Palazestrant in combination with ribociclib demonstrated encouraging activity across all dose cohorts and subgroups Median PFS was 15.5 months in the 120 mg palazestrant cohort across all patients In the 120 mg palazestrant cohort among patients with prior CDK4/6i treatment, median PFS was 9.2 months in patients with ESR1 wild-type tumors and 13.8 months in patients with ESR1 mutant tumors Combination continues to demonstrate favorable tolerability and a safety profile consistent with the known

Novel mechanism of action reverses and prevents death of injured cells Phase II ARPEGGIO trial fully enrolled Topline results to be presented at the World Stroke Congress, October 23, 2025 Oct. 17, 2025 -- Silver Creek Pharmaceuticals, Inc. (Silver Creek), a clinical-stage biotechnology company developing growth factor-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to scp776, its investigational therapy for acute ischemic

TNX-801 is a live virus vaccine investigational candidate, designed to provide durable protection against mpox and smallpox TNX-801 demonstrated favorable safety, immunogenicity, and long-term protection in multiple preclinical models Data support advancement of TNX-801 toward clinical development Oct. 17, 2025 -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”) presented data in an oral presentation at the World Vaccine Congress–Europe 2025, held October 14–16, 20

Data from the Phase Ib Beamion LUNG-1 trial evaluating zongertinib in treatment-naïve patients with advanced HER2 (ERBB2)-mutant NSCLC were presented for the first time at ESMO 2025. Confirmed response by blinded independent central review was 77%, with 96% of patients achieving disease control.1 Zongertinib recently received Breakthrough Therapy Designations for first-line treatment by the U.S. FDA and China’s CDE. Boehringer Ingelheim reported positive results from the Beamion LUNG-1 trial ev

Small cell lung cancer (SCLC) accounts for 15% of all lung cancers and remains an aggressive disease with median survival of approximately 12 months for patients with extensive-stage disease Precede Bio’s platform combines comprehensive epigenomic profiling of circulating tumor DNA (ctDNA) with machine learning to resolve gene expression for thousands of cancer genes from just 1 mL of patient plasma Data presented at ESMO 2025 highlight the platform’s ability to resolve the expression of clinica

BiomX believes that it has fully addressed the FDA’s queries related to the third-party nebulizer used to deliver BX004, which are narrow in scope; an additional FDA request for limited technical clarifications on the nebulizer has also been addressed In parallel, new written FDA feedback underscores the significant unmet need BiomX is addressing and outlines new potential development approaches European enrollment and dosing remain strong; Phase 2b study remains on track to report topline resul

Oct. 17, 2025 -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, announces that it has entered into a binding term sheet (the “Term Sheet”) to acquire a Renal Anti-Fibrotic Therapeutic Program from Vectus Biosystems Limited, an Australian Securities Exchange listed company (“Vectus”). The program includes a novel n

Positive recommendation based on phase II NOBILITY and phase III REGENCY data showing Gazyva/Gazyvaro’s superiority over standard therapy alone1,2 Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study2 Lupus nephritis is a debilitating condition that severely impacts a person’s quality of life and affects more than 1.7 million people worldwide3,4 17 October, 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) ann

PluvictoTM plus standard of care (ARPI + ADT) significantly reduced risk of progression or death by 28% (HR 0.72) versus SoC alone, with positive trend in OS (HR 0.84) in PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC)1 Most patients with mHSPC progress to metastatic castration-resistant prostate cancer, underscoring urgent need for new therapies that can reduce risk of progression in earlier disease settings2,3 The safety profile and tolerability of Pluvicto in this third positive Ph

Oct. 16, 2025 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the investigational new drug (“IND”) application for an open-label, two-arm, randomized, active-controlled, phase 2/3 clinical study comparing the company’s product, recombinant humanized anti-PD-1/VEGF bispecific antibody (code: JS207), to nivol