ORGO) has announced that the FDA has accepted for review its Biologics License Application (BLA) for ReNu, a cryopreserved, amniotic suspension allograft developed for the treatment of...

July 7, 2026

Developments

Alligator highlights first patient dosed in trial of mitazalimab in breast cancer

Alligator Bioscience (STO: ATORX) has announced that the first patient has been dosed in an investigator-led trial evaluating the intratumoral administration of mitazalimab, the company’s lead CD40 agonist, in patients...

July 2, 2026

Developments

FDA grants Sonoma 510(k) clearance for Microdacyn Wound Irrigation Solution

Sonoma Pharmaceuticals (NASDAQ: SNOA) has received a new 510(k) clearance from the FDA for its Microdacyn Wound Irrigation Solution, including expanded claims, clearance for multiple use, and additional packaging...

June 30, 2026

Developments

Pasithea reports positive interim Phase 1 cancer study data

Pasithea Therapeutics (NASDAQ: KTTA) has announced updated interim safety and clinical activity data from its ongoing first-in-human trial of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a...

June 30, 2026

Developments

Sunshine receives Canadian regulatory approval for generic Anastrozole tablets

Sunshine Biopharma (NASDAQ: SBFM) has announced the approval of its generic Anastrozole tablets of 1mg for the treatment of postmenopausal women with hormone receptor-positive breast cancer in the Canadian market...

June 25, 2026

Developments

AFRRI/NIAID designs PBI-BM2.5 protocol to evaluate Valion’s Entolimod for GI-ARS

Valion Bio (NASDAQ: VBIO) has announced that the Armed Forces Radiobiology Research Institute (AFRRI), in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), has completed design of the...

June 25, 2026

Developments

REGENXBIO completes dosing in study of RGX-202 in DMD

REGENXBIO (NASDAQ: RGNX) has completed dosing in the confirmatory study of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy (DMD). According to REGENXBIO, this milestone positions the...

June 24, 2026

Developments

BioMark Diagnostics receives CIPO and EPO patent allowances for early-stage lung cancer blood test

BioMark Diagnostics (CSE: BUX; FSE: 20B; OTCQB: BMKDF) has announced the receipt of patent allowances from both the Canadian Intellectual Property Office (CIPO) and the European Patent Office (EPO) for its...

June 23, 2026

Developments

Zevra highlights publication of positive data from study of MIPLYFFA in NPC

Zevra Therapeutics (NASDAQ: ZVRA) has announced the publication of data suggesting that MIPLYFFA (arimoclomol) was well tolerated in pediatric patients with Niemann-Pick disease type C (NPC) in the peer-reviewed journal...

June 23, 2026

Developments

FDA grants Prime RMAT for PM359 in CGD

Prime Medicine (NASDAQ: PRME) has announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to PM359, an investigational autologous Prime Edited hematopoietic stem cell therapy for the...

June 22, 2026

Developments

Transgene expands platform with trial of INTV in NSCLC

Transgene (Euronext Paris: TNG) has initiated a Phase 1 trial evaluating its Individualized Neoantigen Therapeutic Vaccine (INTV) candidate, TG4070, from its myvac platform, in combination with nivolumab, in the...

June 22, 2026

Developments

USPTO grants Clearmind patent for binge behavior regulators

Clearmind Medicine (NASDAQ: CMND) has been granted a U.S. patent titled “BINGE BEHAVIOR REGULATORS”, by the United States Patent and Trademark Office (USPTO). The patent, which refers to Clearmind’s molecule MEAI (5...

June 19, 2026

Developments

Seegnal launches first U.S. pilot program

Seegnal (TSXV: SEGN) has announced that it has successfully initiated its first pilot program in the U.S., following the letter of intent, announced on May 19, 2026. The company, dedicated to reducing medication-related...

June 19, 2026

Developments

AIM reports final patient dosed in Phase 2 study of Ampligen + Imfinzi in MPC

AIM Immunotech (NYSE American: AIM) has announced that the final patient has been dosed in the Phase 2 DURIPANC trial of Ampligen (rintatolimod) plus AstraZeneca’s (NYSE: AZN; LSE: AZN; STO: AZN) Imfinzi...

June 18, 2026

Developments

FDA grants GRI ODD for GRI-0621 in IPF

GRI Bio (NASDAQ: GRI) has announced that the FDA has granted Orphan Drug Designation (ODD) to GRI-0621 for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive, irreversible and ultimately fatal lung...

June 18, 2026

Developments

Cadrenal plans RPDD request for tecarfarin in KD

Cadrenal Therapeutics (NASDAQ: CVKD) announced plans to submit a Rare Pediatric Disease Designation (RPDD) request to the FDA for tecarfarin as a treatment for pediatric patients with Kawasaki disease (KD) who develop...

June 18, 2026

Developments

Verastem reports positive trial results for avutometinib combination in PDAC

Verastem Oncology (NASDAQ: VSTM) has announced positive updated safety and efficacy results from the RAMP 205 Phase 1b/2a recommended Phase 2 dose cohort of 29 patients evaluating avutometinib plus defactinib in...

June 17, 2026

Developments

Matricelf advances toward first-in-human trial of spinal cord injury treatment

Matricelf (TASE: MTLF) announced the successful completion of its comprehensive GLP safety study for its engineered neural tissue implant, achieving all predefined study endpoints with no abnormal findings. According to...

June 17, 2026

Developments

Microbot signs agreement with Lovell expanding access to veteran and military populations

Microbot Medical (NASDAQ: MBOT) has entered into an agreement with closely held Lovell Government Services to serve federal healthcare systems, establishing Lovell as Microbot’s Service-Disabled Veteran-Owned Small...

June 16, 2026

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