Drug Development

Singapore – October 18, 2026 -- HistoIndex and Singapore's Agency for Science, Technology and Research (A*STAR) have signed a Memorandum of Understanding to jointly run preclinical evaluation and characterization of therapeutic candidates for fibrotic diseases, including cancer-associated fibrosis.

A*STAR pipeline candidates will be measured with HistoIndex's AI-based tissue analysis

The agreement pairs A*STAR's therapeutic development capabilities with HistoIndex's proprietary imaging technology and fully quantitative, AI-powered tissue analysis. HistoIndex's platform will provide objective, sensitive and accurate measures of fibrosis and treatment response across A*STAR's pipeline. Researchers are expected to use the data to decide which candidates to advance.

Boston – October 16, 2026 -- Perceptive Discovery has become the first US provider able to run astatine-211 (At-211) radiopharmaceutical development studies, now available at its US and UK sites through a collaboration with Atley Solutions.

First Atley C100 module purifies At-211 at QMUL laboratory in London

At Perceptive Discovery's laboratory at Queen Mary University of London (QMUL), the first Atley C100 module in the collaboration is installed. It has been used to purify At-211 from an irradiated bismuth-209 target.

A second Atley C100 module is expected at the company's Needham, Massachusetts facility later this month. The Atley C100 is an automated manufacturing platform built specifically for At-211 radiopharmaceuticals.

Cambridge, Mass. – October 15, 2026 -- The U.S. Food and Drug Administration has granted a second Fast Track Designation to Marengo Therapeutics' invikafusp alfa, extending the drug's expedited status from one tumor type to all tumor mutational burden high (TMB-H) solid tumors regardless of tissue of origin.

The new designation covers unresectable, locally advanced or metastatic TMB-H solid tumors that have progressed after prior treatment, including immune checkpoint inhibition, and for which no satisfactory treatment options exist. Marengo believes invikafusp alfa is the first immuno-oncology T-cell agonist to receive Fast Track Designation in a biomarker-defined, tissue-agnostic indication.

Seoul – October 12, 2026 -- Lunit (KRX: 328130) has partnered with Discovery Life Sciences, a lab that supports more than 350 active clinical trial programs, to roll out the Lunit SCOPE suite across biopharmaceutical research.

The AI-powered pathology platform will run inside Discovery's biomarker and tissue analysis workflows. Both companies will tailor it to each client program's design, working directly with pharmaceutical and biotechnology customers.

Discovery brings 25 years of assay experience and 2,000 trial programs to the deal

Discovery has delivered biomarker services for more than 2,000 clinical trial programs. Its specialty laboratory services cover the drug development lifecycle end to end. The partners expect the combination of Discovery's global biospecimen network and Lunit's AI image analysis to broaden worldwide access to the SCOPE platform.

Calgary – October 12, 2026 -- XORTX Therapeutics (NASDAQ: XRTX | TSXV: XRTX) has appointed Mika Grasso, 28, as co-CEO responsible for finance and public markets, and says it aims to advance its lead gout program, XRx-026, toward marketing approval over the next 18 months.

The company says the appointment follows a recent financing and growing investor interest. It is now restructuring its corporate and issuer status, re-initiating drug development programs and preparing regulatory filings for XRx-026. Risk disclosures in the release also refer to a voluntary delisting that may not be completed on the anticipated timeline, or at all.

Calgary – October 12, 2026 -- XORTX Therapeutics (NASDAQ: XRTX) plans to submit an Investigational New Drug application to the U.S. FDA in the fourth quarter of 2026 for its XRx-026 gout program, and estimates the program addresses a US$700M annual market opportunity.

XORTX targets an NDA filing in about one year, contingent on funding

The IND describes the company's clinical development plan for XORLOTM, its proprietary oxypurinol formulation, and its intention to file a New Drug Application after completing the two-part XRX-OXY-102 clinical trial. The trial is designed to characterize the pharmacokinetics and efficacy information the FDA needs to evaluate a future NDA.

Suzhou – October 7, 2026 -- Suzhou Ribo Life Science (06938.HK) and its Swedish subsidiary Ribocure Pharmaceuticals AB have submitted a Phase I Clinical Trial Application in the European Union for RBD3133, a small interfering RNA (siRNA) therapeutic targeting the INHBE gene for overweight and obesity.

RBD3133 silences a gene linked to healthier fat distribution in human genetic studies

RBD3133 is designed to selectively suppress INHBE, which encodes the protein activin E. Human genetic data show that individuals with naturally occurring loss-of-function variants in INHBE exhibit healthier fat distribution, improved metabolic profiles, and a lower estimated risk of coronary heart disease and type 2 diabetes.

Orange County, Calif. – October 07, 2026 -- The Institute for Molecular Medicine (IMM) and Nuravax have dosed the first four participants in TAURUS-1980, a Phase 1 trial testing AV-1980R, described as the world's first active immunotherapy targeting pathological tau protein linked to Alzheimer's disease.

Trial targets at-risk adults before cognitive symptoms appear

TAURUS-1980 will enroll up to 48 cognitively unimpaired adults aged 65 to 80 who have biomarker-confirmed brain amyloid pathology, a known precursor to Alzheimer's. Participants are randomized 3:1 to receive AV-1980R or placebo across three ascending-dose cohorts of 20, 60, and 180 micrograms.

LONDON – – October 07, 2026 -- OncoBayes has completed preclinical work on OB-001, an oral drug candidate designed to overcome antibody-drug conjugate (ADC) resistance and boost brain penetration of tyrosine kinase inhibitors (TKIs), the privately held clinical-stage pharmaceutical company announced.

OB-001 raises osimertinib brain exposure by nearly 400% in mouse studies

In perfused-brain mouse models, pretreatment with OB-001 increased brain exposure of osimertinib by almost 400%, while plasma exposure remained broadly unchanged. The data, presented at AACR 2026, covered four gold-standard kinase inhibitors and showed systemic drug levels were largely unaffected by the efflux-pump inhibition.

Burlingame, Calif. – October 06, 2026 -- Enliven Therapeutics, Inc. (Nasdaq: ELVN) has reached alignment with the U.S. Food and Drug Administration on the final design of ENABLE-2, a pivotal Phase 3 trial testing relcobatinib against standard second-generation therapies in previously treated chronic myeloid leukemia (CML). The company remains on track to initiate the trial before year-end 2026.

FDA clears path for 450-patient head-to-head comparison

ENABLE-2 is designed to enroll approximately 450 adults with CML who have already received one or more tyrosine kinase inhibitors (TKIs). Participants will be randomized 1:1 to receive either relcobatinib at 80 mg once daily or an investigator-selected second-generation TKI -- dasatinib, nilotinib, or bosutinib. The primary endpoint is major molecular response (MMR) at Week 24, with MMR at Week 96 as a key secondary measure.