Covers low tumor burden “watch-and-wait” setting, an unmet medical need Registrational Phase 3 watch-and-wait to start in 2026 EO2463 has broad potential to treat hemato-oncology indications 16 OCTOBER, 2025 Enterome, a clinical-stage company developing first-in-class OncoMimics™ immunotherapies to treat cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for follicular lymphoma in the low tumor burden “watch-and-wait” setting for its lead

Pritelivir demonstrated clinically meaningful and highly statistically significant superiority (p=0.0047) in lesion healing up to 28 days of treatment, compared with standard-of-care (SoC) treatments in refractory Herpes Simplex Virus (HSV) infected immunocompromised patients Pritelivir was well tolerated and had a favorable safety profile over the treatment duration Full results will be presented at an upcoming medical conference and will form the basis for regulatory filings with the FDA and g

In APPLAUSE-IgAN final analysis, Fabhalta demonstrated statistically significant, clinically meaningful improvement in estimated glomerular filtration rate (eGFR) slope vs. placebo over two years1 eGFR is key marker of kidney function; IgAN is progressive autoimmune kidney disease that leads to kidney failure in many patients1-3 Fabhalta is first and only approved complement inhibitor for adults with IgAN and has potential to delay disease progression4,5 Fabhalta received accelerated approval fo

Patients treated with ulixacaltamide in the parallel-group study (Study 1) showed a mean improvement from baseline in the Modified Activities of Daily Living 11 at Week 8, the pre-specified primary endpoint, of 4.3 points (p<0.0001) All key secondary endpoints in Study 1 - rate of disease improvement over 12 weeks, PGI-C and CGI-S - were also statistically significant (p<0.001) Study 2 met its pre-specified primary endpoint, with patients showing superior maintenance of effect while on ul

BPGbio has completed phase 2b enrollment in late August this year for treatment of GBM with BPM31510 Data further validate the MOA of BPM31510’s direct targeting of mitochondrial redox machinery to re-potentiate apoptosis in highly aggressive tumor type Oct. 16, 2025 -- BPGbio Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, today announced that it will present two posters on its lead investigational drug BPM31510 for

AMX-883 uses Amphista’s Targeted Glue™ technology, inducing degradation of BRD9 through the recruitment of DCAF16, a completely distinct mechanism of action from cereblon- or VHL-based PROTACs. The nomination of AMX-883 is underpinned by novel mechanistic insights and a compelling preclinical data package which establishes a pivotal role for BRD9 in acute myeloid leukaemia. As a broad-acting, pro-differentiation agent, AMX-883 acts independently of karyotype status and has the potential to benef

THEO-260 is an oncolytic immunotherapy developed for effective targeting of cancer cells and cancer-associated fibroblasts, whilst inducing immune activation in stromal rich tumours UK clinical trial recruitment is on track, and additional international clinical sites are set to open for OCTOPOD-IV US trial (OCTOPOD-IP) utilising intraperitoneal delivery has been initiated October 13, 2025. Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies,

BOSTON, Oct. 13, 2025 -- General Oncology, Inc. (“General Oncology” or the “Company”), a clinical-stage biopharmaceutical company dedicated to pioneering first-in-class medicines for metastatic cancers, today announced that it will deliver a poster presentation featuring preliminary results from its ongoing Phase 1 SHARON trial (NCT04150042) evaluating GO-4: the Company’s patented Advanced Redox Modulation regimen consisting of melphalan, BCNU, hydroxocobalamin, ascorbic acid, and autologous st

Oct. 13, 2025 -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that preclinical efficacy of its highly selective CDK9 inhibitor, SLS009 (tambiciclib), as a monotherapy and in combination with venetoclax in T-cell prolymphocytic leukemia (T-PLL), will be presented at the European Society for Medical Oncology (ESMO)

Oct. 13, 2025 -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced that its ABO-503 gene therapy for X-linked retinoschisis (XLRS) has been selected to participate in the U.S. Food and Drug Administration (FDA) Rare Disease Endpoint Advancement (RDEA) Pilot Program. The RDEA program facilitates the development and timely approval of rare disease therapies by supporting the use of novel e