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

$2.4 Million in H1 2026 Capital Raises Ahead of Phase 3b ENDURANCE Trial May 19, 2026 – BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that in May it entered into definitive agreements for a private placement yielding gross proceeds of $400,000. The transactions were priced at $0.95 per share, representing a 37.6% premium over the previous day's closing price of $0.69. Investors will also receive

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

May 18, 2026 -- USA News Group News Commentary — For more than two decades, B7-H3 sat on the shortlist of theoretically perfect cancer drug targets that nobody could quite figure out how to hit. The protein is broadly overexpressed across some of the most common — and most lethal — solid tumors, including prostate, lung, breast, ovarian, head and neck, and pancreatic cancers. It is largely absent from healthy tissue. It correlates with poor prognosis. On paper, it has every quality a drug develo

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

Regeneron has ponied up $125 million in cash and an equity investment in Parabilis Medicines to join forces on a new type of antibody-drug conjugate (ADC) that could have better luck binding to tricky target sites. At the center of the deal is Parabilis’ Helicon peptide platform. Helicons are stabilized, cell-penetrant alpha-helical peptides designed to engage intracellular protein targets. Their superpower is the ability to attach to flat surfaces that would otherwise make traditional small-mo

Positive Phase III readout of National Cancer Institute sponsored SWOG S1602 randomized clinical trial demonstrating non-inferior efficacy of the Tokyo strain of BCG (Tokyo-172 BCG) versus TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer ImmunityBio to serve as sole U.S. Biologics License Application applicant for the Tokyo strain of BCG and plans to engage with U.S. Food and Drug Administration (FDA) on regulatory pathway to address the over decade long unresolved BCG shortag

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