First-patient dosing anticipated in the third quarter of 2026 in a U.S. Phase 1 study of a first-in-class dual PI3K/EGFR inhibitor May 19, 2026 -- MEKanistic Therapeutics, a biotechnology company developing first-in-class precision medicines designed to overcome cancer resistance mechanisms, today announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for MTX-531, the company's lead oncology candidate. With the IND now in effect, MEKanistic may

First participant with Parkinson’s disease dosed at the Centre for Human Drug Research in the Netherlands May 19, 2026 -- Vertero Therapeutics, a clinical-stage biotechnology company breaking barriers in neurodegenerative disease treatment, today announced that the first patient with Parkinson’s disease (PD) has been dosed in the Phase 1b portion of its study of its lead candidate VT-5006, a first-in-class, gut-selective small molecule in development to address the significant unmet needs of pe

Enrollment milestone follows FDA IND clearance received in March 2026 and Danish Medicines Agency (DKMA) approval received in April 2026 May 18, 2026 -- Enlivex Ltd. (Nasdaq: ENLV) ("Enlivex" or the "Company"), a quality longevity company powered by a prediction markets treasury, today announced the dosing of the first patient at a United States clinical site in the Phase 2b clinical trial of Allocetra™ for the treatment of patients with moderate-to-severe age-related symptomatic primary kne

May 18, 2026 -- VERTANICAL today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to VER-01, the company's first-in-class non-opioid investigational treatment for chronic low back pain. The FDA Breakthrough Therapy Designation has been granted after two randomized, controlled Phase 3 trials demonstrated significant pain reduction, a favorable tolerability profile, and no evidence of dependence. In a direct Phase 3 head-to-head comparator study, V

Published prospective cohort showed durable responses and manageable safety in patients with HCC following prior immunotherapy Median overall survival of 12.3 months in a heavily pretreated population with poor prognostic features, including ALBI grade 2 liver function Agenus Inc. (Nasdaq: AGEN) , a leader in immuno-oncology innovation, today announced the publication of Phase 1b data evaluating botensilimab (BOT), an Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab (BAL), an

Approved for use before surgery based on DESTINY-Breast11 Phase III trial Approved for use following surgery based on DESTINY-Breast05 Phase III trial Two new indications bring AstraZeneca and Daiichi Sankyo’s ENHERTU into curative-intent setting, reinforcing its role across stages of HER2-positive breast cancer AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved by the US Food and Drug Administration (FDA) for both the neoadjuvant and adjuvant treatmen

Extended follow-up data from the phase 3 study (20 months after reported topline data, median follow-up 58 months) confirmed a statistically significant and clinically meaningful improvement in prostate cancer–specific disease-free survival (DFS) of 39% after aglatimagene administration compared to placebo, reinforcing the potential of aglatimagene to reduce the risk of tumor recurrence in men receiving radiotherapy for localized disease. Clinical benefit demonstrated in the intention-to treat

Patients treated with corabotase showed a rapid onset of action of 0.84 days and peak effect statistically superior to placebo At Week 24, 60.8% of patients treated with corabotase experienced clinically significant sustained duration of effect vs placebo and vs Dysport, defined as a score of “none” or “mild” of line severity Patient satisfaction scores at Week 24 were 82.8% Corabotase is currently being evaluated as an investigational treatment in aesthetic indications 16 May 2026 – Ipsen (Eur

With the help of DNA testing company Natera and its personalized molecular residual disease (MRD) blood test Signatera, Roche’s PD-L1 inhibitor Tecentriq has chalked up its eleventh U.S. indication in the form of a new bladder cancer approval. Tecentriq and subcutaneous Tecentriq Hybreza can now be used as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) following a cystectomy, as identified

Achieved primary endpoint with high statistical significance; 93% of patients achieved microdystrophin expression above 10% (pStatistically significant correlation between RGX-202 microdystrophin expression and functional improvement (NSAA n=9), supporting validity of surrogate endpoint Well-tolerated, differentiated safety profile Company preparing for potential accelerated approval in 2027 Webcast to be held at 8:00 a.m. ET today May 14, 2026 -- REGENXBIO Inc. (Nasdaq: RGNX) announced positiv