The MHRA (Medicines and Healthcare products Regulatory Agency) granted UK Marketing Authorisation for XOANACYL via the International Recognition Procedure (Route B) recognising its prior EU approval (June 2025) XOANACYL is an oral therapy designed to address two major unmet needs in CKD - Iron deficiency and elevated serum phosphorus – in a single drug AVEROA is now actively engaging strategic partners and investors to accelerate European market access and unlock XOANACYL’s full commercial poten

Nov. 04, 2025 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces the completion of patient enrollment of SAFFRON, a global Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with epidermal growth factor receptor (“EGFR”)-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic non-small cell lung cancer (“NSCLC”) following progression on treatment with TAGRISSO®. The last patient was randomize

Immuron receives U.S. Food and Drug administration (FDA) approval for IMM-529 Investigational New Drug (IND) application and clinical study may proceed FDA assigned an IND number (032095) for the IMM-529 application IND 32095 is Immuron’s Investigational new drug (IND) application for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI) and is now active Nov. 05, 2025 -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), is pleased to anno

Enara’s discovery of DARKFOX delivers on the vision of translating the dark genome into a new class of clinically actionable Dark Antigens and will be highlighted in an oral presentation at SITC 2025 DARKFOX demonstrates best-in-class target properties: high tumor specificity, homogeneous expression in tumors and high prevalence in significant patient populations including lung, breast and GI cancers ENA101, a first-in-class bispecific T cell engager against DARKFOX, has been developed and optim

– Data to be featured in two oral presentations on December 8, 2025 – – Broad development program assesses ziftomenib across diverse AML segments and treatment paradigms to inform appropriate use – Nov. 03, 2025 -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that results from the KOMET-007 combination trial of ziftomenib, a once-daily, oral investigational menin inhibitor, will be featured in two oral presentations at the upco

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

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