First patient dosed, with topline results expected in 2027 pHalcon-EoE-201 is the first large, well-controlled clinical trial of an acid secretory treatment in EoE Nov. 04, 2025 -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the first patient has been dosed in its Phase 2 pHalcon-EoE-201 clinical trial evaluating VOQUEZNA® (vonoprazan) tablets as an inves

Nov. 04, 2025 -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on the proposed clinical developmental pathway for BX011, a next-generation fixed multi-phage cocktail targeting Staphylococcus aureus (S. aureus) in diabetic foot infections (DFI). FDA feedback s

–Publication highlights Deramiocel’s anti-fibrotic activity and describes a validated potency assay supporting quality control and product consistency in late-stage development– Nov. 03, 2025 -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing cell and exosome-based therapies for rare diseases, today announced the publication in Biomedicines, an international peer-reviewed journal, describing a novel in-vitro potency assay designed to characterize the anti-fibroti

Agreements formalize research partnership combining InterCure’s global pharmaceutical platform with Cannasoul’s world-class analytics and scientific innovation Collaboration comes amidst reports that the Trump administration is exploring cannabis rescheduling, expected to create unprecedented opportunities in the U.S. for international operators like InterCure Nov. 03, 2025 -- InterCure Ltd. (Nasdaq: INCR / TASE: INCR) (“InterCure” or the “Company”) today announced it has entered into a defin

Comprehensive meeting with FDA conducted in Q3 in conjunction with Breakthrough Therapy Designation Key aspects of a potential NDA application discussed and aligned with the Agency Praxis plans to perform an interim analysis of the EMBOLD cohort 2 pivotal trial in Q4 2025, which if positive should serve as the basis of an NDA in early 2026 Nov. 04, 2025 -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the developme

Nov. 03, 2025 -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, after receiving the official minutes from the FDA Type A meeting conducted in September 2025. ONS-5010 is an investigational ophthalmic formulation of bevacizumab which, if appr

Nov. 03, 2025 -- March Biosciences (March Bio), an emerging clinical stage biotechnology company committed to combating challenging cancers and other diseases, today announced that interim clinical data from its ongoing Phase 2 trial of MB-105 will be presented during an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, being held December 6-9, 2025, in Orlando, Florida. March Bio is developing MB-105, a first-in-class autologous CD5-targeted CAR-T

Initial funding of $25 million from the first of four tranches Facility strengthens Kyverna’s financial flexibility, further supporting advancement of its late-stage indications in generalized myasthenia gravis (gMG) and stiff person syndrome (SPS), while also accelerating pre-launch activities Topline data readout of registrational Phase 2 SPS trial now expected in early 2026; narrowed from previous guidance of first half 2026 Nov. 03, 2025 -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX) (“Kyver

FDA lifts clinical hold following review of Company’s Complete Response submission. Company expects to restart U.S. enrollment in late 2025 or early 2026 across 20 clinical sites. Early data suggests that LTI-03 may not only slow fibrosis but also promote lung healing. Nov. 03, 2025 -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indicatio

Ongoing Phase 1 APOLLO study investigating MT-601 in patients with relapsed B cell lymphomas showed encouraging preliminary efficacy data MT-601 demonstrated robust safety profile with no dose limiting toxicities (DLTs) or immune-effector cell associated neurotoxicity syndrome (ICANS) in the dose escalation cohort Nov. 03, 2025 -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatm