Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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

Developments

Entera reports robust data for pipeline programs in HypoPT and obesity

Entera Bio (NASDAQ: ENTX) has reported preclinical data at ENDO 2026, the annual meeting of the Endocrine Society, for its pipeline programs—EB612 in hypoparathyroidism (HypoPT) and EB618 in obesity and metabolic...

June 16, 2026

Developments

Faron unveils immunotherapy data in myeloid malignancies at EHA

Faron Pharmaceuticals (AIM: FARN; First North: FARON) announced a poster presentation highlighting biological evidence from the BEXMAB Phase 1/2 trial validating its first-in-class immunotherapy candidate, bexmarilimab...

June 15, 2026

Developments

Context reports positive data for CTIM-76 in PROC

Context Therapeutics (NASDAQ: CNTX) has announced positive interim Phase 1 clinical data for its CLDN6 x CD3 T cell engaging bispecific antibody, CTIM-76, in advanced, late-line platinum-resistant ovarian cancer (PROC)...

June 15, 2026

Developments

Evaxion presents new data for off-the-shelf AML vaccine

Evaxion (NASDAQ: EVAX) has announced new preclinical data for EVX-04, an AI-designed off-the-shelf therapeutic vaccine for acute myeloid leukemia (AML) that targets multiple endogenous retrovirus (ERV) tumor antigens...

June 11, 2026

Developments

60 Degrees signs licensing agreement with Florida State for botanical supplement

60 Degrees Pharmaceuticals (NASDAQ: SXTP; SXTPW) has announced that it has executed a patent licensing agreement with Florida State University to commence large-scale production techniques to extract and purify...

June 11, 2026

Developments

Caribou reports long-term vispa-cel data in r/r B-NHL

Caribou Biosciences (NASDAQ: CRBU) has announced that vispa-cel, its off-the-shelf CD19-targeted CAR-T cell therapy, produced durable long-term responses in patients enrolled in the ANTLER phase 1 clinical trial for...

June 11, 2026

Developments

Valion confirms HASC initiative to address urgent need for radiation/nuclear countermeasures

Valion Bio (NASDAQ: VBIO) confirmed that the U.S. House Armed Services Committee‘s FY27 National Defense Authorization Act report directs the Assistant Secretary of Defense for Nuclear Deterrence, Chemical, and...

June 11, 2026

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